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 Medicines 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.
Holders of a WDA within the 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.
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.
With regard to holders of a Manufacturing and Importation Authorization (MIA) issued within another EEA country, there are no changes.
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.
Storage
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.
An overview of EEA wholesalers operating in Norway, with their corresponding Norwegian organization numbers, if relevant, is published on NoMA's web site. The overview is based on voluntary notification to the NoMA, and the purpose is to facilitate customs clearance and hence minimize the risk of delays.
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», and the WDA issued by the relevant competent authority must be attached, as well as a copy of or a link to the registration of the business in the CCR.
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.
Import/purchase of medicinal products from third countries
The requirements relating to the import of medicinal products from a non-EEA country are unchanged.
