In this section
Guidance for all product types
- Certification of medicinal products
- Changing the (invented) name of a centrally authorised medicine: questions and answers
- Changing the labelling and package leaflet (Article 61(3) notifications)
- Classification of changes: questions and answers
- Compliance: post-authorisation
- Data on medicines (ISO IDMP standards): post-authorisation
- Medicine shortages and availability issues
- Notifying a change of marketing status
- Parallel distribution
- Patient registries
- Pharmacovigilance: post-authorisation
- Post-authorisation efficacy studies: questions and answers
- Post-authorisation measures: questions and answers
- Referral procedures: human medicines
- Renewal and annual re-assessment of marketing authorisation
- Templates for assessors
- Transparency: questions and answers
- Transfer of marketing authorisation: questions and answers
- Variations including extensions of marketing authorisations
Guidance for specialised areas
- Advanced therapies: post-authorisation
- Orphan designation: post-authorisation
- Paediatric medicines: post-authorisation
Guidance on interacting with EMA
Question-and-answer (Q&A) document
EMA's post-authorisation procedural advice document provides a printable overview in Q&A format of EMA's position on issues typically addressed with marketing authorisation holders.
EMA regularly updates the Q&A to reflect new developments, additional guidance and the implementation of new European legislation. A track-changes version shows the latest updates. New or revised Q&As are labelled 'New' or 'Rev' respectively together with the relevant date.