Medicines for human use https://www.ema.europa.eu/en/documents/other/list-union-reference-dates-frequency-submission-periodic-safety-update-reports-psurs_en.xlsx T1, T2, T3 Read more " October 14, 2026
Medicines for human use A new version (Rev 164) of the ‘List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)’ has been published T2, T3 Read more " October 14, 2026
Medicines for human use A new version (29.1) of the ‘MedDRA Important Medical Events Terms List’ has been published T1, T2, T3 Read more " October 14, 2026
Medicines for human use An update (version 1.15) to the Q&A document on the electronic transmission of data under Article 57(2) has been published. T1, T2, T3 Read more " October 14, 2026
Medicines for human use The EMA has published version 3.21 of Chapter 3.II – ‘XEVPMR User Guidance’ – of the document ‘Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No 726/2004’ T1, T2, T3 Read more " October 14, 2026
Medicines for human use The EMA has published Revision 2 of Module III of the GVP – ‘Pharmacovigilance inspections’ T1, T2, T3 Read more " October 14, 2026
Medicines for human use The EMA has published version 2.2 of the document ‘EudraVigilance – European database of suspected adverse reactions related to medicines: User Manual for online access via the adrreports.eu portal’ T1, T2, T3 Read more " October 14, 2026
Medicines for human use A new version of the ‘List of European References (EURD) and frequency of submission of periodic safety update reports (PSURs)’ has been published T2, T3 Read more " September 11, 2026
Medicines for human use The EMA has published the list of journals included in IPA (International Pharmaceutical Abstracts), a database monitored by the MLM service T1, T2, T3 Read more " September 11, 2026
Medicines for human use A new version (7 August 2026) of the Product Management Service (PMS) FAQs has been published. T1, T2, T3 Read more " September 11, 2026
Medicines for human use A new version (3.7) of ‘Chapter 3: Process for the electronic submission of medicinal product information’ of the PMS – Implementation of ISO IDMP in Europe has been published. T1, T2, T3 Read more " September 11, 2026
Medicines for human use A new version (v. 2.5) of Chapter 2, ‘Data elements for the electronic submission of information on medicinal products for human use’, of the PMS: ‘Implementation of the ISO IDMP standard in Europe’, has been published. T1, T2, T3 Read more " September 11, 2026