European Medicines Agency’s updates
Following is the list of recent EMA”s updates with links to updated documents/guidelines:
- Heads of Medicines Agencies
- Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes
- Regulatory and procedural guideline: Procedure for reporting of pharmacovigilance inspections requested by the CVMP, adopted
- Quality control of medicinal-product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004 (updated)
- eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) bulk update manager
Questions and answers relating to open tender ”Effectiveness and pharmacoepidemiology studies” – reference number EMA/2014/50/RE - List of medicinal products under additional monitoring
The European Union regulatory network incident management plan for medicines for human use
Referral: Article 20 procedures, Maci, matrix-applied characterised autologous cultured chondrocytes