CMDh News – October 2015


CMDh News - October 2015

2 months to go until the mandatory use of the electronic application form

The Co-ordination Group for Mutual Recognition Procedure and Decentralised Procedure for Human Medicinal Products (CMDh) would like to remind on the very soon beginning of the mandatory use of electronic application form (eAF) for granting marketing authorisations, renewals and variations for medicinal products within national and MRP/DCP procedures. Indeed, the use of these application forms for centralised procedure is mandatory from 1st July 2015, whereas for national and MRP/DCP procedures begins as of 1st January 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:

  • Amitriptyline
  • Amitriptyline/perphenazine
  • Ampicillin/sulbactam
  • Argatroban
  • Cilostazol
  • Ondansetron
  • Tenoxicam

Further information regarding the above-mentioned PSUSA procedures, including information on the implementation, will be published on the EMA website, or here.

Outcomes of informal PSUR work-sharing procedures

The CMDh has adopted the conclusions of PSUR assessments for cefepime, clarithromycin, cyproterone acetate/ethinylestradiol, fentanyl, gabapentin, influenza vaccine (split virion inactivated), iobitridol, ketoprofen (topical use only), lenograstim, milnacipran and pimecrolimus, 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 work-sharing 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.

Request for update of the product information of HMG-CoA reductase inhibitors (statins)

As a follow-up to a PhVWP recommendation from July 2011 to update the product information of fusidic acid containing medicinal products for systemic use to include a warning about the concomitant use with HMG-CoA reductase inhibitors (statins), the CMDh has agreed a corresponding harmonised wording to be included in the product information of medicinal products containing HMG-CoA reductase inhibitors.

The CMDh requests the implementation of the below wording in the product information of concerned medicinal products according to the following timetable:

  • Products that do not have a warning concerning the interaction with fusidic acid should be updated within 2-months of publication of the agreed text by a type IB, C.I.z variation.
  • If the product information has already been updated to include the minimum safety warnings for this interaction, a further variation will not be required immediately. However, the harmonised text should be implemented with the next variation to update the product information.

The agreed harmonised text is accessible on the CMFh webpages, or here.

Implementation of Article 31 referral on adrenaline auto-injectors

The CMDh wants to remind marketing authorisation holders concerned by the Article 31 referral on adrenaline auto-injectors to use the possibility of variation worksharing wherever possible for the implementation of the referral outcome, e.g. submission of a risk management plan as part of the conditions included in the EC decision.

Revision of the CMDh recommendation on the summary of the pharmacovigilance system and risk management plan in MRP/DCP

The CMDh has agreed a revision of the guidance document on the pharmacovigilance system and risk management plan in MRP/DCP to bring it in line with the requirements of the pharmacovigilance legislation. The updated document will be published under "Procedural Guidance, General Information”.

Revision of the Questions & Answers on Pharmacovigilance legislation

The CMDh has agreed a revision of question 2 of the Q&As on Pharmacovigilance legislation to clarify the submission of a new or updated RMP in line with the CMDh recommendation on the summary of the pharmacovigilance system and risk management plan in MRP/DCP. The updated document will be published under "Questions & Answers”.