Decree No. 288 / 2004 Coll.

Order setting out the details of the marketing authorisation of medicinal products, their changes, extensions, classification of medicinal products for dispensing, transfer of marketing authorisation, the issuing of authorisations for the simultaneous importation, submission and design of specific medical programmes using unauthorised medicinal products for human use, the way in which the adverse effects of the medicinal product are notified and evaluated, including the details of periodic safety update reports, and the manner and extent of the notification of the use of the non-authorised medicinal product (registration decree on medicinal products)

Text Versions

11.05.2004 Published
Effective from 11.05.2004
11.05.2004 Previous
Effective from 11.05.2004 to 30.06.2008

Amendments

No amendments are available.

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