Type-IA variations: questions and answers
Submitted by Anonymous (not verified) on 18 December 2023 - 8:29
Type-IA variations: questions and answers
EMA Management Board: highlights of December 2023 meeting
Submitted by Anonymous (not verified) on 15 December 2023 - 15:29
EMA Management Board: highlights of December 2023 meeting
Guideline on the acceptability of names for human medicinal products processed through the centralised procedure - Scientific guideline
Submitted by Anonymous (not verified) on 15 December 2023 - 14:12
Guideline on the acceptability of names for human medicinal products processed through the centralised procedure - Scientific guideline
ACT EU PA08 multi-stakeholder methodology workshop, European Medicines Agency, Amsterdam, the Netherlands, from 23 November 2023, 09:00 (CET) to 23 November 2023, 17:00 (CET)
Submitted by Anonymous (not verified) on 15 December 2023 - 14:10
ACT EU PA08 multi-stakeholder methodology workshop, European Medicines Agency, Amsterdam, the Netherlands, from 23 November 2023, 09:00 (CET) to 23 November 2023, 17:00 (CET)
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2023
Submitted by Anonymous (not verified) on 15 December 2023 - 14:00
Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2023
Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)
Submitted by Anonymous (not verified) on 15 December 2023 - 14:00
Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)
Calculation of dose factor to be submitted to the Union Product Database (UPD) - Scientific guideline
Submitted by Anonymous (not verified) on 15 December 2023 - 14:00
Calculation of dose factor to be submitted to the Union Product Database (UPD) - Scientific guideline
Q & A on implementation of Ph.Eur. Medicinal Product Monographs
Submitted by Anonymous (not verified) on 15 December 2023 - 11:00
Q & A on implementation of Ph.Eur. Medicinal Product Monographs
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2023
Submitted by Anonymous (not verified) on 15 December 2023 - 11:00
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2023
Summary of opinion: Zinplava, 14/12/2023 Positive
Submitted by Anonymous (not verified) on 15 December 2023 - 11:00
Summary of opinion: Zinplava, 14/12/2023 Positive