Newsletter

Regulatory authorizations for medical products in Norway

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Medical lab

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:

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:

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 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:

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.

Do you have any questions?