Frequently asked questions about parallel distribution

Human medicines European public assessment report (EPAR): Vizimpro, dacomitinib, Date of authorisation: 02/04/2019, Revision: 4, Status: Authorised

HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (2016-2024)

Data access to medicinal products for human use - Chapter 5 Annex A: Product data elements accessible by stakeholder group

Good practice guidance for communication to the public on medicines’ availability issues

Medicine shortages and availability issues: guidance for regulators

Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics - Revision 1

Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies

EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)

Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application