Meeting highlights from the CMDh meeting in November 2016
16.11.2016
CMDh positions following PSUSA procedure for only nationally authorised products
The CMDh, having considered the PSURs on the basis of the PRAC recommendations and the PRAC assessment reports, agreed by consensus on the variations of the marketing authorisations of medicinal products containing the following active substances:
- granisetron (other formulations except for transdermal patch)
- dorzolamide
- rabies vaccine
- triamcinolone (intraocular formulations)
- dexamethasone (adopted via written procedure following the October CMDh meeting)
Further information regarding the above mentioned PSUSA procedures, including information on the implementation, will be published on the EMA website.
Certificate of Suitability (CEP) suspensions at Zhejiang Hisun Pharmaceutical Co., Ltd
The CMDh has been made aware that following the issuing of a statement of GMP non-compliance, EDQM has suspended CEPs for manufacturing sites of Zhejiang Hisun Pharmaceutical Co., Ltd.
Marketing Authorisation Holders are advised to take the necessary regulatory actions and follow the recommendations stated in the Statement of Non-Compliance issued by the Spanish Competent Authority in September 2016. More information is available here (search for inspection end date: 2016-06-04).
Request by applicants for WHO ATC code
The CMDh reminds applicants of fixed dose combination products for which no WHO ATC code currently exists to request the ATC code early. The ATC code has an impact on the order of the active substances in the name of the product. A timely provision of the ATC code will avoid problems later in the procedure.
Revision of MRP/RUP flow chart
The CMDh agreed on an updated flow chart for MRP and RUP procedures. The new flow chart foresees a shorter period for comments by EU Member States at the beginning of the procedure. Time periods for applicants remain unchanged. The new flow chart also foresees that RUPs can be closed by day 60 when no potential serious risk to public health is raised/remains. MRPs may be closed at day 60 when no potential serious risk to public health or other concerns remain. The new flow chart will be applicable to procedures submitted after 31 January 2017, and will be published on the CMDh website under "Procedural Guidance, Application for MA, MRP/RUP”.
More news from the CMDh November 2016 meeting are available on the CMDh/HMA website.
