The regulatory regimei Classification
A substance, drug or preparation is classified as a medicine pursuant to the Act on Medicinal Products if it either (1) purports to be suitable to prevent, heal or alleviate disease, disease symptoms or pain, or modify physiological functions in human beings or animals; or (2) can be used or given to human beings or animals to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to detect disease. The definition of medicines comprises prescription, OTC, herbal, plant-based and homeopathic medicines.
Notably, products may be included in the definition simply by being presented as having a certain effect (the first alternative), even if it is not a conventional medicine. In borderline cases, the assessment will normally take into account factors such as product name, packaging, administration mode, claims and end user. Similar products that are particularly susceptible to being covered by the definition include food supplements, cosmetics, feed, biocides and medical devices. Whether a product is included in the definition of medicines pursuant to the second alternative is normally based on an overall assessment of relevant factors, such as the product's composition, pharmacological characteristics, administration mode and the risk it poses in use.
Medical devices are defined as any equipment, apparatus, assistive device, material or any other object used alone or in combination, including with necessary software, on human beings to diagnose, prevent, monitor, treat or alleviate disease, injury or disability; examine, replace or amend anatomy or a physiological process; or prevent pregnancy. Borderline cases often concern the class of risk rather than how they are defined as medical devices. NoMA cooperates with relevant European authorities in borderline cases.ii Non-clinical studies
Non-clinical studies are subject to the general requirements in relation to research as embodied in the Act on Medical and Health Scientific Research of 2008 and the Act on Research Ethics of 2017 – to the extent that they involve testing on human biological material, individuals' health information or in other ways involve human beings. If so, prior approval from the relevant regional health scientific research ethics committee (the Ethics Committee) is required. Research involving surplus embryos or cloning must further observe requirements and restrictions embodied in the Act on Biotechnology of 2003.
Non-clinical studies involving research on animals require prior approval from the Norwegian Food Safety Authority pursuant to the Regulation on the Use of Animals in Research of 2015. Research activities must comply with the requirements embodied in the regulation and must safeguard animal welfare.iii Clinical trials
Clinical trials are also subject to the general requirements in relation to research, as mentioned in Section II.ii – in addition to specific requirements laid down in the Regulation on Clinical Trials of 2009 as regards medicines, and the Medical Devices Regulation as regards medical devices.
All clinical trials for medicines require additional prior approval from NoMA, whereas clinical trials for medical devices require additional prior approval from NoMA when the device is not already CE-marked or when it is to be used outside the scope for which it is CE-marked.
It is generally required that all clinical trials are conducted in accordance with good clinical practices and the Declaration of Helsinki – Ethical Principles for Medical Research involving Human Subjects 1964. This implies, inter alia, that clinical trials must be scientifically based and governed by ethical principles. Subjects may only be enrolled based on prior and informed written consent. Special provisions apply to minor subjects and subjects who do not have the ability to give consent, or whose ability to give consent is reduced.
Subjects must be insured in relation to all types of clinical trials. In many situations, this requirement may be met by way of mandatory insurance schemes, such as the Norwegian Drug Liability Insurance for medicines and the Norwegian System of Patient Injury Compensation (NPE) for medical devices (see Section VI). Adverse effects and incidents must be reported to NoMA.
It is a requirement that the sponsor of the clinical trial, or the producer of the medical device, is domiciled in the EEA or has an appointed representative in the EEA.iv Named-patient and compassionate use procedures
Medicines without marketing authorisations (MAs) in Norway may, under certain circumstances and by way of exemption, be dispensed to patients.
Prescribers may apply to NoMA for an exemption of this kind for individual patients. A number of conditions must be fulfilled, in particular that use of the medicinal product in question is medically justifiable, for example, because no authorised medicine meets the individual's medical need.
NoMA may also approve use for a group of patients of non-authorised medicines in the context of compassionate use programmes, provided certain conditions are fulfilled, including that the programme only concerns patients with life-threatening, long-lasting, recurring or seriously disabling diseases, and that the relevant patients cannot be included in clinical trials and will not benefit from treatment with authorised medicines. It is for the manufacturer and the prescriber to decide on pricing. Medicines shall be dispensed to patients free of charge. Reporting obligations apply to, inter alia, adverse effects and amendments to the protocol for the programme.v Pre-market clearance
Commercial distribution of medicines in Norway generally requires prior approval in the form of an MA from NoMA. Prescription medicines further need price approval from NoMA prior to being marketed.
There are four procedures available for obtaining an MA in Norway: centralised procedure; decentralised procedure; mutual recognition procedure; and national procedure. When an MA is first granted by another EEA Member State or the European Commission with effect also for Norway, a national MA issued by NoMA is nonetheless necessary. Special rules and procedures apply for herbal, plant-based and homeopathic medicines.
Generic products follow a somewhat simplified procedure in as much as they may rely on the toxicological, pharmacological and clinical documentation of a patented product – provided that patent protection, regulatory market protection and regulatory data protection periods have all expired. By contrast, it is necessary to document bioequivalence.
It is a requirement that the MA holder either resides within the EEA or has appointed a representative residing within the EEA.
The first MA is generally valid for a period of five years, after which it needs renewal. The second, renewed MA is normally perpetual.
For commercial distribution of medical devices in Norway, it is required that the manufacturer demonstrates compliance with all fundamental requirements applicable to the product in question, also known as 'declaration of conformity', and that the product bears a CE mark to evidence compliance. Applicable requirements depend on risk assessment and classification of the product in a certain risk class. Further, manufacturers or their representatives must, if they have a Norwegian business address, register themselves and the medical devices they market in the Norwegian Register for Medical Devices.vi Regulatory incentives
Patents may be granted for medicines and medical devices for 20 years from the date of filing, as provided in the Patents Act.
Norwegian law concerning supplementary protection certificates (SPCs) is harmonised with EU directives. SPCs may be obtained for medicines in Norway. The duration of an SPC is limited to a maximum of five years without the possibility of extension.
Norway implemented Regulation (EC) No. 1901/2006 on medicinal products for paediatric use in 2017. Once paediatric studies have been performed according to an approved, implemented paediatric trial protocol, the holder may be given a six-month extension of the supplementary protection for the medicinal product.
An original medicine has automatic data and market exclusivity based on its MA for the first application in the EEA. This protection is a time-limited right to prevent others from basing its application for an MA on the original medicine producer's submitted documentation. If an MA was applied for the reference product in Norway after 1 November 2005 but before 12 January 2010, the document and market protection is 10 years. If an MA was applied for the reference product in Norway after 12 January 2010 or in the EEA after 1 November 2005, the reference product enjoys data protection for eight years, and market protection for 10 years. The protection may be extended by one year if an MA is applied for regarding a new indication of significant clinical importance during the document protection period (i.e., the first eight years).
It follows from Section 10 of the Act on Medicinal Products that, in special cases, exemptions to the requirement for an MA may be given. The exemption may be used for fast-track use of specific medicines (e.g., in situations of urgency), but the exemption is not much used in practice.
Medical devices may be protected through the Patent Act, but there is no SPC.
According to Section 47(1) of the Patent Act, a compulsory licence for exploitation of a patent may be obtained when it is deemed necessary for 'important public interests'. The provision applies in extraordinary situations, for example where there is the threat of an epidemic and the situation may only be prevented or improved through the exploitation of the invention.vii Post-approval controls
Post-approval control requirements in Norway for medicines are largely harmonised with Directive 2001/83 and subsequent amendments thereto. The MA holder is obliged to implement and manage a pharmacovigilance system and to employ, at all times, a sufficiently qualified person who is responsible for system and risk management, as further specified in the Regulation on Medicinal Products. The qualified person must be domiciled and work within the EEA and must be reported to NoMA. All suspected adverse effects must be registered, and suspected serious adverse effects must be reported to the EudraVigilance database. Periodic safety reports must be submitted to the Periodic Safety Update Report repository at intervals stated in the MA, and NoMA must be notified of variations and amendments to the documentation or product information in accordance with Regulation (EC) No. 124/2008. Transfer of an MA from one legal entity to another must be reported to NoMA and must follow a certain procedure.
A medical device manufacturer domiciled outside the EEA is obliged to appoint a representative domiciled within the EEA. Any person who manufactures, distributes, owns or uses medical devices has an obligation to report deviations, errors and failures to NoMA, which also requires that a system for post-market surveillance is established.viii Manufacturing controls
Manufacturing of medicines and any other activities involving packaging, repackaging, labelling, relabelling and release, generally require a manufacturing licence from NoMA. An exception is made, if certain conditions are met, for simple preparation or packaging of medicines in pharmacies, hospitals and other health institutions.
Manufacturing must take place in compliance with the EU Good Manufacturing Practice guidelines. Thus, certain requirements regarding, inter alia, having suitable production facilities, suitable production equipment and a sufficiently qualified person approved by NoMA, must be met. Requirements under the Regulation on Manufacturing and Import of Medicinal Products are harmonised with Directive 2003/94/EC.ix Advertising and promotion
Advertising of medicines is regulated in the Act and Regulation on Medicinal Products and is permitted only for drugs that have been granted an MA. Advertising of medicinal products to the public is only allowed for OTC products and then only if examination or treatment by a doctor, dentist or veterinary surgeon is not a prerequisite. Prescription products may, therefore, only be advertised to healthcare professionals.
Information in the marketing material must be true, accurate, relevant and not misleading. Advertising or promoting a product that is not classified as a medicine but is recommended as a means of preventing, healing or alleviating illness, sickness symptoms or pain or affecting physiological functions, is prohibited. The purpose is to prevent undocumented claims about medical efficacy in advertising of products that are not medicines.
In addition, a Code of Conduct, compiled by the Norwegian Association of Pharmaceutical Manufacturers, applies to any kind of communication between manufacturers, suppliers and healthcare professionals or the public. It is based on the code adopted by the European Confederation of Pharmaceutical Industries and Associations (EFPIA).
The Medical Devices Act does not contain specific regulations on advertising and promotion but, as a general principle, all claims used in advertising and promotion should be true, accurate, relevant and not misleading, and the producers must be able to substantiate the claims.x Distributors and wholesalers
The import, purchase, receipt, storage, delivery, distribution, sale and export of medicines are considered wholesale activities and require a wholesale licence issued by NoMA. Regular pharmacy activities are not defined as wholesale.
The Wholesaler Regulation of 1993 sets out the detailed requirements to be met by wholesalers. This includes requirements for good distribution practice (GDP), issued by the European Commission. In addition to suitable premises and equipment, there is a requirement of competence for the person who is responsible for the wholesale business of pharmaceuticals. Wholesalers must be able to deliver drugs within 24 or 48 hours anywhere in the country.
Wholesalers may sell medicines directly to nursing homes, professional end users of veterinary drugs and hospitals.
As a main rule, only pharmacies may sell medicines directly to consumers. A licence is required to own and run a pharmacy. Nonetheless, the Regulation on Sale etc. of Certain Non-Prescription Medicines Outside Pharmacies of 2003 (the LUA Regulation) allowed for the sale of OTC products from outlets other than pharmacies.
As of 1 January 2016, Norwegian pharmacies that are registered and approved by NoMA have been allowed to sell prescription and OTC products online.xi Classification of products
To determine whether the Act on Medicinal Products applies to a given product or substance, it is necessary to classify it.
For medicines, there are strict requirements regarding quality, safety and efficacy. Moreover, special rules apply to import and sale. A number of products are similar to medicines and particularly susceptible to being defined as medicines, typically supplements, feed, cosmetics and medical devices. See Section II.x.
Norwegian legislation on classification of medicines is harmonised with EU legislation and implemented into the Regulation on Medicinal Products. NoMA has the authority to decide whether a substance is a medicine in borderline cases (see Section II.i). With legal basis in the LUA Regulation, NoMA has issued a list of OTC products that can be sold outside pharmacies, as addressed in Section II.x.
Pursuant to the Medical Devices Act and Regulation, medical devices are classified as active implantable medical devices, in vitro medical devices or other medical devices. In vitro medical devices are subclassified in List A, List B and self-test products. Other medical devices are subclassified in one of four risk classes (see Section II.x).xii Imports and exports
The import and export of medicines generally require a licence issued by NoMA. Imports from the EEA to Norway and export activities are defined as wholesaler activities pursuant to the Wholesaler Regulation and will, in the first instance, require a wholesaler licence issued by NoMA (see Section II.xi). Some exceptions apply to holders of manufacturing licences. First, a manufacturing licence issued by NoMA includes the right to engage in, inter alia, import and export activities in relation to the medicines covered by the manufacturing licence. Second, holders of manufacturing licences issued in another EEA country may import medicines to Norway that are covered by the manufacturing licence, simply by notifying NoMA.
As of 1 October 2015, significant restrictions have applied to imports of medicines by private persons. Only OTC products may be imported and only from another EEA country for personal consumption and only on certain conditions, including that the medicine has a valid MA in Norway and that the imported quantity does not exceed three months' consumption. Whether conditions are fulfilled, for example, whether a medicine is an OTC product, depends on the assessment in Norway.
Imports to Norway directly from countries outside the EEA generally require a manufacturing licence, implying that medicines must be subjected to full inspection prior to release of the products for marketing in Norway. This again implies that the importer must engage a sufficiently qualified person to undertake necessary inspections and to release medicines for sale. Wholesalers with a wholesaler licence may escape the requirement for a manufacturing licence in the case of imports from a country outside the EEA, provided that the exporting country is a member of the Pharmaceutical Inspection Co-operation Scheme or has entered into a mutual recognition agreement with Norway. Medicines manufactured outside the EEA, but released in another EEA country, may be imported without new inspection and new release in Norway.
The Medical Devices Act and Regulation do not require specific import and export licences.xiii Controlled substances
Manufacturers, wholesalers and others who handle medicines classified as narcotics or psychotropic substances need a manufacturing, import or wholesale licence (as the case may be) that specifically includes the substance in question. Further, imports or exports of a controlled substance require a special licence (drug certificate) for each shipment. The processing time for issuing a drug certificate is up to seven working days after NoMA receives the application.
Transport, storage and handling of controlled substances shall be conducted in a safe and secure manner and in compliance with the Wholesaler Regulation and the Regulation of Manufacture and Importation of Pharmaceuticals of 2004. Businesses that import or export controlled substances shall keep records of the last quarterly importation and exportation of the substances that require certificates, and of any certificates that are not used.xiv Enforcement
NoMA is the national administrative and supervisory body for medicines. It is responsible for monitoring and enforcing the Act on Medicinal Products. NoMA, inter alia, supervises clinical trials, manufacturers, importers, wholesalers and pharmacies, and the advertising of medicines. It also monitors controlled substances, including narcotics. NoMA may demand all information necessary for its supervision and decision-making.
The Council for Drug Information is a self-policing body established by the pharmaceutical industry. The Council shall ensure that all drug information and marketing to healthcare professionals and the public are in accordance with the Code of Conduct mentioned in Section II.ix. The Council acts on delegated authority from NoMA. Anyone who holds an MA is obliged to send a copy of all written advertising, regardless of the platform used, to the Council. The Council for Drug Information may issue coercive fines of up to 300,000 kroner for violations of the Code of Conduct.
In the case of repeated violations of advertising rules, NoMA may impose a ban on advertising for individual medicines.
At the outset, NoMA is responsible for the enforcement of the legislation relating to medical devices. For electromedical devices, the Directorate for Civil Protection is responsible for supervision and enforcement. Both supervisory authorities may obtain the information necessary and may require the person who produces, imports or markets a medical device to submit samples needed to carry out their investigations. If the medical devices potentially endanger public health, patients, users or any other persons' health or safety, or the necessary documentation is not obtainable, the supervisory authority shall take all necessary measures to withdraw the equipment from the market, prohibit or restrict the sales or use of it, and may also issue coercive fines.