Template for Applicant's responses to the questions raised by RMS and CMSs   Applicant's response template (September 2023)

Member: vacant Alternate: Neringa Kalinauskaite State Medicines Control Agency Žirmūnų str.139A 09120 Vilnius LITHUANIA

Added in May 2024 27 May NEW - 28-29 May CMDh agenda 2 May NEW - Report from the meeting held on 23-25 April 2024 UPDATE - Request for MRP/RUP / Update assessment report NEW - Art 45 PAR on Alphanate (human von Willebrand factor, human coagulation factor VIII) NEW - Art 46 PAR on Riamet (artemether / [...]

Procedural advice on Zero Day MR Procedures (March 2024)

Added in April 2024 3 April UPDATE - Q&A on Pharmacovigilance Legislation NEW - Procedural advice on Zero Day MR Procedures NEW - Minutes of the Meeting of a subgroup of CMDh with Interested Parties dedicated to LoSC and publication of PI updates NEW - Art. 46 PAR on Verorab (Rabies virus, inactivated) NEW - Art. 46 PAR on Triptorelin (Decapeptyl, Diphereline, [...]

Verorab (rabies virus, inactivated) End of procedure: 17/01/2024 Date of publication: 03/04/2024

Palexia and associated names (tapentadol hydrochloride) DE/W/083/pdWS/001 End of Procedure: 01/07/2014 Date of Publication: 09/10/2014 DE/W/083/pdWS/002 End of Procedure: 15/12/2014 Date of Publication: 30/01/2015 DE/W/123/pdWS/001 End of Procedure: 10/12/2019 Date of Publication: 09/03/2020 DE/W/124/pdWS/001 End of Procedure: 19/11/2019 Date of Publication: 09/03/2020 DE/W/125/pdWS/001 End of Procedure: 16/03/2020 Date of Publication: 11/05/2020

The ICH Secretariat is pleased to announce the publication of the ICH Q12 “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management Introductory Video” following the publication of the ICH Q12 Module 8 in February 2024.

EMA Explanatory Note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines

Template - PSUR Assessment Report (March 2017, correction February 2024)