Current issue of “RMS NEWS”
NEWSTICKER 30.06.2024
- RECENT COMMITTEE NEWS
Medicinal products containing estragole as an active substance or excipient. The CMDh reminds marketing authorisation holders/registration holders of medicinal products/(traditional) herbal medicinal products ((T)HMPs) containing plants or their preparations containing estragole either as an active substance or as an excipient to check whether their medicinal products comply with the guidance published by the HMPC. These can be found on the EMA website. All marketing authorisation holders/registration holders of estragole-containing medicinal products are requested to consider the publication on the BASG website and, if necessary, to take appropriate measures.
Request form template for MRP/RUP. The CMDh agreed to an update of the request form for MRP/RUPs. The updated template can be found on the CMDh website and on the BASG website.
Data requirements for marketing authorisation applications in MRP/DCPs. The CMDh has updated the document "Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers" regarding the requirements of some Member States and published it on the CMDh website.
Active Substance Master File Worksharing. In January 2024, the CMDh approved an update to the document "The worksharing procedure for the assessment of Active Substance Master File (ASMF)", which was created by the Working Group on ASMF procedures. The document has been revised based on the experience gained since the procedure was introduced. The main change is that already approved ASMFs (with an assessment history of at least 2 years) can be included in the ASMF worksharing under certain conditions. The application form for the EU ASMF number will be updated accordingly. The corresponding guidance document has now been adopted by all relevant groups and is published on the CMDh website.
Q&A on MDR and IVDR updated. The CMDh, in collaboration with the EMA and the European Commission, has agreed an update of the joint EMA and CMDh Q&A for applicants, marketing authorisation holders and notified bodies in relation to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (Regulations (EU) 2017/745 and (EU) 2017/746). The main objectives of this update are to take into account the experience gained so far in the implementation of the MDR (in particular Article 117) and the IVDR. The updated Q&A document has been published on the EMA website and linked on the CMDh website under "Questions & Answers".
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
