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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