Medicinal Products

CMDh News – February 2016


First CMDh positions on PASS results according to Art. 107q of Directive 2001/83/EC concerning trimetazidine

The CMDh, having considered the non-interventional PASS results on the basis of the PRAC recommendations and the PRAC assessment reports for medicinal products containing trimetazidine concerned by the final PASS report, agreed by consensus on the variations of the concerned marketing authorisations (i.e. those marketing authorisations for which the final study results were submitted) to remove the below condition imposed as a result of the Art. 31 referral on trimetazidine:

"The MAH should perform a drug utilization study to verify the compliance of prescribers regarding the restricted indication after marketing authorisation changes."

Consequently, where this imposed PASS is the only criteria for additional monitoring, MAHs should submit an additional type IA variation to request the deletion of the black symbol and the related statement in the product information. This type IA variation can be grouped with the variation to request the deletion of the condition.

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:

  • bemetizide/triamterene
  • daunorubicin
  • glibenclamide/metformin hydrochloride

MAHs of medicinal products containing bemetizide or glibenclamide as mono-components or in other combinations are reminded that the above mentioned outcome of the PSUSA procedures for bemetizide/triamterene and glibenclamide/metformin hydrochloride is applicable to their products respectively and should be implemented according to the agreed timelines.

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:

  • acitretin
  • cabergoline
  • mepivacaine, mepivacaine/adrenaline, mepivacaine hydrochloride/dextrose monohydrate
  • piretanide
  • ramipril
  • risperidone

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.

PSUR Repository - procedures for single, pure nationally authorised products (NAPs) - Invitation to submit all PSURs to the Repository

The PSUR repository is now available and it offers a secure electronic submission point for Marketing Authorisation Holders (MAH), streamlining Periodic Safety Update Report (PSUR) submissions for the pharmaceutical industry. It will act as a common storage place for PSURs, PSUR Assessment Reports (ARs), comments and final outcomes, with a secure access for NCAs and the European Commission. The PSUR repository supports both the PSUR Single Assessment Procedure (PSUSA) as governed by the EURD list and the single, pure NAP procedures, where the active substance is not included in the EURD and may only be authorised in one Member State.

Since January 2015, the EMA has been piloting single assessment PSUR procedures in the repository. After a successful independent audit confirming that the repository has reached the required functionality, the EMA Management Board has announced that mandatory use of the repository will commence on 13 June 2016.

The EMA has also announced that the repository will, from 11 February 2016, enter a switch-on phase. This is a phase of simulated mandatory use and allows National Competent Authorities (NCAs) and MAHs to upload PSURs, assessment reports and comments via the repository and takes advantage of the enhanced notification system offered by the repository.

The NCAs will continue receiving nationally authorised NAP PSURs locally until the mandatory use (June 2016).

The switch-on phase will allow for further learning and preparation for the mandatory use of the system for both MAHs and NCAs. Therefore during the switch-on phase (i.e. from 11 February 2016) the CMDh would like to invite MAHs for pure national products to submit their PSURs and any related supplementary information to the repository.

MAHs should note that prior to submission to the PSUR repository, product data in the Article 57 database should be checked to ensure that products are correctly entered and will hence be available in the PSUR repository.

MAHs are also reminded that PSUR submissions both to the PSUR repository and NCAs must be structured electronic submissions, i.e. eCTD or NeeS. PSURs submitted as pdf documents cannot be uploaded into the PSUR repository, and will entail follow up with the relevant MAH.

Additional information on the repository and guidance on how to register can be found on the EMA’s PSUR repository web pages.

Users should report any issues they may have with the system through the PSUR repository mailbox: When communicating issues, please copy the relevant NCA contact for the procedure to ensure the Competent Authority is kept informed of issues with the submission.

List of safety concerns per approved Risk Management Plan (RMP) of active substances per product

MAHs are reminded that in April 2015 the CMDh has published a list of safety concerns per approved RMP of active substances per product. Guidance for Member States and MAHs on how to submit information for updates of the list is provided in the related cover note. The list will be updated by the CMDh on a regular basis, based on the information received.

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