Medicines for human use Chapter 3 of the document ‘Process for the electronic submission of medicinal product information (v 3.5)’ has been published for the implementation of ISO standards in the IDMP in Europe T1, T2, T3 Read more " May 8, 2026
Medicines for human use A new version (V.4) of Chapter 9 of the document ‘Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas’ has been published. T1, T2, T3 Read more " May 8, 2026
Medicines for human use A new version (1.5) of the document ‘Extended EudraVigilance Medicinal Product Report (XEVPRM) user guidance for sponsors of clinical trials’ has been published. T1, T2, T3 Read more " May 8, 2026
Medicines for human use A new version (3.20) of Chapter 3.II of the ‘XEVPRM user guide’ has been published T1, T2, T3 Read more " May 8, 2026
Medicines for human use A document has been published on the access policy for the EU Veterinary Products Database (UPD). T1, T2, T3 Read more " May 8, 2026
Medicines for human use A new update to the MedDRA coding document “Points to Consider v. 4.26” has been published T1, T2, T3 Read more " May 8, 2026
Medicines for human use New questions and answers regarding PSURs in post-authorisation procedures have been published. T1, T2, T3 Read more " April 10, 2026
Medicines for human use New questions and answers regarding risk management plans in the post-authorisation phase have been published. T3 Read more " April 10, 2026
Medicines for human use A new version (Rev. 17) of the document ‘Introductory cover note to the List of European Union reference dates and frequency of submission of PSURs’ has been published. T2, T3 Read more " April 10, 2026
Medicines for human use A new version (3.13) of the ‘IRIS guide for applicants’ has been published. T2, T3 Read more " April 10, 2026
Medicines for human use A new version (4) of Chapter 5 of the European implementation guidelines for veterinary medicinal products has been published in the ‘Union Product Database’. T1, T2, T3 Read more " April 10, 2026
Medicines for human use A new version of the ‘Union Product Database (UPD) release notes (16 March 2026)’ has been published T1, T2, T3 Read more " April 10, 2026
