BfArM - Federal Institute for Drugs and Medical Devices

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Follow-up Procedures

Tasks

After a marketing authorisation has been granted for a medicinal product, a number of other procedures are conceivable that the medicinal product can undergo in the course of time. These procedures are summed up under the term follow-up procedures.

Possible follow-up procedures include e.g. renewal procedures for extension of the marketing authorisation or variations to already licensed medicinal products which also have to be submitted. The follow-up procedures are dependent upon the type of marketing authorisation, e.g. whether the medicinal product was licensed nationally or in a decentralised procedure.