European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Product Management Service (PMS) – Frequently Asked Questions (FAQs)
Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications
Renewal and annual re-assessment of marketing authorisation
Type-IA variations: questions and answers