The Pharma Legal Handbook: Norway

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:

 

Marketing authorisation application (national)	Human
Complete dossier/well established use (WEU)/fixed combinations, Directive 2001/83/EF art. 8(3), 10a, 10b	NOK 476 157
Hybrid/Generic/Biosimilar/Informed consent, Directive 2001/83/EF art. 10(1), 10(3), 10(4), 10c	NOK 178 558
Additional formulations and strengths applied at the same time	NOK 17 857
Annex I: applications except new formulations/strengths	NOK 107 135
Annex I (Line extension): new formulations and strengths	NOK 119 040
Duplicate application (applied at the same time)	NOK 35 711
Application for registration of a traditional herbal medicinal product, with HMPCmonography	NOK 178 558
Application for registration of a traditional herbal medicinal product, without HMPCmonography (upon agreement)	NOK 238 079
Marketing authorisation application for natural remedies	NOK 238 079
Withdrawal of application before procedure start – administrative fee	NOK 23 807

 

Variation applications and applications for renewal (national)	Human
Type IB variation which leads to changes in the SmPC, PL and labelling 2	NOK 10 118
Type II variation: change in therapeutic indication 1 2 3	NOK 89 281
Type II variation: change in legal status 1 2	NOK 89 281
Other type II variations1 2 4	NOK 14 880
Renewal 5	NOK 47 616
Traditional herbal medicinal products: type II variation – change in traditional use indication 1 2 3	NOK 26 783
Traditional herbal medicinal products: type IB variation which leads to changes in the SmPC, PL and labelling 1 2	NOK 10 118
Traditional herbal medicinal products; other type II variations 1 2	NOK 14 880
Traditional herbal medicinal products; renewal 5	NOK 23 807

 

Parallell import (national)	Human
Application for marketing authorisation	NOK 19 046
Renewal 5	NOK 5 95

 

MRP where Norway is the RMS

Marketing authorisation application (MRP-RMS)	Human
Agreement on RMS-ship 6	NOK 59 519
Initiating MRP, regardless of legal basis 7	NOK 119 040
Repeat use, regardless of legal basis	NOK 119 040
Annex I: applications except new formulations and strengths	NOK 107 135
Annex I (line extension): new formulations and strengths	NOK 148 798

 

Variation applications and applications for renewal (MRP-RMS)	Human
Type IB variation which leads to changes in the SmPC, PL and labelling 1 2	NOK 13 093
Type II variation: change in therapeutic indication 2 3	NOK 89 281
Other type II variations 1 2 4	NOK 14 285
Worksharing: change in therapeutic indication 3 8	NOK 89 281
Worksharing: type IB variation which leads to changes in the SmPC, PL and labelling 1 2 8	NOK 11 905
Worksharing: harmonisation of SmPC	NOK 29 759
Worksharing: other type II variations 8	NOK 14 880
Renewal5	NOK 47 616
Traditional herbal medicinal products: type IB variation which leads to changes in the SmPC, PL and labelling 1 2	NOK 9 523
Traditional herbal medicinal products: type II variations 1 2	NOK 14 285
Traditional herbal medicinal products: renewal 5	NOK 23 807

MRP where Norway is CMS

Markering authorisation application (MRP-CMS)	Human
Complete dossier/well established use(WEU)/fixed combinations, Directive 2001/83/EF art. 8(3), 10a, 10b.	NOK 119 040
Hybrid/Generic/Biosimilar/Informed consent, Directive 2001/83/EF art. 10(1), 10(3), 10(4), 10c.	NOK 89 281
Additional formulations and strengths applied at the same time	NOK 17 857
Annex I: applications except new formulations and strengths	NOK 59 519
Annex I (Line extension): New formulations and strengths	NOK 59 519
Application for registration of a traditional herbal medicinal products, with HMPCmonography	NOK 89 281
Application for registration of a traditional herbal medicinal products, without HMPCmonography (upon agreement)	NOK 119 040
Withdrawal of application before procedure start – administrative fee	NOK 23 807

 

Variation applications and applications for renewals (MRP-CMS)	Human
Type IB variation which leads to changes in the SmPC, PL and labelling 1 2	NOK 7 738
Type II variation: change in therapeutic indication 2 3	NOK 41 664
Other type II variations 1 2 4	NOK 11 905
Worksharing: change in therapeutic indication 3 8	NOK 35 711
Worksharing: type IB variation which leads to changes in the SmPC, PL and labelling 1 2 8	NOK 11 905
Worksharing: harmonisation of SmPC	NOK 23 807
Worksharing: other type II variations 8	NOK 11 905
Renewal5	NOK 20 237
Traditional herbal medicinal products: type IB variation which leads to changes in the SmPC, PL and labelling 1 2	NOK 5 952
Traditional herbal medicinal products: type II variations 1 2	NOK 8 331
Traditional herbal medicinal products: renewal 5	NOK 5 952

 

DCP where Norway is the RMS

Application for marketing authorisation (DCP-RMS)	Human
Agreement on RMS-ship	NOK 59 519
Complete dossier/well established use (WEU)/fixed combinations, Directive 2001/83/EF art. 8(3), 10a, 10b.	NOK 416 638
Hybrid/Generic/Biosimilar/Informed consent, Directive 2001/83/EF art. 10(1), 10(3), 10(4), 10c.	NOK 178 558
Additional formulations and strengths applied at the same time	NOK 17 857
Annex I: applications except new formulations and strengths	NOK 130 943
Annex I (Line extension): new formulations and strengths	NOK 148 798
Application for registration of a traditional herbal medicinal products, with HMPCmonography	NOK 178 558
Application for registration of a traditional herbal medicinal products, without HMPCmonography (upon agreement)	NOK 297 598

 

DCP where Norway is CMS

Application for marketing authorisation (DCP-CMS)	Human
Complete dossier/well established use(WEU)/fixed combinations, Directive 2001/83/EF art. 8(3), 10a, 10b.	NOK 119 040
Hybrid/Generic/Biosimilar/Informed consent, Directive 2001/83/EF art. 10(1), 10(3), 10(4), 10c.	NOK 89 281
Additional formulations and strengths applied at the same time	NOK 17 857
Duplicate application (applied at the same time)	NOK 35 711
Annex I: applications except new formulations/strengths	NOK 59 519
Annex I (Line extension): new formulations/strengths	NOK 59 519
Application for registration of a traditional herbal medicinal products, with HMPCmonography	NOK 89 281
Application for registration of a traditional herbal medicinal products, without HMPCmonography (upon agreement)	NOK 119 040
Withdrawal of application before procedure start – administrative fee	NOK 23 807

 

Homeopathic medicinal products	Human
Application for registration. The fee covers all dilutions of one pharmaceutical form of a product	NOK 23 490
Type II variation	NOK 1 190
Renewal	NOK 1 190

 

Clinical studies	Human
New application (Directive EC 2001/20)	NOK 11 624
New application – Norway as reference member state (Regulation nr. 536/2014)	NOK 73 080
New application – Norway as concerned member state (Regulation nr. 536/2014)	NOK 31 320
Variations (Directive EC 2001/20 og Regulation nr. 536/2014)	NOK 6 264
Safety assessments – Norway as reference member state	NOK 4 176
Safety assessments – Norway as concerned member state	NOK 2 088

 

Applications for WHO-certificates	Human
WHO-certificate	NOK 5 812

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.

Also from this Legal Handbook

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

Clinical trials are not required to be conducted in Norway as a condition for obtaining a marketing approval. As part of the application for a marketing approval, the applicant must submit clinical documentation, hereunder results from clinical trials. If the clinical trials have been conducted outside of the European Economic Area, the applicant must also submit a declaration confirming that such clinical studies have been conducted in accordance with research ethical requirements and requirements for good clinical practice in the conduct of clinical trials.

 

17. How are clinical trials funded?

Clinical trials can be funded in different ways. Financing can derive from private or public sources or private-public cooperations.

 

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

Clinical trials require pre-approval. Until 30 January 2025, there is a dual system whereby clinical trial applications submitted prior to 30 January 2023 can follow the national rules set out in Regulation No. 1321 of 30 October 2009 on clinical testing of pharmaceutical products for humans (which implement directive 2001/20/EC), while clinical trials applications submitted or still in progress with at least one active center in the EU on or after 31 January 2023 must follow the rules set out in Regulation (EU) 536/2014. We will in the following focus on the new regime set out in Regulation (EU) 536/2014.

 

An initial application for a clinical trial under Regulation (EU) 536/2014 must be submitted through the EU application portal CTIS. The application consists of two parts; part I is common for all the EU member states concerned and part II is specific per member state. For clinical trials that take place in Norway, the application will be assessed by the Norwegian Medical Products Agency (NOMA) and the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medicinal Devices (REK KULMU).

 

The requirements to the content of an application are set out in Annex 1 to Regulation (EU) 536/2014. The requirements for the trial protocol follow from Annex I letter D and include inter alia a description of the objective and design of the trial, the title of the clinical trial, the name and address of the sponsor, a list of the medicinal products to be investigated, a description of the subjects participating in the clinical trial and the criteria for inclusion and exclusion, a description of the statistical methods to be employed, a description of the ethical considerations relating to the clinical trial if those have not been described elsewhere, a description of technical and organizational arrangement to ensure information security and information regarding the identification of categories of adverse events and the procedures for handling adverse events. The protocol shall also be accompanied by a synopsis of the protocol.

 

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

A clinical trial may not be conducted before the informed consent of the participants has been collected. It is required that the participant receives detailed information with respect to the nature, objective, benefits, implications, risks and inconvenience associated with the trial. The participant must also be informed about his/her rights, including the possibility to withdraw from the trial at any time without having to provide a justification, the conditions under which the trial is to be conducted, the possible treatment alternatives if participation in the trial is discontinued, the applicable damage compensation system and the EU trial number and the availability of trial results.

 

The information provided to the participant should be clear and understandable to a layperson. It must be provided in a prior interview with the member of the investigating team that is appropriately qualified, as well as be prepared in writing and provided to the participant. The consent by the participant shall be in writing, dated and signed by the participant and the person performing the prior interview. Where a participant is unable to write, consent may be given and recorded through other means in the presence of at least one witness.

 

20. May participants in clinical trials be compensated?

Under Regulation (EU) 536/2014, no compensation can be given to incapacitated subjects or minors or their legally designated representatives, except for expenses and loss of earnings directly related to the participation in the clinical trial. The same applies for pregnant or breastfeeding women. Apart from this, the regulation does not forbid compensating subjects, however information about this must be included in the clinical trial application and forms part of the ethical assessment of the application of Part II of the application, cf. question 18 above. It is a general requirement that no undue influence, including that of a financial nature, is exerted on subjects to participate in the clinical trial.

 

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

Unless the manufacturer or importer already holds a relevant insurance, the responsible for a clinical trial is required to take out an insurance through membership in the Drug Liability Association to protect and indemnify the participants against harm that arises from the participation in the trial. This follows from the Product Liability Act Chapter 3. Such insurance will, pursuant to the rules set forth in this Act, indemnify the injured individual on a non-fault basis. Claims for compensation can be put forward before the Norwegian System of Patient Injury Compensation (NPE).

Also from this Legal Handbook

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

The Ministry of Health and Care Services (Helse- og Omsorgsdepartementet, “HOD”) is the superior administrative authority in Norway, with jurisdiction over drugs, biologicals, and medical devices.

 

The Norwegian Medical Products Agency (Direktoratet for medisinske produkter, “NOMA”), has both a supervisory and regulatory role. With regards to the assessment of medicines and medical devices, NOMA is inter alia responsible for assessing and issuing market authorisations for medicines, assessing clinical trials regarding medicines and medical devices, and authorising the manufacturing, import, sale and distribution of medicines, as well as authorising the use of medicines that do not have marketing authorisation. NOMA also determines the prices of prescription medicines, determines the medicines that should be included in the general reimbursement scheme, evaluates cost effectiveness of medicines used in the specialist health service, and is responsible for charging fees as regards revenues from the sale of medicines. With regards to its supervisory role, NOMA is responsible for pharmacovigilance, as well as for the supervision of clinical trials, manufacturers, and the marketing of medicines. With regards to medical devices, NOMA is responsible for enforcing the medical devices legislation, and monitoring the market and the actors involved.

 

The Norwegian Health Economics Administration (Helseøkonomiforvaltningen, “HELFO”) is responsible for the reimbursement scheme which involve reimbursing patients of expenditure for medicines and medical supplies, including deciding on reimbursement for individual patients where there is no general reimbursement or indication is not covered by general reimbursement. HELFO is also in charge of the reimbursement of expenditure incurred by health service providers relating to patient treatment.

 

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

Authorization:

The primary regulatory framework for the authorization of medicines is set out in the Medicines Act (LOV-1992-12-03-132) and the Medicines Regulation (FOR-2009-12-18-1839). The Medicines Act and associated regulations implement the relevant EU legislation. This includes Regulation 726/2004 and Directive 2001/83/EC.

The main regulatory framework for the authorization of medical devices is set out in the Medical Devices Act (LOV-2020-05-07-37) and the Medical Devices Regulation (FOR-2021-05-09-1476), which implements Regulation (EU) 2017/745, which replaces Directive 90/385/EC and Directive 93/42/EC. The Medical Devices Act and associated regulations also implement Regulation (EU) 2017/746 regarding vitro diagnostic medical devices, which replaces Directive 98/79/EC.

 

Pricing:

Before any prescription-only medicines can be marketed and sold in Norway, a maximum price for the medicines must be set, cf. the Medicines Regulation Chapter 12. This maximum price is set by NOMA based on an application for maximum price from the marketing authorization holder. The maximum price consists of two elements: the maximum pharmacy purchase price (“PPP”) and the maximum pharmacy retail price (“PRP”). The PPP is decided based on several factors, set out in the Medicines Regulation Section 12-2:

• The main factor for deciding the PPP is international price comparisons. The Medicines Regulation sets out that the prices for the medicine in other EEA countries shall form the main basis for determining the PPP. Per the NOMA “Guidelines for price setting in Norway”, the price of a prescription-only medication in Norway is set as the mean of the three lowest market prices of the product in a selection of countries. The current reference countries are Sweden, Finland, Denmark, Germany, UK, Netherlands, Austria, Belgium, and Ireland.
• The price comparisons will be made with the price of the same product in the reference countries, as well as for similar products, including biosimilars and generics. Such price comparisons can also be made with similar products on the Norwegian market.
• In special cases, the production costs of the medicines can be taken into account.

 

Both the marketing authorization holder and NOMA may suggest a re-evaluation of the price in Norway per the Medicines Regulation Section 12-5, if this is justified by changes of circumstances or new information. Prices are normally not re-evaluated more than once a year, with the exception of newly launched products, for which NOMA may request information about new prices half-yearly with regards to pricing in Norway.

 

The PRP is decided by adding the maximum profit for the pharmacy to the PPP. The maximum profit for the pharmacy is decided by NOMA based on the following criteria:

• 2,0% add-on from the PPP,
• NOK 29,00 add-on per package,
• 0,5% add-on from the PPP if the medicine requires cooling,
• NOK 19,00 add-on for A/B-preparations. A and B preparations are medicines that are classified as highly addictive and that require special prescriptions and a personal ID prior to issuing.

 

After the patent (and supplementary protection certificates) for a medicine has expired, competing generic medicines has been introduced and the medicine has been included on the NOMA list of interchangeable medicines (list of medicines distributed to the pharmacies listing which medicines are interchangeable with another), medicines are subject to a “price step model” price reduction scheme, as set out in the Medicines Regulation. The “price step model” entails a certain price reduction of the medicine over a certain period of time: the price is reduced by a certain percentage of the original medicines maximum PPP. The PPP is reduced in three steps. First when there is generic competition on the market, while the second commence six months later. The third step commences 18 months after the first step at the earliest. The scope of the price reduction is dependent on the annual turnover of the original drug. The Medicines Regulation Section 12-15 differentiates between drugs with an annual turnover either exceeding or not exceeding NOK 100 000 000 in a 12-month period within the two years prior to the generic competition entered the market.

For non-prescription drugs, the price is generally set without restrictions. The same applies for medical devices. If the manufacturer or importer of the medical device want the medical device in question to be included in the Blue Prescription reimbursement scheme, an application must be filed with HELFO. As part of this application process, the manufacturer/importer and HELFO agrees on a maximum net reimbursement price.

 

Reimbursement:

In Norway, prescription medicines are financed by the state through the reimbursable prescription regime, also called “blue prescriptions” and the regional health authorities (H-prescriptions and medicines used in hospitals), by other health institutions and by the patients through self-payment (“white prescriptions”).

 

Blue prescriptions are regulated in the Blue Prescription Regulation (FOR-2007-06-28-814). The blue prescription regime entails that the state, through the National Insurance Scheme (“NIS”), covers expenses for medicines, medical supplies, medical devices, etc. prescribed by a physician for outside of hospital-use. The patient must per the Blue Prescription Regulation usually pay a co-payment for the blue prescriptions. This co-payment is in most cases limited to 50% of the price of the prescription but not exceeding NOK 520 per prescription, with a yearly maximum limit of NOK 3165 in 2024. The coverage under the blue prescription scheme is limited to the treatment of serious illnesses or of risk factors that are likely to cause or intensify serious illness and where there is a need or risk of recurring treatment over a prolonged period of time.

 

The Blue Prescription Regulation sets out in Section 2 that certain medicines are pre-approved for reimbursement. These medicines are set out in the reimbursement list. This list can be found on NOMA’s website. For medicines not pre-approved, reimbursement can be provided by individual application, cf. the Blue Prescription Regulation Section 3. Reimbursement can also be provided for medicines used to treat serious contagious diseases which endanger the public health.

 

HELFO also reimburses certain costs for medical devices for certain deceases through the blue Prescription regime. The medical devices covered are limited to the devices listed in the Blue Prescription Regulation Section 5. The specific products and prices are specified in the HELFO product and price list. In order for the medical device to be listed in the product and price list, the supplier must apply to HELFO.

 

For some medicines prescribed by hospital doctors, the regional health authorities (hospitals) may reimburse the costs (H-prescriptions). This reimbursement scheme can apply even if treatment is conducted outside of the hospital. The medicines that fall under the regional health authorities’ reimbursement responsibility is listed in the attachment to the Blue Prescription Regulation, cf. the Blue Prescription Regulation Section 1b.

 

In the white prescription scheme, the expenses for the medicines and medical devices are in most cases covered fully by the patient, with some exceptions. These expenses are however limited by the maximum cost scheme for health services. As mentioned above, per 1 January 2024 the threshold is set to NOK 3165. The maximum cost scheme however only covers certain expenses:

• Pharmacists/bandagists
• Doctor,
• Treatment with physiotherapists
• Psychologist
• Hospital/Clinic
• Laboratories and X-ray
• Certain forms of dental diseases
• Patient travel
• Stay at rehabilitation institutions and other private rehabilitation institutions that have an agreement with regional health authorities
• Treatment trips abroad organised by Oslo University Hospital – Rikshospitalet HF

 

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

Medical products:

The authorization to develop test and market medicinal products in Norway is mainly regulated in the Medicines Regulation and the Regulation on clinical trials of medicinal products for human use (FOR-2009-10-30-1321), which incorporates inter alia Regulation (EU) No 536/2014, Regulation (EU) 2017/1569 and Regulation (EU) 2022/20. It is NOMA that is overseeing the evaluation of new medical products in Norway.

 

In order for the new medical product to achieve marketing authorization, the producer must complete three main steps:

• Pre-clinical trials: These trials are not subject to regulation under the regulatory framework mentioned above.
• Clinical trials (human trials): These trials are subject to regulation under the Regulation on clinical trials of medicinal products for human use.
• Marketing authorization application: The producer of the medicinal product must submit an application for marketing authorization to NOMA or to the European Medicines Agency. The application must comply with the requirements to document the medicinal products quality, safety and efficacy. In order for a prescription-only medicinal product to be put on the market, a PPP and PRP must have been set, cf. the Medicines Regulation Section 12-1.

 

Medical devices:

Medical devices are regulated in the Medical Devices Act and Medical Devices Regulation. This regulatory framework does not require a prior authorization from NOMA or any other public authority in order to place a medical device on the market. It is the producer which is obligated to ensure that the medical device in question satisfies the requirements set out in the regulatory framework. Before a medical device can be marketed, sold or used it however must have a CE mark. Norwegian producers of medical devices are also obligated to register the medical device in the Norwegian Register for Medical Devices. The marking and instruction manual for the medical device must be in Norwegian, cf. the Medical Devices Regulation Section 6.

 

Nye Metoder:

The Nye Metoder scheme is be applied to new health technologies entering the specialist health care service. As a main rule, until a positive decision has been made by Nye Metoder’s Decision Forum, new products and indications cannot be procured and prescribed in the specialist health services. There is an exemption scheme containing specific requirements.

 

4. What are the approximate fees for each authorization?

NOMA collects a fee for applying for marketing authorization, for renewing a marketing authorization and for changing the basis for a marketing authorization, cf. the Medicines Regulation Section 15-3. The fee varies depending on the procedure, type of medicinal product, and other factors. The fees are available on NOMA’s website. The fees were adjusted 1 January 2024. Marketing authorization holders in the Norwegian market must also pay supplier tax of 1.0% of annual turn-over.

 

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

Medicinal products:

The 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 of the medicinal product in question, cf. the Medicines Regulation Section 3-57. This evaluation is conducted by NOMA. Once renewed, the marketing authorization shall be valid for an unlimited period, unless NOMA decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.

 

The renewal application should contain a consolidated version of the file in respect of quality, safety and efficacy including all variations introduced since the marketing authorisation was granted or since the last renewal. The renewal application must be submitted to NOMA at least nine months prior to the end of the five-year period.

 

Medical devices:

There are generally no time restrictions for medical devices as long as the requirements for the marketing, sale and use of the medical device in question are fulfilled (CE mark and registration of the medical device in the Norwegian Register for Medical Devices). Note however that the CE mark generally has a five-year limit and the marketing authorization holder must make sure that the medical device in question has a valid CE mark in order for the medical device to be placed on the Norwegian market.

 

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

Originator products are subject to the full marketing authorization application procedure, as laid down in the Medicines Regulation and the Regulation on clinical trials of medicinal products for human use (see Chapter 1, question 3).

 

For generic medicinal products, the product may obtain a marketing authorization through a simplified procedure as set out in the Medicines Regulation Section 3-9. In this simplified procedure, it is sufficient for the producer to document that the medicinal product has the same qualitative and quantitative composition of active substance and the same pharmaceutical form as the reference medicinal product. If the reference medicinal product does not have a marketing authorization in Norway, it is sufficient to state an EEA country where the reference medicinal product has or has had marketing authorization.

 

The Medicines Regulation Section 3-10 to 3-11a sets out when the application for marketing authorization can be submitted and when the marketing authorization can be used in Norway. This depends on which procedure the marketing authorization application has been approved under and when the marketing authorization for the reference medicinal product was granted.

 

There is no difference between Norwegian manufacturers and foreign owned manufacturers with regards to the process for obtaining authorization.

 

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

The Medicines Regulation Section 3-13 regulates combination medicines: medicines that combines active substances that are already used in medicines with a marketing authorization but has not previously been combined in the same medicine. For such medicine, the producer must submit results from pre-clinical and clinical trials regarding this new combination of substances. It is not necessary to submit documentation regarding each active substance.

 

Where the product is a combination of medicines and medical devices, it must be determined on a case-by-case basis whether the product is to be regulated as a medicine or medical device. In case of doubt, NOMA can decide whether the product shall be categorized as medicine, cf. the Medicines Regulation Section 1-2.

 

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?

NOMA monitors and evaluates compliance with the applicable rules and regulations, both with regards to medicinal products and medical devices. The regulatory regime is in line with the European Medicines Agency’s expectations and requirements.

 

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

A range of sanctions ranging from criminal sanctions to administrative fines are set out in Sections 28-30 of the Medicines Act. It is set out in the Medicines Act Section 28 a that the ministry may issue administrative fines for violation of provisions in the Medicines Act. Per the Medicines Regulation Section 15-12 NOMA has been given jurisdiction to issue such administrative fines.

 

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

Norway has a national healthcare system. All residents (if a person intends to stay or has stayed in Norway at least 12 months) or people working in Norway with a Norwegian employer is as a general rule mandatory members of the National Insurance Scheme (folketrygden), cf. the National Insurance Scheme Act Section 2-1. The National Insurance Scheme is managed by HELFO. The healthcare system is financed through taxation, employer contributions and co-payment from patients. There are significant limits to the patients’ co-payments. See above (Chapter 1, question 2).

 

The Norwegian healthcare system is semi-decentralized with four Regional Health Authorities that are responsible for the specialised care, and municipalities that are responsible for primary care.

 

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

There is only a small number of privately owned hospitals which, for the most part, are financed publicly. There is only limited private medical insurance. See also Chapter 1, question 10 above.

 

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

See Chapter 1, question 2 above.

 

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

See Chapter 1, question 2 above.

 

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

Medicinal products:

Prescription drugs can only be dispensed to patients by pharmacies. The pharmacy can only dispense the prescription drug if the patient has been given a prescription by a physician. Certain non-prescription drugs can be sold outside of pharmacies (grocery stores, kiosks, and petrol stations). The sale of certain non-prescription drugs outside of pharmacies (the LUA scheme) is regulated in the Regulation on the sale of certain non-prescription medicines outside of pharmacies (FOR-2003-08-14-1053, the LUA-Regulation). Other relevant regulations regarding the sale of medicinal products are the Pharmacy Act (LOV-2000-06-02-39), the Pharmacy Regulation (FOR-2001-02-26-178), and the Regulation on the requisition and delivery of medicinal products (FOR-2022-06-02-977).

 

With regards to the sale of prescription medicines, most of the pharmacies’ expenses are covered by the state, ca. 80%. These expenses are shared between the National Insurance Scheme and the hospitals. The Hospital Trusts (helseforetakene) covers the expenses for medicines used in hospitals and for medicines which are prescribed to patients through an H-prescription are covered by the Hospital Trusts. Most of the remaining expenses are covered by the patient through co-payment, ca. 18%. There are significant limits to the patients’ co-payments. See above (Chapter 1, question 2).

 

For medical devices, see 1.15, below.

 

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?

All health care personnel, which includes physicians, pharmacists and other persons providing health care services, have an obligation to conduct their work in accordance with the requirements to professional responsibility and diligent care that can be expected based on their qualifications, the nature of their work and the situation in general, cf. the Healthcare Personnel Act (LOV-1999-07-02-64) Section 4. Healthcare personnel have a duty to provide their services, including the dispensing of drugs and medical devices, in accordance with the requirement of responsible conduct.

 

Per the Pharmacy Act Section 6-5, the pharmacy has an obligation to provide information about the drug that it dispenses, so that the drug or device is used correctly. For medical devices, the same is set out in the Regulation on handling medical devices Section 8. If there are more than one available drug that is considered equivalent, the pharmacy must inform the patient about the alternatives and the price, cf. the Pharmacy Act Section 6-4.

 

For medicinal products that are sold outside of pharmacies, the distributor shall not give any oral information on the choice of product or on the products characteristics or use. Any questions shall be referred to a physician or pharmacist, or the information included on the packaging or the package leaflet of the product, cf. the Regulation on the sale of certain non-prescription medicine outside of pharmacies Section 12.

Also from this Legal Handbook

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

Liability under Norwegian law can be distinguished between civil and criminal liability. Criminal liability may be incurred by anyone who violates penal provisions, either in the penal code, or provisions in other acts of legislation which is sanctioned with criminal liability. Civil liability can be distinguished between liability for breach of contracts, and for damages incurred outside contracts (torts), which also includes product liability.

 

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

The Norwegian Act relating to product liability of 23 December 1988 No. 104 (“Product Liability Act”) contains general provisions on product liability, as well as special provisions relating to drug liability.

 

General provisions on product liability

 

The general provisions on product liability stipulate that a producer must compensate any harm or injury caused by their products, provided this is caused by the product failing to meet the security standards which a user or the public should reasonably be able to expect from the product (referred to as a ‘safety defect’, Nw: sikkerhetsmangel). The liability applies irrespective of fault from the producer, i.e. regardless whether the producer was negligent or not, provided the product suffers from a safety defect (however, there are some exceptions, cf. “defenses” below).

 

This liability applies to all “producers” of products. “Producer” is broadly defined and includes inter alia:

 

• Anyone who manufactures a product,
• Anyone who offers for sale a product by using their name, trademark or other mark on the product or its packaging,
• Retailers of a product, where the producer cannot easily be identified and where the retailer does not identify the producer’s or former retailer’s name and address,
• Importers of a product from outside the EEA,
• Retailers of an imported product from outside the EEA, where the importer’s or the intermediary’s name and address is not provided within a reasonable time.

 

Liability pursuant to the Product Liability Act is mandatory, meaning that any contractual provisions which attempts to limit a producer’s liability pursuant to the Act is rendered void.

 

The liability applies to damages to both natural persons and property.

 

Special provisions for drug liability

 

The Product Liability Act’s chapter 3 includes special provisions which applies for damages to natural persons caused by medical products. According to these provisions, all producers, importers (where the producer is not insured) and anyone who conducts trials on humans, are required to be insured against drug liability (Nw: legemiddelforsikring) through membership in the Drug Liability Association (Nw: Legemiddelansvarsforeningen). The drug liability insurance is in turn objectively responsible to compensate any damages to natural persons caused by medical products.

 

The drug liability insurance will compensate damages irrespective of fault by the producer, importer or other parties required to have such insurance, and irrespective of responsibility for a safety defect, where applicable. However, there are some modifications and exemptions which apply:

 

• Where a damage is caused by a safety defect, the Drug Liability Association is liable unless the exemptions under the general provisions apply (cf. above).
• Provided the damage falls within the special provisions for drug liability and the damage is not caused by a safety defect, the Drug Liability Association is not liable to the extent the damage is:
• A result of wrongful handling or confusion between medical products or other neglect occurring at a pharmacy, by a physician, at a hospital or other distributor,
• Caused in other manner than by foreseeable use of the medical product, such as use in violation of proper and specified warning label or improper use due to neglect by a physician by wrongful prescription or improper guidance,
• Caused by the medical product not working or not working to a sufficient extent, or
• Caused by side effects which, taking into consideration the damaged person’s situation, is reasonable that the damaged person carries the consequences of.

 

Retailers of medical products must ensure that the producer or importer is a member of the Drug Liability Association. A retailer who distributes medical products from a producer or importer who is not a member of the association, is responsible for the premiums which the producer or importer should have paid.

 

The insured party is liable to the damaged party equal to the amount which the drug liability insurance is required to pay. The limitation for the drug liability insurance is NOK 80 million for injury which occurs in the same calendar year, and NOK 100 million for injury which is caused by the same substances in one or several medical products. However, if the damages exceed the limitations for the drug liability insurance, the producer may be liable for the exceeding amount pursuant to the general provisions on product liability (cf. above).

 

If a producer is not insured as required by the Act and a damage occurs which falls within the liability regime, the Drug Liability Association is entitled to seek recourse from the producer.

 

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

Liability may be incurred by the «producer» (although the Drug Liability Association will be liable under the special provisions for drug liability cf. question 54 above). Provided that the manufacturer is considered «producer», liability will normally only be imposed on this legal entity.

 

Criminal liability can in principle be imposed on natural persons within the legal entity (such as executives, employees or representatives), if a criminal offense has been committed. However, this would require that the individual acted with either negligence or intent with respect to the offense. Norwegian criminal law does not recognize objective liability for natural persons.

56. How can a liability claim be brought?

Generally, under Norwegian civil procedure, a claim can be brought in front of the ordinary courts, the first instance being the district courts (Nw: tingrett). As such, liability claims may be brought by anyone who asserts to have suffered harm or damages due to a product.

 

Due to the statute of limitations, claims must be brought forward within three years after the day which the claimant obtained or should have obtained knowledge about the damage, the safety defect and the producer. Absolute limitation normally occurs 10 years after the producer placed the product on the market. For medical products, the maximum period of limitation is 20 years.

 

For medical products and liability for personal damage, claims can be filed through the Norwegian System of Patient Injury Compensation (Nw: Norsk Pasientskadeerstatning, “NPE”), which according to their own websites is “a government agency subject to the Norwegian Ministry of Health and Care Services. We handle compensation claims from patients who think they may have gotten an injury from an error or omission in the health care treatment. The claims handling is free of charge.”

 57. What defenses are available?

Generally, the producer may argue that one or more of the requirements for liability is not met. The producer can argue that the product did not suffer from a safety defect, or that the injury or damage was not caused by the product.

 

Under the general product liability, there are also exemptions from liability which a producer can invoke. The producer is exempt from liability where the producer can substantiate that either:

 

• The producer did not place the product on the market as part of their business,
• The safety defect was not present when the product was placed on the market, and the damage should not have been prevented or mitigated afterwards, or
• The safety defect was caused by the product being in accordance with mandatory requirements from the public authorities.

 

For medical products, where the damage is caused by a safety deficiency, the above exceptions apply. If the liability is not caused by a safety defect, meaning that the specific provisions for drug liability apply, please refer to the exemptions above in question 54.

Also from this Legal Handbook

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

 

Patents:

The most basic requirements follow from the Norwegian Act relating to patents of 15 December 1967 No. 9 (“the Patents Act”). The Patents Act § 2 stipulate that patent protection may be granted to anyone who has made an invention that is susceptible of industrial application, which is novel, and which involves an inventive step. «Novelty» entails that the invention was new on the filing day of the application. «Inventive step» requires that the patent was not obvious to the skilled person on the filing day of the application, taking into account everything which was publicly known at the filing date (the state of the art).

 

Norway is a contracting party to the European Patent Convention (EPC), and as such, has very similar patent laws and patent requirements as its European counterparts.

 

A patent gives its proprietor exclusive rights to the invention from a period of 20 years from the filing date of the application. The rights can be described as a «right to prohibit», in the sense that it is a right to prohibit others from exploiting the invention commercially during the protection period, such as the right exclusive right to manufacture, offer for sale, place on the market and use a product protected by the patent.

 

Supplementary protection certificates (SPC) are available in Norway, which grant additional period of exclusivity for medical products up to a maximum of five years. Seeing that the protection period is 20 years from the filing date, the effective protection period for medical products will in practice be significantly less than 20 years due to regulatory requirements for medical products, such as those relating to marketing authorizations (MA). Norway has implemented Regulation (EU) 469/2009 concerning SPCs in its entirety (the legal basis for granting SPCs), which is aimed at mitigating this regulatory delay.

 

Both applications for patents and SPCs must be submitted to the Norwegian Intellectual Property Office (Nw: Patentstyret, “NIPO”).

 

Trademarks:

Trademarks are governed by the Norwegian Act relating to trademarks of 26 March 2010 No. 8 (“the Trademark Act”). Norwegian trademark law is harmonized on an EU/EEA level due to the implementation of Directive (EU) 2015/2436.

 

Trademark protection can be obtained by registration. Pursuant to the Trademark Act § 2, a trademark can consist of any sign capable of distinguishing the goods or services of one company from those of another. As such, a trademark must have distinctive character, and therefore cannot be descriptive of the goods and services which the trademark is applied registered for.

 

Unregistered marks can also obtain trademark protection, granted the mark has become well known as someone’s sign.

 

Trademark protection for registered trademarks is initially granted for a period of 10 years and may be prolonged indefinitely for additional 10-year periods. Unregistered trademarks are protected for as long as the mark is well known as someone’s sign.

 

Trademark protection entitles the holder to prevent others from 1) using identical signs for the same goods and services for which the trademark is protected, and 2) signs which are identical or similar to the trademark for similar goods and services, provided there is a risk of confusion between the marks.

 

Furthermore, for marks that are well-known, the trademark protection entails that no one may (without authorization from the holder) use signs which are identical or similar to the mark, for similar goods and services, provided this constitutes an unreasonable exploitation or damage to the well-known mark’s distinctive character or goodwill.

 

59. What agencies or bodies regulate patents and trademarks?

Patents, trademarks and SPCs are regulated by the Norwegian Intellectual Property Office (“NIPO”, Nw: Patentstyret). NIPO is responsible for examining applications (including international designations), granting applications, handle and decide as the first instance objections and requests for administrative review, as well as handle renewals. Claims relating to patents, trademarks and SPCs can also be brought in front of the ordinary courts, with Oslo district court (Nw: Oslo tingrett) being the mandatory first instance.

 

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

Patents:

 

Patent protection can be granted for “inventions”. An invention is generally defined as a practical solution of a problem where the solution has technical character, technical effect and is reproducible.

 

On the other hand, subject-matter which merely consists of discoveries, scientific theories cannot be considered an “invention” and is excluded from patentability (cf. the Patents Act § 2).

 

Furthermore, the Patents Act stipulates that a number of substances, processes and other subject-matter is explicitly excluded from protection. This includes:

 

• Plant sorts and animal races,
• Biological processes for the reproduction of plants or animals, meaning processes which largely relies on natural phenomena such as crossing or selection. Patents can however be granted for microbiological processes or other technical processes or a product which is reproduced using such processes,
• Processes for surgical treatment, therapy or diagnosticating, intended for humans or animals. However, patents may be granted for products intended for use in such processes,
• The human body in all of its stages of formation and development, and the simple discovery of one of its elements, such as a sequence of a gene,
• Inventions whose commercial exploitation would be contrary to public order and moral. This includes procedures for the cloning of humans; procedures to modify the genetic identity of human sex cells; use of human embryos for industrial or commercial purposes, and processes for modifying the genetic identify of animals, which could cause them suffering without also obtaining significant medical benefit to man or animal, as well as animals which are produced through such processes.

 

Trademarks:

Pursuant to the Trademark Act § 2, a trademark can consist of all signs which are suited to distinguish one company’s goods and services from others. This includes words and combinations of words, such as slogans, names, letters, numbers, figures, depictions, colors and sounds, the shape of a good, equipment or packaging.

 

The Trademark Act contains some examples of signs which are explicitly designated as un-registrable, some of which are mentioned below:

 

• Signs which solely consist of a form or other characteristic which follows from the nature of the good, or which is necessary to achieve a technical result, or which adds a significant value to the good,
• Marks which are contrary to Norwegian legislation, public order and moral,
• Any mark which is suited to mislead, for instance with regard to the nature, consistency or origin of a good or service,
• Marks which are excluded from registration in accordance to protected designations of origin,
• Marks which are applied for in bad faith.

 

 61. How can patents and trademarks be revoked?

Patents:

 

Granted patents can be challenged by anyone through a request for administrative review to NIPO, or through claims brought to the ordinary courts. In cases of administrative review, NIPO will reach a decision, which then can be appealed to the Norwegian Board of Appeal for Industrial Property Rights (Nw: Klagenemnda for industrielle rettigheter, “KFIR”). A decision from KFIR can be appealed to the ordinary courts.

 

Patents can be challenged on a number of reasons, cf. the Patents Act § 51. This includes that:

 

• The patent was filed despite not meeting the requirements of patentability. This could for instance be that the invention lacked novelty, or inventive step,
• The patent concerns an invention which the skilled person is not able to reproduce from reading the description of the patent,
• The patent concerns an invention which was not disclosed by the application at the filing date,
• The scope of the patent has been extended after the patent was granted,
• The patent has been modified following a request for limitation in a way that has expanded the scope of the patent.

 

Trademarks:

 

Like patents, trademarks can also be challenged through a request for administrative review to NIPO, or through claims brought to the ordinary courts. Trademarks can be challenged on a number of reasons cf. the Trademark Act § 35, which includes:

 

• That the trademark was granted despite not meeting the basic requirements. This could for instance be that the trademark was devoid of distinctive character, or that the trademark is infringing another trademark.
• Non-use: The holder of a trademark is required to use the trademark within five years from the mark was granted protection.
• That the trademark has become the common description of the goods or services. This happens rarely. A famous example of this is “trampoline”, which was originally a trademark, but has since become the common description for trampolines.

 

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

Trademarks, patents and SPCs are national rights, and therefore the clear principle is that foreign patents, trademarks and SPCs do not have effect in Norway. However, there are some modifications to this principle.

 

With respect to trademarks, under the international Madrid system, an international trademark application in a country which is a WIPO member state can be internationally designated to other WIPO member states, such as Norway. Such trademarks must however be processed as applications, which must be accepted by NIPO.

 

With respect to patents, European patents can be validated in Norway through NIPO. Furthermore, international patent application procedures through the Patent Cooperation Treaty (PCT) can also be used to apply for patent protection in Norway by designating Norway in the application process, provided the country of origin is a contracting party to the PCT.

 

Unitary Patents do currently not have effect in Norway. Nor do European Union Trade Marks (EUTM).

 

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

As part of the EEA Agreement, Norway has corresponding rules as that of the EU on market exclusivity and document protection.

 

Norway has implemented Regulation (EU) 141/2000 on the protection of orphan drugs through the Norwegian Medicines Regulation (Nw: legemiddelforskriften) § 15-7. This entails that the member state shall, on certain conditions, refrain from granting a marketing authorization for similar orphan drugs for the same therapeutic indication for a ten-year period.

 

Norwegian law also grants protection for trade secrets through the Act relating to the protection of trade secrets of 27 March 2020 No. 15 (“Trade Secrets Act”), which is a result of the implementation of Directive (EU) 2016/943. In essence, the Trade Secrets Act stipulates that no one may infringe a trade secret by obtaining knowledge or possession of a trade secret by unlawfully obtaining access to documents or other objects, or by otherwise conducting unfair business practices. There are also restrictions on spreading trade secrets to others. “Trade secrets” are defined as:

 

• Pieces of information which is secret (in the sense that the information is not as a whole or due to their composition is not easily accessible),
• Has commercial value because they are secret,
• The proprietor has made reasonable efforts to ensure that the information is secret.

 

As such, the Trade Secrets Act will provide protection to proprietors of medicines or devices, provided the substantive conditions in the Act are met (such as that the proprietor must have made reasonable efforts to keep the information secret). Infringements may result in liability for damages, and even criminal liability on certain conditions. The court may also order infringing items and documents to be destroyed to prevent further infringement.

 

More generally, the Act relating to the control of marketing and contract terms and conditions, etc. of 9 January 2009 No. 2 (“The Marketing Control Act”) stipulates general provisions which prohibits acts in the course of trade which “conflicts with good business practice among traders”. This is not specifically aimed at medicines or devices, but instead has general application.

 

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

We refer to question 60 above which in more detail outlines what products, substances, and processes cannot be protected by patents or trademarks.

 

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

No. Licenses may be registered with NIPO, but this is not required. However, this is beneficial, as failure to register a license with NIPO can lead to the license becoming void in instances where e.g. the licensor has transferred the patent altogether to a third party, or where the licensor becomes bankrupt.

Also from this Legal Handbook

Keen to learn more about regulatory reforms in Norwegian Pharma? Read on! Prepared in association with DLA Piper, a leading law firm in Norway, this is an extract from The Pharma Legal Handbook: Norway, available to purchase here for GBP 99.

 

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

The most relevant changes to the Norwegian healthcare system expected to enter into force in the near future are the following:

The new EU regulation on clinical trials on medicinal products for human use, Regulation (EU) 536/2014, which has been implemented in the Norwegian Medicines Regulation Section 15-6a will replace the provisions in the current regulations on clinical trials which implements EU Directive 2001/20/EC once the EU Portal and EU Database have been successfully established. The main changes are: 

• a harmonized electronic submission and assessment process for clinical trials conducted in multiple Member States including the EEA EFTA States;
• an improved collaboration, information-sharing and decision-making between and within Member States and EEA EFTA States;
• an increased transparency of information on clinical trials;
• the highest standards of safety for all participants in EEA/ EU clinical trials.

More information is available.

 

2. When are they likely to come into force?

In relation to the above, the following applies:

Regulation (EU) 536/2014 has been implemented into the EEA Agreement, and been implemented into Norwegian law. As the entry into force will depend on when the EU Portal and EU Database have been successfully established in accordance with Art. 82 of the Regulation, the entry into force is still uncertain. However, as of May 2021 audit of the EU Portal and EU Database is expected to commence by 31 January 2022, which implies that the Regulation, is not likely to enter into force in Norway until 2022.

Also from this Legal Handbook

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

Traditional medicine:

The main legal framework regarding traditional medicinal products, regardless of whether the product is a prescription-only or non-prescription (OTC) product, is set out in the Medicines Act (LOV-1992-12-04-132) and the Medicines Regulation (FOR-2009-12-18-1839). The import of traditional medicinal products is regulated in the Regulation on the manufacturing and import of medicines (FOR-2004-11-02-1441).

 

All traditional medicinal products which are to be sold on the Norwegian market must have a marketing authorization, regardless of whether it is a prescription-only or non-prescription (OTC) product. The process of obtaining a marketing authorization is described above, including the requirements for pre-clinical trials, clinical trials and the marketing authorization application process (Chapter 1, Question 3).

 

Wholesale activities regarding medicinal products (procurement, storage, distribution and exports) are regulated in the Regulation on the wholesale activities with medicinal products (FOR-1993-12-21-1219). All wholesale activities require a wholesale permit from NOMA, cf. the Regulation on wholesale activities with medicinal products Section 2. Businesses with a manufacturing license for medicinal products from another EEA country, can conduct wholesale business with the medicinal products that are covered by the manufacturing license. NOMA must be notified about such wholesale activities.

 

The import of traditional medicinal products (prescription-only products, non-prescription products and OTC products) are regulated in the Regulation on the manufacturing and import of medicines (FOR-2004-11-02-1441). The Regulation differentiates between the import of medicine from EEA countries and from countries outside of the EEA. Businesses engaged in wholesale activities in Norway, which have a wholesale permit from NOMA, cf. Regulation on the wholesale activities with medicinal products Section 2, can import medicine from other EEA countries without the need of any other import license, cf. the Regulation on the manufacturing and import of medicines Section 3-1. The import of traditional medicinal products from countries outside the EEA requires an import license from NOMA, cf. Regulation on the wholesale activities with medicinal products Section 3-1, cf. Section 2-5, cf. Section 3-3. Additional requirements regarding the importing of traditional medicinal products are set out in the Regulation on the manufacturing and import of medicines Chapter 3. The personal import of medicinal products is regulated in the Manufacturing and Import Regulation Section 3-2.

 

Herbal, complementary and alternative medicinal products:

The marketing of traditional plant based medicinal products and homeopathic medicine is regulated in the Medicines Regulation Sections 13-16 and 13-17.

 

Supplements, dietary supplements, vitamins and mineral products are not regulated in the legal framework for medicinal products. These products often fall under the responsibilities of the Norwegian Food Safety Authority.

 

Medical devices:

The main legal framework regarding medical devices is set out in the Medical Devices Act (LOV-2020-05-07-37) and the Medical Devices Regulation (FOR-2013-11-29-1373). The regulatory requirements with regards to medical devices is described in more detail above (Chapter 1, Question 3).

 

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

See above (Chapter 3 Questions 29, 39 and 40).

 

Traditional medicine:

Yes and no.

 

The advertising of traditional drugs or medicine is regulated in the Medicines Act Chapter VII and the Medicines Regulation Chapter 13. The prerequisite for marketing drugs or medicine is that the drug or medicine has a marketing authorization, cf. the Medicines Regulation Section 13-3.

 

Advertising for medicines to the public is only allowed for non-prescription drugs and for medicines that are recommended exclusively for illnesses or symptoms that do not require examination or treatment from a physician or dentist, cf. the Medicines Regulation Section 13-4 and 13-5. It is also prohibited to advertise drugs that contains psychotropic or narcotic substances according to the UN Convention of 1961 and 1971. For drugs and medicines that are allowed to be advertised, it is set out in the Medicines Act Section 19 that advertisement for drugs shall be “sober and “truthful”. The Medicines Regulation Section 13-3 requires that the advertisement shall promote the “rational use of the drug by presenting it in an objective manner without exaggerating its properties” and shall not be “misleading or deceptive”, cf. also the Medicines Act Section 21. The advertisement shall be presented in such a manner that it is clear that it is advertisement and that the drug which is advertised clearly can be identified as a drug.

 

It is prohibited in advertising or the like, by text or images, directly or indirectly, state that a drug or a preparation other than a drug is recommended as a means to prevent, cure, or alleviate illness, disease symptoms or pain or affect physiological functions in humans, cf. the Medicines Act Section 20.

 

NOMA is the supervisory authority for the advertisement of drugs. If the advertisement infringes the Medicines Act and Medicines Regulation, NOMA can impose penalties and/or compulsory fines.

 

Traditional plant-based products:

It is set out in the Medicines Regulation Section 13-16 that the marketing of traditional plant-based medicines shall comply with the requirements set out in the Regulation Chapter 13 (the same as for regular medicines). Additionally, the marketing shall contain the following statement: “Traditional plant-based medicine with a specific area of use based exclusively on long tradition of use” (our translation (in Norwegian: “Tradisjonelt plantebasert legemiddel med et bestemt bruksområde utelukkende basert på lang brukstradisjon”).

 

Homeopathic products:

It is set out in the Medicines Regulation Section 13-17 that for homeopathic products registered in accordance with the Regulation Section 3-21, 3-22 and 3-22A shall only contain the information set out in Section 3-39. The products shall be clearly marked “homeopathic medicine”. In addition, only the following information shall appear:

1. the scientific designation of the stock solution followed by the degree of dilution using symbols as described in the applied pharmacopoeia, cf. Section 3-8 letter h. If the homeopathic medicine consists of two or more stock solutions, in addition to the scientific name of the stock solutions, a trade name may be included on the package,
2. the name and address of the registration holder,
3. the name and address of the manufacturer where he is another registrant,
4. method of administration and, if necessary, route of administration,
5. the expiry date (month, year),
6. pharmaceutical form,
7. package size,
8. any special precautions regarding the storage of the medicinal product,
9. special warnings, if necessary,
10. the production batch number,
11. registration number,
12. “homeopathic medicine – without approved area of use”,
13. Homeopathic medicine for humans should be marked with a recommendation to the user to seek medical advice if the symptoms persist, and
14. If the medicinal product is for animals, the species for which it is intended.

 

Alternative products:

Marketing of herbal and alternative products is regulated in the Alternative Treatment Act (LOV-2003-06-27-64), with more detailed regulation in the Regulation on marketing for alternative treatment of illness (FOR-2003-12-11-1501). These provisions apply to any form of marketing using any medium.

 

It is set out in the Alternative Treatment Act Section 8 that the provider of alternative treatments can only provide “a sober and factual description of the nature of the business” in its marketing. This is repeated in the Regulation on marketing for alternative treatment of illness Section 2 which also sets out that the provider of alternative treatments cannot “claim that a certain form of treatment has an effect against specific deceases or disorder or in other ways design the marketing so that it gives this impression” in its marketing.

 

The provider cannot either market forms of treatment that the provider is not able to provide pursuant to the Alternative Treatment Act Sections 5 to 7 or any other act which limit the treatments that the provider can provide. This includes medical interventions (for example surgery) or treatment that may lead to serious health risk for patients, as well as the treatment of serious contagious deceases which pose a threat to the public health. The provider is however allowed to use more general descriptions of the conditions which the alternative forms of treatment can be used. Examples provided by the Consumer Authority in its guide to the marketing of alternative treatments (available only in Norwegian on the Consumer Authority website) are:

• Back and neck problems,
• Stiff muscles,
• Pain,
• Indigestion,
• Fatigue/slackness,
• Impaired immune system,
• Psychological issues

 

It will generally not be permitted to make or present statements, recommendations or conclusions from professional journals, research institutions, research projects or any other authoritative source relating to the treatment. The provider will generally neither be permitted to use statements from satisfied customers, user surveys or healthcare personnel. Such statements can easily be perceived by the customer as assertions of effect which the Consumer Authority and Market Council has found to generally not be in line with the regulations.

 

The Consumer Authority and the Market Council is the supervisory authorities for the marketing of alternative products, cf. the Marketing Control Act (LOV-2009-01-09-2), cf. the Alternative Treatment Act Section 6.

 

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

Traditional medicine:

See Chapter 4 Question 45.

 

Traditional plant-based products:

See Chapter 4 Question 45.

 

Homeopathic products:

See Chapter 4 Question 45.

 

Alternative products:

See Chapter 4 Question 45.

 

In its marketing, the provider of alternative treatments shall provide the name, address, telephone number and all other necessary contact information of the provider. If the provider is a member of a practitioner organization, the name of that organization shall also be stated.

 

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

See above (Chapter 1 Questions 2 and 3, and Chapter 3 Questions 22 and 23).

 

The sale of over-the-counter (OTC) non-prescription medications in pharmacies is regulated in the Pharmacy Act Section 6-7. It is set out in that provision that the pharmacy shall contribute to the customer receiving the necessary information about the medicine, including controlling that the medicine is supplied with the necessary information about use, storage and shelf life, that the customer has the necessary information about the medicine so that it is used correctly, and that the customer is informed about the possible harmful effects of the medicine.

 

Certain non-prescription medicines may also be sold OTC outside of pharmacies, like grocery stores, kiosks, and petrol stations. The sale of non-prescription medicines OTC outside of pharmacies is regulated in the Medicines Act Section 16 and the Regulation on the sale of certain non-prescription medicines outside of pharmacies (FOR-2003-08-14-1053, the LUA-Regulation). NOMA establishes a list of the medicines that are permitted to be sold OTC outside of pharmacies, cf. LUA-Regulation Section 6. This list can be found on NOMA’s website. The list was last updated 5 September 2023.

 

Non-prescription medicines permitted to be sold OTC outside of pharmacies can only be sold in outlets that sell foodstuffs, cf. the LUA-Regulation Section 2. These outlets must be registered in the register of the Food Safety Authority and be subject to its supervision. NOMA can also claim a fee (LUA-fee) for the sale of medicines pursuant to the provisions in the LUA-Regulation (0,5%), cf. LUA-Regulation Section 3. These outlets must employ a dedicated person responsible for the medicinal products sold, cf. the LUA-Regulation Section 14.

 

Upon request from NOMA, the outlet must report on the sale of non-prescription medicine.

 

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

See above (Chapter 4 Question 47).

 

The LUA-Regulation regulates inter alia how the non-prescription OTC medicines shall be stored. It is set out in the LUA-Regulation Section 10 that medicines that is sold pursuant to the Regulation shall be stored behind the counter in a locked cabinet or otherwise physically inaccessible to the customers of the outlet. Automated dispensing of the medicine is permitted if the customer purchases a substitute for the medicine in question, for example a product card, from the staff which is then exchanged for the medicine, as long as sufficient control mechanisms are implemented.

 

NOMA establishes a list of medicines that can be placed in self-selection at the point of sale. These medicines shall be:

1. placed so that they are separate from other goods at the point of sale,
2. placed so that they are not available for minors, and
3. placed so that they are under the supervision of the staff.

 

Certain medicine may also be sold at online pharmacies. Online pharmacies are regulated in the LUA-Regulation Section 10a. Outlets that sell medicine online must provide NOMA with updated information on the following:

1. the address of the place from which the medicines are to be dispensed,
2. the time when the sale of medicines over the Internet begins, and
3. the web address of the site to be used and any other relevant information necessary to identify the site.

 

The website shall contain the following:

1. a logo, set by NOMA, on each page of the website, which identifies where the seller of the medicines is established,
2. a link to NOMA’s information page on the Internet about the sale of medicines over the Internet, and
3. a link from the logo mentioned in letter a) to NOMA’s electronic list of companies who are authorized to sell medicines over the Internet.

 

The LUA-Regulation also provides a more general provision on the storage of medicines, cf. the LUA-Regulation Section 8. The medicine must be stored properly in such a way that they do not deteriorate and must not be exposed to direct sunlight or large temperature fluctuations. Medicines must be stored under the conditions specified for each individual product. The outlet must store and deliver the medicine in the same condition and in the same packaging as they were received from the wholesaler.

 

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

It is set out in the LUA-Regulation Section 13 that the marketing of OTC-products shall comply with the provision in the Medicines Regulation Chapter 13. See above (Chapter 4 Question 45).

 

The LUA-Regulation specifies that the use of “reminder marketing” (reminders) for medicines or other marketing measures which aims to promote the purchase of medicines are prohibited. It is also prohibited to have marketing for medicines in or in close proximity to the outlet.

 

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

Yes and no. There are limitations to the marketing and advertising of OTC products to the public. See above (Chapter 4 Question 49).

 

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

It is set out in the Medicines Regulation Section 7-8 that NOMA on the basis of new information can re-evaluate the prescription status of a medicinal product. NOMA’s re-evaluation of the prescription status is based on the provisions set out in the Medicines Regulation Chapter 7.

 

52. What are the requirements for the import of either traditional medicines or OTC products?

Traditional medicine (prescription and non-prescription):

The import of medicines (both prescription and non-prescription) is regulated in the Regulation on the manufacturing and import of medicines (FOR-2004-11-02-1441, the Manufacturing and Import Regulation). The Regulation differentiates between the import of medicine from EEA countries and from countries outside of the EEA.

 

Businesses engaged in wholesale activities in Norway, which have a license per the Regulation on the wholesale activities with medicinal products (FOR-1993-12-21-1219) Section 2 (wholesale permit from NOMA), can import medicine from other EEA countries without the need of any other import licenses, cf. the Manufacturing and Import Regulation Section 3-1. Section 3-1 also sets out that pharmacies can import medicine from an approved wholesaler in another EEA country.

 

Applicable to all import of medicinal products into Norway, the Manufacturing and Import Regulation Section 3-5 sets out that the importer shall ensure that medicinal products imported in accordance with its import license are handled in a safe and professionally responsible manner. For this purpose, the importer is obligated to have at its disposal sufficient and competent staff, as well as premises and equipment that are suitable in relation to the scope of the business.

 

The import of medicines from countries outside the EEA requires an import license from NOMA, cf. the Manufacturing and Import Regulation Section 3-1, cf. Section 2-5, cf. Section 3-3. The importer must submit an application for an import license to NOMA which satisfies the requirements in the Regulation Section 3-3. The application must contain:

• the scope of the import activities which the application concerns,
• the country from where the medicine is to be imported from,
• the place where the business is to take place,
• documentation that shows how the requirements in the Manufacturing and Import Regulation Section are fulfilled.

 

Import of medicinal products from countries outside the EEA is also regulated in the Manufacturing and Import Regulation Section 3-6. It follows from this provision that the importer shall ensure that the medicinal products are manufactured in accordance with guidelines for good manufacturing practice within the EEA. The importer shall also ensure that the medicinal product is manufactured by a manufacturer with the necessary manufacturing license.

 

Every batch of manufactured medicine which is imported from a third country, regardless of whether it is manufactured in the EEA or a third country, shall be subjected to a complete qualitative analysis of at least all substances, as well as other controls that are necessary to ensure that the quality of the medicine is in accordance with the requirements that are set in the license for each of the products that is imported, cf. the Manufacturing and Import Regulation Section 3-6. There are however certain exceptions to this for:

• test preparations,
• medicinal products which are exempt from the obligation to have a marketing authorization in accordance with Section 2-5 to 2-7 in the Medicines Regulation,
• production batches that have been subjected to the same control in another EEA country, provided that a report from this control, produced by a qualified person, is attached to the medicinal product,
• instances where Norway through mutual recognition agreements with the export country has taken suitable measures to ensure that the manufacturing of the medicinal product uses standard for good manufacturing practice that are at least equivalent with the requirements in the Regulation, and that each batch has been subject to the necessary controls in the exporting country,
• active substances and excipient substances for manufacturing in accordance with the Regulation Section 2-8.

 

The importer of medicinal products is also obligated to include a written confirmation from the national health authorities in the export country stating that the active substances in the product are manufactured in accordance with good manufacturing practice, which are at least equivalent to the standards adopted in the EU/EEA, and that the manufacturing of the substance is subject to supervision from the relevant national authorities.

 

For personal use:

The personal import of medicinal products is regulated in the Manufacturing and Import Regulation Section 3-2. The quantity which is permitted to bring into Norway by travel depends on the type of medicine concerned and the country from where one is traveling from:

• Within the EEA, one can carry prescription medicines for personal use equivalent to up to one year’s use for each medicine. The same limit applies for non-prescription medicines.
• Outside the EEA, one can carry medicines for personal use equivalent to up to three months’ use for each medicine.

 

Different rules apply to medicines that contain narcotic active substances and doping products.

 

When travelling to Norway, one must prove that the medicines carried are for personal use. Examples of such proof include a prescription, medical certificate, or pharmacy label on the packaging. One may also be required to provide that the medicinal product was purchased lawfully, for example by providing a receipt for the purchase.

 

All import of medicinal products (both prescription and OTC) by mail is prohibited, cf. the Manufacturing and Import Regulation Section 3-2. There are however approved Norwegian online pharmacies which can sell and send both prescription and non-prescription medicines by post.

 

If medicinal products for personal use are imported in violation of the requirements in the Manufacturing and Import Regulation Section 3-2, the medicinal products may be confiscated and destroyed by Norwegian Customs, cf. the Regulation Section 3-2a.