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

The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA), a decentralized Health Ministry (HM) agency, is responsible for applying and enforcing the regulatory framework regarding human medicines, biologicals, and medical devices.

 

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

The primary legislation for the authorization, pricing, and reimbursement of medicines, biologicals, and medical devices is the Health Law (HL) and its regulations, which are based on the World Health Organization (WHO) guidelines.

ARCSA is the regulatory agency for sanitary control. Marketing authorizations are required for imported and domestic products such as medicines, biologicals, and medical devices. The National Council for Fixing and Reviewing Drug Prices (CNDP), part of the HM, is responsible for the approval and revision of pricing.

In Ecuador, the commercialization of medicines and biologicals without marketing authorization and price determination is prohibited.

 

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

Essentially, applicants applying for marketing authorizations must prove the safety and efficacy of their products through clinical trials, according to the rules set out by the HL and its regulations, which cover not only the products but also the active ingredients.

Manufacturers must provide all information about the development, testing, and marketing of their products in the Ecuadorian territory and, when applicable, from abroad. The information must include the following:

• Analytical methodology of the active ingredient and the final product.
• Certificate of analysis in drug control test standards.
• Stability studies (3 batches) to be carried out in Climate Zone IV subtropical with possible high humidity, according to the OMS classification.
• Analysis procedure for identifying, quantifying, and evaluating the finished product’s physical, physical-chemical, biological, chemical, microbiological, and pharma-ecological characteristics.
• Preclinical studies (where appropriate).
• Toxicity report.
• Pharmacological, toxicological, and clinical work must be published in scientific journals of international prestige within the last five years.
• Immunogenicity report.
• Pharmacokinetics Studies.
• Pharmacodynamics Studies.
• Clinical Trials.
• Certificate of Pharmaceutical Product (CPP)
• GMP Good Manufacturing Practices certificate
• Labels
• Packaging Information
• Certificate of Analysis (CoA)
• Color index by FDA (when appropriate)
• Product specifications.
• Manufacturing process description.
• Those established by articles 5 and 6 of the Regulation of Sanitary Registration for Medicines.

Research and Development companies can benefit from an approval procedure for medicines when they have been previously approved by:

• The European Medicines Agency (EMA), recognized locally
• The US Drug and Food Administration (FDA)
• Health Canada

It is the responsibility of the investigating laboratory to issue a responsibility letter stating:

• Certification of the research plan (according to international references)
• Certificate of experimental phase conclusion of the medicine
• Pharmacovigilance programs (3 years after the marketing authorization granting date)
• Additional requirements for subsidiaries and products with more than five proven years of commercialization abroad are established in Article 9 of the Regulation of Sanitary Registration for Medicines.

 

4. What are the approximate fees for each authorization?

Since Ecuador does not conduct research and development of new molecules (medicines), the Government has not established official fees for this purpose. However, there is a homologation process to obtain marketing authorizations applicable to foreign drugs, which amounts to USD2258.41. and 904.34 for medical devices.

The fees for registering and reviewing requirements for international and national sponsored clinical trials are national sponsors ($870.10) and international sponsors ($1670.65). For the application for approval of the clinical trials, the amount of the fee to national-sponsored clinical trials ($1520.18) and international-sponsored clinical trials (USD 2,721).

 

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

Marketing authorizations for medicines, biologicals, and medical devices must be renewed every five years. The renewal process involves official fees (20% of the registration inscription fee) and is the procedure for updating the marketing authorization once its validity period has ended. The renewal process is carried out in ARCSA’s electronic system; however, it only applies to products that have not changed their characteristics since approval. If any legal or technical information changes without the previous approval of the authority, the process to follow is the same as for a new marketing authorization.

 

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

There is no differing process between brand-name products and generic products; however, for brand-name products, it is necessary to prove safety and provide efficacy parameters. For generic products, it is required to prove the medicine’s interchangeability and biocompatibility. Labeling requirements also differ since generics have to declare the International Common Denomination (ICD) and include “Generic Medicine.”

The differences between local and foreign manufacturers include the registration form for foreign manufacturers, which may be by homologation, and the applicable government fees, which are less for local manufacturers. There is also a difference in the time it takes to overcome technical-chemical or safety-efficiency objections (30 days for local manufacturers and 60 days for foreign manufacturers).

 

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

Combination products will be registered under the same marketing authorization when in their commercial presentation, another medication or medical device whose purpose is to supply medication is included.

These combination products are regulated by ARCSA which will require a classification process prior to applying for the marketing authorization. Given their particular features, these products can be classified as: medicines (medicines/ biologicals) and/or medical devices (drug/device). Requirements and application timeframes differ in each case, depending on the nature of the combination 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?

ARCSA monitors and evaluates compliance. Compliance with GMP, GSP, GTP, and standard operating procedures is comparable with the expectations and requirements of the U.S. Food and Drug Administration or the European Medicines Agency.

All GMPs must be registered in the platform of the authority linking the products registered in Ecuador and the authority linking the products registered in Ecuador, the platform of the authority linking the products registered in Ecuador, and the authority’s platform linking the products registered in Ecuador with a list of products manufactured by the same manufacturing site.

ARCSA is strengthening the pharmacovigilance program to ensure that all procedures are controlled from manufacturing until post-registration.

 

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

ARCSA is empowered to visit any premises at any time and verify compliance. It can also initiate ex-officio legal proceedings to sanction non-compliance. Penalties include the cancellation or suspension of the marketing authorization, the temporary or definitive closure of facilities, and fines amounting to approximately USD 4250.

 

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

The healthcare system comprises public (social security) and private insurers, out-of-pocket payments, and informal arrangements.

The Ecuadorian Institute of Social Security (IESS) is the central public segment. This entity provides health services for the self-employed and employees in public and private companies. Other systems with unique structures exist, for example, for members of the military and police.

The public health sector typically faces financial problems. To limit costs, it implements measures such as pressing for price reductions in public bids, encouraging competition, and using generics.

 

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

Private health insurance generally covers the private sector’s higher economic levels. Enrolment in private health insurance has increased considerably over the past few years.

The public and private health sectors function separately. However, some private sector healthcare facilities assist IESS patients.

 

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

Yes, the HM regulates drug prices through the CNDP. However, medical device prices are not regulated.

There are three applicable regimes for establishing medicine prices:

Regulated: This regime sets the price caps for each market segment of essential or new medicines. The price caps for each segment will be calculated using the average retail prices in the private market. For new medicines, the level of therapeutic innovation will be used as the basis for establishing the price cap.

Direct: The Government unilaterally sets medicine prices only in specific situations, such as when essential and new medicines are commercialized without price regulation or companies do not adhere to the price caps.

Open: This applies to products not included in the two previous regimes. Manufacturers will be free to set prices, but the CNDP must be notified of the price used.

 

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

Insurance companies are currently improving the level of coverage by making themselves responsible for the supply of medicines since the private market for medicines has grown considerably.

All payments are made out-of-pocket. In the public sector, patients should receive the products from the Government; however, in practice, patients obtain the products out-of-pocket.

 

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

The public health system dispenses the products prescribed by their healthcare professionals. Products are prescribed from an essential medicinal products list issued by the HM. The Government acquires those listed products mainly through public tender processes, public auctions, and medicine acquirement governed by a particular regime. As for 2022, public health system patients can acquire prescribed medicines from private pharmacies with no out-of-pocket payment.

In private health systems, patients can purchase products from private pharmacies and request reimbursement or purchase products from their insurance provider.

 

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?

The HM issues prescription regulations that are of mandatory compliance for all members of the National Health System. The medicine dispensers must obtain an operating permit.

ARCSA conducts special controls for controlled medicines. These controls include a monthly report to be submitted by the pharmacy to the authority. The report must be accompanied by the original copy of the prescription (a special prescription issued by the Health Ministry) and signed by the responsible biochemist.

ACESS (Quality Assurance of the Health Services) controls the health professionals who prescribe controlled medicine. Health professionals must archive a copy of all perceptions for the review of the authority,

The manufacturer and local distributor (if applicable) are responsible for the products’ safety and information. Safety and information requirements should be complied with when obtaining product marketing authorizations.

Also from this Legal Handbook

As a general introduction, clinical trials are regulated in Ecuador via the Ministerial Agreement (MA) 0075-2017 and reform 0006-2020, which relates to regulations for approving, developing, monitoring, and controlling clinical trials. This regulation was enacted on June 30th, 2017. Other rules and regulations make MA 0075-2017 enforceable.

The Constitution of the Republic of Ecuador, in subparagraph d), 3, of Section 66, prohibits using genetic material and scientific experimentation that violates human rights.

Every person without discrimination has, concerning health, the right not to be the subject of tests, clinical trials, laboratory or research, without their knowledge and prior written consent, nor be subjected to tests or examinations diagnoses, except when the law expressly determines it or in case of emergency or urgency in which his/her life is in danger, as defined in article 7, literal l) of the Health Law.

The Code of Childhood and Adolescence, in Section 20, states: “Right to life. Children and adolescents have the right to life from the moment of conception. The state, society, and family must ensure their survival and development by all means. Medical and genetic experiments and manipulations may not be conducted on pregnant women, children, or adolescents, nor any technique or practice that endangers the lives or affects the integrity or integral development of any of those mentioned above.”

It is ARCSA’s responsibility “to approve clinical trials of medicines, medical devices, natural products for medicinal use and other products subject to registration and sanitary control based on regulations issued by the HM.”

 

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

Clinical trials must be conducted under conditions that ensure respect for human dignity, human rights, autonomy, informed consent, the precautionary principle, personal integrity, privacy, confidentiality, equality, justice, equity, discrimination, cultural diversity, and the well-being of people. According to our law, the rights, safety, and well-being of individuals and society will prevail over scientific and economic interests. Therapeutic benefits and the risks and disadvantages for the subject of the trial and public health will be evaluated.

 

2. How are clinical trials funded?

Clinical trials are generally funded privately. To carry out a clinical trial in our country, all persons, whether public, private, national, or foreign, who are sponsoring the trial must request prior approval from ARCSA. ARCSA will also verify and inspect compliance with legal, ethical, and methodological aspects for developing the clinical trial in the country before, during, and after it is carried out and all aspects related to research technology.

 

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

To authorize a clinical trial, ARCSA will request the sponsor submit the necessary documents in Spanish or its official translation, duly legalized. Requirements for preclinical and clinical trial protocols are those defined in Section 8 of MA 0075-2017. Approval for conducting clinical trials is made by ARCSA, which must abide by the Constitution of the Republic of Ecuador; the directives contained in the Declaration of Helsinki (PARF network); CIOMS guidelines; and Good Clinical Practices established by agreements to which Ecuador is part of.

 

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

Participants must voluntarily participate in clinical trials, be previously informed about the trial, and accept it through an informed consent document. These people may or may not suffer from diseases and be aware of the possible treatments, risks, being able to withdraw the consent treatments, and risks of being able to withdraw their consent at any time. The research subjects will be supplied with the investigational product or the product used as a control once their informed consent or that of their legal representative has been obtained in the corresponding cases.

Clinical trials conducted with senior people, people with disabilities, people deprived of their freedom, and those suffering from catastrophic and highly complex diseases because they are considered priority or vulnerable care groups, must be authorized by the Ethics Committee and should be of specific interest and limited to those that by their nature can only be carried out with these population groups.

Confirming that the participant is not pregnant is basic for women of reproductive age who have consented to participate in a clinical trial before starting it. Access to and use of an effective contraceptive method must be ensured during the development of the clinical trial, which will be provided at no cost by the sponsor during their participation in the study, including male subjects.

People with disabilities may be subjects of clinical trials, with the approval of the Ethics Committee evaluating the clinical trial.

For clinical studies conducted in Indigenous towns and on Indigenous peoples, in addition to individual informed consent, a prior community consultation should be performed, which should be favorable to the completion of the study. Additionally, the community authorities’ approval in the case must be obtained. Said approval must be included in a document duly signed by these authorities, a copy of which will be attached to the procedures for requesting authorization to conduct the clinical trial. It will not be possible to carry out clinical trials in villages in voluntary isolation.

In these clinical studies, sponsors and researchers should develop culturally appropriate ways and means with anthropologists, sociologists, and translators to communicate all the necessary information regarding the trial to the research participants and meet the standards required in the informed consent process. In addition, the research protocol should describe and justify the procedure they plan to use to communicate the information to the subjects under investigation.

 

5. May participants in clinical trials be compensated?

In exceptional cases, clinical trial participants may be compensated economically, considering they must be healthy adults. Additionally, if pregnancy occurs during the clinical trial, the mother will be excluded as a research subject; the study sponsor will also monitor the patient and the newborn until the newborn is at least two (2) years old. The sponsor will repay both the mother and the newborn in case of subsequent damage produced during the pregnancy or caused to the newborn due to the execution of the research.

 

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

ARCSA regulates Good Clinical Practices (BPC) that must be observed during trials. ARCSA will periodically inspect and control BPCs complied with under penalty of declaring the trial’s continuity. Sponsors must establish a plan to remediate any nonconformity or ensure the participant’s safety.

The sponsor must provide participants with a liability insurance policy. In cases where such policy does not cover/apply, the sponsor will be responsible for relief of any harm or damages suffered by the participant. The sponsor will guarantee and provide free medical assistance until all health problems derived from their participation in a clinical trial are solved.

The sponsor must provide economic compensation to the participant in case of evidence of harm or damage and its causal relationship with the product under investigation.

Also from this Legal Handbook

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

The authorization process for marketing new drugs, biologics, medical devices, OTC, and other medicinal products is through a marketing authorization as detailed in question 3 of Chapter 1.

 

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

The authorization process and requirements for marketing generic versions are the same; the only difference is the labeling requirements.

 

3. What are the typical fees for marketing approval?

• Official fees for foreign manufactured pharmaceuticals USD 2,258.41
• Official fees for locally manufactured pharmaceuticals are USD 904.34
• Official fees foreign manufactured generics USD565.21
• Official fees for locally manufactured generics are USD 510.51
• Official fees for generic pharmaceuticals included in the basic pharmaceuticals chart USD452.17

 

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

A marketing authorization for a pharmaceutical or medical device is valid for five years. The automatic renewal proceeding applies to products that have not been subject to suspension by the Health Authority during their period of validity and have not had changes or modifications in their intended use, quality, safety, and efficacy.

The marketing authorization holder must file an automatic renewal request at least ninety (90) days before the health registration’s expiration date.

The marketing authorization is renewed within 15 working days for five years.

 

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

The holders of a marketing authorization for medicines that are marketed in Ecuador have the obligation to:

• Notify the National Pharmacovigilance Council of all suspected adverse events that occur in the country or in another country where clinical trials are conducted and/or the product is marketed;

Maintain activity in the e-reporting platform.

• Keep a detailed record of all suspected adverse events that occur in the country or in another country where clinical studies are conducted and/or the product is marketed;
• Submit safety reports every six months for new medicines (new API in Ecuador), which will allow the rectification or ratification of indications, contraindications, and adverse effects and obtain relevant information on the safety and therapeutic efficacy of the product. When a negative response is detected that exceeds the established safety limits, it must be reported immediately to the National Pharmacovigilance Council;
• Implement modifications in the technical sheet, the labeling, and the prospectus or insert them as ARCSA requires.

 

The establishments of medical devices and in vitro diagnostic biochemical reagents for human use that produce, import, export, distribute, market, store, dispense, and sell such goods have the following obligations:

• Collaborate with the National System of Technological Surveillance to identify, prevent, and notify ARCSA about the risks associated with medical devices;
• Notification of any suspected adverse events and adverse incidents to the National Pharmacovigilance Council;
• Keep a detailed record and a physical or digital file system of all suspected adverse events and incidents for at least five years.
• Continuous staff training in technological surveillance.

Additional obligations for the holder of the marketing authorization are established in Art. 26 in ARCSA Resolution 020-2016.

 

6. Are foreign marketing authorizations recognized?

Homologations are allowed for medicines, which means official recognition of the marketing authorization granted by health authorities of the countries whose regulatory agencies for medicines have been certified by the Pan American Health Organization (PAHO) / World Health Organization (WHO) as Regional Reference Authorities, as well as those marketing authorizations granted by the health authorities of the United States of America, Canada, Australia, Japan, the European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of South Korea. This list is updated periodically by ARCSA.

For a homologation to be approved in medicines, it must originate in the countries mentioned above, be part of the basic medicines required by the country (National Table of Basic Medicines), and have not been registered in the country or have less than five records of the country’s active principle, concentration, and pharmaceutical form.

 

LIST OF APPROVED COUNTRIES FOR THE HOMOLOGATION PROCESS

REGULATION	AGENCY	COUNTRY	OBSERVATIONS
Regulatory agencies qualified by the PAHO/ WHO	INVIMA, ANVISA, ANMAT, COFEPRIS, COCMED	Colombia, Brazil, Argentina, Mexico, Cuba	Marketing authorization or its equivalent
United States of America	FDA	United States of America	Marketing authorization or its equivalent
Canada	Health Canada	Canada	Marketing authorization or its equivalent
Australia	Therapeutic Goods Administration	Australia	Marketing authorization or its equivalent
Japan	Pharmaceuticals and Medical Devices Agency	Japan	Marketing authorization or its equivalent
Ministry of Food and Drug Safety	Ministry of Food and Drug Safety	Republic of South Korea	Marketing authorization or its equivalent
European Medicines Agency (EMA)	European Medicines Agency (EMA)	All member countries of the European Community through the EMA*	Only Certifications of Medicines issued by the European Medicines Agency (EMA) are accepted. Certifications of regular authorities of the member countries of the European Community are not accepted.

*Member Countries of the European Medicines Agency (EMA): Belgium, Bulgaria, Czech Republic, Denmark, Germany, Austria, Croatia, Slovakia, Slovenia, Estonia, Greece, Spain, France, Finland, Ireland, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, Netherlands, Poland, Portugal, Romania, United Kingdom, Sweden.

 

7. Are parallel imports of medicines or devices allowed?

Parallel imports are prohibited in Ecuador since marketing authorization is required to import, sell, manufacture, and import and export pharmaceuticals and medical devices.

 

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?

The promotion of medicines and medical devices must be made available to health professionals authorized to prescribe them through a pharmaceutical sales representative only for non-controlled products. During these visits, it is forbidden to grant or offer gifts, prizes, economic incentives, trips, and similar by pharmaceutical establishments dedicated to manufacturing, storing, distributing, commercializing, and dispensing medicines generally, processed natural products of medicinal use, and homeopathic medicines.

Sponsoring scientific, sporting, cultural, and other similar events under the name of medicines in general, natural medicinal products, homeopathic medicines, and medical devices is forbidden. Pharmaceutical sales representatives are also prohibited from all public health services.

 

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

The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) enforces the regulatory framework for medicines and medical devices.

Arcsa controls the permissions and good manufacturing certificates; they can inspect the permissions and good manufacturing certificates at any time to ensure the quality of products.

 

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

In Ecuador, the certificate of GMP is granted by ARCSA after complying with the requirements established in the local GMP Regulations for Pharmaceutical Laboratories, which is based on Report 37 of the World Health Organization.}

Indeed, all GMPs must be recognized on the authority platform.

 

11. What is the inspection regime for manufacturing facilities?

ARCSA is empowered to make on-site visits at any time to inspect premises and verify compliance and can initiate ex-officio legal proceedings to sanction non-compliance. Ultimately, these legal proceedings can result in fines, seizures, the revocation of the marketing authorization, and the closing of facilities. GMP, stability, labeling standards, and all other applicable provisions must be complied with. The marketing authorization holder must have a program to recall and destroy products that do not meet quality standards.

GMP inspections will be carried out by qualified technical personnel from ARCSA, and eventually, depending on the case, advisors with a specialized technical background but without voting rights can participate.

 

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

Inspections are performed solely by ARCSA.

 

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

The main requirement is the Good Storage, Distribution, and Transportation Practices (GSP/GDP/GTP) Certificate issued by ARCSA.

To obtain it, the company must comply with the following:

1. a. Legal status
2. Legal representative;
3. Equipment and facilities that correspond to the activities developed.
4. Operation permit issued by ARCSA.
5. Technical advice from a Biochemical Pharmacist with an employment contract.
6. Documentation describing the functions and responsibilities of the staff in the pharmaceutical establishment according to the organization chart.
7. Standard Operating Procedures (SOPs) according to the activities developed.
8. Technical documentation of all activities.

To obtain the GSP/GDT/GTP certificate for an establishment that outsources Storage, Distribution, and/or Transport, the company must comply with the following:

• The contract between the establishment and the company.
• List of products.
• Letter of application.

 

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

Medicines in general:

1. Name of the product.
2. Generic name (DCI)
3. Pharmaceutical form.
4. Container net content expressed in the International System of Units (SI, from the French Le Système International d’Unités)
5. Qualitative-quantitative formula.
6. Administration routes (they may be cut off except in injectable products, ovules, and vaginal pills).
7. Batch number or code.
8. Pediatric use if the product requires it.
9. Conservation temperature.
10. Manufacturer’s name, city, and country (if it operates under another license, control, and other forms of responsibility or has packaging companies other than the manufacturer, the name must be stated. It is possible to omit this in the internal packaging and place only the logo).
11. Date of manufacture and expiration.
12. Marketing authorization number.
13. m. Sales specification:
14. OTC.
15. Under medical prescription.
16. Under controlled prescription.
17. Restricted circulation (may be omitted in the inner labeling)
18. Sales price (PVP)

All labeling information must be clear and in Spanish.

In the case of the medical samples, the inner and outer labels must include MEDICAL SAMPLE SALE PROHIBITED.

 

Generics: In the case of generics, including the generic name in capital letters, the color red, Pantone Red 032, and a size 20% larger than the product’s brand name is also mandatory.

 

Medical Devices:

1. Commercial name of the product;
2. Container or packaging contents;
3. Use indications, where appropriate;
4. Warning and precautions of use; the use of symbols is permitted;
5. Storage conditions, the use of symbols is permitted;
6. Manufacturer’s name, city and country;
7. Manufacturing locations, where appropriate,
8. Expiration date, where appropriate;
9. Shelf life, where appropriate;
10. Storage temperature, where appropriate;
11. Batch number/series;
12. Marketing authorization number;
13. Sales price (PVP);
14. Legends; the use of symbols or images is permitted when appropriate:
15. “Antes de usar este producto, ver inserto/manual de uso adjunto” for those medical devices that require the inclusion of the legend. ;
16. “Estéril,” for products that require it; 3. “Producto desechable o no reusable,” for non-reusable sterile medical devices;
17. “Proteger de la luz,” when applicable.

The label for medical devices may be in English or Spanish. ARCSA reserves the right to request all relevant information in Spanish.

 

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

a. For OTC, the label shall include:

Warning: “If symptoms persist, consult your doctor.”

b. For medical samples, labels must declare:

“Medical Sample, sales prohibited”.

c. Other information; using images or symbols description, where appropriate.

“Medical Sample, sales prohibited.”

1. For medical device information, use images or symbol descriptions, where appropriate.

Example.

1. “Protect from light”.
2. “This product should not be administered during pregnancy or when its existence is suspected.”

 

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

Slogans such as “the greatest choice,” “the most frequently recommended,” “the best,” “totally reliable,” and “the most effective” are not scientifically verifiable.

 

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

Goods that require a prescription cannot be advertised.

General publicity for OTC medicines and devices is possible with prior authorization from the ARCSA.

The advertisement must indicate the product’s therapeutic indications or uses. The advertising content should contrast its color with the background in audiovisual and printed media (such as brochures, flyers, and leaflets).

The advertising permit will be valid for six months under the conditions on which it was approved.

Publicity restrictions are:

• Offensive comparisons
• Promote the indiscriminate use of the product
• Include underage’s
• Use of censored images.

 

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

The HL establishes that all medicines, including OTC, must be sold in authorized establishments with the corresponding permits.

Medicines and devices can be delivered by entities holding the necessary permits (GSP/GDP/GTP).

 

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

The HM oversees monitoring this type of publicity and checking that they have all the corresponding permits. The HM also monitors the advertising to ensure it is within the authorization parameters. If there is a breach, the authority will give the offender five days to change the publicity. If the offender fails to comply, the advertising authorization can be suspended, and fines can be imposed.

 

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

Only OTC products can be advertised to the general public with prior approval. All medicinal goods must be sold in facilities holding the necessary permits.

ARCSA permanently controls all aspects of medicines and medical devices.

 

21. How is compliance monitored?

It is also common for competitors to raise claims for non-compliance with ARCSA.

ARCSA can review compliance at any moment before approval of the market authorization.

 

22. What are the potential penalties for noncompliance?

The sanctions for not complying with the advertising rules are the suspension of advertising activities and fines and, in some instances, the temporary or definitive closure of the establishment, including the revocation of the marketing authorization.

In addition, if the breach of the advertising rules deceives consumers and generates a competitive advantage, the Superintendence for Market Power Control (SCPM) may impose a fine of up to 10 % of the infringing party’s total turnover in the fiscal year preceding the fine.

Also from this Legal Handbook

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

The General Health Law (HL) and its regulations govern traditional, complementary, and alternative medicines.

These medicines are known as natural, whose active ingredients are formed by any part of natural medicinal resources or combinations thereof, such as crude drugs, extracts, or recognized pharmaceutical forms used for therapeutic purposes.

These will not be considered processed natural products for medicinal use if the natural resource for medicinal use is combined with chemically active substances, including isolated and chemically defined constituents of natural resources.

These medications will not be injectable; their use will only be oral or topical.

 

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

Advertising is possible with prior authorization from the ARCSA. Advertising can be done through any means.

It is not possible to advertise medicines that require a prescription.

 

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

The advertising of traditional, herbal, complementary, or alternative products directed at the general public should include the therapeutic indications or uses of the medicine. It must be following the marketing authorization certificate. The information contained in the advertising material cannot induce a false, erroneous, and/or confusing interpretation of the product. It must be clear and understandable.

The product should include the following phrases: “Medicinal product, keep out of the reach of children” and “In case of adverse effects, immediately contact your doctor.” Additionally, it is prohibited to induce indiscriminate use or suggest that the lack of use can cause health problems.

 

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

OTC medications must demonstrate efficacy and safety in relation to the prevention and relief of symptoms or signs of mild diseases of easy identification; that they have a wide range of safety, in such a way that the voluntary or involuntary administration of doses higher than those recommended does not represent a severe danger to the patient’s health; that they have a wide range of dosage, which can be adapted to the age and weight of the patient; that their use does not generate tolerance or dependence and that they are not susceptible to abuse; that when used according to the instructions, they do not mask serious diseases or delay the diagnosis and treatment of a condition that requires medical attention; that their use is safe in all groups of the population; that the dosage forms are generally oral or topical and not injectable; that the active ingredient has been marketed under medical prescription for at least ten (10) years, demonstrating a favorable safety and efficacy index documented with drug monitoring data; that reports of adverse reactions have not increased during the period in which the medication has been in use.

 

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

OTC products must be commercialized in legally authorized establishments with mandatory permits.

To advertise on TV or any other form of media, prior authorization issued by ARCSA is required.

 

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

The HL states that all medicines, including OTC products, must be commercialized in legally authorized establishments with mandatory permits.

 

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

Advertising of OTC products directed at the general public should include the therapeutic indications or uses of the medicine and must be in accordance with the marketing authorization certificate. The information contained in the advertising must be clear and understandable.

The phrase “If the symptoms persist, consult your doctor” should be included in the product.

 

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

No process is expressly established to convert a product sold only by prescription into an OTC product. However, the marketing authorization holder may submit a written request to ARCSA to request the reclassification. ARCSA will determine the reclassification process, following the criteria mentioned in Chapter 4

 

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

The HL establishes that marketing authorizations for medicines, including traditional medicines, must be obtained from ARCSA before importation. In addition to the marketing authorization, the importer must have the operating permit, which has to be linked to a warehouse with a Good Storage, Distribution, and Transportation Practices (GSP/GDP/GTP) Certificate issued by ARCSA.

Also from this Legal Handbook

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

In general terms, liability arises from the Civil and Criminal Codes, and it is personal responsibility for actions or omissions. However, the Consumer Protection Law establishes that civil damages may be claimed in case of damages caused by a defective or damaged product, where the manufacturers, importers, distributors, sellers, or whoever may have put their trademark on the goods are responsible.

Those jointly liable may repeat the action against the primary responsible party.

The proceedings for damages in Ecuador are not common since it is necessary to quantify and demonstrate the damage and also show the relationship of cause/effect between the actions/omissions and the damages caused using substantial evidence.

 

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

The law establishes that the holder of the marketing authorization for the medicine or medical device is legally and technically responsible for the quality of the product within the country. If the owner of the registration and the manufacturer of the product are different companies, agreements are expected to be entered into setting out the obligations of each party involved if litigation arises involving the products, additionally with joint liability that applies to all people involved in the damage.

 

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

Civil liability only extends to the holder of the marketing authorization and jointly to those who participate in the product’s production, manufacturing, and sale, provided they participate directly as individuals. Joint liability does not extend to those individuals who work or represent a legal entity.

 

4. How can a liability claim be brought?

The affected party can appear before a contraventions court, which will determine the existence of an infringement and order, if applicable, the payment of compensation in favor of the claimant, which must be paid in a new civil proceeding.

The affected party may also go directly before a civil judge. However, they must provide all evidence proving the existence of the infringement, the relationship between the action/omission and the effect, and the defendant’s responsibility.

If a group of people claim to be affected, each must ratify the claim and appear in the proceeding. They could all name the same attorney, thereby creating conditions similar to those of a class action.

Consumer associations duly established following the law could also take this action.

 

5. What defenses are available?

The holder of the marketing authorization is the one who must respond in a proceeding.

Through contractual provisions, the other parties involved in manufacturing and selling the goods may appear in the proceeding or, in turn, assume the costs of the defense. If ordered to pay damages, the action can constantly be repeated through a separate action against the party responsible for the infringement or non-compliance (not the legal representative, as it will always be the holder of the marketing authorization).

Also from this Legal Handbook

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

Any sign distinguishing goods and services on the market shall constitute a mark. Signs capable of graphic representation shall be eligible for registration as a mark; in particular, the shape of a product, its packaging, or wrapping may constitute a trademark.

Patents will be granted for inventions, whether for goods or processes, in all areas of technology, provided that they are new, involve inventiveness, and are industrially applicable.

 

2. What agencies or bodies regulate patents and trademarks?

The local IP Office, SENADI, regulates patents and trademarks.

 

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

There are no restrictions on trademarks; protection will be granted to all non-traditional marks, including 3D marks.

The patentability exceptions are a) discoveries, scientific theories, and mathematical methods; b) Any living thing, either complete or partial, as found in nature, natural biological processes, and biological material, as existing in nature, or able to be separated, including the genome or germ plasma of any living thing; c) literary and artistic works or any other aesthetic creation protected by copyright; d) plans, rules, and methods for the pursuit of intellectual activities, playing of games, or economic and business activities; e) computer programs and software, as such; f) methods for presenting information; g)therapeutic or surgical methods; and, h) second and novel uses, e) plants, animals, and essentially biological processes for producing plants or animals other than non-biological or microbiological processes.

 

4. How can patents and trademarks be revoked?

TRADEMARKS

Cancellation: A mark becomes vulnerable to a cancellation action for lack of use (total or partial) if it has not been used by its registered owner (for all the protected goods/services in the case of a partial cancellation) within the past three years in at least one of the Andean Countries (Colombia, Ecuador, Peru, and Bolivia). The burden of proof of use of the mark falls on the registration owner. A positive resolution in a cancellation action grants the plaintiff preferential rights to register the canceled mark, and this action may also be brought as a defense in an opposition proceeding.

A cancellation action for notoriety may be brought when notoriety existed in any country party to the Paris Convention and/or member of the Andean Community at the time the challenged Ecuadorian mark was filed and continues at the time the action is brought.

Where the owner of the mark has caused or allowed that mark to become a common or generic sign to identify or denote one or several of the goods or services for which it was registered, the competent national office shall order, ex officio, or at the request of a party, the cancellation of the mark or the limitation of its scope.

Nullity: The authority shall, either ex-officio or at the request of an interested party and at any time, declare the registration of a mark null and void when registration of such mark was granted against absolute grounds for refusal. The authority shall, either ex-officio or at the request of a third party with a legitimate interest, declare the invalidation of a registration where granted in contravention of relative or absolute grounds for refusal or obtained in bad faith.

 

PATENTS

Andean Decision 486, which is the IP supra-national law applicable in Ecuador, determines that the competent national authority may, either ex-officio or at a request of a party, and at any time, declare a patent null and void when the subject matter of the patent is not an invention (i.e., discoveries, scientific theories, mathematical methods, living things as found in nature, literary and artistic works, plans, rules, and methods for pursuing intellectual activities, playing of games, or economic and business activities, computer programs and software, as such, and methods for presenting information).

Other causes of nullity are the lack of fulfillment of the patentability requirements (novelty, inventiveness, industrial applicability), matter excluded from patentability (inventions whose commercial exploitation is necessary to protect public order, human or animal health, and the environment, plants or animals and essentially biological process for their production other than non-biological or microbiological processes, diagnostic, therapeutic, and surgical methods for the treatment of humans or animals), lack of proper disclosure of the invention or lack of deposit of biological material; claims not duly supported by the specification; a granted patent that is of broader scope than the original application; lack of the access contract of genetic resources in such inventions, or lack of a document certifying the existence of a license or authorization for the use of traditional knowledge belonging to local communities.

The nullity of a patent can also be declared when there are grounds for absolute invalidation according to domestic law covering administrative acts and applies to the claims or parts thereof that are affected. The defects in administrative acts that have not brought about absolute invalidity shall result in relative invalidity. In such cases, the competent national authority shall declare such invalidity within the following five years, as counted from the date of the patent grant, as provided by the national law.

The patent, claim, or part of a claim that has been invalidated shall be deemed null and void from the filing date of the patent application.

The competent national authority may cancel a patent where it has been granted to a person not entitled to such grant. The action for cancellation may only be brought by the person to whom the right to the patent belongs. Such action shall not be possible after five years following the date of grant of the patent or after two years following the date on which the person to whom that right belongs became aware of the exploitation of the invention in the country, whichever period expires first.

The competent national authority ruling on a case of invalidity shall inform the patent owner so that he may present such arguments and submit such evidence as he may consider fit. Where this is necessary for a ruling on the invalidity of a patent, the national authority may request the patent owner to submit documents referring to expert opinions or related patentability examinations performed by other patent authorities.

In addition, the local IP Law in force since December 2016 introduces sanctions for the falsehood, deliberate omission, deliberate obscurity, or deliberate complication of the information in the application or the description of the invention, hindering the national competent IP authority from examining the patent application, misleading it in the examination or not allowing it to be put into practice, which will be grounds for rejection of the application or absolute nullity of the granted patent, without prejudice to the claim for damages of any third party affected.

On the other hand, the local IP Law introduced limitations as to the patentability of several products, defining as non-inventions the new forms of a substance, including salts, esters, ethers, complexes, combinations, and other derivatives; polymorphs, metabolites, pure forms, particle sizes, and isomers. These restrictions would be against the Supranational Law, and therefore not applicable.

 

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

Foreign trademarks and patents are generally not recognized. Ecuador is a first-to-file country for trademarks. The sole exception is for well-known trademarks.

 

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

No non-patent/trademark barriers exist to competition to protect medicines or devices.

 

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

There are no restrictions.

 

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

License agreements do not require approval; however, registration with the IP Office is necessary to ensure enforceability against third parties.

Also from this Legal Handbook

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

Since former president Lenin Moreno vetoed the Health Code bill (September 2020), no developments have occurred.

 

2. When are they likely to come into force?

Uncertain.

Also from this Legal Handbook

Cannabinoid Drugs

1. Are Cannabinoid Drugs authorized in your country?

On September 17, 2019, Congress approved a reform of the Criminal Code, which reforms included the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use or the practice of alternative medicine. In addition, the Law of Control and Prevention of the Use of Drugs was amended, excluding non-psychoactive or hemp cannabis from control, extended to the cannabis plant or any part of the plant whose delta-9-tetrahydrocannabinol (THC) content is less than 1% which among other, excludes non-psychoactive cannabis or hemp of the listed substances subject to control, which shall be understood as the cannabis plant and any part of such plant whose dry weight concentration of delta-9-tetrahydrocannabinol (THC) is below 1%. This reform came into effect on June 21st, 2020.

On February 26, 2021, the Ministry of Health issued Ministerial Agreement No. 148-2021, which regulates the prescription, provision, and therapeutic use of medicinal cannabis and pharmaceutical products containing cannabinoids. This agreement came into effect on March 15th, 2021.

On August 23rd, 2022, the Agency for Health Regulation, Control, and Surveillance (ARCSA) issued Resolution No. ARCSA-DE-2022-014-AKRG with the “Sanitary Technical Norm for the regulation and control of products for human use and consumption containing non-psychoactive cannabis or hemp, or derivatives of non-psychoactive cannabis or hemp.”, which came into effect the same day. This resolution allows the production, package, import, export, store, dispense, and commercialization of the following finished products with the concentration of THC specified for each category:

• Pharmaceutical products, in general, processed natural products fr medicinal use, and homeopathic products (Pharmaceutical products that contain a concentration of THC equal to or greater than 1% in their formulation will be regulated as drugs subject to control.): Less than 1% THC;
• Processed foods and food supplements: Less than 0.3% THC;
• Cosmetic products: Less than 1% THC;
• Medical devices, Hygienic Products for Industrial Use, Pesticides for Household Use, Pesticides for Public Health or Industrial Use, Household Hygiene Products, and Absorbent Personal Hygiene Products: Less than 1% THC.

 

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

The Health Ministry (HM)

National Agency for Regulation, Control and Sanitary Surveillance (ARCSA)

 

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

No, there is no specific regulatory framework for pricing and reimbursement of cannabinoid drugs. However, for products registered as medicines, the price-fixing regime will apply to all other medicines.

 

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

To obtain marketing authorization, the product must have the respective document issued by ARCSA based on it and additional analysis certifying its THC concentration.

Pharmaceutical products must submit an analysis according to the pharmacopeia or the analytical methodology, adjusted to the protocol, and validated (within the results).

 Pharmaceutical products not subject to control are considered to be medicines in general, processed natural products for medicinal use, and homeopathic products that have predominantly cannabidiol (CBD) and cannabis or cannabis derivatives in their formulation, as appropriate, with a percentage lower than 1% of delta-9-tetrahydrocannabinol (THC). All products for human use and consumption that contain in their formulation cannabis or cannabis derivatives with a percentage equal to or greater than 1% of THC will be regulated as drugs that contain listed substances subject to control. Currently, there are approximately 200 products on the market with cannabinoids with a THC content of less than 1% for medicinal, food, household hygiene, and cosmetic use. With cosmetics controlling approximately 65% of the market.

 

5. Who can prescribe Cannabinoid Drugs?

It depends on whether the product is classified as OTC or a prescribed drug. If classified as a prescribed drug, it can be prescribed by health professionals registered in the National Secretariat for Higher Education, Science, Technology, and Innovation (SENESCYT) or through ARCSA as a suggestion for the treatment of refractory epilepsy or convulsive syndromes.

According to Ministerial Agreement No. 148-2021, medications subject to control that contain cannabinoids and a concentration of THC equal to or greater than 1% will be prescribed to users/patients with the following suggested therapeutic indications or other diseases or health conditions, according to the best available scientific evidence:

a. Anorexia-cachexia asthenia syndrome and other symptoms found in the palliative care/end-of-life setting associated with HIV, cancer, or other pathologies;

b. Treatment of nausea and vomiting associated with chemotherapy;

c. Complementary treatment for the symptomatic relief of spasticity and pain in users/patients with multiple sclerosis (MS);

d. Complementary treatment for the symptomatic relief of chronic non-cancer pain in adult users/patients;

e. Adjunctive analgesic treatment in users/cancer patients experiencing moderate to severe pain;

f. Other therapeutic indications duly based on the best available scientific evidence.

“Health professionals authorized to prescribe drugs containing narcotic or psychotropic substances are:

a) Physicians (general and specialist authorized to issue special prescriptions); and

b) Dentists.

The prescription of drugs containing narcotic and psychotropic substances by dental professionals authorized to prescribe must be tied to user/patient treatment protocols approved by the National Health Authority.”

 

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

Yes. The list of professionals with special prescriptions issued by ARCSA.

 

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

Health professionals approved to prescribe controlled drugs that contain cannabinoids with a THC concentration equal to or greater than 1% are authorized to issue special prescriptions. These prescriptions will be issued in accordance with the medical conditions detailed in Article 4 of these Regulations and with the provisions of the treatment protocols for national or international use.

 Health professionals authorized to prescribe pharmaceutical products containing cannabinoids in a THC concentration of less than 1% are health professionals authorized to prescribe with a professional license issued by a Higher Education Institution recognized by SENESCYT or whoever has these duties and registered with the National Health Authority. Said prescription shall contemplate what is listed in these regulations and follow the provisions of the recognized treatment protocols for national or international use.

 

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

The commercialization and sale of drugs containing cannabinoids and a THC concentration equal to or higher than 1% may only be carried out by private pharmacies and pharmacies of public and private health facilities that have or are renovating the corresponding operating permit granted by the ARCSA or ACESS, respectively, upon evidencing a Special Prescription for medicines containing listed substances subject to control, duly signed by the health professional authorized to issue special prescriptions, as established in this Regulations.

Private pharmacies, medicine cabinets, and pharmacies of public and private health facilities that have the corresponding operating permit granted by the health authority may commercialize and sell pharmaceutical products containing cannabinoids with a THC concentration of less than 1%.

 

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

There is a list of qualified establishments for the management of drugs subject to audit, but there is no list of distributors.

 

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

The issuance of a new regulation for human-use products and consumption containing non-psychoactive cannabis or hemp is pending. Resolution No. ARCSA-DE-2022-014-AKRG -Technical Sanitary Standards for the Regulation and Control of Finished Products for Human Use and Consumption Containing Non-Psychoactive Cannabis or Hemp, or Derivatives of Non-Psychoactive Cannabis or Hemp-, is effective as of August 23, 2022.

 

11. When are they likely to come into force?

There is no Information.

 

Medicinal Cannabis

12. Is Medicinal Cannabis authorized in the country?

On September 17, 2019, the National Assembly approved the Reform of the Criminal Code, which reforms included the decriminalization of possession of drugs that contain cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use or for the practice of alternative medicine. In addition, the Law of Control and Prevention of the Use of Drugs was amended, excluding non-psychoactive or hemp cannabis from control, extended to the cannabis plant or any part of the plant whose delta-9-tetrahydrocannabinol (THC) content is less than 1% whose among other, excludes non-psychoactive cannabis or hemp of the listed substances subject to control, which shall be understood as the cannabis plant and any part of such plant whose dry weight concentration of delta-9-tetrahydrocannabinol (THC) is below 1% and allows. This reform came into effect on June 21st, 2020.

On February 26, 2021, the Ministry of Health issued Ministerial Agreement No. 148-2021, which regulates the prescription, provision, and therapeutic use of medicinal cannabis and pharmaceutical products containing cannabinoids. This agreement came into effect on March 15th, 2021.

 

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

The Health Ministry

National Agency for Regulation, Control and Sanitary Surveillance (ARCSA).

 

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

Yes, the requirements for the registration of Medicinal Cannabis are:

• Registration with ARCSA as an importer/vendor/distributor of medications that contain substances categorized as subjects of audit.
• Certificate the percentage of THC of the product.
• Specify the therapeutical indications of the product that must have scientific evidence of their safety and efficacy.
• Qualification for handling medicines containing scheduled substances subject to control issued by the ARCSA. (for medicinal cannabis containing THC concentration equal to or greater than 1%)
• Annual projections of consumption of imported medications that contain substances categorized as subject to control.
• List of possible clients (if registering as a vendor).

The Ministry of Health, through the Technical Secretary for Medication Price Control, will set the maximum sale price of the drugs.

 

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

The Ministry of Agriculture regulates the production and importation of non-psychoactive hemp seeds.The National Agency for Regulation, Control, and Health Surveillance ARCSA will oversee medicinal cannabis.

 

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

The import, planting, cultivation, harvest, post-harvest, storage, transportation, processing, commercialization, and export of non-psychoactive Cannabis or hemp and hemp for industrial use is regulated by the Ministry of Agriculture under Ministerial Agreement No. 109. The manufacture of medicines, in general, processed natural products for medicinal use and homeopathic products that contain in their formulation cannabis or cannabis derivatives, as appropriate, in a percentage lower than 1% of THC should only be carried out in pharmaceutical laboratories that have the permission granted by the ARCSA and must have a certification of Good Manufacturing Practices, according to the regulations issued for that purpose.

Medicines in general, processed natural products for medicinal use, and homeopathic products that contain in their formulation cannabis or cannabis derivatives, as appropriate, in a percentage lower than 1% of THC must be marketed in pharmaceutical establishments authorized for this purpose by the ARCSA, following the activity described in its operating permit, with the sale method determined during the process of granting the corresponding marketing authorization, following current regulations. Imported cannabis products must comply with all requirements established by ARCSA and count with a marketing authorization. For the importation of cannabis derivatives that will be used in the manufacture of pilot batches of drugs in general and that have not yet obtained the corresponding marketing authorization, the legal representative of the interested party must upload through ARCSA´s Management System y – Quipux, a request for each import of the raw material to produce the pilot batch or to a maximum of 3 batches per year. The following requirements apply:

a. Composition formula of the product to be produced as pilot batches, which describes and justifies the use and quantity of the cannabis derivative per pilot batch;

b. Establishment where the pilot lots will take place and marketing authorization number;

c. Execution schedule of the pilot batch;

d. Invoice or proforma of the raw material addressed to the manufacturing establishment of the pilot batch;

e. Proof of payment of official fee;

f. Product elaboration process to be carried out in the pilot batch;

g. Technical data sheet and certificate of analysis of the raw material from the country of origin.h. The GMP of the pharmaceutical laboratory is responsible for the batch or batches.

 

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

Medicines in general, processed natural products for medicinal use, and homeopathic products that contain in their formulation cannabis or cannabis derivatives, as appropriate, in a percentage lower than 1% of THC must be marketed in pharmaceutical establishments authorized for this purpose by ARCSA, following the activity described in its operating permit, with the sale method determined during the marketing authorization process, following current regulations.

 

18. How can patients obtain Medicinal Cannabis?

It is not possible yet.

 

19. Who can prescribe Medicinal Cannabis?

It depends on whether the product is classified as an OTC or prescribed drug. If classified as a prescribed drug, it can be prescribed by health professionals registered in the National Secretariat for Higher Education, Science, Technology, and Innovation (SENESCYT) or through ARCSA for the treatment of refractory epilepsy or convulsive syndromes. If classified as a prescribed drug, it must be prescribed through special prescriptions issued by ARCSA according to the treatments of diseases described in Article 4 of the Ministerial Agreement for the use of cannabinoids.

 

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

Yes. Professionals that have special prescriptions (controlled substances).

 

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

The Professional must count on special prescriptions and validate his degree in ACESS.

 

22. Where is Medicinal Cannabis available?

The commercialization and sale of drugs containing cannabinoids and a THC concentration equal to or greater than 1% may only be carried out by private pharmacies of public and private health facilities that have or are in the process of renewal of the corresponding operating permit granted by the ARCSA or ACESS, respectively. Upon evidencing a special prescription for medicines containing controlled substances, it is duly signed by the health professional authorized to issue special prescriptions.

The commercialization and sale of pharmaceutical products containing cannabinoids with a THC concentration of less than 1% may only be carried out by private pharmacies and medicine cabinets and pharmacies of public and private health facilities that have or are in the process of renewal of the corresponding operating permit granted by the ARCSA or ACESS, respectively, upon evidencing a medical prescription duly signed by the professional authorized to prescript.

 

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

No.

 

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

No.

 

Opioid Drugs

25. Are Opioid Drugs authorized in your country?

No.

 

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

Ministry of Health (MH)

National Agency for Regulation, Control and Sanitary Surveillance (ARCSA)

 

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

Yes, for the registration of an opioid medication, there are specific requirements, as follows:

• Register with ARCSA as an importer/vendor/distributor of medications that contain substances categorized as subject to control.
• Qualification for handling medicines containing scheduled substances subject to control issued by the ARCSA. • Annual projections of consumption of imported medications that contain substances categorized as subject to control.
• List of possible clients (if registering as a vendor).

The Ministry of Health, through the Technical Secretary for Medication Price Control, will set the maximum price for the sale of these medications.

 

28. Which are the Opioid drugs that have received market approval to date?

There are various opioids registered in Ecuador, either as combination drugs or mono drugs. The main ones are as follows:

• Hydrocodone
• Oxycodone
• Morphine
• Codeine
• Methadone
• Fentanyl

 

29. Who can prescribe Opioid Drugs?

Health professionals are authorized to prescribe medications that contain substances categorized as subject to control (opioids).

 

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

Yes, the Minister of Health maintains an up-to-date register of authorized professionals.

 

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

Be a health professional who treats illnesses that have shown effective therapeutic responses to the use of opioids. The Minister of Health must authorize such professionals.

 

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

Private or public pharmacies or drugstores registered with ARCSA administer medications containing substances categorized as subject to control (opioids).

 

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

The Minister of Health holds an up-to-date list of distributors who may sell these medications.

 

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

No.

 

35. When are they likely to come into force?

N/A

Also from this Legal Handbook

1. What is the definition of Rare Diseases in your country?

Our law states a specific definition for rare diseases, which is the following:

They are mainly considered life-threatening or debilitating in the long term. They have low prevalence and high complexity and constitute many diseases. They are characterized by being chronic and disabling. Their therapeutic resources are limited and expensive; some are in the experimental stage.

 

2. Does the designation of ‘Orphan Drug’ exist in your country? (Does it correspond with the definition of Rare Diseases?)

Orphan Drugs. – Those listed in the CNMB (NATIONAL TABLE OF BASIC MEDICINES) are manufactured by biotechnology or by complex pharmaceutical technology processes, are sold at high prices, generally have only one manufacturer worldwide, are not sold as generics, and its supply is difficult.

 

3. What is the regulatory framework for the authorization of an Orphan Drug? (Is this regulatory framework based on Rare Disease status or can it alternatively be based on Orphan Drug foreign status?)

The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) is the regulating agency that establishes the requirements to authorize orphan drugs. The regulations that establish and regulate orphan drugs are:

• Regulation of Sanitary Registration for Medicines in General
• Instructions for the Treatment of Rare and Catastrophic Diseases
• Technical Standard Import Medications, Specialized Treatments
• Substitute technical regulations to authorize import by exception and import by donation of drugs, biological products, medical devices, and biochemical and diagnostic reagents
• A replacement regulation to authorize the acquisition of medicines not included in the National Basic Medicines Chart (current CNMB).

There is a proceeding to authorize the import and commercialization of orphan drugs and recognize the authorizations in other countries; however, it is necessary to consider that for the regulatory authority to issue the corresponding permit, evidence that the drug is required must be provided.

 

4. Does your country have provisions for relaxed clinical trial/scientific evidence requirements in respect of Orphan Drugs as compared to other drugs?

No provisions establish requirements for clinical trials or scientific evidence for Orphan Drugs.

 

5. Is there an expedited pathway for Orphan Drugs?

Importing orphan drugs is quicker than importing other drugs. The importation of goods that have the authorization by exception (orphan drugs) must be made within six (6) months following the issuance of the authorization from ARCSA (regulating entity).

This authorization will also be valid for partial shipments that, due to their volume or nature, require several shipments to complete the authorized import quantity; they will be covered by or referred to the same shipping document and, in the same way, must be imported within six (6) months from the issuance of the authorization.

Once the authorization is granted, the applicant must notify ARCSA within two (2) months of the product’s date and place of arrival or departure, indicating its expiration date, batch or serial number (as applicable), invoice, or other documents that the authority deems necessary if not submitted with the initial application.

All imports must obtain authorization from ARCSA.

 

6. Are foreign marketing authorizations recognized in your jurisdiction for Orphan Drugs? If yes, marketing authorizations from which countries are recognized?

Our legislation requires that drugs for rare diseases or orphan drugs have the respective health notification in force from the country where they originate or from the country where they are sold.

For the drug to be recognized, it must be authorized and sold in at least one of the countries from the Pan-American Health Organization (PAHO) or the World Health Organization (WHO) since they are the Regional Authorities, or they must have a health notification issued by the Authorities in the United States, Canada, Australia, Japan, by the European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of South Korea. However, recognition from one of these foreign authorizations is only one of the requirements for obtaining authorization to import the goods.

 

7. Can Orphan Drugs be reimbursed? If so, is there a specific reimbursement procedure for Orphan Drugs?

There are no procedures regarding the reimbursement of orphan drugs.

 

8. How are the prices of Orphan Drugs regulated? 

The price regulation is the same as that of general medicine; once the health registration of the medicine has been obtained, the “regime confirmation” must proceed, which will be carried out in the Technical Secretariat for the Approval of Prices for Drugs, which will determine whether the price is regulated (established by the authority) or free (determined by the owner of the goods).

 

9. If the reference price is based on a basket of countries, what countries are included?

There is no reference based on other countries. The price parameter is fixed based on the analysis of the competent Authority.

 

10. Have there been any significant legal/judicial developments in relation to Orphan Drugs in your country?

No developments exist regarding these types of orphan drugs.

 

11. Are there proposals for reform or significant change to the regulation of Orphan Drugs? If yes, when are they likely to come into force?

No orphan drug reform proposals have been widely published, but drug regulation generally accepts comments on new proposals.

Also from this Legal Handbook

1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies?

New productive investments made from January 2022, including those in the pharmaceutical sector, may be eligible for tax benefits. Investors generally benefit from a 3-point reduction in the corporate income tax rate. Additionally, if the investor enters into an investment agreement, they will benefit from a 5-point reduction in the corporate income tax rate, exemptions from customs tariffs and the outflow tax (ISD) on importing capital assets and raw materials

Furthermore, a new Free Trade Zone (FTZ) regime will be applicable starting in 2024, designed to promote exports. An FTZ is a designated area for developing industrial, commercial, or service activities under a special regime. The benefits of FTZs include:

1. A 5-year income tax exemption, followed by a 15% corporate income tax rate for the remaining duration of the FTZ authorization.
2. Exemptions from VAT, outflow tax (ISD), customs duties, and any future taxes on transactions carried out within the FTZ.
3. A VAT refund on purchases of raw materials, goods, and construction materials.
4. An income tax exemption on the distribution of dividends.

 

2. Have there been any recent significant changes involving localization rules? If yes, when did they take place and what did they involve?

The benefits described above for new investments were established in 2021 and became applicable in 2022. In 2024, the Government Investments Committee (CEPAI) introduced certain conditions for entering into investment agreements, such as requirements to generate employment and invest in environmentally friendly machinery.

The FTZ regime was established by the Law of Economic Efficiency and Employment Generation, published on December 20, 2023, and became applicable in 2024. These changes are part of a broader government initiative to attract manufacturing investments, including those in the pharmaceutical sector.

 

3. Is obtaining a marketing authorization impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Ecuador provides several incentives for companies that establish local manufacturing or partner with domestic producers. Ecuador does not explicitly mandate localization for obtaining authorization, but localization can provide strategic advantages. These incentives include a simplified registration process and reduced fees.

 

4. Is your country’s pricing process for pharmaceutical products impacted by localization policies? If yes, how so (what are the incentives received or the requirements)?

While there are no explicit pricing incentives solely for local manufacturers, indirect benefits and advantages arise from localization, which can impact the overall cost structure and pricing strategies of pharmaceutical products.

 

5. Is the reimbursement of pharmaceutical products impacted by localization policies in your country? If yes, how so (what are the incentives received or the requirements)?

Localization has no effect.

 

6. Is the access to public or public pharmaceutical product tenders impacted by your country’s localization policies? If yes, how so (what are the incentives received or the requirements)?

While Ecuador’s localization policies do not outright restrict foreign companies’ access to public pharmaceutical tenders, they provide specific incentives and preferences for local producers.

 

7. Are import tariffs, importation and/or exportation permits, trade and/or taxation of pharmaceutical products impacted by localization policies in your country? If yes, how so?

Pharmaceutical products are taxed equally regardless of localization policies. For example, pharmaceutical products are taxed with 0% VAT regardless of where they were produced. Additionally, pharmaceutical products are generally taxed with 0% import tariffs.

 

8. Are there any other incentives or advantages offered by the current local localization rules in your country? If yes, what are they?

No, only those set out at point 1.

 

9. Are there discussions about the possibility of implementing localization policies in your country? If yes, what are the proposed reforms and when should they come into place?

No, there are no discussions about implementing localization policies in Ecuador.

 

Recap Table

Country ECUADOR	Research	Clinical Trials	API Content	Fill and Finish	Packaging
Require/Benefit	B	B	B	B	B
Requirement
Benefits	Tx	Tx	Tx	Tx	Tx

 

Line 1
0 – if neutral
R – if a requirement B – if provides benefit

Line 2 and 3 Fill in (according to answer in Line 1)

MA – Market Access
P – Pricing
R – Reimbursement
T – Tenders
Tx – Taxes and import tarifs

 

 

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Click the following links to read more legal articles from Ecuador:

1. Regulatory Pricing and Reimbursement Overview
2. Preclinical and Clinical Trial Requirements
3. Marketing, Manufacturing, Packaging & Labelling, Advertising
4. Traditional Medicines and OTC Products
5. Product Liability
6. Patents & Trademarks
7. Regulatory Reform
8. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
9. Orphan Drugs and Rare Diseases
10. Localization
11. Biosimilars and Biologics

Also from this Legal Handbook

1. Are biosimilar medicines considered the same as generic medicines in your country?

No, the generic term is used only for medicines made by chemical synthesis, and the term biosimilar is used for medicines of biological origin.

A biosimilar medicine is similar in quality, safety, and efficacy to the reference biological medicine. It must demonstrate its equivalent capacity to the reference biological medicine through its comparability.

 

2. Are all biologic medicines, including biosimilar medicines, patentable in your country?

All medicines are patentable, regardless of their nature, provided they meet the patentability requirements requested by current Laws (Andean Decision No.486 and local IP law).

 

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

Yes, to obtain the marketing authorization of a biosimilar, it is necessary to comply with Ministerial Agreement 385, “Reform and Codification of the Regulations for obtaining marketing authorizations, control and surveillance of biologicals for human use”

 

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

The information necessary to obtain marketing authorization for a biosimilar is similar to that of a biological one, with the difference that biosimilars do not require non-clinical and clinical studies, and biologicals should submit clinical studies as appropriate and must comply with the following:

• Administrative information and prescription information.
• Summaries of standard technical documents.
• Quality information.
• Studies of physicochemical and biological characterization of the active pharmaceutical ingredient and the finished product.
• Pharmacovigilance program (risk management plan).
• Studies of non-clinical comparability of the biosimilar medicine compared to the reference biological medicine and should include at least:

• • Toxicity
  • Pharmacokinetic and pharmacodynamic studies are conducted on at least one suitable model in animals.
  • Local tolerance test.
  • Immunogenicity studies and reports of these studies according to the ICH guidelines.

The scope and magnitude of clinical studies will depend on the size of the residual uncertainty about the biosimilarity of the two products after performing a structural and functional characterization.

 

5. What are the requirements for the choice of the reference comparator product?

When choosing a reference biological medicine in a comparability study, the following considerations should be taken into account:

• The reference biological medicine must have been marketed for at least one year so that the demonstration of similarity with this product highlights a substantial amount of acceptable data regarding its safety and efficacy.
• The manufacturer shall demonstrate that it is appropriate to support the application for authorization to market the biosimilar medicinal product.
• Must have been registered based on complete quality, safety, and efficacy data.
• Use the same reference biological medicine throughout the entire biosimilar medicine development process.

 

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Yes, the reference biological medicine must be authorized and marketed by at least one of the countries whose drug regulatory agencies have been qualified by the Pan American Health Organization (PAHO) as Regional Reference Authorities or hold a marketing authorization granted by the Health Authorities of:

• Usa
• Canada
• Australia
• South Korea
• UK
• European Medicines Agency (EMA) process

 

7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?

The price regulation system is the same as that of biological medicine. Once the marketing authorization of the biosimilar medicine has been approved, the proceeding must be confirmed in the Technical Secretariat for the Approval of Prices for Drugs, which will determine if the price is regulated or free.

 

8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?

The return or refund policy does not exist in biosimilar medicines in Ecuador.

 

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

N/A.

 

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

The Health Law establishes that health professionals are the only ones authorized to prescribe prescription medications, whether chemical synthesis or biological, regardless of their nature. In public institutions, prescriptions will be mandatory according to the legally established protocols and treatment schemes.

The commercialization of biosimilar medicines will depend on the corresponding health risk and may be found in establishments approved by the National Authority to sell these products (pharmacies).

 

11. Is the system considering physician-led switching and/ or pharmacy-level substitution (without involvement of the clinical decision maker)?

No, medications can only be prescribed by a health professional. The professional determines the use of the medication based on the therapeutic information and scientific evidence of the product.

 

12. . What are biosimilar medicines’ post-authorization requirements (including pharmacovigilance, risk management plans, and post-approval studies)? Is this any different from the requirements for the original Biologics drug?

No, they are the same as for biological medicines, and the subsequent requirements once the health record is obtained are:

• Price approval.
• Post-registration control (sampling).
• Records of adverse reactions and submission of periodic updated safety reports (PSUR)

 

13. Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?

No, they must comply with the labeling requirements of biological medicines and must include:

• Secondary container:
  • Name of the medicine
  • International Nonproprietary Name, when applicable or name of the active substance when there is no INN
  • Type of biological medicine (vaccine, blood products, processed and related products, biotechnology, biosimilar and other biological medicines)
  • Concentration, potency or viral titer, as appropriate
  • Number of doses per vial (for multidose presentation), as appropriate
  • Route of administration
  • Lot number
  • Qualitative quantitative formula in biological units with their equivalence in units of weight. Including excipients. It should be added where appropriate the INN of ingredients.
  • Pharmaceutical Form of the product
  • Package contents used to dilute where appropriate
  • Temperature and storage conditions
  • Solutions used to dilute where appropriate
  • Preparation instructions and use instructions
  • Name of the manufacturer, city and country of this laboratory
  • In the case of products packaged by a third party other than the manufacturer, the name of each party must be declared, indicating their participation status
  • Manufacturing and expiration date – health registration number o Modality of sale o General warning: “Delicate product. Administer by prescription and medical surveillance ”
  • Additional warnings following the active substance (s) of the product
  • If the product has been teratogenic for any animal species contemplated in toxicological preclinical studies, the warning is “Contraindicated in pregnancy or when its existence is suspected
  • Marketing authorization number
  • General warning “Producto de uso delicado. Administrarse por prescripción y vigilancia médica”

• Primary container (label)
  • Name of the medication
  • INN when applicable or name of the active ingredient when there is no INN
  • Content expressed in the international system
  • Dose
  • Number of doses per vial (for multidose presentation), as appropriate
  • Qualitative quantitative formula in biological units with their equivalence. Excipients can be excluded when the package is very small
  • Route of administration
  • Manufacturer’s name
  • Lot number or code
  • Temperature and storage conditions
  • Manufacturing and expiration dates
  • If the product has been teratogenic for any animal species contemplated in toxicological preclinical studies, the warning is “Contraindicated in pregnancy or when its existence is suspected.”
  • Content of the active pharmaceutical ingredients per dose or volume.
  • Marketing authorization number.

 

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

The only change was that Ministerial Agreement No. 3344, “Regulations for obtaining marketing authorizations, control and surveillance of biologicals for human use,” was repealed and replaced by Ministerial Agreement No. 385, “Reform and codification of the Regulations for obtaining marketing authorizations, control and surveillance of biologicals for human use.”

 

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

No.

Also from this Legal Handbook

The cannabis and hemp industry is an emerging new industry in Ecuador with the Reform of the Criminal Law, enacted on June 21^st, 2020.

 

Included among the reforms is the decriminalization of possession of drugs containing cannabis or derivatives as their active ingredient for therapeutic, palliative, or medicinal use, or for the practice of alternative medicine. In addition, the Law of Control and Prevention of the use of Drugs has been amended, excluding non-psychoactive or hemp cannabis from control, extended to the cannabis plant or any part of the plant, whose delta-9-tetrahydrocannabinol (THC) content is less than 1% dry weight.

Based on the abovementioned Reform of the Criminal Law, the Ministry of Agriculture had 120 days to issue the regulations applicable to the agro-industrial activities around non-psychoactive cannabis and hemp in Ecuador; hence on October 19th, 2020, the Ministry of Agriculture issued the Ministerial Agreement No. 109-2020, which regulates the Import, Planting, Growing, Harvest, Post-Harvest, Storage, Transportation, Processing, Marketing and Export of Non Psychoactive Cannabis or Hemp and Hemp for Industrial Use. This Ministerial Agreement came in force upon its signing and execution. This regulation stablishes the requirements that have to be fulfilled in other to obtain the seven types of licenses, which authorize the following activities only regarding cannabis or hemp with a concentration of THC below 1%:

1. License for the Import and Commercialization of Non-Psychoactive Cannabis or Hemp Seeds or Cuttings, or Seeds of Hemp for Industrial Use.
2. License for the Import and Commercialization of Non-Psychoactive Cannabis or Hemp Seeds, or of Non-Psychoactive Cannabis or Hemp Cuttings, or Hemp Seeds for Industrial Use.
3. License for the Cultivation of Non-Psychoactive Cannabis or Hemp.
4. License for the Cultivation of Hemp for Industrial Use.
5. License for the Processing of Non-Psychoactive Cannabis or Hemp and Production of Non-Psychoactive Cannabis or Hemp Derivatives.
6. License for Plant Breeding and / or Germplasm Banks and Research.
7. License for the Acquisition of Non-Psychoactive Cannabis or Hemp Derivatives and / or Biomass or Flowers, or Hemp Biomass for Industrial Use, for Export.

On the other hand, this generated the need for the Ministry of Health (abbreviated as MSP in Spanish) and the Agency for Health Regulation, Control and Surveillance (abbreviated as ARCSA in Spanish) to accelerate the development of regulations applicable to finished products, since the Reform of the Criminal Law also opened the door to the production and import of finished product, which as defined in the Ministerial Agreement No. 109-2020, is:

Finished Product: Preparation obtained from the production of Non-Psychoactive Cannabis Derivatives or Hemp, to be marketed or distributed as a product for human or animal use or consumption and that has a sanitary registration, sanitary notification or the permit that applies according to the type of product based on the Ecuadorian regulations. Among them, but not limited to, are the following: processed foods, dried flower, beverages, food additives, food supplements, cosmetics, homeopathic products, medicines, medical devices, processed natural products for medicinal use and veterinary products.

 

Based on the above mentioned and considering how fast the industry moves, on February 25^th, 2021 the Agency for Health Regulation, Control and Surveillance (ARCSA) issued Resolution No. ARCSA-DE-002-2021-MAFG with the “Sanitary Technical Norm for the regulation and control of products for human use and consumption containing non-psychoactive cannabis or hemp, or its derivatives”, which came into effect the same day. This resolution allows the production, import and commercialization of the following finished products with the concentration of THC specified for each category:

 

• Pharmaceutical products in general, processed natural products for medicinal use and homeopathic products (Pharmaceutical products that contain a concentration of THC equal to or greater than 1% in their formulation will be regulated as drugs subject to control.): Less than 1% THC;
• Processed foods and food supplements: Less than 0.3% THC;
• Cosmetic products: Less than 1% THC;
• Medical devices, Hygienic Products for Industrial Use, Pesticides for Household Use, Pesticides for Public Health or Pesticides for Industrial Use, Household Hygiene Products and Absorbent Personal Hygiene Products: Less than 1% THC.

 

Considering how quickly the regulations moved, the Ministry of Health did not want leave anything out, therefor it gathered a group of experts and developed the regulation for the prescription, provision and therapeutic use of medicinal cannabis and pharmaceutical products containing cannabinoids and on March February 26, 2021 issued the Ministry Agreement No. 148-2021, which came into effect on March 15^th, 2021.

 

It is worth noting that the cannabis/hemp regulatory framework has moved quite fast in Ecuador and has opened the eyes of many local and international investors. The authorities are aware of what this industry can generate to the country in terms of research and investment, therefore, as long as the players comply with all the rules, they will be able to develop a myriad of products, since Ecuador, for now is the only country in the region that has showed so much openness; and as a consequence, it is expected that it may become a research and development cluster for cannabis and hemp products that will be sold all around the world.