Pharmacovigilance Legislation  [Track version] (December 2020, correction March 2024)

Practical guidance on the implementation of the Protocol on Ireland/Northern Ireland for medicinal products for human use approved via MRP/DCP  (May 2022) [Track version]

The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.4 reached Step 4 of the ICH process in December 2020.

ICH is conducting a public consultation on its ICH Reflection Paper on Patient-Focused Drug Development (PFDD), which was endorsed by the Assembly in November 2020.

The International Council for Harmonisation (ICH) met virtually on 18 November in place of face-to-face meetings that were to take place in Athens, Greece, and preceded by virtual meetings of the ICH Management Committee and MedDRA Management Committee.

Type II variation Preliminary Variation Assessment Report (November 2020) Type II variation Final Variation Assessment Report (February 2025) [Track version] 

Member: Priscilla Schoondermark Medicines Evaluation Board P.O Box 8275 3503  Utrecht RG The Netherlands

Member: Priscilla Schoondermark Alternate: Ingrid Bijsmans Medicines Evaluation Board P.O Box 8275 3503  Utrecht RG The Netherlands

Recommendations on submission dates in 2025 for Applications of the MRP (October 2024)Recommendations on submission dates in 2024 for Applications of the MRP  (October 2023)

Hormone Replacement Therapy - Core SmPC (May 2023) [Track version] Hormone Replacement Therapy - Core Package Leaflet (May 2023) [Track version] PRAC recommendation on safety signal related to HRT products adopted at the PRAC meeting of 11 - 14 May 2020  (please see EMA's website)