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"N"

national procedure
Definition
Until 1998, the pharmaceutical industry could apply for a national approval. The product can then only be sold in that particular EU country. A marketing authorisation (MA) is valid for five years and after the first renewal, the MA is valid for an unlimited period. In order to obtain an approval the product must be submitted with an SPC (Summary of Products Characteristics) which is the basis for the marketing of the product. For some products, i.e. roducts intended for national use in one Member State only, it will be possible to use the national procedure also after 1998.
Abbreviation for
NP
Broader Term
marketing authorization procedure
procedure, authorization
Related Term
centralised procedure
decentralised procedure
mutual recognition procedure
nationally authorised product
 

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