Pharmaceutical regulatory affairs consulting services Poland

Pharmaceutical consulting Poland

EMA procedural guidelines

► European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

► European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes

► List of centrally authorised products requiring a notification of a change for update of annexes

More details and source documents available on EMA website (see links section).

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EMA scientific guidelines

EMA procedural guidelines