Wholesaling in Norway based on a Manufacturing and Importation Authorisation (MIA) or a Wholesaler Distribution Authorisation (WDA) issued within the EU/EEA
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Holders of a MIA or a WDA issued within the EU/EEA can perform wholesaler activities in Norway for the products and activities covered by the MIA/WDA. NoMA should be notified when such activities are planned.
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Background
The Ministry of Health and Care Services has, in connection with the assessment of an administrative appeal, stated that Directive 2001/83/EC relating to medicinal products for human use implies the mutual recognition of Wholesaler Distribution Authorizations (WDAs) issued by national competent authorities within the EEA (EU, Norway, Iceland and Liechtenstein), cf. 2001/83/EC preamble 37 and article 77 no. 1. The Ministry affirms that the principle of mutual recognition requires The Medicines Act of 4 December 1992, § 14, to be interpreted on this basis.
According to the Ministry's assessment, the requirement that wholesaler activities with medicinal products in Norway cannot take place without an authorization from the Norwegian Medical Products Agency (NoMA), as stated in The Medicines Act as well as in the regulation of 21 December 1993 relating to the distribution of medicinal products, must be regarded with respect to this principle. This means that a WDA issued by the NoMA is required when the planned wholesaler activity is not covered by a WDA issued by the national competent authority within another EEA country.
What applies exclusively for firms with a MIA within the EU/EEA?
Only the holder of a valid MIA or WDA issued by a National Competent Authority within the EU/EEA can notify The Norwegian Medical Products Agency. Holders of a Marketing Authorisation (MA) for a medicinal product cannot use this process unless the MA holder is also the holder of the MIA.
The admission to perform wholesaler activities in Norway is restricted to the following:
- For holders of a MIA, only the sites and the specific medicinal products covered by the MIA in question. The release of products into EU/EEA (manufactured in third countries) is regarded as a manufacturing activity.
- For holders of a MA: If multiple manufacturers are approved for a specific product, each manufacturer delivering the product to Norway will have to send independent notifications to the Norwegian Medical Products Agency.
What applies exclusively for firms with a WDA within the EU/EEA?
Wholesaler activities with medicinal products are defined in The Medicines Act, § 14. The Act requires wholesaler activities to be authorized by the NoMA. The regulation relating to the distribution of medicinal products details the requirements for such authorizations.
The admission to perform wholesaler activities in Norway is restricted to only the medicinal products and the activities covered by the WDA in question.
Based on the Ministry's decision, an authorization issued by the NoMA is only necessary when the planned wholesaler activity is not already covered by a WDA from another EEA country. This means that holders of a WDA based on the directive relating to medicinal products for human use, issued within the EEA can perform wholesaler activities in Norway without an authorization from the NoMA, provided that the planned wholesaler activity is specifically mentioned in the EEA authorization.
WDAs already issued by the NoMA to «NUFs» of EEA based wholesalers may be terminated, provided that the EEA WDA covers all planned wholesaler activities to be performed in Norway.
Storage and Importation
Wholesalers intending to store medicinal products in Norway must hold a WDA issued by the NoMA. Wholesalers making use of an authorized third-party wholesaler for the storage of their products are exempted from this requirement.
Import
Companies planning to import medicinal products to Norway must be identifiable with a Norwegian organization number due to customs regulations. Norwegian organization numbers are obtained at the Central Coordinating Register for legal entities (CCR). Questions regarding customs regulations must be directed to Norwegian Customs.
The requirements relating to the import of medicinal products from a non-EEA country are not affected by the regulation regarding wholesaling in Norway based on a MIA or a WDA issued within the EU/EEA.
Wholesaling related to Norwegian wholesalers and pharmacies
Some companies holding a WDA from the NoMA are Norwegian registered foreign businesses (NUFs). In most cases, such foreign companies will hold a WDA issued by a competent authority within the EEA, thus a Norwegian WDA will not be necessary for the import, distribution, sales and delivery of medicinal products within Norway, to the extent that the intended wholesaler activities are specifically covered by a valid WDA issued within another EEA country.
Registration at NoMA
We recommend that such notification is sent to post@noma.no. The e-mail must be designated «Wholesaler in the EEA planning to operate in Norway».
The following information must be sent to NoMA
- Name of the holder of the MIA/WDA
- Legal address of the MIA/WDA holder
- Site address of the manufacturing site, if relevant
- EU/EEA country in which the authorisation has been issued
- A copy of the MIA/WDA issued by the relevant competent authority, or reference to the MIA- or WDA-number in the Eudra-GMDP-database
- If relevant, a copy of or a link to the registration of the business in the Central Coordinating Register for legal entities, CCR (Enhetsregisteret).
- Information as to which medicinal products or groups of medicinal products are to be distributed in Norway
- Information as to which wholesaler activities are to be performed
The NoMA will assess the information received within 30 days, upon which the EU/EEA manufacturer/wholesaler will be added to the overview of companies performing wholesaler activities in Norway.