Current issue of “RMS NEWS” New
- RECENT COMMITTEE NEWS
RMS may start the procedure if CMSs do not respond. The CMDh agreed an update of the Procedural advice on validation of MR/Repeat-use/DC Procedures. Under the update, the RMS may start the procedure in exceptional cases where CMSs do not react to validation responses within the given timeframe. The updated document has been published on the CMDh website.
Update of the request forms for RMS in DCP and MRP/RUP. The CMDh revised the request form for RMS in DCP. From now on, only correctly and fully completed forms will be considered. In addition:For applications under Article 10a, applicants must state whether a suitable reference product for an application under Article 10 is available in the EU. If so, the choice of Article 10a as legal basis must be justified accordingly.
- For bioequivalence studies or other studies supporting equivalence, the (expected) date of completion must be stated.
- For ASMFs, the ASMF number must be provided.
- The MRP/RUP request form has also been revised. The footnote on CEPs was updated. It concerns the need to submit a variation to update the dossier with the latest CEP version before the start of the MRP/RUP. The requirements for the Environmental Risk Assessment (ERA) in Module 1.6 were also specified further.
Both updated templates are available on the CMDh website and the BASG website.
National requirements: validation relevance now clearly indicated. The CMDh agreed updates to the two compilation documents on national requirements of the Member States. One covers new applications, the other covers variations and renewalsin MRP/DCP. The Member States concerned have now classified each requirement as either a validation issue, which prevents the procedure from starting, or a non-validation issue, which does not. Some national requirements have also been deleted. The documents have been published on the CMDh website.
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
