CMDh News – May 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:

  • diclofenac (systemic formulations)
  • glycopyrronium (all indications except for chronic obstructive pulmonary disease)
  • glycopyrronium/neostigmine
  • iodine (131I) iobenguane (revised CMDh position)

With regard to the PSUSA for diclofenac (systemic formulations), the CMDh clarified in its position the wording to be included in the package leaflet.

A revised CMDh position on the PSUSA for iodine (131I) iobenguane has been adopted. The wording of the product information has been amended following the initial adoption in January 2016. The new date of implementation is 7 September 2016.

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:

  • atorvastatin/amlodipine
  • paracetamol/tramadol
  • clarithromycin

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 CMDh SOP on the processing of PSUSAs for NAPs and template of CMS’s comments on Lead Member State’s Preliminary PSUR assessment report

The CMDh agreed revised versions of the CMDh SOP on the processing of PSUSAs for NAPs and of the template for CMS’s comments on the Lead Member State’s Preliminary PSUR assessment report. The revisions reflect the mandatory use of the PSUR repository as of 13 June 2016. Further editorial changes have been introduced.

The updated documents will be published on the CMDh website under "Pharmacovigilance, PSUR, PSUR Single Assessment” and "Templates, PSUR”, respectively.

In addition, CMDh agreed to delete the CMDh Guidance "Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products authorised via National Procedures, MRP and DCP (NAPs)” from the CMDh website as of 13 June 2016.

Regulation (EC) No 1234/2008 on variations

The CMDh has discussed a request for a recommendation for the classification of an unforeseen variation and agreed that the proposed change ("Addition of an external storage site of the finished product after secondary packaging”) does not require a variation, but is covered by GMP.

The outcome will be published on the CMDh website under "Procedural Guidance, Variation, Article 5 recommendations”.

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