Post-authorisation

The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. This is known as the post-authorisation stage of the product lifecycle. The information in this section sets out the responsibilities of marketing authorisation holders in areas such as pharmacovigilance, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls.

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

In this section - Guidance for specialised areas

• Advanced therapies: post-authorisation
• Orphan designation: post-authorisation
• Paediatric medicines: post-authorisation

In this section - Guidance on interacting with EMA

• Contacting EMA: post-authorisation
• Improving quality of submissions
• Submitting a post-authorisation application

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.

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

Reference Number: EMEA-H-19984/03 Rev. 117

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

Reference Number: EMEA-H-19984/03 Rev. 117