Meeting highlights from the CMDh meeting in March 2017
CMDh positions following PSUSA procedure for nationally authorised products only
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:
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 the PSUR assessment for:
- varicella vaccine (live)
which may require changes to the product information or introduction of other risk minimisation measures.
The public summary 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.
Annual update of human influenza vaccines for season 2017/2018
Following the report of the CHMP BWP ad hoc Influenza Working Group, the CMDh agreed that the EU recommendation of the CHMP BWP ad hoc Influenza Working Group including the data requirements/format for submission of the annual strain update is applicable also for MRP/DCP and purely nationally authorised seasonal influenza vaccines (see also CMDh Best Practice Guide on variations, Chapter 9 on fast track procedure for the annual update of human influenza vaccines). The EU recommendation of the CHMP BWP ad hoc Influenza Working Group has been published on the EMA website.
The updated EMA Guideline on influenza vaccines - submission and procedural requirements is also applicable to products authorised via MRP/DCP and via purely national procedure.
EU Work-sharing Articles 45 & 46 of the Paediatric Regulation - Public Assessment Reports
The CMDh has agreed on a public assessment report for paediatric studies submitted in accordance with Article 45 of the Paediatric Regulation for:
- sulfamethoxazole and trimethoprim
including recommendations for the text to be included in SmPCs and package leaflets.
Marketing Authorisation Holders of medicinal products with same active substances and pharmaceutical forms are requested to include this information in their SmPCs and package leaflets within 90 days of publication of the public assessment reports, in accordance with the Best Practice Guide - Article 45, EU work-sharing procedure.
No changes to the product information have been requested based on outcomes of these procedures.
The CMDh has also agreed on public assessment reports for paediatric studies submitted in accordance with Article 46 of the Paediatric Regulation for:
- Asmanex Twisthaler (mometasone furoate)
- Riamet (artemether/lumefantrine)
The public assessment reports will be published on the CMDh website under "Paediatric Regulation, Assessment reports”.
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 Lovenox and associated names will be published on the CMDh website.
MAHs of biosimilars 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 described 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 March 2017 CMDh meeting are available on the CMDh/HMA website.