Medicinal Products

CMDh News – March 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:

  • chloroquine
  • everolimus (indicated against rejection of transplanted organs)
  • paracetamol/tramadol
  • thiocolchicoside.

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:

  • budesonide
  • deoxyribonuclease human (dornase alpha)
  • isradipine
  • sertindole

which may require changes to the product information or introduction of other risk minimisation measures.

The public summaries 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 2016/2017

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. The EU recommendation of the CHMP BWP ad hoc Influenza Working Group has been published on the EMA website.

The data which should be submitted and the format for the submission of annual strain update are prescribed in the guideline CMDh Best Practice Guide on variations, Chapter 9 on fast track procedure for the annual update of human influenza vaccines.

News from the CMDh March meeting are available on the CMDh/HMA webpages.