Regulatory authorizations for medical products in Norway
As medical products concern the health and life of patients, manufacturing, import, wholesale distribution and marketing of medical products are subject to extensive provisions and require authorization from the Norwegian Medicines Agency. The specialized lawyers from our life science practice group regularly advise existing and new clients on which authorizations specific activities require. In this month’s newsletter we give you an introduction on what the different authorizations cover.
The Norwegian Medicines Act requires separate authorizations for A) sale of medical products, B) processing of medical products, C) import of medical products from outside the EEA, and D) wholesale distribution of medical products.
A) Marketing authorizations
All sale of (i) medical products for humans and animals, which are produced industrially or through an industrial process, and (ii) premix for medicated feed, generally require marketing authorization by the Norwegian Medicines Agency ("NMA"). This requirement does not apply to homeopathic medical products and traditional herbal medical products, that are registered in accordance with the regulation on medical products.
The regulation on medical products contains several exemptions from the requirement for a marketing authorization, including but not limited to the following exemptions for:
- magisterial and officinal medical products;
- medical products intended for research or development trials;
- intermediate products to be further processed by a manufacturer with a processing authorization;
- medical products for humans containing radionuclides in the form of closed sources;
- whole blood, plasma and blood cells of human origin, other than plasma produced using an industrial process;
- medicated feed and additives in feed products, that is permitted under other legislation;
- inactivated immunological medical products for animals, produced from pathogenic organisms and antigens isolated from an animal or herd and used to treat that animal or herd in the same place, if the NMA has granted an exemption upon application;
- medical products, for use in machine dose dispensing, covered by a Norwegian marketing authorization in a different packaging size;
- certain medical products that are exclusively intended for aquarium fish for ornamental purposes;
- certain radioactive medical products; and
- upon application from a doctor, dentist, veterinary or fish health biologist.
The NMA may permit sale of medical products without Norwegian marketing authorizations that have been granted marketing authorization in another country within the EEA, if sale of the medical product is in the public interest.
A marketing authorization covers a specific strength and pharmaceutical form of a medical product. Consequently, a separate authorization is required for each strength and each pharmaceutical form of a medical product, even if the product is otherwise identical.
B) Authorization for processing of medical products
All processing of medical products require authorisation by the NMA. This requirement does not apply to hospitals or other health institutions for medicinal products that must be prepared for immediate use. Further, pharmacies are governed by the Pharmacies Act and subject to the authorization requirement in the Pharmacies Act.
Authorization to process medical products covers:
- manufacture, packaging, repackaging, labelling, relabelling and delivery of the medical products specified in the authorization, and required controls in relation to these activities for the specified medical products;
- wholesale distribution of the medical products specified in the authorization; and
- import of the raw materials and so on that are necessary to manufacture the medical products specified in the authorization. Import or export of controlled substances, as defined and regulated in the regulation on controlled substances, requires explicit authorization per shipment of controlled substances.
An authorization only covers the abovementioned activities in the premises specified in the authorization.
C) Authorization to import of medical products from outside the EEA
All import of medical products from outside the EEA requires authorization from the NMA. An exception is made for certain import by natural persons for personal use.
The authorization covers:
- import of medical products from outside the EEA; and
- wholesale distribution of the medical products specified in the authorization.
Import of controlled substances requires explicit authorization per shipment of controlled substances. The authorization does not cover import of medical products from within the EEA, which requires authorization for processing or wholesale distribution of medical products.
D) Authorization for wholesale distribution
All wholesale distribution of medical products by legal or natural persons requires authorization by the NMA. Dispensing medical products to the general public is not considered as wholesale distribution and thus not subject to this authorization.
Authorization for wholesale distribution covers:
- procurement of medical products that are obtained from either
- other authorized wholesale distributors; or
- processors or importers of medical products provided that the medical product is covered by authorizations for processing or import.
- import of medical products from within the EEA;
- storage of medical products;
- export of medical products; and
- dispensing of medical products to, as a general rule:
- other wholesale distributors;
- processors with authorization to process medical products;
- importers with authorization to import medical products from outside the EEA;
- to pharmacies and medical products outlets selling medical products to the public, including health institutions and other users of medical products;
- professional end users such as hospitals, doctors or dentists offices, public and publicly authorized healthcare institutions, laboratories, scientific institutions and other similar institutions or business pursuant to conditions decided by the Ministry of Health and Care Services; and
- dispensing of medical products for animals to professional end users pursuant to conditions decided by the Ministry of Health and Care Services.
The application process
It is important to decide on a strategy for the application process and plan the process well in advance, in order to ensure that the correct application is submitted within the applicable deadline(s). We regularly advise clients on all stages of the application process, including but not limited to drafting of applications and correspondence with the public authorities.