The EDQM hospital medicine traceability guidelines aim at reducing medication errors and enhancing patient safety. It has been drafted by a Working Group and two Committees of Experts under the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH),...

MDCG 2021-12 Rev.2: Updated FAQ on EMDN The revised MDCG 2021-12 Rev.2 FAQ on the European Medical Device Nomenclature (EMDN) is now available This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU)...

Certification of suitability to the Monographs of the European Pharmacopoeia GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS   The holder of a certificate of suitability (CEP) shall inform the...

  Questions and Answers (Q&As) on the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070) work-share initiative with Health Canada (HC) The work-share process is a voluntary collaborative...