Medicinal products

For medicinal products the core of the legislative framework is:

• The Medicines Act (In Norwegian: Lov om legemidler).
• The Medicines Regulation, (In Norwegian: Forskrift om legemidler til mennesker), which implements various EU legislation into Norwegian law.

For the research and development of medicinal products the core legal framework is:

• Act on medical and health research, the Health Research Act (In Norwegian: Lov om medisinsk og helsefaglig forskning)
• Regulation on clinical trials of medicinal products for human use (In Norwegian: Forskrift om klinisk utprøving av legemidler til mennesker).
• EU legislation on clinical trials is also relevant.

For pharmacovigilance, the core legal framework is:

• The Medicines Regulation (In Norwegian: Forskrift om legemidler til mennesker).
• Regulation on the system for reporting adverse reactions of medicinal products, the Pharmacovigilance Register Regulation (In Norwegian: Forskrift om system for rapportering av bivirkninger av legemidler (bivirkningsregisterforskriften)).

The following EU legislation is also relevant for Norway:

• Directive 2001/83/EC on the Community Code relating to medicinal products for human use.
• Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC
• Regulation (EC) No 726/2004 laying down Union procedures for the authorization and supervision of medicinal products for human use and establishing a European Medicines Agency
• Regulation (EU) No 1235/2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 7236/2004 and Regulation (EC) NO 1394/2007.

The Guideline on Good pharmacovigilance practices (“GVP”) by the European Medicines Agency (“EMA”) also applies.

Medical devices

For medical devices, the legislative framework is in essence:

• Act No 37 of 7 May 2020, the Medical Devices Act (In Norwegian: Lov om medisinsk utstyr).
• Regulation No 1476 of 9 May 2021, the Norwegian Medical Devices Regulation
• Regulation No 1373 of 29 November 2023, the Regulation on handling of medical devices.

The Medical Devices Act implements the following regulations into Norwegian law:

• Medical Devices Regulation (EU) 2017/745 (“MDR”), and
• In Vitro Diagnostics Medical Devices Regulation (EU) 2017/746 (“IVDR”).

The Norwegian Medical Devices Regulation implements various EU legislation into Norwegian law.

Food

There is a very extensive number of regulations in the food area which will not be described in detail. The main legislative framework for food is:

• The Food Act (in Norwegian: Lov om matproduksjon og mattrygghet mv. (matloven)).
• The Regulation on production and sales of foodstuff (In Norwegian: Generell forskrift for produksjon og omsetning mv. av næringsmidler).

Food supplements

Food supplements are considered as food/foodstuff and is therefore regulated by the Food Act.

Additionally, the following legislation applies for food supplements:

• Regulation No 755 of 20 May 2004, Regulation on food supplements (In Norwegian: Forskrift om kosttilskudd).
• The Regulation on food supplements refers to Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, which is also relevant for Norway.

Medicines

Medicines are developed through various types of research where the development takes place in accordance with both international and national regulations, such as the Health Research Act and Regulation on clinical trials of medicinal products for human use.  An important part of the process is clinical trials. Clinical trials are regulated under EU Regulation No 536/2014 on clinical trials on medicinal products for human use and associated EU-legislation. Despite not being a full EU Member State, Norway is an EEA Member State and implements EU legislation relevant to Life Sciences by virtue of the EEA Agreement.

When applying for a marketing authorisation an applicant may use a national procedure, a mutual recognition procedure (“MRP”), a decentralised procedure (“DCP”) or a centralised procedure (“CP”). We will describe only the national procedure, and refer to the European chapter for the EU procedures.

In order to sell and advertise a medicinal product on the market, a pharmaceutical company must apply for a marketing authorization.  In Norway the Norwegian Medical Products Agency (“NOMA”) is responsible for providing authorizations under the national procedure. The authorizations are granted pursuant to the Medicines Regulation. The product’s quality, safety and (medical) efficacy must be demonstrated.  In order for an authorization to be issued there must a risk-benefit analysis. An authorization will not be issued unless there is a positive risk-benefit balance. The documentation requirements are often extensive.

The manufacturer has the primary responsibility for monitoring, and pharmaceutical companies must have in place an appropriate system of pharmacovigilance and risk management, and have a system for registration of adversary effects. NOMA performs market surveillance and collects information regarding use of the medicine in question. They are responsible for monitoring adverse reactions. NOMA can in some instances, in accordance with the rules of relevant EU directives mentioned above, suspend or withdraw the marketing authorization.

Medical devices

The marketing of medical devices follows the MDR and the IVDR, meaning that the devices shall fulfil the requirements given in those regulations. Devices must be CE-marked in order to circulate freely in the internal market, and such a marking must pursuant to the Medical Device Act be in place before marketing in Norway takes place.

With regards to market surveillance, we make reference to the European Chapter of the Guide. In Norway, NOMA is the supervisory authority.

The relevant regulatory authority is the Norwegian Food Safety Authority (“FSA”)

There is no requirement of a market authorization in order to put food supplements on the market. However, in order to ensure an effective market surveillance, all food supplements must be reported to the FSA. Information includes; name and address of the notifier and manufacturer, all ingoing ingredients, total content of all vitamins and minerals per recommended daily does.

All changes to the reported information, as well as any withdrawal of products to the market must be reported to the FSA. Furthermore, there are rules regarding which health claims that food supplements may be marketed with.

Medicinal products

The pharmaceutical company musth have an appropriate system of pharmacovigilance. It is mandatory to have a system for the gathering and treatment of information regarding adverse reactions. NOMA is the supervisory authority in Norway.

Pharmacovigilance takes place at both a national and an international level, and the same method is used in the entire internal market. In other words, following a market authorization, there are no strictly national rules and requirements on pharmacovigilance. Instead, Norway follows the safety monitoring of medicinal products alongside the other EU and EEA EFTA States. Against this background, we make reference to the European Chapter of the Guide for more information.

Medical devices

Once a medical device is CE-marked and put on the market various obligations apply, for instance obligations and rules on mandatory reporting on incidents and serious incidents, as well as rules on corrective actions, field safety corrective actions or field safety notices. For manufacturers there is also a requirement of establishing a post-market surveillance system, which includes a plan for collecting and using data related to serious incidents and complaints etc. In Norway, NOMA is the relevant supervisory authority.

For more information, we make reference to the European Chapter of the Guide.

Norwegian Medical Products Agency (NOMA). Their responsibility is to ensure that people and animals have access to safe medicines and medical devices. They also contribute in research and innovation regarding medical products.

The Norwegian Food Safety Authority (FSA). Their responsibility is to ensure that food and drinking water is safe for consumers. They also have responsibility related to plants, fish, and animal health. They are responsible for both food and food supplements (as the latter is also considered as foodstuffs).

All regulatory decisions relating to denial or withdrawal of marketing authorization are considered administrative decisions subject to the Public Administration Act, and may be appealed under the legal framework of this act. An appeal must be made to the regulatory authority within three weeks from the date on which notification of the administrative decision has reached the party concerned. It is also possible to contest the validity of a decision in court, however it is usually recommended to lodge an appeal to the regulatory authority, prior to seeking court actions. It is also possible to file a petition for an interim measure directly to the courts if considered necessary to provisionally secure the claim because the action or execution of the claim would otherwise be considerably impeded.

Clinical trials for medicinal products

Clinical trials for medicinal products are regulated by the Medicines Regulation, which implements Regulation (EU) No 536/2014 (“The Clinical Trials Regulation – CTR”) into Norwegian law.

The CTR replaces Directive 2001/20/EC (“The Clinical Trials Directive”), previously implemented into Norwegian law through the Regulations on the clinical trials of medicinal products for human use. From 30 January 2023 to 30 January 2025, there is a transitional period allowing the transfer of trials from the Directive to the Regulation framework. By the end of this period, all ongoing trials must comply with the CTR.

The regulatory process governing clinical trials for medicinal products follows the requirements outlined in the CTR. All clinical trials must be submitted via the Clinical Trials Information System (“CTIS”). The protocol synopses and information detailed in points 24 and 59-73 of the Regulation’s Annex 1 must be presented in Norwegian. Additionally, any documentation intended for trial subjects, such as patient information and consent forms, should be in Norwegian.

Clinical trials for medical devices

Clinical trials for medical devices are governed by the Medical Devices Act, which implements MDR, and the Regulation on medical devices, which implements IVDR. Additionally, the Health Research Act applies to clinical trials for medical devices where relevant.

The MDR governs the regulatory processes of clinical trials within its scope. In addition, certain national requirements follow from the Regulation on medical devices Sections 14 and 16. Summaries of clinical trials must be presented in both Norwegian and English. Additionally, trials not conducted for purposes specified in MDR article 62.1 must adhere to the stipulations outlined in article 62.

Even if a clinical trial falls outside the scope of the MDR, it may still be subject to requirements stipulated by the Health Research Act. The Act pertains to medical and health-related research involving humans, human biological material, or health information. Clinical trials falling inside the scope of the Health Research Act must be pre-approved by the regional committee for medical and health research ethics (“REK”).

There is no dedicated public Norwegian database for clinical trials.

As a general rule, the Act on ethics and integrity in research (Forskningsetikkloven) states that researchers should act with diligence to ensure that all research is conducted in accordance with recognized research ethical principles, such as the Declaration of Helsinki. This applies to all research-related activities, such as use of data from clinical trials.

Anonymized data from clinical trials can be used freely under Norwegian law. However, if individuals can be identified, the use of data from clinical trials must comply with the requirements of the Personal Data Act (Personopplysningsloven), which implements Regulation (EU) 2016/679 (“The General Data Protection Regulation – GDPR”) into Norwegian law. This entails, among other things, that sharing and publishing of health information or other personal data must have a legal basis, and the obligation to inform the data subjects of the processing must be fulfilled.

The Health Research Act contains certain provisions regarding the use of health information in research. Under the Act, health information cannot be disclosed for insurance purposes, to employers, to law enforcement, or to the courts, even if consent is given. Commercial exploitation of health information is prohibited.

NOMA aims to facilitate competence building and effective implementation of new forms of clinical trials, including decentralized clinical trials. To our knowledge, there are no other trends or legislative proposals on digitizing the process of conducting clinical trials.

Medicinal products

Manufacturing of medicinal products requires approval from NOMA.

Manufacturing must take place in accordance with the guidelines on good manufacturing practice for medicinal products in the EU (EU-GMP) issued by the European Commission, cf. Directives 2003/94/EC and 91/412/EEC. In addition to suitable premises and production equipment, requirements are set for the competence and approval of the person or persons who will release the medicinal products for sale (qualified person – QP).

Before a manufacturing license can be issued, an inspection from DMP must be carried out at the production site. Before the inspection, the following must be in place:

• Quality system, including procedures.
• Premises, equipment and any analytical methods must be fully qualified/validated, and final reports must be available, so that DMP can see that the requirements set out in the GMP are fulfilled.

Additionally, a pharmacy with a manufacturing license may produce medicinal products. The legal requirements for pharmacies are generally similar to manufacturing plants, although somewhat more lenient, as there are additional requirements to obtain a pharmacy license.

Medical devices

There are, in general, no specific national authorization required with regards to manufacturing plants for medical devices.

The Norwegian legal requirements for medical devices are mainly related to advertising and sales.

Please refer to the European legislative framework for legal requirements of the production.

Food

All manufacturers of food must be authorized by the Norwegian Food Authority. The legal requirements for an authorization are:

• suitable premises
• equipment to produce safe food products
• a food safety system that shows that they have control over basic operations (e.g. cleanliness, maintenance, pest control), have introduced HACCP and have routines for traceability, etc.

Food production must follow a number of rules to ensure that the food sold is safe. Hygiene requirements are primarily set out in the Animal Hygiene Regulations and the Food Hygiene Regulations.

Food supplements

There are no national requirements for authorization of manufacturing plants for food supplements. However, these will have to fulfill the general requirements relating to Food.

Medicinal Products

The vast majority of medicines used in Norway are produced abroad. Norway is therefore dependent on import to meet the need for pharmaceuticals. There is however some production in Norway, from producers and pharmacies.

The distribution of pharmaceuticals usually happens through a wholesaler, which distributes to pharmacies, hospitals and other health and care services.

The product usually reaches the individual patient in the following ways:

• Prescription is ordered from a doctor or hospital, and the prescription is dispensed at the pharmacy to the patient or deputy if the patient has an agreement for medication management via the home care service in their municipality.
• The municipal health and care service requisitions medicines from contract pharmacies for distribution to the individual patient. Individual municipalities or groups of municipalities may have a tender agreement with a pharmacy chain for the supply of medicines to municipal institutions.
• Hospitals order medicines from the hospital pharmacy with which they are co-located for distribution to individual patients. The four regional health authorities have jointly entered into an agreement with a wholesaler for the supply of medicines via hospital pharmacies.

Medical Devices

Medical devices that are imported and distributed in Norway must be CE marked and have a declaration of conformity. The device’s declaration of conformity will show whether it is a medical device and whether the device also complies with other regulations.

The manufacturer issues a declaration of conformity and declares compliance with the regulations for MDR and IVDR.

The distribution process is generally similar to medicinal products. The product goes either from a producer in EU/EEA to a wholesaler, or via an importer if the producer is located outside EU/EEA. The wholesaler then distributes the product to the buyer, such as hospital or other health or care services.

Food Supplements

Anyone who intends to manufacture, import, sell or export food supplements must register the business with the Norwegian Food Safety Authority before starting.

For import from outside Norway, there are no additional notification requirements for supplements from the EU/EEA. However, all imports from countries outside the EU/EEA must be pre-notified to the Norwegian Food Safety Authority before the shipment arrives in Norway.

Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met, in accordance with Regulation (EC) No 178/2002 article 17.

The typical process of distribution is mostly similar to medicinal products, with producers and importers using a wholesaler who sells directly to pharmacies and other stores where food supplements are sold.

Medicinal products

All registered, prescription-only medicines (POM) for humans must have a maximum price, set by the Norwegian Medical Products Agency (NOMA), before they can be marketed in Norway. The market authorization-holder must apply for a maximum price.

Norway has a statutory pricing policy for prescription-only medicines with MA for human use. The policy is currently put into practice by the maximum price regulation and the stepped-price (trinnpris) regulation.

The maximum price regulation at pharmacy purchase price (PPP) level, regulated in the Norwegian Act on Medicinal Products, was implemented in 2002. Before entering the Norwegian market, the Marketing Authorisation Holder must apply for a maximum price with NOMA. The maximum price is set in order to ensure that the national social security system and the patients do not pay too much in a market where there is often little or no competition.

The Stepped price model (Trinnprismodellen) with generic competition was introduced in 2005 to reduce costs incurred by the National Insurance Scheme (NIS) and patients in relation to the use of generic medicines. Since august 2021 there has also been a stepped price model for biosimilars.

In the stepped price model, for generic or biosimilar medicines, the price of a pharmaceutical product is reduced stepwise through predefined rates. This occurs after the pharmaceutical product has lost patent protection and hence is exposed to generic or biosimilar competition. The Stepped price model for generic medicines has been modified four times after its introduction with the aim of reducing medicine prices.

From a patient perspective, medicinal products are mainly financed by the hospitals, the municipalities and the national social security system (Folketrygden).

The Social Security system is regulated in Act on the social security system (Social Security Act) (Lov om folketrygd). The social security system provides coverage of certain medicinal products.

Prescription drugs are prescribed on either a so-called “white-prescription” or a “blue-prescription”. There are maximum amounts that should be paid for important medicinal products, and certain types of medical devices by the persons that are members of the social security system. The social security system therefore reimburses or grants support to expenses related to important medicinal products and specific types of medical equipment and consumables. There are more detailed rules on which medicinal products that are reimbursed and when.

The regional health care authorities are responsible for medicinal products that fall under the specialist health care service, such as for instance medicinal products used in hospitals. Where the specialist health care services provide medicinal products, they cannot demand payment from the patients or users.

The regional health care authorities buy medicinal products through a common system labelled “new methods”. The “new methods-system” is used to decide which treatment may be offered in the specialist health care system. This is done by looking at the benefits of the medicine, the use of resources related to its purchase and the seriousness of the disease. The process of introducing the medicine into the specialist health care system is rather detailed.

A regional health care authority (Sykehusinnkjøp HF) is tasked with buying supplies and equipment on behalf of hospitals and health and care services. Sykehusinnkjøp HF performs negotiations with suppliers, on behalf of the health care providers, and presents the results, including the price, for a so-called decision forum. If the decision forum decides to use the medicinal product, based on the indications mentioned above, it can be included in coming or existing procurement processes that are organized by Sykehusinnkjøp HF.

The price of the medicinal product may never be higher than the price presented by Sykehusinnkjøp HF to the decision forum. There are more detailed rules on how the prices on medicinal products are set and how the procurement processes are carried out.

The Municipalities are responsible for medicinal products used in municipal health care institutions. In certain instances, the municipality may demand a personal contribution for covering the expenses. There are detailed rules regarding such contributions.

Medical devices

Most medical devices will be granted as a part of the patients right to health care under the social security system. These medical devices will have fixed maximum prices, in accordance with the prices presented to Sykehusinnkjøp HF.

Medical devices sold directly to end users have free pricing.

Food supplements

Certain types of food supplements or foodstuffs may also, in some cases, be prescribed with a “blue-prescription” if they are relevant for the condition of the person seeking reimbursement.

Please note that EU/EEA legislation regarding advertising for medicinal products, medical devices and food supplements is applicable for Norway. The local acts and regulations mentioned in this section mostly implements the relevant EU/EEA legislation.

Medicinal Products

The Norwegian Medicines Regulation applies to advertising for medicinal products, however this is mostly implementing EU/EEA legislation. Only non-prescription pharmaceuticals can be advertised to the public, and only in a neutral way. Prescription medicines may not be advertised to the public, but can be advertised to Health Care Professionals (HCPs). Advertisement towards HCPs is not specifically regulated, but it is custom to follow the recommendations of the Association of the Pharmaceutical Industry in Norway (LMI) which has issued guidelines. In essence, any advertising must be neutral, fair and not formulated in a manner that undermines trust in the pharmaceutical industry.

Medical Devices

There are no specific local regulations for advertising of medical devices, but the LMI guidance mentioned above should be considered by analogy. MDR and IVDR applies.

Food supplements

All foods are regulated by the Food Act and associated regulations. Food supplements are also regulated by the Regulation on Food Supplements and must meet all requirements in this regulation. Which other regulations and rules regulations that apply to food supplements will depend on, among other things, the ingredients, from which countries the food supplement/ingredients come from and whether you plan to use nutrition and health claims. Generally speaking, claims and advertising related to food supplements must be fact-based and neutral.

The Norwegian Patents Act (Patentloven) governs patents for medicinal products, medical devices, and food supplements. The Act incorporates Regulation (EU) 469/2009 (“The Supplementary Protection Certificate Regulation”), which provides extended patent protection for medicinal products.

The Trademarks Act (Varemerkeloven) governs trademarks for medicinal products, medical devices, and food supplements.

Patent infringements in relation to medicinal products and medical devices are addressed in the same manner as other patent violations. Typically, the infringed party will issue a cease-and-desist notice. If this is not heeded, the matter is resolved through regular civil litigation, or possibly a request for a temporary injunction.

One possible defense strategy is to counterclaim for invalidity. Such a counterclaim will, in almost all cases, be handled alongside the infringement issue.

It is worth noting that Norwegian courts are used to dealing with extensive patent litigation with English language documents and expert witnesses. Furthermore, the legal proceedings are relatively quick and timelines from application to judgment and possible appeals are favorable compared to many other jurisdictions.

The general requirements of the Trademarks Act apply to all trademarks. However, certain additional restrictions regarding use of trademarks for medicinal products, medical devices, food, and food supplements apply.

Medicinal products

Any promotional material, including the use of trademarks, must comply with regulations regarding advertising medicinal products to healthcare professionals and the public. Please refer to question 14 for further information on the legislative framework related to advertising for medicinal products.

Medical devices

Restrictions on the use of trademarks for medical devices are stipulated in the MDR and IVDR. Under these regulations, it is prohibited to use trademarks or other signs that may mislead the patient with regard to the device’s intended purpose, safety and performance.

Food and food supplements

The Regulation on Nutrition and Health Claims for Foods (Forskrift om ernærings- og helsepåstander om næringsmidler) implements Regulation (EC) 1924/2006 on nutrition and health claims on foods into Norwegian law. The regulation of the use of nutrition- and health claims is harmonized throughout the EU. The framework establishes requirements and guidelines for the timing, placement, and manner in which nutrition and health claims, including trademarks, can be employed on food and food supplements.

The Regulation on Food Information (Matinformasjonsforskriften), which incorporates Regulation (EU) no 169/2011 (“The Food Information to Consumers Regulation – FIC”), stipulates that any labelling of food, including trademarks, must not be misleading to the consumer.

General liability laws apply. The producer of a medicinal product, medical device or food supplement may be held liable for damages if a) it is more likely than not that the product, device or food supplement was a necessary cause of the injury, and b) the damaged party incurred a financial loss due to the injury.

For medicinal products, however, through membership of the Norwegian Pharmaceutical Liability Association (cf. section 3-5 of The Product Liability Act (Produktansvarsloven)), the manufacturer of a pharmaceutical product is obliged to have insurance for pharmaceutical liability under this chapter. The same applies to importers of pharmaceuticals when the manufacturer does not have such insurance.

It is therefore important to register with the Liability Association prior to undertaking any marketing towards Norway.

As provided in section 18, the civil liability for medicinal products is usually avoided due to the pharmaceutical insurance by the Norwegian Pharmaceutical Liability Association.

The pharmaceutical insurance may however claim recourse from a producer who is not a member of the Norwegian Pharmaceutical Liability Association and does not have approved insurance, even if the producer is not personally liable to the injured party for the injury.

For medical devices, the user may be held liable if the instructions for use are not followed, as the medical device must be used in accordance with the intended use stated in the equipment’s documentation/instructions for use.

In severe cases, the producer may risk criminal liability. This is rare.

For food and food supplements, the Norwegian Food Authority may impose fines, and in severe cases criminal liability including imprisonment.

Norway has no national legislation for digital health applications and other medical software. The relevant framework is therefore the general regulations regarding medical devices in MDR and IVDR.

It should be noted that Norway is a highly digitalized society, and almost all prescriptions are issued virtually to patients which can collect prescriptions directly from pharmacies by using their national registration details. Furthermore, online and virtual doctor consultations are becoming more normal and a integrated part of the treatment landscape.

There are no national regulations regarding a producer’s duty to provide a supply of medicinal products and medical devices.

Directive 2001/83/EC on the community code relating to medicinal products for human use applies. Article 81 imposes a duty for holders of marketing authorization to ensure appropriate and continued supply of medicinal products.

Norway, however, have some specific rules regarding wholesalers of medicinal products.

Wholesalers who deliver to pharmacies must, as a general rule, be able to deliver anywhere in the country within 24 hours. In areas with difficult communication conditions, delivery must generally take place within 48 hours. The delivery obligation includes all medicines that the wholesaler carries. When special reasons exist, the Directorate for Medical Products may make exceptions to this requirement.

Wholesalers who deliver to pharmacies may be subject to a supply obligation for deliveries outside normal opening hours.

Pharmaceutical wholesalers who distribute pharmaceuticals to pharmacies are obliged to maintain an extra stock of pharmaceuticals in Norway.

For medical devices, there are no specific national legislation. MDR and IVDR applies.

The main compliance standards in Norway are provided by the Association of the Pharmaceutical Industry in Norway (“LMI”), who have written rules for the marketing of medicines. The rules apply to communication between manufacturers/suppliers and healthcare professionals or the general public. Although the LMI rules only technically applies to members of LMI, it does create a certain norm to which Norwegian HCPs (and their employers, as the case may be) are likely used to.

For medical devices, there are no specific local regulations, although the LMI rules should be relied on by analogy. MDR and IVDR applies.

The EFTA Surveillance Authority (ESA) has initiated proceedings against Norway before the EFTA Court due to a dispute regarding national legislation and practice regarding the right of individuals to seek hospital treatment in other EEA States. The case follows a number of complaints to ESA and following ESAs dialogue with Norway. ESA has found that the Norwegian rules on access to hospital treatment do not comply with EEA law. As Norway and ESA have not come to an agreement, it is now up to the EFTA Court to settle the matter.

In 2023, there was a court case regarding unlawful production of facemasks during Covid-19. The majority of the Court of Appeal found it proven that the defendant contributed to companies providing masks for distribution, despite the fact that the masks were incorrectly or insufficiently labeled in accordance with the Medical Devices Act and relevant regulations. The penalty was a 30-day suspended prison sentence and an unconditional fine of NOK 30,000.

There are also several judgements in the last years regarding trademark and patent rights, related to medicinal products.

Norway is a highly digital society, and several trends, initiatives and projects exist to increase digitalization in the health care sector. We will focus on some key initiatives and on certain projects which can be of interest and inspiration.

One of the core digitalization projects is the national solution for e-health that is entitled the e-prescription service.  (In Norwegian: E-resept). E-prescription has been introduced to ensure that information regarding prescriptions can be transferred electronically in a safe manner and also reduces the risk of making mistakes when writing out prescription medicines. The personal doctor, the emergency room, hospital and pharmacies should all use the e-prescription solutions and at this point in time almost 93% of prescription are made through this solution. The use is made mandatory for certain health care providers and from 1 January 2023 it was made mandatory to use also for private hospitals and specialists under an operation services agreement with the regional health care authorities.

Another e-health solution of importance is the introduction of the “core medical record” (kjernejournal). In this record doctors, nurses and various health care workers can get an overview of the patients’ medicinal products, visits, and critical information. The core medical record is necessary for using other digital resources such as for example e-prescriptions. The core medical record is made mandatory for certain health care providers and from 1 January 2024 it was made mandatory to use also for specialists under an operation services agreement with the regional health care authorities.

Complete digital follow-up services are to a larger extent being used by Norwegian municipalities.  Digital follow-up in essence means that consultation and follow-up happen electronically, for example communication between patient and the responsible for the treatment, the follow-up from the first consultation, the treatment through an internet base treatment program and the patient education and training. Several digital follow-up solutions exist, and more and more municipalities are using this method in carrying out their health care services and responsibilities. Projects to assist the municipalities in taking these types of solutions in use are also carried out.

There are numerous initiatives taking place with regards to the use of artificial intelligence. In 2020, a national strategy for the use of artificial intelligence was launched. The strategy wanted Norway to take lead on artificial intelligence in areas where there is a strong academic presence and where Norway is in a good position to take lead, such as the area of health. and strong.

A national coordination project with the title “Better use of artificial intelligence” was started as a part of the national health care and hospital plan in 2019. The project has identified and assessed numerous questions related to the use of and development of artificial intelligence in health care services. Furthermore, a national network for artificial intelligence, including artificial intelligence in the Norwegian health care service is established. The network looks at various legal issues and limitations in the current applicable legislation. Furthermore it looks at the technical infrastructure and how this infrastructure can facilitate the use of various data. It also works on strengthening education and expertise in artificial intelligence.

Medical Products Agency – change of name and responsibilities 

The Norwegian Medicines Agency changed their name, and increase their responsibility, from 1 January 2024. The new name is the Norwegian Medical Products Agency. The new Agency assumed responsibility relating to procurement, public financing of medical products and ensuring the overall responsibility for security of supply and emergency preparedness on medical products.

A public hearing on the results of the public committee on gene technology

In November 2020 a public committee on gene technology was appointed by the government in order to report on the development of gene technology and make recommendations on possible regulations on the sector. The report was presented by the committee chair on June 6, 2023. The report describes how gene technology is developing rapidly and make suggestions for new regulations. The report was sent on a public consultation with a deadline for feedback set to February 22, 2024.

A new export strategy for the health industry

The Minister of Health and Care Services and the Minister of Trade, Industry and Fisheries presented the export strategy of the Norwegian government in February. The government is launching 15 measures to increase the exports of the health industry, amongst other the bundling of digital products, a new marketing strategy for the health industry, the continued development of the Nortrials partnership between the health trusts and industry.

Closer cooperation between the EEA EFTA States and the EU on health preparedness and response

The EEA EFTA States, namely, Norway, Iceland and Liechtenstein, are intensifying discussions with the European Commission on health preparedness and response. Some of the cooperation is achieved through the EEA Agreement, but additional key elements are added, such as bilateral agreements. The Commission issued a joint statement by executive vice-president Sefcovic and Commissioner Kyriakides on the health cooperation between the EU and the EEA EFTA States. There they stated that they intend to make recommendations to the Council top adopt decisions authorising the opening of formal negotiations with the EEA EFTA States to this end. It is stated in the press release that it is believed that a closer cooperation on emergency preparedness and response structures will increase their effectiveness and bring mutual benefits for both sides.