Hormone Replacement Therapy - Core SmPC (November 2024) [Track version]Hormone Replacement Therapy - Core Package Leaflet (November 2024) [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)
Hiberix (haemophilus influenzae type b polysaccharide (PRP) conjugated to tetanus toxoid (TT))IE/W/0012/pdWS/002End of procedure: 22/01/2020Date of publication: 04/11/2020IE/W/0012/pdWS/0003End of procedure: 08/05/2025Date of publication: 23/10/2025
EU ASMF number request form (July 2024) [Track version] Link to Contact Points for request for EU ASMF number
The CMDh has introduced a Request Form for an MRP/RUP procedure available for the National Competent Authorities (NCA). Due to the different organisations and thereby also different working procedures for the approved medicinal products in member states, the Request form may need to be adapted at national level and is not mandatory for the NCAs to use. The Request Form is published [...]
Template Assessment Report MRP Overview (October 2020, correction February 2024)
Further to the ICH Q3D(R2) draft document reaching Step 2b of the ICH Process, the Step 2 Informational Presentation developed by the ICH Q3D(R2) Maintenance EWG has been finalised.
Procedural Advice on Repeat Use (January 2025) [Track version]
Vaxigrip Tetra (quadrivalent influenza virus vaccine (inactivated, split))DE/W/0074/pdWS/003End of procedure: 10/07/2020Date of publication: 29/09/2020DE/W/0074/pdWS/004End of procedure: 04/07/2024Date of publication: 25/09/2024
The ICH Q3D(R2) draft Guideline on Elemental Impurities reached Step 2 of the ICH process on 25 September 2020.
The ICH E14/S7B draft Q&A document on “Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential” reached Step 2b of the ICH Process on 27 August 2020.