CMDh News – April 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:

  • asparaginase
  • meropenem
  • nifedipine
  • rilmenidine

With regard to the PSUSA for nifedipine, the CMDh clarified in its position the necessary wording to be included in the package leaflet.

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:

  • carboplatin
  • ethinylestradiol/levonorgestrel

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.

Revision of position paper on the use of the Quick Response (QR) codes to provide information about the medicinal product

The CMDh has agreed an update of the position paper on the use of the Quick Response (QR) codes. In the revised document information is given on the use of the QR code in combination with safety features as per the Falsified Medicines Directive 2011/62/EU.

The updated document will be published on the CMDh website under "Procedural guidance, General information”.

Revision of CMDh guidance documents on validation

The CMDh has agreed updates of the following documents:

  • Best Practice Guide on the compilation of the dossier for new applications submitted in MRP/DCP
  • Procedural advice on validation issues/national requirements common grounds for invalidation/delaying validation
  • Member State agreement upon conditions under which the RMS can start the MRP/DCP

Information on actions related to potential similarity for orphan medicinal products has been added to the documents.

The updated documents will be published on the CMDh website under "Procedural Guidance, Application for MA”.

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