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REG-89 version 6

Documents Attached to Marketing Authorisation Renewal Applications for medicinal products authorised via national procedure

This guideline supersedes guideline REG-89 version 5 with the effect from July 1 2024.

The Guideline is issued in accordance with the provision of Section 11 of Decree no. 228/2008 Coll.

The Guideline is for recommendation.

Its content is based on legal requirements and EMA and CMDh recommendations which are legally binding.