CMDh News - September 2015


3 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:

  • Altizide, spironolactone
  • Cyproheptadine
  • Delapril
  • Furosemide
  • Hydrochlorothiazide, spironolactone
  • Lormetazepam
  • Methylprednisolone
  • Phenylephrine
  • Tizanidine
  • Valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpriomide / valproate bismuth / calcium valproate / valproate magnesium
  • 5 fluorouracil (topical application)

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 acipimox, atovaquone, azitromycin, ciprofloxacin, finasteride, oxcarbazepine and ropivacaine, 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.

Updates of the list of safety concerns per approved Risk Management Plan (RMP) of active substances per product

Following the publication of the list of safety concerns per approved Risk Management Plans (RMPs) of active substances per product in April, the CMDh agreed to update the related cover note to provide guidance for Member States and MAHs on how to submit information for updates of the list. Templates for providing the information will also be made available.

The updated cover note together with the templates will be published under "Pharmacovigilance, RMP”.

Implementation of Commission Decisions after Article 30 referral procedures

A link to the Commission decisions, including SmPC, package leaflet and labelling, on the finalised Article 30 referral procedures for Amoxil and associated names will be published on the CMDh website.

Generic Companies are encouraged to contact the Reference Member State to harmonise the product information of the medicinal products authorised via MRP/DCP to conform to the Commission Decision, through submission of a type IB variation under classification C.I.1.b, provided the conditions set up in Regulation (EC) No 1234/2008 are met.

The CMDh will update the tracking table on referrals in accordance with Article 30 of Directive 2001/83/EC to include MRP procedure numbers following the referral procedures, once known. The updated tracking table will be published on the CMDh website.

News from the CMDh September meeting are available on the CMDh/HMA webpages, or here.