Legal & Regulatory > Norway > Marketing, Manufacturing, Packaging & Labeling, Advertising

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

See answer to Chapter 1, question 3.

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

To obtain a marketing authorization for generic drugs, an application meeting the general criteria of the Medicines Regulation Section 3-4 must be submitted.

In addition, specific provisions for generic drugs are outlined in Section 3-9.

If the applicant can demonstrate that the drug is a generic version of a reference medicine, the results from toxicological, pharmacological, and clinical studies, as specified in Section 3-4 i and j, are not required.

If the reference medicine does not have or has not had marketing authorization in Norway, the applicant must provide information about the EEA country where the reference medicine has or has had marketing authorization.

In cases where the drug does not fit the definition of a generic medicine, or bioequivalence cannot be established through bioavailability studies, or there are differences between the generic drug and the reference medicine regarding active ingredients, therapeutic indication, strength, pharmaceutical form, or administration method, relevant toxicological, pharmacological, and clinical study results must be submitted.

The applicant must provide documentation in the application regarding the safety and/or efficacy of various salts, esters, derivatives, etc., of an approved active ingredient, if differences as mentioned in Section 3-8 b last sentence exist.

NOMA may, in certain cases, exempt the applicant from conducting bioavailability studies.

If a biological medicine does not meet the definition of a generic drug due to differences in raw materials or manufacturing processes compared to the biological reference medicine, relevant results from toxicological, pharmacological, and clinical studies must be submitted. The documentation should comply with the requirements in Annex I to Directive 2001/83/EC as amended by Directives 2003/63/EC, 2004/24/EC, 2004/27/EC, 2009/53/EC, and 2009/120/EC.

The timing of the submission of the application varies and is regulated by the Medicines Regulations Section 3-10 to 3-11a.

24. What are the typical fees for marketing approval?

Under Section 15-3 of the Medicines Regulation, NOMA may charge a fee for processing a marketing authorization application.

For products intended for MUMS (Minor Use/Minor Species) there is a 50 % reduction in the fee. MUMS-status must be clarified with NOMA before submission.

NOMA will invoice the fee on the basis of a received application. Please note that the Agency will invoice the company that submits the application, should no other receiver be stated in the cover letter. Reference, such as PO-number, must be stated in the cover letter. Payment is due at the latest within 30 days from date of invoice.

In specific cases NOMA may waive the required fee.

The fee rates adjusted from January 1st 2024 are provided in the Medicines Regulations chapter 16 and are presented below:

MRP where Norway is the RMS

MRP where Norway is CMS

DCP where Norway is the RMS

DCP where Norway is CMS

Please note that the fee rates may be subject to changes.

Note

• For variations including several formulations and strengths of the same product, one fee is invoiced
• Variations leading to other consequential variations are invoiced as one.
• Not applicable for linguistic changes, moving of text or information on limited documentation on the use in children etc. These are other type II variations
• Applicable for posology changes
• Applicable for each Marketing Authorisation
• Applicable per procedure/agreement. Non refundable
• Applicable independently of legal basis for the submission
• Applicable independently of legal basis for the submission

25. What is the period of authorization and the renewal needed process?

A marketing authorization is generally valid for five years.

The marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the competent authority. Once renewed, the marketing authorization shall be valid for an unlimited period unless the competent authority decides on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.

The renewal dossier should contain a consolidated version of the file in respect of quality, safety and efficacy including all variations introduced since the marketing authorization was granted or since the last renewal.

A renewal application shall be submitted to NOMA at the latest nine months before the end of the five-year period. The renewal application can also be submitted earlier than nine months after agreement with the Norwegian Medical Products.

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

Pharmacovigilance plays an important role in ensuring safe and effective drugs. The purpose of pharmacovigilance is to gather information about safety in clinical use and shorten the time until the safety profile of a drug is well known.

The pharmaceutical company that markets the individual medicine in Norway has the primary responsibility for the effect and safety of their medicinal products. The Market Authorization Holder must ensure that it has an appropriate system of pharmacovigilance and risk management in place in order to assume responsibility and liability for their products on the Norwegian market and to ensure that appropriate action may be taken when necessary. In order to fulfil the requirements, the Market Authorization Holder must ensure that all information relevant to the risk- benefit balance of medicinal products is reported to the authorities periodically through Periodic Safety Update Reports (PSUR) and continuously through expedited reporting of Individual Case Safety Reports (ICSR).

In particular, the market authorization holder is required to:

• Establish and manage a pharmacovigilance system with the purpose of evaluating received information,
• assess and implement necessary measures for risk reduction and prevention of side effects, and
• regularly review the system, file a report on the main findings in the pharmacovigilance system master file, and prepare and implement a plan for closing discrepancies.

As part of the pharmacovigilance system, the holder of the marketing authorization shall at all times have a qualified person responsible for pharmacovigilance. The person’s name and contact information shall be sent to NOMA and EMA. The individual shall:

• be resident and work within the EEA area,
• maintain and, upon request, submit the pharmacovigilance system master file to the authorities,
• manage a risk management system for each medicinal product,
• monitor the results of risk reduction measures carried out in accordance with the risk management plan or as stipulated in the marketing authorization conditions,
• update the risk management system and examine pharmacovigilance data to determine whether new risks have been identified, whether the risk has changed, or whether the benefit-risk ratio of the medicinal product has changed, and
• inform EMA and national drug authorities about new safety issues, changes in the safety of the medicinal product, or changes in the benefit-risk ratio.

Any terms and conditions stipulated under § 5-11 and § 5-11a shall be incorporated into the risk management system.

See also the regulations for Post-authorization safety studies (PASS) described in Good pharmacovigilance practices (GVP) module VIII and its addendum.

27. Are any foreign marketing authorizations recognized?

Marketing Authorization issued in the EEA are recognized by NOMA under the Mutual Recognition Procedure.

The Mutual Recognition Procedure is based on a national marketing authorization. The applicant must first update their marketing authorization in an EU/EEA country where the medicinal product already holds national marketing authorization.

When the mutual recognition procedure commences, the concerned countries receive the application and documentation from the applicant, along with an assessment report from the reference country. The concerned countries have the opportunity to provide comments on the assessment. The processing time is 90 days.

If the application is approved, each country must approve the Summary of Product Characteristics, package leaflet, and labeling and issue marketing authorization within 30 days.

In addition, foreign marketing authorizations issued in countries Norway has a Mutual Recognition Agreement with will be recognized.

28. Are parallel imports of medicine or devices allowed?

Yes, based on application. The submitted application must include documentation on quality, safety and effect of the medicinal product.

There are no particular provisions on parallel import in the Norwegian medicinal product legislation establishing conditions for approval. However, NoMA normally sets the following conditions for parallel import of medicinal products to Norway:

• The imported medicinal product must have a marketing authorization in the export country
• Marketing authorization of a directly imported medicinal product is a prerequisite for parallel import of a medicinal product.
• The medicinal product contains the same active substance and has the same therapeutic effect as the directly imported medicinal product
• Differences between the directly and parallel imported medicinal products may be accepted if these do not concern the therapeutic effect and do not raise any significant issues related to public health
• NoMA shall assess the possibility for parallel import on a case by case evaluation

Note that specific requirements for the application apply to applications for parallel import from Bulgaria, Estonia, Croatia, Latvia, Lithuania, Poland, Romania, Slovakia, Slovenia, the Czech Republic, Hungary. Applications for marketing authorizations for patented drugs covered by the Patents Regulation (FOR-2007-12-14-1417) must document that the patent holder or the holder of a supplementary protection certificate, or a person whose rights derives from the patent or supplementary protection certificate, have been notified at least one month in advance.

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

General conditions

In general, any advertisement for a medicinal product directed at healthcare professionals shall include:

• relevant information that is comprehensive and in accordance with the summary of product characteristics approved by NOMA,
• information about the dispensing conditions of the medicinal product,
• price, and
• information about pre-approved reimbursement.

Alternatively, the advertisement can be presented as a reminder and should then only include the name of the medicinal product, active ingredient, and the marketer’s name.

Benefits to healthcare professionals

When marketing medicinal products to healthcare professionals, it is prohibited to provide, offer, or promise these individuals gifts, economic benefits, or benefits in kind unless they are of negligible value and are related to the exercise of the respective healthcare professional’s activities.

Representation in connection with advertising activities for medicinal products should be kept at a reasonable level and strictly subordinated to the main purpose of the meeting and must not include persons other than healthcare professionals.

Free samples to healthcare professionals

Free samples to healthcare professionals can only be provided under the following conditions:

• For prescription medicines, the arrangement only includes medicines that the individual is authorized to prescribe.
• Only one sample of the medicine per year can be provided to each person qualified to prescribe or dispense medicines. If the medicine is available in multiple forms or strengths, one sample of each form and strength can be provided.
• Any distribution of samples must occur based on a written, dated, and signed request from a person authorized to prescribe this medicine.
• Each company must keep a record of the medicine samples that have been distributed. These lists must be kept for two years and provided to the drug authorities upon request.
• Each sample should not be larger than the smallest package available on the market.
• Each sample should be labeled with “free medicine sample – not for sale” or equivalent marking with a similar meaning.
• A complete summary of product characteristics must accompany each sample.
• Samples of medicines containing psychotropic or narcotic substances under international conventions such as the UN Convention of 1961 and 1971 must not be provided

Hospitality

The Medicines Regulation does not provide provisions specifically regarding hospitality, such as travel or entertainment. Such marketing practices must be considered under the general prohibition on offering benefits to health care professionals.

This prohibition is also reflected in the Health Care Personnel Act Section 9 which states that health care professionals must neither personally nor on behalf of others receive gifts, commissions, services, or other benefits that are likely to unduly influence the professional actions of healthcare personnel.

The accompanying Regulation on gifts to healthcare personnel (FOR-2005-08-29-941) Section 4 elaborates on what may constitute gifts, commissions, services etc. According to this provision having expenses for attending courses and conferences fully or partly covered, may constitute gifts. Compensation for, for example, participation in research projects, drug trials, medical equipment testing or recruiting patients for research projects or referring patients may also constitute gifts which healthcare professionals are prohibited from receiving.

Further guidance

Further guidance on these subjects can be sought from the Association of the Pharmaceutical Industry (“LMI”) and the Norwegian Association for Medtech and Lab (“Melanor”). LMI has adopted industry regulations on advertising of medicinal products available here: download.php (lmi.no), while Melanor has adopted a Code of Ethics providing guidance on gifts on Chapter 8 available in Norwegian here Etisk_regelverk_1.pdf (overcastcdn.com).

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

Medicines

The manufacturing of medicines is regulated by the Regulation on manufacture and import of medicinal products (FOR-2004-11-02-1441). Pursuant to Section 2-1 of this Regulation, the manufacturing of medicines requires an authorization from NOMA.

An application for a manufacturing license must be submitted to NOMA by the entity intending to hold the license or by a representative acting on their behalf. The application should provide information on:

• the pharmaceuticals and/or forms of pharmaceutical to be manufactured or imported,
• the relevant manufacturing or import activities,
• the manufacturing process, if applicable, such as the inactivation of viral or non-conventional agents, and
• the location where the activities will take place

Prior to granting a manufacturing license, NOMA shall conduct necessary investigations to verify the information in the application.

NOMA shall, within 30 days of receiving the application, inform the applicant whether the application is considered to contain the necessary documentation for it to be processed. Within 90 days of receiving a complete application, the application shall either be approved or rejected, and the applicant notified. If NOMA requests the applicant to rectify deficiencies in the application or provide additional information, the deadline is suspended until the issues are addressed.

Applications concerning the permission to manufacture an active substance shall be decided by NOMA within 60 days of receiving the application. However, this does not apply if NOMA, within the deadline, informs the applicant that an inspection of the facility is necessary before issuing the permit. If the applicant has not received feedback within the deadline in the first paragraph, the application may be considered approved.

Manufacturing must comply with the provisions in Chapter 2, part II of the Regulation on manufacture and import of medicinal products. Pursuant to these provisions, the manufacturer must inter alia:

• ensure that manufacturing is carried out in accordance with good manufacturing practice guidelines and good distribution practice guidelines, as well as the requirements specified in the manufacturing license.
• at all times have at least one person available who meets specific requirements and is approved by NOMA.
• Establish, implement, and maintain an effective pharmaceutical quality system within the organization. The system should actively engage the management and employees of the organization.
• Ensure appropriate and effective placement of equipment.

Medical devices

There is no authorization process mandated by Norwegian law for the production of medical devices. Nonetheless, it is the manufacturer’s responsibility to ensure that the medical devices adhere to the relevant rules and regulations.

Through the EEA Agreement, Norway has the same regulations as EU Member States regarding the requirements for marketing and distributing medical devices. Medical devices are primarily regulated by Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

As a main principle, the manufacturer of medical devices is legally responsible for ensuring the safety and efficacy of medical devices. Devices that meet safety requirements are labelled with the CE mark and can be freely circulated within the EEA area. Medical devices do not require approval from national authorities before they can be marketed. For certain risk classes of medical devices, a notified body must conduct a conformity assessment before the devices can be freely marketed. This involves the notified body evaluating whether the product complies with the safety requirements in the regulations.

MDR and IVDR allows for national authorities to introduce national provisions, meaning that national authorities can establish national requirements and adapt the regulations to national conditions. The following requirements specifically applying to medical devices in Norway are listed by NOMA:

• Information on the label and in the user manual of the device must be provided in Norwegian.
• Documentation used in conformity assessment procedures, including technical documentation, as well as audit, assessment, and inspection reports, must be provided in English.
• Information in the Declaration of Conformity must be in English or Norwegian.
• Certificates issued by notified bodies established in Norway must be in English or a language accepted by the notified body.
• Upon request from NOMA, the manufacturer and authorized representative must provide all necessary information and documentation to demonstrate compliance with the requirements in Norwegian or English.
• Information in the application for designation of a notified body and the documents assessed during inspections must be in English.
• Safety notifications from manufacturers to users of devices must be in Norwegian.
• Information provided to patients with implantable devices and intended to be accompanied by an implant card must be in Norwegian.
• The general summary of clinical trials must be in Norwegian and English.
• Clinical trials must meet the requirements of Regulation (EU) 2017/745 (MDR) Article 62. This also applies to clinical trials not conducted for the purposes specified in Article 62(1) of the regulation.

 31. 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)?

The Norwegian system is closely aligned to the European system. The Norwegian Regulation on manufacture and import of medicinal products (FOR-2004-11-02-1441) states that manufacturing shall be in accordance with guidelines for good manufacturing practice and guidelines for good distribution practice, and the requirements specified in the manufacturing authorization, see Section 2-8.

The EEA Agreement Annex II, Chapter XIII, No. 15qd (Regulation (EU) No. 1252/2014 supplementing Directive 2001/83/EC regarding principles and guidelines for good manufacturing practice for active substances in medicinal products for human use applies as a regulation with certain adaptations.

32. What is the inspection regime for manufacturing facilities?

Production of medicine

As part of the company’s pharmaceutical quality system, the manufacturer shall conduct regular self-inspections to verify the implementation and compliance with good manufacturing practices, as well as propose any necessary corrective actions. Self-inspections and all subsequent corrective actions shall be documented.

In addition to self-inspections conducted by the manufacturer, NOMA conducts inspections to ensure compliance with the provisions of the Regulation on manufacture and import of medicinal products. Inspection activities shall be carried out in accordance with an appropriate quality system and in compliance with the Compilation of Union procedures on inspections and exchange of information published by the European Medicines Agency (EMA) on behalf of the EU Commission.

In connection with inspections, NOMA may demand access to all premises covered by a permit under the Regulation on manufacture and import of medicinal products and may request the submission of samples and information deemed necessary to conduct the inspection. The permit holder is obliged to assist by providing the representative from NOMA with the necessary support during the inspection.

Inspections are typically notified two to four weeks in advance. NOMA may also choose to conduct inspections unannounced.

The duration of an inspection varies, ranging from one day to one week. The inspection itself includes an opening meeting, interviews/conversations with staff, a tour of premises, review of documentation, and a closing meeting. During the inspection, inspectors compile a list of observations. The inspection concludes with the closing meeting, where the observation list is reviewed, and any ambiguities or misunderstandings are clarified. Representatives of the facility approve the observation list by returning it via email with a statement of acceptance. This list serves as the basis when inspectors subsequently write their report classifying the observations of deviations as minor, major or critical deviations.

The inspection report specifies deadlines for addressing the deviations. The time given to the facility to rectify the issues depends on the severity.

Inspectors are bound by confidentiality according to the Public Administration Act Section 13 and the Medicines Act Section 30 and do not sign the facility’s own confidentiality agreements.

Production of medical equipment

NOMA conducts inspections. Inspections are conducted in accordance with Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

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

Pursuant to the Regulation on manufacturing and import of medicinal products Section 4-1, NOMA is given authority to conduct inspection.

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

Medicines

In regard to storage, Section 7 of the Regulation on Wholesale Distribution of Medicinal Products requires that the wholesaler has access to adequately sized and suitable premises, as well as the necessary equipment, to store and handle pharmaceuticals in a safe and professionally sound manner.

Furthermore, wholesalers must ensure the secure transportation of pharmaceuticals to prevent damage, loss, or harm, cf. Section 8 of the Regulation on Wholesale Distribution of Medicinal Products.

More detailed regulations on storage and handling of pharmaceuticals are provided in the European Commission Guidelines on Good Distribution Practices of medicinal products for human use, which according to Section 9 of the Regulation on Wholesale Distribution of Medicinal Products applies.

Additionally, the Regulation on Wholesale Distribution of Medicinal Products (FOR-1993-12-21-1219) Section 7 grants NOMA the authority to provide guidelines for wholesalers’ premises and necessary equipment to ensure that medicinal products can be stored and handled safely and professionally.

Medical devices and their constituent components

The handling of medical equipment is regulated by the Regulation on the Handling of Medical Equipment (FOR-2013-11-29-1373). The purpose of the regulation is to ensure the safe use of medical equipment. Pursuant to Section 12 of the Regulation, medical equipment must be stored and preserved in accordance with the attached instructions for the equipment. Section 8 to 11 of the Regulation establishes requirements regarding, the placement, use and maintenance of medical equipment.

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

Medicinal products

General requirements

Medicinal product packaging should be designed in a way that reduces the risk of confusion and misuse. The final packaging design is approved by NOMA. NOMA may require that medicinal product packaging be equipped with graphical elements, including the use of colors.

The packaging information must be provided in Norwegian, be easily readable, clearly understandable and it should not be possible to delete the information. The declaration of ingredients may be provided in Latin.

Requirements for information that must accompany medicinal products are specified in the Regulation on Medicinal Products Section 3-29 onwards.

Note that specific provisions apply to radioactive medicinal products, homeopathic medicine, traditional plant-based medicine.

Outer packaging

The outer packaging of the medicinal product or, if it does not exist, its inner packaging, shall include the following information:

• The name of the medicinal product followed by strength and pharmaceutical form, and if appropriate, an indication of whether the medicine is intended for infants, children, or adults. If the preparation contains up to three active substances, the generic name shall be specified. If such a name does not exist, the commonly used designation shall be given. The trade name should not be confused with the generic name and should not be capable of being confused with other medicinal products or lead to misuse.
• Quantitative and qualitative composition of all the active substances of the medicinal product, specified per dosage unit, volume unit, or weight unit, depending on the pharmaceutical form.
• Pharmaceutical form, as well as content by weight, volume, or number of doses.
• A list of excipients with known effects according to the EU’s detailed guidelines on excipients. However, if the medicinal product is for parenteral use, local use, or for use in the eyes, all excipients shall be specified.
• Method of administration.
• A warning that the medicinal product should be kept out of reach of children.
• A specific warning if necessary for the particular medicinal product.
• Expiry date in plain text (month/year).
• Any special precautions for storage.
• Any special precautions for the disposal of unused medicines or waste, as well as a reference to existing suitable collection systems.
• Name and address of the marketing authorization holder and, if applicable, the name of the agent where appointed.
• Marketing authorization number.
• Batch number.
• Instructions for use of the medicinal product if it is non-prescription.
• Nordic article number.

Prescription medicines must have a security feature for identifying individual packages to confirm authenticity. Non-prescription medicines should only have the mentioned security feature if they appear on a list established by the EU Commission.

All medicines can have a security feature on the outer packaging, allowing all entities in the distribution chain to verify that the outer packaging is intact.

Prescription medicines, including non-prescription ones listed by the EU Commission, must have a security feature on the outer packaging to enable all participants in the distribution chain to confirm the integrity of the outer packaging. This requirement is in accordance with Regulation (EU) 2016/161.

The outer packaging of medicinal products shall be marked with the name of the medicinal product in Braille, as well as the strength if the medicinal product is available in multiple strengths.

The packaging should also leave space for dosage information.

In addition to the above, NOMA may require the medicinal product to be labeled with information about the price of the medicinal product, conditions for reimbursement from the National Insurance Scheme, status of dispensing to the user and identification and confirmation of authenticity.

Inner packaging

The requirements applying to the outer package listed above, also applies to the inner package except for small packages and perforated blister packs.

The packaging of medicinal products shall include package inserts with information for the user unless all required information is provided on the inner or outer packaging. Requirements regarding the package inserts are provided in Section 3-43 to 3-56 of the Regulation on Medicinal Products.

Packages that are too small to provide the information specified in the Regulation on Medicinal Products Section 3-29 shall provide at least the following information:

•  The name of the medicinal product, as specified in § 3-29 letter a
•  Method of administration
• Strength, if necessary
• Expiry date
• Batch number
•  Content by weight, volume, or number of doses

Inner packaging for a medicinal product containing radionuclides shall, in addition, be labeled with the name or chemical symbol of the radionuclide, the international symbol for radioactivity, the quantity of radioactivity as specified in § 3-32, and the name and address of the marketing authorization holder.

Perforated blister packs shall include at least the following information:

• The name of the medicinal product, as specified in § 3-29 letter a
• Pharmaceutical form and strength
• The name of the marketing authorization holder
• Expiry date
• Batch number

Medical devices

The requirements for information in Regulation (EU) 2017/745 (MDR) apply. Subsequent to the Norwegian Regulation on Medical Equipment (FOR-2021-05-09-1476) Section 6, labels and user manuals containing the required information must be provided in Norwegian.

For example, all equipment shall be accompanied by the information necessary to identify the equipment and its manufacturer, as well as information on safety and performance that is relevant for users and any other individuals.

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

For medicinal products, the package insert may contain symbols or pictograms to explain certain information required in Section 3-43 to 3-49 of the Regulation on Medicinal Products and other information compatible with the approved product information that can serve as health information, excluding any element with a promotional character.

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

Packages should not include advertising for pharmaceuticals. This includes free samples of pharmaceuticals to consumers. The approved package insert can, and must, be included.

See Chapter 3, Question 35 above for more information on requirements for labeling and packaging.

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

Medicinal products

General requirements

Advertising is only allowed for medicines that have marketing authorization in Norway.

All forms of advertising for a medicinal product shall comply with the information in the product information approved by NOMA. In addition, advertising for a medicinal product shall not be misleading and shall promote the rational use of the medicinal product by presenting it objectively without exaggerating its properties.

There are different restrictions and requirements for marketing and advertising medicine applying to prescription drugs and non-prescription drugs.

Prescription medications

It is prohibited to advertise prescription medication to the general public. The same applies to medicines that contain psychotropic or narcotic substances according to international conventions, such as the UN conventions of 1961 and 1971. The prohibition does not apply to vaccination campaigns launched by the pharmaceutical industry and approved by the authorities.

Advertising for prescription medications is only allowed for what is defined as healthcare professionals and must meet specific requirements.

In general, any advertisement for a medicinal product directed at healthcare professionals shall include:

• relevant information that is comprehensive and in accordance with the summary of product characteristics approved by NOMA,
• information about the dispensing conditions of the medicinal product,
• price, and
• information about pre-approved reimbursement.

The information provided must be accurate, up-to-date, verifiable, accessible to the recipient, and sufficiently detailed to allow the recipient to form their own opinion on the medicinal product’s therapeutic value. The material must also indicate the date of creation or last revision of the material.

Alternatively, the advertisement can be presented as a reminder and should then only include the name of the medicinal product, active ingredient, and the marketer’s name.

Quotations, tables, and other illustrations taken from medical journals or scientific works, must be faithfully reproduced with accurate source attribution. Medical journals must undergo peer review for professional quality assurance. Scientific works must undergo peer review for professional quality assurance and be published.

See Chapter 3, question 29 above for more details on advertising in form of gifts and benefits and free samples to healthcare professionals.

Non-prescription medications

Advertising for over-the-counter medications to the general public is permitted, but it must meet specific requirements.

Advertising to the general public for medicines is only allowed when the medicines are exclusively recommended for diseases or symptoms that do not require examination or treatment by a doctor or dentist, unless otherwise specified in Article 14 of Directive 89/552/EEC.

In advertising to the general public, it is not allowed to mention serious diseases such as tuberculosis, sexually transmitted diseases, cancer or other tumor diseases, chronic insomnia, diabetes, or other metabolic diseases. It is prohibited for the pharmaceutical industry to distribute medicines directly to the general public for advertising purposes.

Furthermore, there are stringent rules governing the design of advertising to the general public. Advertising to the general public must be designed in such a way that it is clear it is advertising and that the medicine being advertised is clearly identified as a medicinal product.

The following information must always be included in advertising to the general public:

• The name of the medicinal product, including the names of the active ingredients (common names),
• Information necessary for the correct use of the medicinal product, including its intended use and important precautions and warnings.
• An encouragement for the user to read the package insert and the information found on the packaging.
• In addition, it is prohibited to include in advertising for medicines to the general public material that:
• Implies that consulting a doctor or other healthcare professional or undergoing surgery is unnecessary by offering diagnosis or recommending treatment through correspondence,
• Suggests that the effects of the medicine are guaranteed, without side effects, or are better than or equal to other treatments or medicines,
• Implies that a person’s health can be improved by taking the medicine,
• Implies that a person’s health can be affected by not taking the medicine, except for vaccination campaigns, cf. the Regulation on medicinal products Section 13-5 third paragraph,
• Exclusively or predominantly targets children,
• Refers to recommendations from scientists, healthcare professionals, or individuals who are neither scientists nor healthcare professionals but can promote the use of a medicine based on their reputation,
• Suggests that the medicine is equivalent to a foodstuff, cosmetic, or other commercial product,
• Implies that the safety of the medicine or its effectiveness is due to its natural origin,
• By describing or detailing a medical condition, may mislead individuals into self-diagnosing incorrectly,
• In an exaggerated, frightening, or misleading manner, refers to claims of cure,
• In an exaggerated, frightening, or misleading manner, uses visual representations of changes in the human body due to disease or injury, or the effect of a medicine on the human body or its parts.

Medical devices

It is allowed to advertise medical equipment in Norway, targeting both healthcare professionals and the general public. There is no distinction between advertising directed at healthcare professionals and the general public, unlike the approach taken for pharmaceuticals.

In general, advertising for medical equipment should be objective, truthful, and provide balanced and factual information about the equipment. Advertising must always align with the manufacturer’s instructions, which inform about the purpose, proper use, and precautions

MDR and IVDR article 7 provide restrictions on the claims that may be used in the labelling, instructions for use, and advertising of medical devices. It is forbidden to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or patient with regards to the intended purpose, safety and performance of the device. It is forbidden to make claims that may:

• ascribe functions and properties to the device that it does not have
• create a false impression regarding the treatment or diagnosis, functions or properties which the device does not have
• fail to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose
• suggest uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

In addition, general marketing legislation applies to claims regarding consumer products.

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

Pursuant to the Medicinal Products Act, sale of pharmaceuticals to the general public can, as a general rule, only be carried out by pharmacies. However, exemptions are made in the Regulation on the sale of certain non-prescription medicinal products (FOR-2003-08-14-1053). Pursuant to Section 2 of the Regulation, medicinal products listed in Section 1 can be sold by businesses that trade in food products, such as grocery stores, kiosk and petrol stations. Included in the list are:

• Medicines covered by a list established pursuant to the Regulation Section 6,
• Medicines that, according to the Regulation on Medicinal Products § 3-15 or § 3-16, are approved by NOMA as natural remedies or traditional plant-based medicines,
• Medicines containing nicotine for use in smoking cessation (nicotine-containing medicines),
• Homeopathic medicines registered with NOMA in accordance with the Regulation on Medicinal Products § 3-21, § 3-22, § 3-22A, § 3-23, and
• Medicines exempt from the requirement for marketing authorization in accordance with the Regulation on Medicines for Animals § 4-6.

Although pharmacies, as a general rule may sell prescription drugs, the Norwegian Medicinal Product Agency may exempt certain prescription drugs from being sold though pharmacies. In its decisions to restrict the dispensing of prescription medications, NOMA shall in particular consider whether the medication:

1. Due to its pharmaceutical or medical properties, either as a new medication or for public health considerations, should be reserved for treatments that can only be administered in a hospital setting,
2. Is used for the treatment of diseases that must be diagnosed in a hospital environment or in institutions equipped with suitable diagnostic tools, while supply and follow-up can occur outside the hospital,
3. Is intended for outpatient use, but the monitoring of effectiveness and side effects requires the involvement of a specialist both at the initiation of treatment and throughout the course of treatment.

Both non-prescription drugs and prescription drugs can be sold through authorized online pharmacies, facilitating both home delivery and in-store pickup options.

Pharmacies selling medications online must be approved and registered with the pharmaceutical authorities. In general, online pharmacies must adhere to all the requirements outlined in pharmacy legislation. Specific requirements regarding online sale apply, see for example the Regulation on Pharmacies (FOR-2001-02-26-178) Section 42.

Pharmacies selling medications over the Internet are obliged to provide the Norwegian Medicines Agency with updated information on the following:

1. The address from which the medications will be dispensed,
2. The commencement date of online sales of medications, and
3. The website address to be used and other relevant information necessary to identify the website.

When selling prescription medications online, pharmacies must offer all medications permitted for sale in Norway, pursuant to the Pharmacy Act Section 5-3. Pharmacies may refrain from shipping medications with specific requirements for shipping, storage, or durability, and medications that require special care during dispensing. Information about delivery time, price, and which medications may not be shipped should be clearly stated on the website. The sale of over-the-counter medications online should not be carried out for individuals under 18 years of age.

The website must include the following:

1. A logo, established by NOMA, on each page of the website, identifying the location of the medication seller,
2. A link to NOMA’s information page on the Internet regarding the sale of medications online, and
3. A link from the logo mentioned in point a) to NOMA’s electronic list of entities authorized to sell medications online.

In the sale of medications online, the website must be designed in a way that confidential information is not shared with third parties using cookies or similar means, except when this occurs within the framework of a data processing agreement and in compliance with confidentiality rules.

Pharmacies should provide information on how customers can contact pharmacy personnel and collect customer contact information.

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

The restrictions and requirements outlined in section 13 of the Regulation on Medicinal Products apply to online advertising, including the internet, social media, and other digital platforms. Thus, the same restrictions and requirements apply to electronic marketing and advertising via email, by internet, social media and other channels as for marketing in traditional channels.

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

Prescription medicines may only be advertised and sold as outlined above, see Chapter 3, questions 29 38 and 39.

Medicinal products can be advertised as described above, se Chapter 3, question 38.

42. How is compliance monitored?

Compliance with provisions on advertising of medicines, is monitored by NOMA. According to the Regulation on Medicinal Products Section 13-14, NOMA shall monitor and control advertising for pharmaceuticals. NOMA oversees that advertising and medical claims for medical devices are accurate and truthful. The Agency’s monitoring of advertising is largely based on complaints.

In addition, the Consumer Authority monitors compliance with the Marketing Act.

43. What are the potential penalties for noncompliance?

Pursuant to the Pharmaceuticals Act Section 31, anyone who intentionally or negligently violates the Act, or regulations, prohibitions, or orders issued under the authority of the Act, shall be liable to fines or imprisonment for up to 3 months, or both.

For serious or repeated violations of the regulations on advertising, NOMA may impose penalty fees. When assessing penalty fees for violations of advertising regulations, NOMA will particularly consider:

• Whether the advertising poses a threat to public health and society
• The potential economic gain from the advertising
• Whether there are repeated infractions
• If the advertising is directed towards children and youth

Noncompliance with the Marketing Act can result in a prohibition or mandatory order under Section 40 of the Marketing Act, coercive fines under Section 41 of the Marketing Act, or a penalty fee for violations under Section 42 of the Marketing Act.