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

ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals - Scientific guideline

EMA business hours over holiday period