- Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)
- Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture "The QP declaration template" - Scientific guideline
- Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies
- Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies - tracked changes
- Overview of NCAs participating in the voluntary Simultaneous National Scientific Advice (SNSA) project
- Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-9 April 2025
- Veterinary medicines European public assessment report (EPAR): Nobilis Multriva Gm+REOm, avian infectious bursal disease,avian reovirus vaccine (inactivated), Status: Opinion
- Veterinary medicines European public assessment report (EPAR): Nobilis Multriva IBm+ND, Avian infectious bronchitis virus ,Newcastle disease virus vaccine (inactivated), Status: Opinion
- Veterinary medicines European public assessment report (EPAR): Emevet, maropitant, Status: Opinion
- PSUSA/00000742/202408
- PSUSA/00000986/202409
- Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2025
- Composition of the Emergency Task Force (ETF) for preparedness
- Superseded - Composition of the Emergency Task Force (ETF) for preparedness
- Rules of procedure of the Emergency Task Force (ETF)
- Class 2 Medicines Recall: Synalar GEL 30g, Synalar GEL 60g,(fluocinoline acetonide 0.025%) Reig Jofre UK,EL(25)A/16
- Field Safety Notices: 31 March to 4 April 2025
- Class 4 Medicines Defect Notification: Renacet 475 mg and 950 mg Tablets (calcium acetate), RenaCare NephroMed GmbH, EL(25)A15
- Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution, EL(25)A/14
- Field Safety Notices: 24 to 28 March 2025
- Class 2 Medicines Recall: Utrogestan Vaginal 200 mg Capsules (progesterone), EL(25)A/13
- Class 4 Medicines Defect Notification: Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, EL(25)A/12
- Field Safety Notices: 17 to 21 March 2025
- MHRA Safety Roundup: March 2025
- Suzhou Surgicare disposable Hysteroscopy Sheath– Recall due to withdrawn CE certificate, (DSI/2025/001)
- Field Safety Notices: 10 to 14 March 2025
- Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11
- Field Safety Notices: 3 to 7 March 2025
- Class 2 Medicines Recall: Boots Paracetamol 500 mg tablets (16s), EL(25)A/10
- Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.V., Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/ML (8mg/ml) Infusion bag, EL(25)A/09
FDA
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