Medicines for human use Version 3 of Chapter 7 (‘XEVMPD and SIAMED II to PMS-Initial Migration guide’ )of the ‘PMS-Implementation of ISO standards for the identification of medicinal products (IDMP) in Europe’ has been published. T1, T2, T3 Read more " May 22, 2024
Medicines for human use Version 3 of chapter 1 ‘Registration requirements’ has been published in the documentation ‘ Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in Europe’. T1, T2, T3 Read more " May 17, 2024
Medicines for human use The EMA has published the document “New Organization first user EU QPPV/RP or change of EU/QPPV/RP”. T1, T2, T3 Read more " May 15, 2024
Medicines for human use The EMA has published the document ‘Eudravigilance registration documents’ as a summary of the registration procedures that TACs, among others, must follow with the EMA. T1, T2, T3 Read more " May 15, 2024
Medical devices Revision 2 of the ‘Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD’ has been published. T1, T2, T3 Read more " May 2, 2024
Medicines for human use The EMA has published a new update (v. 137) of the ‘ List of European Union reference dates and frequency of submission of periodic safety update reports’. T2,T3 Read more " April 30, 2024
Medical devices The MDCG has published a guide on the contents of the investigator’s manual for clinical research with medical devices. T1, T2, T3 Read more " April 15, 2024
Other areas MDCG has published revision 1 of the ‘Summary of safety and performance’ format. T1, T2, T3 Read more " April 15, 2024
Other areas The MDCG has published the document ‘Safety reporting in perfomance studies of in vitro diagnostic medical devices under Regulation 8EU) 2017/746’. T1, T2, T3 Read more " April 15, 2024
Other areas The EMA has published revision 2 of the document on anonymization of personal data and assessment of marketing confidential information during the development of PGRs. T3 Read more " April 10, 2024
Other areas A new version of the document ‘Q&A-Pharmacovigilance Legislation’ (Rev.24) has been published. T1, T2, T3 Read more " April 3, 2024
Medicines for human use The minutes of the meeting of the CMDh subgroup dedicated to the publication of the list of safety concerns and prospectuses have been published with proposals for the current failure to update the list of safety concerns (T3). Read more " April 3, 2024
