Meeting highlights from the CMDh meeting in October 2016
26.10.2016
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:
- alprostadil (erectile dysfunction)
- bilastine
- carboplatin
- gabapentin
Further information regarding the above mentioned PSUSA procedures, including information on the implementation, will be published on the EMA website.
Outcomes of informal PSUR work-sharing procedures
The CMDh has adopted the conclusions of PSUR assessments for:
- human coagulation factor VIII inhibitor bypassing fraction
- meloxicam (adopted via written procedure following the September 2016 CMDh meeting)
- pravastatin sodium and buffered aspirin (adopted via written procedure following the September 2016 CMDh meeting)
which may require changes to the product information or introduction of other risk minimisation measures.
The public summaries have been/will be published on the CMDh website under "Pharmacovigilance, PSURs, Outcome of informal PSUR worksharing procedures”.
MAHs of the products concerned should implement the outcome of the assessment by the appropriate variation or other procedure (as advised) within 90 days of publication.
Revision of Best Practice Guide for the exchange of regulatory and administrative information regarding orphan medicinal products between the EMA and the NCAs
The CMDh has agreed an update of the BPG for the exchange of regulatory and administrative information regarding orphan medicinal products in order to clarify the responsibilities during the validation of procedures and to clarify in which cases the EMA should be informed.
The updated document will be published on the CMDh website under "Procedural Guidance, General Information”.
Implementation of Commission Decisions after Article 30 referral procedures
A link to the Commission decisions, including SmPC, package leaflet and labelling, on the finalised Article 30 referral procedures for Durogesic and associated names will be published on the CMDh website.
Generic companies are encouraged to contact the Reference Member State to harmonise the product information of the medicinal products authorised via MRP/DCP to conform to the Commission Decision, through submission of a type IB variation under classification C.I.1.b, provided the conditions set up in Regulation (EC) No 1234/2008 are met.
The CMDh will update the tracking table on referrals in accordance with Article 30 of Directive 2001/83/EC to include MRP procedure numbers following the referral procedures, once known. The updated tracking table will be published on the CMDh website.
More news from the CMDh October 2016 meeting are available on the CMDh/HMA website.
