(debug: legal) The Pharma Legal Handbook: Serbia

1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?

Competences for implementation and enforcement of pharmaceutical and medical devices legislation are shared between three governmental bodies:

• the Agency for Medicines and Medical Devices (ALIMS), which is an independent regulatory body entrusted with enforcement of legislation regulating pharmaceuticals (including biologicals) and medical devices for human and veterinary use. ALIMS issues marketing authorizations, carries-out registration of medical devices, performs quality control of medicines and medical devices, and provides information to ensure their safe and rational use;
• the Ministry of Health, which has certain competences in the area of pharmaceuticals and medical devices for human use, particularly with respect to licensing and administrative oversight; and
• the Ministry of Agriculture, Forestry and Water Management, which is competent for matters concerning the pharmaceutical products intended solely for veterinary use.

 

In addition to these, there is the Ethics Committee of Serbia, which is a professional body responsible for providing and implementing healthcare in accordance with the principles of professional ethics, principles of respect for human rights and values, and children’s rights, at the level of the Republic of Serbia. An approval of the Ethics Committee of Serbia is required for the start of a clinical trial in Serbia. The members and of the Ethics Committee of Serbia are appointed by the Government and their term of office is five years.

 

2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?

Drugs, including biologicals, in Serbia are regulated in the Medicines and Medical Devices Act of 2010 (Zakon o lekovima i medicinskim sredstvima, “Official Gazette of the Republic of Serbia”, nos. 30/2010, 107/2012 and 113/2017) (“Medicines Act“). The sections of the Medicines Act regulating medical devices ceased to apply as of 1 December 2018 and medical devices are now regulated separately in the Medical Devices Act of 2017. A considerable number of by-laws regulate in more detail different matters governed by the Medicines Act and Medical Devices Act, including authorization, and pricing and reimbursement.

 

Authorization

In addition to the Medicines Act, the authorization of medicines, i.e. the procedure for issuance of a marketing authorization, is governed in more detail by the Rulebook on the Content of the Request and Documentation, as well as the Procedure for Obtaining a Marketing Authorization for a Medicinal Product (Pravilnik o sadržaju zahteva i dokumentacije, kao i načinu dobijanja dozvole za stavljanje leka u promet, “Official Gazette of the RS”, nos. 30/2012, 72/2018 and 94/2018).

 

The authorization of medical devices, i.e. the procedure for registration of medical devices prior to their placement on the market in Serbia is governed, in addition to the Medical Devices Act, by the Rulebook on Registration of a Medical Device (Pravilnik o registraciji medicinskog sredstva, “Official Gazette of RS”, nos. 84/2018, 58/2021 and 6/2023).

 

Pricing and reimbursement

The pricing of prescription-only medicines is governed by the Medicines Act, as well as the Decree on Criteria for Forming of Prices of Prescription-Only Pharmaceuticals for Human Use (Uredba o kriterijumima za formiranje cena lekova za upotrebu u humanoj medicini čiji je režim izdavanja na recept, “Official Gazette of RS” nos. 86/2015, 8/2016, 14/2018, 18/2019, 48/2021 and 93/2023), and the Decision on Maximum Prices of Prescription-Only Pharmaceuticals for Human Use (Odluka o najvišim cenama lekova za upotrebu u humanoj medicini čiji je režim izdavanja na recept, “Official Gazette of RS”, nos. 48/2021, 90/2021, 92/2021, 125/2021, 18/2022, 67/2022, 107/2022, 141/2022, 39/2023, 60/2023, 85/2023 and 110/2023).

3. What are the steps to obtain authorization to develop, test, and market a product?

In order to place a product on the market in Serbia, there are the two main phases: (i) obtaining an approval to conduct a clinical trial, and (ii) obtaining a marketing authorization. In addition to that, after obtaining a marketing authorization, the Government must prescribe a maximum price for prescription-only medicines, and the ALIMS must sign-off on any promotional materials for general and professional public.

 

Clinical trials

Clinical trials for medicinal products are regulated in the Medicines Act, as well as the Healthcare Act (Zakon o zdravstvenoj zaštiti, “Official Gazette of RS” no. 25/2019) and the Rulebook on Clinical Trials for Medicines for Human Use (Pravilnik o kliničkom ispitivanju lekova u humanoj medicine, “Official Gazette of RS” no. 51/2022, 65/2023 and 86/2023), which lay down detailed rules related to ethics committee approval and performance of clinical trials. Clinical trials must be conducted in accordance with the guidelines on Good Clinical Practice (Smernice Dobre kliničke prakse, “Official Gazette of RS” no. 108/2017), which are fully aligned with the EU guidelines on Good Clinical Practice.

 

To obtain the approval for a clinical trial, sponsors must simultaneously submit a request for approval of a clinical trial to ALIMS and to the Ethics Committee of Serbia. A prior approval of a clinical trial is required for:

• Clinical trials for medicines which do not have marketing authorization or for which a different use from the one prescribed in the approved summary of product characteristics is proposed, or medical devices for which a conformity assessment has not been carried out; and
• an interventional post-marketing clinical trial, where the medicinal product is used according to conditions prescribed in the marketing authorization, but requires additional diagnostic procedures, as well as the monitoring procedures defined by the clinical trial protocol, or where a medical device has been subject to conformity assessment, but the clinical trial is conducted for a purpose not included in the conformity assessment.

 

Sponsors are not obliged to obtain a prior approval, but must only notify ALIMS on the commencement of a clinical trial for:

• a non-interventional post-marketing clinical trial of a medicinal product or a medical device in accordance with an approved summary of product characteristics of a pharmaceutical for which a marketing authorization has already been issued, and
• a clinical trial of a medical device for which a conformity assessment has already been carried out.

 

Phase I clinical trials in Serbia may only be conducted in state-owned healthcare institutions, while phase II and III trials may be equally conducted in private healthcare institutions. The request for approval of a clinical trial may be submitted by a sponsor, or a contract research organisation with a registered seat in Serbia. Requests are submitted to ALIMS in electronic form in the Serbian language, while some supporting documents may be in English. Requests to the Ethics Committee of Serbia are submitted at the same time through ALIMS.

 

The statutory deadline for the Ethics Committee and ALIMS to review the request for approval of a clinical trial and adopt their respective decisions is 60 days from the date of submission of a complete request. If the Ethics Committee or ALIMS consider the request incomplete, they will give the sponsor a maximum of 30 days to complete the request, which stops the clock. The deadlines for decision-making by the Ethics Committee and ALIMS may be extended by a maximum of 30 days if the clinical trials relate to gene therapy or somatic cell therapy, or medicinal products containing genetically modified organisms, and by another 90 days if expert consultations are necessary. ALIMS may not approve the clinical trial without a positive decision of the Ethics Committee.

 

Clinical trials of medical devices are regulated in the Medical Devices Act and the Rulebook on Clinical Trials for Medical Devices of 2018 (Pravilnik o kliničkom ispitivanju medicinskog sredstva, “Official Gazette of RS”, no. 91/2018 and 40/2019) and must also be conducted in accordance with the guidelines of Good Clinical Practice.

 

Obtaining a marketing authorisation

In order to be granted a marketing authorisation, a medicinal product must undergo pharmaceutical (i.e. pharmaceutical, chemical and biological), pharmaco-toxicological and clinical trials in order to prove that it has the required quality, safety and efficacy.

There are several available options available before ALIMS for obtaining a marketing authorisation for medicinal products:

• through regular procedure with complete documentation;
• through simplified (short-form) procedure; and
• through fast-track procedure.

 

A marketing authorisation may be issued in a fast-track procedure, for medicinal products that obtained a marketing authorization in accordance with the EU centralized procedure and for medicines for human use of utmost importance for public healthcare.

 

ALIMS may issue a conditional marketing authorisation under a special agreement with the applicant, which may also be issued in an fast-track procedure. The ALIMS then assesses the continued fulfilment of the requirements agreed upon with the applicant on an annual basis and, if satisfied, renews the authorisation. A conditional marketing authorisation may be issued for:

• medicines used in the treatment, prevention or diagnosing of life-threatening diseases;
• medicines used in emergency cases or for treatment of rare diseases;
• medicines that have received a marketing authorisation under centralised procedure in the EU; or
• other medicines of special public health interest.

 

If special circumstances so require, the ALIMS may issue a special marketing authorisation for medicines in the specific interest of public health for a period of 12 months, obliging the applicant to report any adverse effects to the ALIMS of the use of such medicine and on the undertaken safety measures.

 

Finally, in case of an epidemic, natural disaster, or state of emergency, ALIMS, based on the request of the Ministry of Health, may issue a temporary permit for a specific type and quantity of medication before the conditions for issuing a marketing authorisation are fulfilled. This procedure was recently used during the COVID pandemic, when the Government adopted the Decree on the issuance of a temporary marketing authorisation for the vaccine for immunization of the population against the infectious disease COVID-19.

 

4. What are the approximate fees for each authorization?

Approval of a clinical trial for a medicinal product

The fee for issuing a permit for conducting a clinical trial of a medicinal product and for the administrative and technical tasks required for work of the Ethics Committee of Serbia is 413,000 Serbian dinars. This amount of the fee is increased for the amount of the remuneration for the work of members of the Ethics Committee of Serbia, and depending on the number of sites where the clinical trial is planned to be conducted, namely for the first site of conducting a clinical trial of a medicinal product this remuneration is 200,000 Serbian dinars, and for each subsequent site of conducting a clinical trial additional 150,000 Serbian dinars.

 

Approval of a clinical trial for a medicinal device

The fee for issuing a permit for conducting a clinical trial of a medical device and for the administrative and technical tasks required for work of the Ethics Committee of Serbia is 371,700 Serbian dinars. This amount of the fee is increased for the amount of the remuneration for the work of members of the Ethics Committee of Serbia, and depending on the number of sites where the clinical trial is planned to be conducted, namely for the first site of conducting a clinical trial of a medical device this remuneration is 200,000 Serbian dinars, and for each subsequent site of conducting a clinical trial additional 150,000 Serbian dinars.

 

Approval of a marketing authorization

The cost for obtaining marketing authorization for a medicinal product with complete documentation, considering its pharmaceutical form, strength, and packaging, amounts to 542,800 Serbian dinars. Additional fees are required for each additional pharmaceutical form (283,200 Serbian dinars), each additional strength of the same pharmaceutical form (177,000 Serbian dinars), each different type of inner packaging for the same pharmaceutical form and strength (35,400 Serbian dinars), and each additional package size (35,400 Serbian dinars). These fees also apply for conditional marketing authorization, marketing authorization under exceptional circumstances, and temporary marketing authorization. Reduced fees are applicable for marketing authorization based on reduced documentation.

 

Registration of a medical device 

The amount of the fee for issuing a decision on the registration of a medical device for which conformity assessment has been carried out is determined for each individual medical device from the application. The fee depends on the class of the medical device and the number of products for which the applicant seeks registration.

 

 

5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?

Validity of marketing authorizations and registrations of medical devices

Marketing authorisation is valid for five years, and it may be renewed based on the reassessment of the risk-benefit ratio of the medicine. If ALIMS determines that a medicine is safe, based on the available pharmacovigilance data, it grants a permanent marketing authorisation.

For Class I medical devices (excluding Class Is and Im) and other in vitro diagnostic medical devices placed on the market based on a Declaration of Conformity issued by the manufacturer, the medical device registration decision is issued for a period of five years from the date of issuance of the decision.

 

Renewal of marketing authorizations

Marketing Authorization Holders (MAHs) are required to apply for the renewal of marketing authorizations after the initial five-year validity period expires, based on a reassessment of the risk-benefit ratio. The application should include expert reports on the medicinal product’s quality, safety, and efficacy, along with a comprehensive list of all requested and approved variations by ALIMS. The renewal request must be submitted no earlier than 180 days before and no later than 90 days after the expiration of the marketing authorization. ALIMS will conduct a formal assessment within 15 days of receiving the application and a substantive review within 90 days after confirming the application is complete. The MAH is obligated to market the medicinal product in accordance with the approved renewal within 12 months from the date of ALIMS’ positive decision.

 

Extension of registration of a medical device

 Manufacturer, or the authorized representative of the manufacturer, must submit a request to ALIMS for the extension of the registration of a medical device at least 30 days before the expiry date of the registration decision. ALIMS must issue a decision on the extension of the registration of a medical device no later than 15 days from the date of receiving the request, based on the valid conformity certificate and other required documents. If the request is incomplete, ALIMS will request from the applicant within ten days from the date of submission of the request to complete the request no later than 15 days from the date of receiving the notification. This request for additional information stops the clock until the submission of the requested supplement. If ALIMS fails to issue a decision on the extension of the registration of a medical device within the 15-day deadline, it is considered that the medical device can be placed on the market in accordance with the previously issued registration decision for the medical device.

 

 

6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?

The Medicines Act defines a generic medicinal product as a medicine that has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence to the reference medicinal product is proven by appropriate bioavailability studies. Different salts, esters, ethers, isomers, isomer mixtures, complexes, or derivatives of active substances are considered to be the same active substance of a generic medicinal product, unless they differ significantly in terms of their safety or efficacy. Also, different oral forms of the medicinal product with immediate release are considered to be the same pharmaceutical form of a generic medicinal product.

 

Generic medicinal products, generic hybrid medicinal products, as well as biosimilars, benefit from an application procedure for obtaining a marketing authorization with reduced documentation. For generic medicinal products, the application includes data on bioequivalence to the reference brand-name product based on bioavailability studies, instead of the applicant’s own data. For hybrids and biosimilars, the applicant submits data on safety and efficacy that differ from the reference product.

 

However, in order to be able to rely on the reference product in the application procedure for obtaining a marketing authorization, the manufacturers of generic medicinal products must wait until the expiry of the data exclusivity period for the reference medicinal product.

 

Different rules on regulatory data exclusivity apply to manufacturers with and without a seat in Serbia. Foreign manufacturers may benefit from a eight-year data exclusivity and ten-year market exclusivity period. The market exclusivity period of ten years may be extended (cumulatively) for one more year if, during the eight years from the issuance of the marketing authorization for the reference medicinal product, the marketing authorization holder for the reference medicinal product obtains a new marketing authorization for one or more new indications that show a significant improvement in that reference medicinal product therapy. The exception is provided for the manufacturers with a seat in Serbia, which may rely on the data for the reference medicinal product before ALIMS after the expiry of six years after the issuance of the marketing authorization for the reference product, except in case of biotechnological medicines for which the 10-year exclusivity period applies.

 

 

7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?

The Medicines Act defines a medicinal product containing a fixed combination of active substances as a product where this fixed combination of active substances has not been used as a medicine for therapeutic purposes before the issuance of the marketing authorization for the medicinal product, and each of its individual active substance is part of a medicinal product that has been granted marketing authorization in the Republic of Serbia or in European Union countries. With the application for obtaining a marketing authorization for a medicinal product containing a fixed combination of active substances, the applicant is required to submit the results of new preclinical or clinical trials related to the given combination of active substances. However, it is not necessary to provide expert references for each individual active substance.

 

As for the products containing a combination of a drug and a medical device, the Medical Devices Act provides that its provisions apply to medical devices used for application of a medicine. If such a medical device is placed on the market in such a way that it forms an integral product with a medicine intended exclusively for use in that combination and cannot be reused, the provisions of the Medicines Act apply to that medical device. However, the basic safety and performance requirements of that medical device remain subject to the provisions of Medical Devices Act and regulations enacted for its implementation.

 

If a medical device contains a substance which, if used separately, could be considered a medicinal product in accordance with the Medicines Act, but which has an effect on the body which is supplemental to the action of the medical device, such device will be regulated by the Medical Devices Act. The same is applicable to a medical device that contains a substance which, if used separately, could be considered a medicine that is a component of human blood or human plasma, or a medicine derived from human blood or human plasma.

 

When deciding whether the rules on medicines or the rules on medical devices apply to a product, special attention is given to the main (primary) mode of action of the product.

 

 

8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?

Regulatory oversight with respect to compliance with regulations in the field of medicines and medical devices is conducted by (i) the competent Ministry of Health through inspectors for medicines and medical devices, as well as (ii) the Ministry of Agriculture, Forestry, and Water Management responsible for veterinary affairs – for veterinary medicines through veterinary inspectors, and (iii) to some extent ALIMS, within the scope of its entrusted competences.

Health inspectors have wide authority, to, inter alia:

• determine and control the compliance with Good Manufacturing Practice Guidelines, Good Laboratory Practice, Good Clinical Practice, and Good Distribution Practice;
• check for compliance with the conditions for production of medicines or medical devices, compounding of galenic medicines, wholesale distribution of medicines or medical devices, retail distribution of medical devices in specialized shops, as well as the testing of medicines, in terms of the space, equipment, and personnel;
• prohibit manufacturing, sale or laboratory testing of medicines, if they do not meet the prescribed regulatory conditions;
• order measures to remove incompliance with the regulatory requirements;
• prohibit manufacturing of medicines or medical devices, wholesale distribution of medicines or medical devices, retail distribution of medical devices, compounding galenic medicines, and laboratory testing of medicines and chemicals if they do not comply with orders or if there is a critical non-compliance of production with the Good Manufacturing Practice Guidelines;
• suspend the sale of a medicine or its batches that do not meet the conditions prescribed by this law and regulations enacted for its implementation or order the withdrawal of a medicine or its batches from circulation;
• order the destruction of defective medicines;
• suspend or prohibit the conduct of a clinical trial of a medicine, based on the proposal of ALIMS or ex-officio;
• prohibit the advertising of medicines or medical devices that is carried out contrary to the conditions prescribed in the law;
• review the documents and records of the marketing authorization holder for medicines or medical devices entered in the Register of Medical Devices, on all reported and received pharmacovigilance or medical device vigilance data, as well as the reports submitted to the Agency, healthcare institutions, and veterinary institutions.

 

Inspectors have wide authorities to conduct announced or unannounced inspections, review documents, question responsible and interested persons, inspect premises, facilities, and equipment, check compliance with guidelines and procedures, take samples of medicines and some types of medical devices, and other measures related to the subject-matter of control.

ALIMS primarily monitors compliance with the regulations within the scope of:

• the process of issuing regulatory approvals within its competence (approval of clinical trials, issuance, renewals and transfers of marketing authorizations, approval of variations, approval of promotional materials for medicines, import licenses for unregistered medicines, registration of medical devices, etc.);
• the process of assessment of quality of medicines for the purpose of issuing of certificate of analysis, as well as through planning and implementing systematic control of medicines and medical devices and taking random samples from circulation on the market; and
• the process or organization and monitoring of pharmacovigilance on the basis of the data collected from marketing authorization holders and from cooperation with other international regulatory agencies and centers for pharmacovigilance.

 

9. What is the potential range of penalties for noncompliance?

Noncompliance with the Medicines Act may constitute a commercial offence or a misdemeanor. Potential penalties may be in the form of monetary fines and protection measures.

Commercial offences may be serious, for which the threatened fine is prescribed in the range between RSD 1 and 3 million, or less serious, for which the threatened fine is prescribed in the range between RSD 800,000 and 2 million. Along with the penalty prescribed for both types of commercial offences, a protection measure may also be imposed on a legal entity in the form of prohibition of certain business activities for a period of three to ten years. In addition, medicines that are the subject-matter of the commercial offense will be confiscated without compensation.

Other less serious types of breaches of obligation prescribed in the Medicines Act constitute a misdemeanor, for which the threatened fine is prescribed in the range between RSD 300,000 and 1 million.

Responsible persons in legal entities which committed a breach of obligations prescribed in the Medicines Act may also be fined, for serious commercial offences in the range between RSD 100,000 and 200,000, for less serious commercial offences in the range between RSD 80,000 and 150,000, and for misdemeanors in the range between RSD 10,000 and 50,000.

 

10. Is there a national healthcare system? If so, how is it administered and funded?

The Serbian healthcare system aspires to provide universal healthcare, guaranteed by Article 68 of the Serbian Constitution. The competences for provision of healthcare are shared between the central government, which is competent for regulation, provision, and monitoring of healthcare, and regional and local self-government units also have certain powers related to the organization and provision of healthcare.

The healthcare services sector in Serbia comprises public healthcare institutions and private practice. A majority of hospitals are public (state-owned), however, with the development of the private insurance market, private healthcare institutions have experienced significant growth over the last years. Medical centers and hospitals provide public healthcare services at three functional levels. State-owned primary health centers (clinics, polyclinics, pharmacies, and health offices (zavodi)), established for the territory of one or more municipalities or towns, provide services at the primary level. At the secondary level, general and specialized hospitals provide stationary and specialist consultation services, while health centers act as clinics and general hospitals. At the tertiary level, clinics, institutes, hospital medical centers, and university clinical centre provide the highly specialized healthcare services.

The public healthcare network is organized and governed by three main institutions:

• the Ministry of Health (the Ministry), in charge of policymaking, adoption of standards and quality control;
• the Institute for Public Health, tasked with collection and analysis of public health data and proposing of relevant measures; and
• the National Health Insurance Fund (NHIF), competent for financing of healthcare on all levels.

 

Serbia has a mixed system of healthcare financing. The contributions for the compulsory health insurance paid to the NHIF account for more than 90% of the financing of medical care in both outpatient and inpatient sectors. At the same time, the Constitution provides that children, women during pregnancy and maternity leave, single parents with children up to seven years and the elderly are entitled to healthcare financed from the state budget. The Healthcare Act of 2019 identifies additional vulnerable groups with respect to which healthcare is financed from the budget. Persons with disability, persons suffering from certain serious diseases, uninsured persons, Roma population, and refugees and displaced persons, are among such vulnerable groups. Compulsory health insurance contributions are charged in the form of premium levied on salaries of employees. The employer and the employee contribute in equal parts. The NHIF allocates the funds to healthcare institutions on the basis of contracts, usually entered into for a period of one calendar year. The percentage of expenses paid by the citizens ‘out-of-pocket’ is very high. According to the World Bank Data, total expenditure on health in 2020 in Serbia was 8.73% of GDP, out of which around 36% was out-of-pocket expenditure.

 

11. How does the government (or public) healthcare system function with private sector healthcare?

Healthcare institutions in Serbia can in general be established as public or private institutions, subject to limitations in the Healthcare Act which specifies which healthcare institutions may only be established by the Republic of Serbia, autonomous region or a local self-government. Healthcare institutions may also be established as public-private partnerships.

 

Private healthcare institutions may perform healthcare services subject to the approval issued by the Ministry of Health. Based on the said approval, private healthcare institutions are registered with the Serbian Business Registers Agency. Private healthcare institutions are prohibited from performing emergency medical assistance, blood preparation, organ collection, storage and transplantation, vaccine production, autopsy and forensic medical activities, as well as healthcare activities in the field of public health.

 

Public healthcare institutions are financed through (i) contributions for mandatory health insurance, (ii) the budget of the Republic of Serbia, or their founder and (iii) revenues generated from the use of public funds for services not covered by the mandatory health insurance. Healthcare institutions pertaining to private practice are financed from private funds and by the health insurance organizations through contracts for the provision of healthcare services. Private health insurance is voluntary.

 

The Act on Healthcare Documentation and Records (2023) introduced a National Integrated Healthcare Information System (NIHIS), which is intended to, inter alia, integrate the records of public and private healthcare institutions. NIHIS will be implemented as of 1 January 2025.

 

12. Are prices of drugs and devices regulated and, if so, how?

The prices of prescription-only medicines are regulated by the Government. The government determines the criteria for the pricing of medicines and calculates their maximum prices at the joint proposal of the ministries competent for health and trade. The Ministry of Health calculates the maximum wholesale price for prescription-only pharmaceuticals.

The pricing of prescription-only medicines is governed by the Medicines Act, the Decree on Criteria for Forming of Prices of Prescription-Only Medicines for Human Use, and the Decision on Maximum Prices of Prescription-Only Medicines for Human Use. The Ministry of Health calculates the maximum wholesale price for prescription-only pharmaceuticals based on a number of criteria. One of these criteria is price parity – i.e. the comparable wholesale prices of pharmaceuticals in reference countries, namely, Slovenia, Greece and Italy, and the current wholesale price in Serbia, in addition to other applicable criteria.

Prescription-only medicines for which the government has not established the maximum wholesale price cannot be made available on the market.

 

Once the government decides on the maximum permitted wholesale price of the medicine, marketing authorization holders may apply to include the medicine into the positive reimbursement list of medicines (“Positive List”), to be prescribed and issued at the expense of the compulsory health insurance.

 

On the other hand, marketing authorization holders are free to determine the prices of over-the-counter medicines and must only notify the Ministry before March 1st of the current year of the price for the previous year.

13. How are drugs and devices used by patients paid for? What roles do public and private payers play?

Please see the main principles for reimbursement of medicines in Question 12. As a rule, a medicinal product is eligible for reimbursement by health insurance only if it is included in the Positive List. The Central Medicines Commission, established by the National Health Insurance Fund, reviews the applications for medicines to be included in the Positive List and conducts the health technology assessment of medicines. The general criteria for including a medicine to the Positive List are the:

• pharmacotherapeutic justification of the medicine;
• pharmacoeconomic justification of the medicine; and
• financial resources provided by the annual financial plan of the National Health Insurance Fund.

 

When there are no budgetary means to include in the Positive List all the medicines that comply with general criteria, the National Health Insurance Fund further considers two special factors: the existence, if any, of a managed entry agreement, and the priority for adding the medicine to the list. The Fund gives priority to medicines based on:

• a lack of medicines from the same pharmacotherapeutic group on the Positive List for a particular medical indication;
• the medicine’s significance to public health; and
• ethical aspects.

 

14. Who dispenses drugs and devices to patients and how are those dispensers compensated?

Healthcare professionals who provide healthcare services in a healthcare institution or private practice, or in a social care institution with which the Republic Health Insurance Fund has a contract for the provision of healthcare services, are authorized to prescribe medicines.

 

It is prohibited to dispense or sell medicines at retail level outside of pharmacies, private practices, or other healthcare institutions. In the process of issuing a marketing authorization, ALIMS classifies medicines and determines the dispensing regimen for medicines, as either (i) prescription-only medicines; (ii) medicines that are dispensed without a medical prescription or over-the-counter (OTC) medicines. ALIMS may also establish specific subcategories for prescription-only medicines, which include:

• medicines that are dispensed with a medical prescription for multiple (renewable) and single use;
• medicines that are dispensed with a special medical prescription; and
• medicines that are dispensed with a medical prescription with restrictions for use in specific specialized areas.

Pharmacies may be established as public or private. Private pharmacies may conclude an agreement with Republic Health Insurance Fund to dispense the prescription-only medicines at the expense of public health insurance.

 

15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?

Pharmaceutical activity encompasses, in addition to its main tasks to dispense medicines and medical devices, also the activities implementation of preventive measures for preserving, protecting, and improving the health of the population, including health promotion, disease prevention, and health education. When dispensing medications and medical devices, pharmacies provide advice on their storage, expiry dates, use, adverse reactions and interactions, proper use, and disposal.

 

The pharmacist must not dispense a prescription-only medicine if they professionally assess that the medicine could endanger the patient’s health or if the prescription does not contain the information prescribed by the applicable regulations. They must refuse to dispense a prescription-only medicine which is prescribed contrary to the provisions of the laws regulating medicines, healthcare, health insurance, or any of the implementation regulations.

 

Pharmacists perform their duties also in accordance with the Guide for Good Pharmacy Practice, which is adopted by the Chamber of Pharmacists, with consent of the Ministry of Health.

Also from this Legal Handbook

1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?

No, there is no requirements for clinical trials to be conducted locally as a condition for marketing approval.

 

2. How are clinical trials funded?

Clinical trials are funded by the sponsors. The sponsor of a clinical trial can be a manufacturer, legal entity, or individual and is responsible for initiating, directing, ensuring quality, and financing the conduct of the clinical trial. Information on the financing of a clinical trial must be disclosed in the request for approval of a clinical trial, within the protocol or an agreement which is attached to the application.

 

3. What are the requirements for pre-clinical and clinical trial protocols? Who must approve the protocols?

The clinical trial protocol is a document that describes the objectives, design, methodology, statistical considerations, and organization of the clinical trial. It includes the protocol, protocol versions, and protocol amendments. The main required contents of the protocol are general information about the trial, basic information, objectives and purpose of the clinical trial, clinical trial plan, selection of participants, information on the treatment of participants, assessment of efficacy and safety, statistical data, information on direct access to source data or documents, data on quality control and assurance, ethical aspects of the clinical trial, information on data handling and documentation storage information, information on financing of the clinical trial and insurance of the participants, and method of publication of results in the clinical trial.

ALIMS and the Ethics Committee approve the protocol in the procedure for approval of a clinical trial, or within the scope of the procedure for amendment of the protocol.

 

4. What are the requirements for consent by participants in clinical trials?

The Medicines Act contains mandatory rules for obtaining trial subjects’ consent to participate as one of the conditions for conducting a clinical trial. Subjects, or their legal representatives, must be fully informed about the clinical trial and of their right to withdraw their consent to participate at any moment, in writing and in a language they can understand. Consent must be in written form, signed and dated. If a person is illiterate, they must give oral consent in the presence of at least one witness. Special provisions provide for the protection of minors and adults who are not able to give written consent to participation in clinical trials due to unconsciousness or physical or learning disability.

 

5. May participants in clinical trials be compensated?

No. Clinical trial participants may be reimbursed for their necessary expenses related to participation in the clinical trial. The information on the method of compensation for expenses must be included in the request for approval of the clinical trial and is assessed by the Ethics Committee.

 

6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?

Prior to the commencement of a clinical trial, the sponsor of a clinical trial must insure the persons subjected to the clinical trial against personal injury, where the damage to health is caused by the clinical trial. When the clinical trial is conducted on children, the participants, or their parents or relatives, must not be inappropriately induced to participate in the trial in any way, including through compensation, so the compensation and the living expenses must be at the level of costs of a pediatric clinical trial. The compensation should be approved by the Ethics Committee.

 

Also from this Legal Handbook

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products?

As outlined in the answer to question 3 in Chapter 1, marketing authorisation of medicinal products (including new drugs and biologics, regardless of the manner of reimbursement) may be obtained in a regular procedure and summary procedure (short-form). There is also a fast-track procedure for medicinal products that obtained a marketing authorization in accordance with the EU centralized procedure and for medicines for human use of utmost importance for public healthcare.

In a regular procedure, ALIMS conducts a formal review of an application for marketing authorisation within 30 days, while the substantive review must be completed within the next 210 days. If ALIMS requests additional documents from the applicant, it will give a 30-day deadline for the submission, and the deadline for issuing the marketing authorisation will be paused until the documents are submitted.

The accelerated procedure for obtaining a marketing authorization is reserved for medicinal products that obtained a marketing authorization in accordance with the EU centralized procedure and for medicines for human use of utmost importance for public healthcare. The deadline for review of an application for a marketing authorization in an accelerated procedure is 150 days from receipt of a complete application. If the application is not complete, ALIMS will ask the applicant to complete the application within 30 days, and the deadline for issuing the marketing authorization will be paused from the day of request until the submission of the requested documents.

A marketing authorisation is not required for medical devices, but they must be registered with ALIMS in order to be placed on the market. Medical devices must comply with essential requirements set out in the Medical Devices Act of 2017 (Medical Devices Act 2017) regarding conformity assessment, labelling and supporting documents; be properly procured, installed and maintained; and used in accordance with their purpose. A medical device is assumed to comply with the essential requirements if it is manufactured in accordance with Serbian standards in the field of medical devices, which have transposed the corresponding standards of the European Union. The Medical Devices Act also contains an exhaustive list of medical devices for which the registration is not required in order to be placed on the market or put to use.

 

2. What is the authorization process for the marketing of generic versions of these products?

Summary procedure or short-form procedure is available for generics, hybrids, or biosimilars. The application for obtaining a marketing authorization for the generic drug, instead of its own pharmacological-toxicological and clinical data, contains data on the bioequivalence of the generic drug compared to the reference drug based on appropriate bioavailability studies. For hybrids and biosimilars, own pharmacological-toxicological and clinical data must be submitted, namely data on the safety and efficacy of the drug that differ from the corresponding data of the reference drug or reference biological drug.

The applicant for issuance of a marketing authorization in summary proceedings may submit its application only after the period of data exclusivity for the reference product has expired and may obtain the marketing authorisation after the expiry of the market exclusivity period. With respect to the data exclusivity period, different regimes apply to Serbian and foreign manufacturers of generic product, which will be in force until Serbia joins the EU. Originators without a seat in Serbia may benefit from a ten-year exclusivity period from the issuance of the marketing authorisation for the data submitted to obtain that marketing authorisation. Originators may not extend the exclusivity period on account of amendments to the marketing authorisation in terms of medicinal product strength, pharmaceutical form, methods of administration, packaging, or variations and claims for extension of the scope of the marketing authorisation.

Therefore, an applicant for a marketing authorisation issuance in a short-form procedure may obtain a marketing authorisation after ten years from the date of issuance of the marketing authorisation for the reference product, but may apply for that marketing authorisation earlier, after at least eight years have elapsed from the date when the initial marketing authorisation had been issued in Serbia, in the European Union or in countries that have the same or similar requirements for the issuance of the authorisation.

If, during the eight years from the issuance of the marketing authorisation for the reference medicinal product, the marketing authorisation-holder for the reference medicinal product obtains a new marketing authorisation for one or more new indications that show a significant improvement in that reference medicinal product therapy, the period of ten years may be extended (cumulatively) for one more year.

These rules will also apply to manufacturers with a seat in Serbia from the moment of accession of Serbia in the European Union. Currently, the ten-year protection period applies only to biotechnological medicines, while for the other medicinal products the protection period is six years from the date of receiving the first marketing authorisation for the reference pharmaceutical.

 

3. What are the typical fees for marketing approval?

The cost for obtaining marketing authorization for a medicinal product with complete documentation, considering its pharmaceutical form, strength, and packaging, amounts to 542,800 Serbian dinars. Additional fees are required for each additional pharmaceutical form (283,200 Serbian dinars), each additional strength of the same pharmaceutical form (177,000 Serbian dinars), each different type of inner packaging for the same pharmaceutical form and strength (35,400 Serbian dinars), and each additional package size (35,400 Serbian dinars). These fees also apply for conditional marketing authorization, marketing authorization under exceptional circumstances, and temporary marketing authorization.

Reduced fees are applicable for marketing authorization based on reduced documentation, namely for a medicinal product with reduced documentation, considering its pharmaceutical form, strength, and packaging, amounts to 383.500 Serbian dinars. Additional fees are required for each additional pharmaceutical form (247,800 Serbian dinars), each additional strength of the same pharmaceutical form (141,600 Serbian dinars), each different type of inner packaging for the same pharmaceutical form and strength (35,400 Serbian dinars), and each additional package size (35,400 Serbian dinars).

 

4. What is the period of authorization and the renewal process?

The initial marketing authorization is valid for five years. It may be renewed based on the reassessment of the risk-benefit ratio of the medicine. If ALIMS determines that a medicine is safe (based on the available pharmacovigilance data), it grants a permanent marketing authorization. If ALIMS finds that the pharmaceutical product is not safe, it will decline to issue a permanent authorization. Instead, ALIMS will consider whether to extend the authorization for another five years. An authorization can only be renewed once for an additional five-year period. If ALIMS continues to have valid concerns regarding the safety of the product, it will revoke the previously issued marketing authorization.

MAHs may submit a request for renewal of a marketing authorization in the period between 180 and 90 days before the expiry of the validity period of the initial marketing authorization. The deadline for the formal assessment by ALIMS is 15 days, and if the request is incomplete, ALIMS will instruct the MAH to supplement the submission within 30 days. The deadline for substantive assessment is 90 days from the submission of a complete request, and the clock stops with each request from the ALIMS to supplement the documents and data until the submission of the requested data.

 

5. What are the requirements, if any, for post-approval pharmacovigilance?

Pharmacovigilance obligations of the marketing authorization holders are laid down in the Medicines Act and the Rulebook on the manner of reporting, collecting, and monitoring of adverse drug reactions (Pravilnik o načinu prijavljivanja, prikupljanja i praćenja neželjenih reakcija na lekove, “Official Gazette of RS” no. 64/2011, 75/2017, 82/2017 and 107/2023).

In the post-marketing phase, marketing authorization holders (MAHs) must:

• organize continued monitoring of adverse drug reactions (ADRs) and have a permanently employed person with adequate qualifica­tions responsible for pharmacovigilance;
• keep records on all suspected ADRs notified in Serbia, EU countries or any third country, and provide ALIMS with electronic reports;
• keep records of all suspected serious ADRs reported by health or veterinary professionals, or records of ADRs that MAHs can reasonably be expected to be aware of, and promptly report this information to ALIMS no later than 15 days following the receipt of information;
• submit to ALIMS periodic drug safety reports in six-month intervals if the marketing authorization was conditional or under special circumstances; and
• submit periodic drug safety reports every six months for a period of two years following the placing of the medicine on the mar­ket, then annual reports for another two years and finally submit reports in three-year intervals.

 

For medical devices, the obligations for manufacturers (or their authorized representatives) are laid down in the Rulebook on Market Surveillance of Medical Devices of 2018 (as amended) and the Rulebook on Vigilance of 2019. A manufacturer or its authorized representative is required to appoint a person responsible for vigilance, whose duty is to continuously monitor the medical device on the market to identify any necessity for corrective or preventive actions. This designated individual maintains records of all actions taken and reports them to ALIMS as necessary.

The manufacturer or its authorized representative is also required to notify the notified or appointed body that conducted the conformity assessment about any modifications to the vigilance system that impact the conformity assessment. If incidents occur, the manufacturer or its authorized representative must promptly inform ALIMS about any initiated field safety corrective actions taken to mitigate the risk of death or serious health deterioration associated with the medical device.

 

6. Are foreign marketing authorizations recognized?

Foreign marketing authorizations are not recognized for the purpose of placing a product on the market in Serbia. However, if a marketing authorization has been granted in the European Union or in a country that has the same or similar requirements for issuing a marketing authorization, a marketing authorization holder in these countries may also authorize a representative with a seat in Serbia to submit a request for a marketing authorization even though they are not a manufacturer.

A country that has the same or similar requirements for issuing a license under this regulation is considered a country that is a founding regulatory member of the ICH (EU, EEA, USA, and Japan) and a country that is a permanent regulatory member of the ICH (Canada and Switzerland), as well as a country that has the same or similar requirements for issuing a license as in the Republic of Serbia, which includes countries that were part of the former Socialist Federal Republic of Yugoslavia, as well as a country that has acquired candidate status for the EU membership.

During the approval process, ALIMS has started using the reliance procedure with respect to medicines which were issued a marketing authorization in the EU centralized procedure, and there are indications that they might apply the same rule for the medicines approved in the EU decentralized procedure in the near future.

 

7. Are parallel imports of medicines or devices allowed?

The Trademark Act adopted in 2020 removed the ban on parallel imports. Under this Act, a trademark owner who has introduced, or agreed to the introduction of, goods protected by the trademark to the market anywhere globally cannot prevent further distribution of these goods. However, the Medicines Act and its related regulations have not been amended to reflect the changes in the Trademark Act and do not address parallel imports. The government has indicated plans to introduce a new Medicines Act, but there is currently no publicly available draft. The potential inclusion of regulations on parallel imports in the new law remains uncertain.

 

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

Advertising of medicines and medical devices is regulated in the Medicines Act and the Medical Devices Act, respectfully, while detailed rules are laid down in the relevant by-laws. In addition, in 2014 the Serbian Association of Manufacturers of Innovative Drugs (INOVIA) adopted the Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Healthcare Professionals (the INOVIA Code).

The Medicines Act and the relevant by-laws prohibit inducement of healthcare professionals (HCPs) to prescribe, issue or order a specific medicine or recommend its use or purchase through offering, giving or promising money or any other benefit.

With respect to sponsorship of professional events, HCPs must not provide any material or non-material benefit as a consideration for the sponsorship of professional events, and the sponsor must not influence the contents of the event. Companies may sponsor professional events only up to the amount needed to cover the necessary costs of travel, accommodation, and participation in the event, and only for the duration of the event, including two days for travel.

The Healthcare Act introduced additional limitations in 2019 that HCPs must not accept money or gifts, except for small non-monetary gifts in the individual value not exceeding 5% of the average net monthly salary in Serbia or in the aggregate value not exceeding one average monthly net salary.

The INOVIA Code establishes limits on the value of informational or educational materials provided to HPCs, set at around 3,500 Serbian dinars, and prohibits companies from offering HCPs any food and beverages exceeding EUR 60 (approx. 7,000 RSD) in value. Additionally, companies sponsoring or organizing events are prohibited from offering accommodation in five-star hotels. The INOVIA Code also outlines industry regulations regarding donations and grants to individual HCPs not related to event sponsorship, as well as donations and grants to associations of HCPs or entities involved in healthcare or research. The primary goal of the INOVIA Code is to prevent companies from influencing HCPs to recommend, prescribe, purchase, supply, sell, or administer specific medicines.

 

9. How is the manufacturing of medicines and devices regulated and by which agencies?

Manufacturing of Medicines

A license issued by the Ministry of Health to legal entities is required for manufacturing of medicines. The application for a manufacturing license must contain information and documents regarding the location and premises of the manufacturing site, equipment, personnel, medicines to be produced, relevant procedures, as well as other information required by the law. The Ministry issues a license for a particular manufacturing site and certain forms of pharmaceutical manufactured at that site, and the license may include an entire manufacturing process or only a part of the process. The license is valid for an indefinite period.

 

Manufacturing of Medical Devices

Manufacturers of medical devices may be both legal entities and individuals. A manufacturing license is required for manufacturing of:

• class I medical devices (other than Is and Im class);
• other in vitro diagnostic medical devices;
• medical devices for which no conformity assessment has been performed;
• medical devices not covered by the sign of conformity;
• custom-made devices for a particular patient;
• medical devices for clinical trials; and
• as well as a system or a kit.

The Ministry of Health issues a manufacturing license for medical devices, which is valid for five years.

 

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

Yes. The Guidelines for Good Manufacturing Practice (Smernice dobre proizvođačke prakse, “Official Gazette of RS” no. 97/2017 and 19/2023) are fully transposed from the EU Good Manufacturing Practice (GMP) guidelines.

 

11. What is the inspection regime for manufacturing facilities?

Inspection of manufacturing facilities is conducted in the procedure for issuance or amendments of the manufacturing license, as well as in the procedure of conformity assessment for the purpose of issuing of the GMP certificate. Outside of these procedures, the inspectors from the Ministry of Health may conduct regular and extraordinary inspections.

Regular compliance inspections are based on an annual compliance verification plan prepared by the Ministry of Health by the end of the current year for the next calendar year. Regular compliance inspections are carried out every two years from the date of issuance of the Good Manufacturing Practice certificate or Good Laboratory Practice certificate.

Extraordinary compliance inspections are carried out at the request of the competent authorities, organizations, other interested parties, as well as in cases of reported suspicions regarding the quality and safety of medicines, reports of incidents or errors in the production of medicines, or other situations that could affect the quality and safety of medicines.

If, during the regular or extraordinary inspection process, the competent inspection finds non-compliance in the production of medicines or active substances with the Good Manufacturing Practice, it is obliged to impose corrective measures on the manufacturer. A repeated inspection is conducted to determine whether the imposed corrective measures have been implemented, and in that process the competent inspector assesses the compliance of the production with the Good Manufacturing Practice and prepares a final report with conclusions on the compliance of the production of medicines or active substances with the Good Manufacturing Practice Guidelines.

 

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

The manufacturer of medicinal products is obligated to seek approval from the Ministry of Health in order for an inspector for medicines from another jurisdiction to conduct an inspection of the production site for which the Ministry of Health has issued a production permit.

 

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

Proper storage, packaging and handling of medicines and devices is regulated in the process of manufacturing, wholesale and retail of medicines and medical devices. Requirements for manufacturers are prescribed in the Rulebook on the Conditions for the Production of Medicines, the Content of the Manufacturing License Form, and the Register of Issued Licenses for Manufacturing of Medicines, as well as in the Guidelines for Good Manufacturing Practice.

Wholesale, storage, packaging, and handling of medicines and devices on the wholesale level is governed by the Rulebook on the Conditions for Wholesale Trade of Medicines and Medical Devices, the Data Entered in the Register of Issued Licenses for Wholesale Trade of Medicines and Medical Devices, and the Manner of Entry, as well as the Guidelines for Good Distribution Practice (GDP) which are fully aligned with the EU GDP Guidelines. These documents provide for the required conditions and standards that a wholesaler must fulfil to ensure that the quality and integrity of medicines is maintained throughout the supply chain.

With regard to retail trade, the applicable rules for handling of medicines and medical devices are set out in the Healthcare Act and the Guidance for Good Pharmacy Practice.

 

14. What information must be included in medicine and device labeling?

Medicines

The following information must be provided on the outer packaging of the medicine (as well as the inner packaging where it serves also as the outer packaging of the medicine):

• name of the medicine and the International Nonproprietary Name (INN) if available, or the generic or chemical name. If there is no INN or generic/chemical name, the generally accepted name of the active substance should be provided;
• active substances, expressed qualitatively and quantitatively per dosage unit;
• pharmaceutical form, strength (content per unit of mass, volume, or per unit of single dosage) and package size;
• list of auxiliary substances with confirmed-effect, and for medicines in the form of injections, medicines for local use, and medicines for ophthalmological use, all auxiliary substances must be listed.
• method of administration;
• warning that the medicine must be kept out of reach of children, as well as other necessary warnings;
• expiry date (month and year);
• storage conditions, if there are special storage conditions;
• specific precautions for disposal and destruction;
• name and address of the marketing authorization holder;
• number and date of issuance of the marketing authorization;
• batch number;
• instructions for the use of the medicine with a non-prescription regime;
• ATC classification, and for veterinary medicines, ATC-vet, and
• EAN code.

The outer packaging of the medicine must also be labeled with the inscription: “Read the package leaflet before use”, and other specific warnings relevant to the use of the medicine, as required.

 

The inner packaging of the medicine must include at least the following information:

• name of the medicine and the INN if available, or the generic or chemical name, and if there is no INN or generic or chemical name, the accepted name of the active substance;
• strength of the medicine and its pharmaceutical form;
• name of the marketing authorization holder;
• the expiry date (month and year);
• the batch number.

 

Medical devices

Labelling of medical devices is governed by the Medical Devices Act, Rulebook on Labelling and Contents of the Information Leaflet for Use of a Medical Device, and the Rulebook on Essential Requirements for Medical Devices.

The labelling must include the following information:

• The name or trade name and address of the manufacturer, and for imported products, the labelling or outer packaging or instructions for use must also include the name and address of the authorized representative in Serbia;
• detailed information necessary for the user to identify the medical device and the contents of the packaging;
• if applicable, the word “STERILE”;
• if applicable, the batch code preceded by the word “BATCH” or the serial number;
• if applicable, the expiration date of the medical device, expressed in year and month;
• if applicable, a mark indicating that the medical device is intended for single use. The manufacturer’s marking for single-use must be consistent with the marking in the EU;
• if the medical device is custom-made for a specific patient, the words “custom-made medical device”;
• If the medical device is intended for clinical trial, the words “for clinical trial”;
• any special storage or handling conditions;
• any special instructions for use;
• any warnings or precautions to be taken;
• the year of manufacture for active medical devices except those under (v). This marking may be included in the batch code or serial number;
• if applicable, the method of sterilization;
• if applicable, an indication that the medical device contains a derivative of human blood.

 

The inner packaging of the medical device contains at least:

• the name of the medical device;
• if applicable, the word “STERILE” or a statement indicating any specific microbiological condition or degree of purity;
• shelf life;
• the batch code preceded by the word “BATCH” or the serial number, or lot number.

 

 

15. What additional information may be included in labeling and packaging?

The outer packaging of a medicines may also contain information on:

• Reimbursement of costs from mandatory health insurance;
• Method of dispensing the medicine (prescription-only, or without a prescription);
• Verification of the identification and authenticity of the medicine’s packaging.

For medical devices, the text of the instructions for use of a medical devices may be included on the outer packaging, if applicable.

 

16. What items may not be included in labeling and packaging?

Labelling and packaging as a rule should contain only information prescribed in the relevant laws and by-laws applicable for a particular medicine or medical device and approved by the ALIMS in the precure for issuance of a marketing authorization or registration of a medical device.

 

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

Advertising is defined in the Medicines Act as every form of provision of accurate information about a medicinal product to the general or professional public, to encourage prescription, supply, sale, or consumption of the product or device. Stating the name of a medicinal product, its international non-proprietary name, or a trademark, if it serves only as a reminder, is not considered advertising.

ALIMS must approve promotional materials and other documentation supporting the advertising of medicines, which in practice causes delays in placing the product on the market. Advertising may be directed towards the general public (via media) and to the professional public (via promotion to health and veterinary professionals who prescribe medicines). There is no obligation for ALIMS to approve promotional materials for medical devices.

It is forbidden to advertise a medicine without a marketing authorization or a medical device which is not in conformity with essential requirements and registered in the ALIMS’ register of medical devices. Advertising medicines and medical devices in a misleading manner or advertising the success of the treatment in an exaggerated way is also prohibited. The advertiser may not suggest that the medicine can be classified as food, cosmetics or another item of general use. Advertising of medicines used for the treatment of children by addressing children directly is prohibited, as is provision of free samples of medicines (or medical devices) to the general public.

 

The Medicines Act contains an exhaustive list of medicines for which advertising is prohibited:

• prescription medicines;
• medicines issued at the expense of health insurance;
• medicines containing opiates or psychotropic substances; and
• medicines for diseases such as tuberculosis, sexually transmitted or infectious diseases, chronic insomnia, diabetes and other metabolic diseases.

 

Promotion of a medicinal product to the professional public must include the basic data contained in the marketing authorization and be consistent with the summary of product characteristics. That information must be accurate, updated, verifiable and sufficiently complete as to enable the healthcare professional to form his or her opinion on the therapeutic value of a medicinal product. It is permitted to give to a healthcare professional one minimal package of a new medicine being introduced on the market containing a note stating: ‘A free sample, not for sale.’

 

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

Medicines may be sold only in pharmacies established either as healthcare institutions or private practice, while medical devices may be sold in pharmacies, private practices, or specialized stores for retail sale of medical devices. Online sale of medicines or sale via post, of medicines and medical devices, is prohibited in Serbia.

 

19. What are the restrictions and requirements for electronic marketing and advertising via email, via the Internet, social media, and other channels?

General restrictions on advertising outlined in question 17 of this chapter apply also to advertising via Internet and other channels. If the advertising message is delivered via the Internet, information about the medicine or medical device must be an integral part of the initial or main page of the online advertisement or message, and not a separate page provided as a link or reference to the main page.

20. May medicines and devices be advertised or sold directly to consumers?

With regard to advertising, please see question 17 of this chapter, and with regard to sale, please refer to question 18 of this chapter.

 

 

21. How is compliance monitored?

ALIMS monitors compliance with the provisions of the Medicines Act and Medical Devices Act and the implementing by-laws through the approval of the promotional materials for medicines. Monitoring is also conducted through inspections carried-out by the health inspection of the Ministry of Health.

 

22. What are the potential penalties for noncompliance?

For potential penalties for noncompliance with the applicable regulations, please refer to question 9 of chapter 1.

 

Also from this Legal Handbook

1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

Traditional medicines are subject to a marketing authorization issued by ALIMS. Marketing authorization is not required for traditional herbal medicines or homoeopathic medicines which fulfil conditions prescribed in the Medicines Act. Instead, they are registered in the appropriate registries kept by ALIMS.

To be registered, a traditional herbal medicine must meet the following conditions:

• it has indications that are characteristic exclusively for traditional herbal medicines which, in their composition and purpose, are intended for use without medical supervision for diagnosis, issuing prescriptions, or monitoring the course of treatment;
• it is intended exclusively for use according to the prescribed strength and dosage;
• it is intended for oral use, external use, or inhalation;
• its period of traditional use has expired, or at least 30 years of use have passed before the date of application for the marketing authorization, including at least 15 years within the territory of the European Union;
• There is sufficient data on the traditional use of the medicine, showing that it is not harmful under prescribed conditions of use, and that its pharmacological effects or effectiveness can be expected based on its long-term use and experience.

 

An herbal medicine that contains vitamins or minerals with well-documented therapeutic safety can be considered a traditional herbal medicine if the effect of these vitamins or minerals is merely auxiliary compared to the effect of active herbal ingredients concerning the established indication or indications.

A homeopathic medicine may be registered if it meets the following conditions:

• it is intended for oral or external use;
• there are no therapeutic indications stated on its packaging or in any other information related to the medicine (e.g., in promotional material);
• there is a sufficient degree of dilution of the medicine that ensures its therapeutic safety, and the medicine does not contain more than one part of the mother tincture in ten thousand parts or more than 1/100 part of the minimum dose used in allopathic (conventional) medicine, for active substances whose presence in an allopathic medicine requires the medicine to be prescribed with a doctor’s prescription.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

Yes, there are no additional restrictions related to advertising of traditional, herbal or homeopathic medicines.

 

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

Advertising of traditional, herbal, or homeopathic products is subject to the same rules as the advertising of other medicines. Advertising of a medicine that misleads or leads to the conclusion that the safety and efficacy of the medicine are ensured by its natural origin, or describes a disease and treatment successes in a way that encourages self-treatment, is prohibited. Additionally, advertising of a medicine in an inappropriate and sensationalistic manner about their treatment successes by showing images, etc., is also prohibited.

Medicines must not be advertised in a manner which suggests that the medicine falls under food, cosmetics, or other items for general use.

In general, when advertising or marketing traditional, traditional herbal or homeopathic medicines, only the claims approved by ALIMS in the process of issuing of marketing authorization or the process of registration may be used.

 

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Over-the-counter (OTC) medications are subject to the marketing authorization, and their wholesale may be carried out on the basis of the appropriate wholesale license. Compared to the prescription-only medicines, OTC medicines are subject to different rules with regard to advertising and pricing.

 

5. Are there any limitations on locations or channels through which OTC products may be sold?

The regime of sale for OTC medications is the same as for the prescription-only medicines in terms of available sales locations and channels.

 

6. What health, advertising, and marketing claims may be made for OTC products?

Please refer to question 17 of this chapter.

 

7. Can OTC products be marketed or advertised directly to the public?

Please refer to question 17 of this chapter.

 

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

ALIMS classifies medicines into prescription-only (and their subcategories) and OTC medicines in the process of issuing the marketing authorization. The marketing authorization holder may request a re-classification into OTC product on the basis of significant preclinical and clinical trials. Change in the prescription regime must be approved as a type II variation of the marketing authorization.

 

9. What are the requirements for the importation of either traditional medicines or OTC products?

Import of traditional medicines or over-the-counter products is subject to the general rules on import of medicinal products.

Import is a part of the wholesale activity and is subject to obtaining a wholesale license issued by the Ministry of Health. The exception is the import by entities performing only import or export activities on behalf of and for the account of a medicines wholesale license-holder, who may import medicines without a wholesale license.

As a general rule, only medicines with a valid marketing authorization (or registration, for homeopathic or traditional herbal medicines) may be imported. Medicines which are not registered in Serbia may be imported on the basis of a special approval issued by ALIMS for import of registered medicines.

 

 

 

Also from this Legal Handbook

1. What types of liability are recognized in your jurisdiction?

In Serbia, there are two parallel regimes of product of liability applicable to medicinal products. The first one is established by the Obligations Act of 1978 (as amended), while the second type is prescribed by the Consumer Protection Act of 2021. In addition to that, manufacturers may be subject to criminal liability regulated under the Criminal Code of 2005 (as amended).

 

2. How do these types of liabilities apply to the manufacturers of medicines and devices?

The Obligations Act outlines the general responsibility of manufacturers concerning potentially hazardous products. Manufacturers who release products containing defects capable of causing harm or damage to individuals or property are held liable for any resulting injury or loss, regardless of their fault. Under the Obligations Act, causal link between the damage and the product is assumed. Manufacturers are also accountable for any hazardous characteristics of their products, if they fail to implement necessary precautions measures to prevent foreseeable harm or loss. Individuals who suffered harm may seek compensation for both, material and non-material losses.

Contrary to the legislative regime where a causal link between the product and the damage is assumed, the Consumer Protection Act prescribes that the injured party must demonstrate a causal link between the damage (such as death, personal injury, or destruction of any property other than the defective product itself) and the defect. Furthermore, under the Consumer Protection Act compensation may only be obtained for material damage.

According to the Criminal Code, a manufacturer who manufactures, sells, or releases into the market a hazardous medicine or medical device is subject to criminal liability, which may result in fine and imprisonment ranging from six months to five years.

3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?

In addition to the manufacturer, who is a legal entity, individuals involved in the production or distribution of the medicine or device, in contravention of relevant legal regulations, will also be subject to liability if they have the status of responsible persons in a legal entity.

 

4. How can a liability claim be brought?

Under the Obligations Act, the individual who suffered losses may file legal action within three years from the day he/she becomes aware of both the damage and the identity of the manufacturer. In any event, the statute of limitations ends five years after the damage occurred.

According to the Consumer Protection Act, the lawsuit may be filed within three years after learning about the damage, defect and manufacturer’s identity. Nevertheless, the right to file a lawsuit expires ten years after the manufacturer placed the hazardous product on the market.

Finally, criminal proceedings are commenced by the public prosecutor ex officio. The statute of limitations for criminal prosecution varies depending on the severity of the prescribed punishment. For instance, if a criminal offense of production and sale of harmful products is committed, the statute of limitations is set at five years from the date of the criminal offense.

 

5. What defenses are available?

The manufacturer may not be held responsible if one or more of the following conditions are met:

• they did not place the product to the market;
• the defect was non-existent at the time the product was placed on the market;
• the product was neither manufactured for sale nor distributed in the course of their business activities; or
• the defect stems from the product’s compliance with mandatory regulations imposed by a competent authority.

The manufacturer may be partially or fully exempt from liability if the injured person or any person under their responsibility, contributed to the damage. Finally, the liability of the manufacturer for losses resulting from defective products cannot be restricted or eliminated by contract.

 

Also from this Legal Handbook

1. What are the basic requirements to obtain patent and trademark protection?

Under the Patent Act (Official Gazette of the Republic of Serbia, nos. 99/2011, 113/2017 – other act, 95/2018, 66/2019 and 123/2021), in order to obtain patent protection for an invention, the invention must satisfy the basic requirements of novelty, inventive step, and susceptibility of industrial application.

According to the Trademark Act (Official Gazette of the Republic of Serbia, no. 6/2020), trademark protection may be granted to a sign that is capable of distinguishing goods and services of one undertaking from those of other undertakings, and capable of being presented in the Register of Trademarks in a manner that enables the competent authorities and the public to determine the clear and precise subject matter of the protection. A trademark may consist of any signs, including words, drawings, letters, numbers, colours, three-dimensional shapes, the shape of goods or their packaging, combinations of these signs. Sounds can also be protected as trademarks.

 

2. What agencies or bodies regulate patents and trademarks?

The Intellectual Property Office of the Republic of Serbia carries out tasks related to intellectual property rights, including patents and trademarks. The Intellectual Property Office is responsible, among other things, for examining and granting patents and trademarks and maintaining the relevant intellectual property registers.

 

3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?

Inventions of products, substances, and processes in any field of technology may be eligible for patent protection if they meet the requirements of novelty, inventive step, and industrial application. The Patent Act explicitly permits patent protection for inventions involving biological material, including isolated biological material, plants, animals, and microbiological processes.

Certain inventions are excluded from patent protection. Inventions whose commercial use conflicts with public order or morality, such as human cloning processes, are ineligible. Methods for treatment by surgery, or diagnostic methods, or therapy practised directly on the human or animal body, cannot be patented. However, products, particularly substances or compositions, intended for use in these methods (that is, medicines and medical devices) are patentable. Patents are not granted for inventions related to plant or animal varieties, or essentially biological processes for producing plants or animals, excluding microbiological processes.

A sign can be registered as a trademark if it is used to distinguish goods and services in trade and may be graphically presented. Any type of a product, substance, or process may be protected by a trademark. The law list nearly 20 grounds on which a mark cannot be registered as a trademark. The absolute grounds for refusal of registration exist in the following situations, among others:

• the mark is devoid of any distinctive character;
• the mark consists exclusively of the shape which results from the nature of the goods themselves, the shape of goods which is necessary to obtain a technical result, or the shape which gives substantial value to the goods;
• the mark consists exclusively of signs or indications which may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin, or the time of production of the goods or of providing of the service, or to designate other characteristics of the goods or services;
• the mark may deceive the consumers, as to the nature, quality or geographical origin of the goods or services; or
• the mark which is contrary to public order or morality.

4. How can patents and trademarks be revoked?

Patents and trademarks may be revoked if the requirements for protection were not met at the time of granting. Any individual can initiate the process of revoking a patent by submitting a written request to the Intellectual Property Office. The office then forwards the request to the patent owner for response. This process may involve multiple submissions and, if necessary, a hearing. The procedure concludes with the Intellectual Property Office’s decision to refuse the revocation request, partially or fully revoke the patent, or maintain it with amendments. The procedure for trademark revocation follows a similar process. Depending on the specific grounds for revocation, authorized initiators can be an interested party, the public prosecutor, or the owner or applicant of an earlier trademark. The procedure ends with the Intellectual Property Office’s decision to revoke the trademark in whole or in part, or to refuse the revocation request.

 

5. Are foreign patents and trademarks recognized and under what circumstances?

Patents and trademarks registered in a foreign country do not enjoy protection in Serbia. To obtain protection in Serbia, patents and trademarks must be registered specifically for the Serbian territory. However, foreign patents and trademarks may benefit from the international treaties of which Serbia is a member: Paris Convention, Patent Cooperation Treaty, European Patent Convention, and the Madrid System for international trademark protection. Based on Paris Convention, applicants who have filed for patent or trademark protection in one member state of the Paris Convention may claim priority when applying for protection of the same invention or trademark in Serbia, provided they file within 12 months for patents or 6 months for trademarks from the date of the first (foreign) application. The Patent Cooperation Treaty, European Patent Convention, and the Madrid System enable simultaneous application for patent or trademark protection in multiple countries, including Serbia, by filing a single application with a competent trademark or patent administration.

 

6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?

In addition to patents and trademarks, medicines may benefit from regulatory data protection and market exclusivity period.

The regulatory data exclusivity period for a reference medicinal product in Serbia is eight years, while the market exclusivity period is 10 years in line with the current EU regulatory data protection and market exclusivity periods. Regulatory data protection means that an applicant for a marketing authorization in a summary procedure (i.e., a manufacturer of generics, hybrids, or biosimilars) may submit a request to obtain a marketing authorization following the expiry of eight years from the date of issuance of a global marketing authorization in Serbia, the European Union, or a country with the same or similar requirements for issuing marketing authorization. The market exclusivity period provides that a marketing authorization following an application may be issued after 10 years from the issuance of global marketing authorization.

However, manufacturers with a registered seat in Serbia may benefit from an exception to the data and market exclusivity periods for a reference medicinal product, as they are entitled to apply for the marketing authorization after the expiry of six years from the day of issuance of the global marketing authorization for the reference medicinal product. This exception applies to large molecules, while for a biotechnological medicinal product, the period of market exclusivity is still 10 years. The Medicines Act provides in transitional provisions that the regulatory data protection period of eight years and market exclusivity period of 10 years will be applicable to manufacturers with a seat in Serbia from the day of accession of Serbia into the European Union.

Variations in terms of medicinal product strength, pharmaceutical form, methods of administration, packaging or variations and claims for extension of the scope of the marketing authorization will not extend the exclusivity period. However, the period of 10 years may be extended (cumulatively) for one more year, if, during the eight years from the issuance of the marketing authorization for the reference medicinal product, the marketing authorization holder of the reference medicinal product obtains a new marketing authorization for one or more new indications that show a significant improvement in that referent medicinal product therapy, or is a new classification has been determined on the basis of significant pre-clinical tests of clinical trials.

 

7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?

No, the laws do not differentiate in terms of eligibility for protection based on the type of medicines or devices.

 

8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?

No, patent and trademark license agreement are not subject to approval or acceptance by any public authority.

 

Also from this Legal Handbook

1. Are there proposals for reform or significant change to the healthcare system?

There is an overall tendency by the Government to improve the healthcare system in Serbia, especially through digitalization and investments into creating conditions for biotechnology and innovative therapies. Regarding legislative changes, a new medicines act has been in the works for some time, though the draft has not yet been published. There were significant changes in clinical trials regulation in the second half of 2023, with restrictive amendments adopted in August and mostly retracted in October. These changes limited certain clinical trial phases to public healthcare institutions but allowed others to take place in privately owned healthcare institutions. A new requirement for chief investigators was introduced, mandating full-time employment in a healthcare institution, with exceptions for professors in higher education.

ALIMS has been working to streamline procedures, particularly for marketing authorizations, variations, and promotional materials for medicinal products. It is anticipated that ALIMS will meet legally prescribed deadlines for these procedures by the end of 2026, facilitating quicker access to medications in the market.

The Government established the Centre for the Fourth Industrial Revolution in Serbia in March 2022, in collaboration with the World Economic Forum. This center, the first of its kind in the region and the third in Europe after Oslo and Moscow, focuses on biotechnology and artificial intelligence in healthcare. Its goal is to bridge science and the economy, fostering research in biotechnology, molecular biology, and medicine for healthcare applications. A large part of this plan is the construction of the BIO4 Campus in Belgrade, which began in December 2023 and is expected to be completed by the end of 2026. This campus will serve as a hub for biotechnology and healthcare innovation, bringing together research centers of companies in biomedicine, biotechnology, bioinformatics, and biodiversity. The government has signed MoUs with major global pharmaceutical companies for investment and collaboration. Additionally, the BIO4 Campus will host a startup accelerator to support Serbian companies in biology-related fields.

 

2. When are they likely to come into force?

There is still no concrete timeline for the adoption of the expected regulatory changes.

 

Also from this Legal Handbook

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

Yes, cannabinoid-based medicines may be authorised, under the requirements prescribed by the relevant legislation.

Cannabinoid-based substances are classified as the psychoactive controlled substances that are regulated by the Psychoactive Controlled Substances Act (“Official Gazette of the Republic of Serbia”, no. 99/2010 and 57/2018). As a general rule, the production, sale, and use of psychoactive controlled substances as well as the delivery of psychoactive controlled substances are prohibited, except otherwise prescribed by the Psychoactive Controlled Substances Act. In particular, the cannabinoid-based medicines may be permitted only if listed as substances used for therapeutic or research purposes by the Minister of Health.

 

2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?

The regulatory authority that has jurisdiction over the production, sale, and use of the cannabinoid-based drugs is the Ministry of Health. The Ministry of Health is also authorized to, inter alia:

1. issue approvals for the conduct of preclinical testing related to psychoactive controlled substances;
2. issue manufacturing licenses for the production or distribution of psychoactive controlled substances;
3. issue consents for the use of medicines containing psychoactive controlled substances before initiating clinical trials of the medicine;
4. monitor the consumption of psychoactive controlled substances in healthcare institutions and private practice.

 

Further, the Medicines and Medical Devices Agency of Serbia (ALIMS) is authorised to issue a marketing authorisation for placing the cannabinoid-based medicine on the market, provided that the active substance contained in the medicine is classified as safe for therapeutic purposes by the Minister of Health.

The Commission for Psychoactive Controlled Substances (the Commission) provides expert opinions on issues regulated by the Psychoactive Controlled Substances Act. The Commission consists of representatives from ministries responsible for health, education, internal affairs, labor, social policy, defence, youth and sports, culture, justice, agriculture, environmental protection, veterinary, public administration and local self-government, finance – customs administration, representatives of the Security and Intelligence Agency and the Office for the Fight against Drugs, as well as prominent experts in the field of psychoactive controlled substances.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?

The legal framework applicable to the cannabinoid drugs consists of:

• The Psychoactive Controlled Substances Act (“Official Gazette of the Republic of Serbia”, no. 99/2010 and 57/2018);
• The Rulebook on Establishing the List of Psychoactive Controlled Substances (“Official Gazette of the Republic of Serbia”, No. br. 40/2023);

 

In addition to that, the regulations governing the medicines in general are also applicable to the cannabinoid drugs, namely the Medicines and Medical Devices Act (“The Official Gazette of the Republic of Serbia”, No. 30/2010 107/2012, 105/17 and 113/2017) and its implementing regulations.

To date, no cannabinoid-based medicine has been registered. Hence, it was not possible to include such medicines on the list to medicines to be reimbursed by the health insurance.

 

4. Which are the cannabinoid drugs that have received market approval to date?

Dronabinol (delta-9-tetrahydrocannabinol and its stereoisomeric varieties), is listed by the Minister of Health as the substance that may be used for limited therapeutic and scientific research purposes, meaning that medicines containing this substance may be registered with the MMDA. However, at the moment no cannabinoid-based medicines received market approval in Serbia.

 

5. Who can prescribe Cannabinoid Drugs?

Cannabinoid drugs that received the market approval may be prescribed by the doctors, in public health care institutions and private practice within the regular medical treatment.

They are to be prescribed on a mandatory medical prescription form issued in duplicate, given that they contain psychoactive controlled substances.

 

6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?

Drafting of the list of doctors who will be authorized to prescribe cannabinoid-based medicines was announced in 2016 when the Working Group formed by the Ministry of Health issued an opinion according to which internationally registered medicines containing natural or chemical tetrahydrocannabinol (THC) have a place in the treatment of symptoms of some serious illnesses, in particular multiple sclerosis. However, to this day, the specific list of doctors authorized to prescribe cannabinoid-based drugs has not been issued.

 

7. What approvals or notifications are required to prescribe Cannabinoid Drugs?

No special approvals are required when prescribing the cannabinoid-based drugs. The cannabinoid drugs must be prescribed within the regular medical treatment by the licensed healthcare professional. The Ministry of Health monitors the prescriptions of such drugs in healthcare institutions and private practice.

 

8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?

By far, no specific cannabinoid drug is registered in Serbia. Hence, no organization is authorised to sell or distribute such drugs.

 

9. Is there a list of retailers/distributors authorized to sell Cannabinoid Drugs?

There is no such list in Serbia.

 

10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?

Reform proposals are predominantly focused on the production, use and distribution of medical cannabis. There are no initiatives focused exclusively to the reforms regarding cannabinoid drugs.

 

11. When are they likely to come into force?

N/A.

 

Medicinal Cannabis

1. Is Medicinal Cannabis authorized in the country?

Cannabis is classified as a psychoactive controlled substance. In principle, the production, sale, and use of psychoactive controlled substances as well as the delivery of psychoactive controlled substances are prohibited, except otherwise prescribed by the Psychoactive Controlled Substances Act.

 

2. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?

The regulatory authority that has jurisdiction over the production, sale, and use of the medical cannabis is the Ministry of Health. The Ministry of Health is authorized to, inter alia:

1. issue approvals for the conduct of preclinical testing regarding psychoactive controlled substances;
2. issue licences for the production or distribution of psychoactive controlled substances;
3. issue consents for the use of medicines containing psychoactive controlled substances before initiating clinical trials of the medicine;
4. monitor the consumption of psychoactive controlled substances in healthcare institutions and private practice.

 

The Commission for Psychoactive Controlled Substances is authorized to provide expert opinions on issues regulated by the Psychoactive Controlled Substances Act, including the issues on the use of medical cannabis. The Commission consists of representatives from ministries responsible for health, education, internal affairs, labor, social policy, defence, youth and sports, culture, justice, agriculture, environmental protection, veterinary, public administration and local self-government, finance – customs administration, representatives of the Security and Intelligence Agency and the Office for the Fight against Drugs, as well as prominent experts in the field of psychoactive controlled substances.

 

3. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?

Regulations relevant for the use of medical cannabis are the Psychoactive Controlled Substances Act and the Rulebook on Establishing the List of Psychoactive Controlled Substances.

 

4. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?

Medical cannabis is not being produced or imported to Serbia. Once approved, the rules on the production and import of psychoactive controlled substances will apply.

In line with the Psychoactive Controlled Substances Act, the production and import of these substances may be carried out by a legal entity to which the Ministry of Health has issued a license. The license for the production or trade of psychoactive controlled substances is issued for a specific controlled substance, a specific quantity that is being produced or traded, for a specific place of production and specific facility.

The legal person to which the license has been issued is obliged to inform the Ministry of Health about the quantity of psychoactive controlled substances that will be produced or imported in the next calendar year, no later than 30 April of the current year. In addition, the legal person holding the manufacturing license is prohibited from transferring the license to any other legal or natural person.

 

5. What approval or notifications are necessary to produce or import Medicinal Cannabis?

Once the production and import of medical cannabis is approved, the Ministry of Health will regulate the approvals and notifications.

6. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?

Currently, there is no legal framework regulating the marketing and distribution of medical cannabis. However, back in 2015, when the Cannabis Legalization Working Group was active, it was announced that marketing and distribution of medical cannabis will be strictly controlled in order to ensure that the product is used exclusively for its intended purposes.

 

7. How can patients obtain Medicinal Cannabis?

At the moment, it is not possible to obtain medical cannabis in Serbia.

8. Who can prescribe Medicinal Cannabis?

At the moment it is not possible to get a prescription for medical cannabis in Serbia.

 

9. Is there a list of doctors authorized to prescribe Medicinal Cannabis?

No, there is no list of doctors authorized to prescribe medical cannabis.

 

10. What approvals or notifications are required to prescribe Medicinal Cannabis?

Once the therapeutic use of medical cannabis is approved, the Ministry of Health will regulate the approvals and notifications.

 

11. Where is Medicinal Cannabis available?

Medical cannabis is not available in Serbia.

 

12. Is there a list of retailers authorized to sell Medicinal Cannabis?

No, there is no list of retailers authorized to sell medical cannabis.

 

13. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?

Yes, during the past years, there have been numerous calls in the Parliament and the media to reform the legal framework that regulates the use and distribution of medical cannabis. As a result, the Ministry of Health formed a Working Group for the legalization of cannabis for medical purposes. The Working Group consisted of representatives from the Ministry of Health, the Ministries of Internal Affairs, Justice, and Agriculture, as well as a representative from the ALIMS and patient association representatives.

The Working Group issued an opinion stating that internationally registered medicines containing natural or chemical THC deserve place in the medical treatment of severe diseases, in particular multiple sclerosis. The Working Group emphasized that clinical studies have shown that medical cannabis alleviates the symptoms but in no way cures the illness (e.g. multiple sclerosis, cancer or HIV).

According to the Working Group, the use of cannabinoid-based drugs such as Dronabinol (for treating weight loss in HIV and AIDS patients and chemotherapy-induced nausea and vomiting), Nabilone (for treating nausea and vomiting in chemotherapy patients), and Sativex (a spray given to multiple sclerosis patients for relieving spasms) is acceptable. However, when it comes to cannabis oil, the Working Group concluded that it should not be legalized, given that there are no defined standards for the production and composition of the oil.

 

Opioid Drugs

1. Are Opioid Drugs authorized in your country?

Yes, opioid drugs are authorized in Serbia.

 

2. What are the regulatory authorities with jurisdiction over Opioid Drugs?

The regulatory authority that has jurisdiction over the opioid drugs is the Ministry of Health. The Ministry of Health supervises the implementation of the Psychoactive Controlled Substances Act and the Medicines and Medical Devices ACT. The ALIMS is responsible for issuing marketing authorisations for placing the opioid drugs on the market.

 

3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?

The legal framework applicable to opioid drugs consists of:

1. the Medicines and Medical Devices Act;
2. the Psychoactive Controlled Substances Act;
3. the Rulebook on Establishing the List of Psychoactive Controlled Substances;
4. numerous implementing regulations governing specific issues, such as quality control, clinical drug trials, labelling and advertising of drugs.

General rules on pricing and reimbursement apply to opioid drugs. The opioid drugs registered in Serbia are reimbursed by the health insurance, given that they are listed at the “List A” and fall under the category of drugs that must be prescribed on a mandatory medical prescription form.

 

4. Which are the Opioid Drugs that have received market approval to date?

The ALIMS issues and keeps up to date the list of all approved medicines, including the opioid medicines.

The following opioid drugs are registered in Serbia:

• morfin – MORPHINI HYDROCHLORIDUM
• hidromorfon – JURNISTA,
• petidin hidrohlorid – DOLANTIN 100
• butorfanol – MORADOL
• fentanil – DUROGESIC
• tilidin – VALORON
• tramadol – TRAMADOL, TRAMAFLASH, TRODON, SINTRADON, PROTRADON, TRAMA 24 RETARD

 

5. Who can prescribe Opioid Drugs?

Opioid drugs are to be prescribed by the doctors on a mandatory medical prescription form issued in duplicate, given that they contain psychoactive controlled substances.

 

6. Is there a list of doctors authorized to prescribe Opioid Drugs?

No, there is no list of doctors authorized to prescribe opioid drugs.

 

7. What approvals or notifications are required to prescribe Opioid Drugs?

No special approvals are required when prescribing the opioid drugs. The opioid drugs must be prescribed within the regular medical treatment by the licensed doctor. The Ministry of Health monitors the prescriptions of such drugs in healthcare institutions and private practice.

 

8. Which organizations are authorized to sell/distribute Opioid Drugs available?

Opioid drugs are sold/distributed only in licensed pharmacies, which must be approved by the Ministry of Health (Department of Health Inspection) and registered with the Serbian Business Register Agency.

 

9. Is there a list of retailers/distributors authorized to sell Opioid Drugs?

There is no specific list of retailers/distributors of opioid drugs. However, the ALIMS keeps a record of marketing authorisation holders and manufacturers of opioid drugs registered in Serbia.

 

10. Are there proposals for reform or significant change to the regulation of Opioid Drugs?

There are no public initiatives to reform regulations on opioid drugs. Occasionally, experts call for caution in prescribing the opioid drugs as they cause addiction.

 

11. When are they likely to come into force?

n/a