CMDh News - December 2015
23.12.2015
Mandatory use of the electronic Application Form (eAF) from 1 January 2016
As earlier stated in the CMDh minutes and press release, the eAF will be mandatory for all procedures in the EU (Centralised procedure, MRP, DCP and by default National procedure), for Human and Veterinary products. This applies to all new Marketing Authorisation Applications, Renewals and Variations and is in line with the EU eSubmission Roadmap that can be found at the EMA eSubmission website.
A webinar session dedicated to Industry was held providing information about where to find relevant documents, addressing the most common issues and workaround solutions faced by Industry when filling the forms. It also explained the support structure to be followed for business related queries for MRP/DCP/National applications and Centralised ones.
The webinar has been recorded and the video file - including slides - is available via the following links: video and slides. Applicants are highly encouraged to consult it before submission of applications and also to regularly consult the eAF website to keep track of updated workarounds and other relevant information.
Furthermore, based on the high interest shown towards this training it is planned to organise a further training session and a follow-up Q&A session in the near future. The dates for these sessions will be announced on the eAF website.
Should you encounter any problems with the use of the electronic forms, any comments or change requests, these should be communicated to eaf@ema.europa.eu.
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:
- Amlodipine besilate/ramipril
- Carmustine (powder and solvent for solution for infusion)
- Influenza vaccine (surface antigen, inactivated)
- Ofloxacin (systemic use)
- Ofloxacin (topical use)
With regard to the outcome of the PSUSA procedure for the combination of amlodipine besilate/ramipril, further information on the implementation of a corresponding wording of the safety changes for the monocomponents and/or other combinations will be made available by the CMDh in due time.
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:
- Epirubicin
- Felbamate
- Folinic acid / (di)sodium folinate / calcium folinate / calcium levofolinate
- Gadopentetic acid dimeglumine
- Imipenem/cilastatin
- Labetalol
- Macrogol 4000 and combinations
- Mesalazine
- Nedocromil
- Paracetamol for infusion
- Quetiapine fumarate
- Ropinirole
- Strontium (89Sr) Chloride
- Tiagabine (hydrochloride)
- Tixocortol, Tixocortol/chlorhexidine
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 the Questions and Answers on QP declaration
The CMDh has agreed an updated version of the Q&As on QP declaration. The answers to question 5 and 6 have been further clarified.
The updated document will be published on the CMDh website under "Questions and Answers”.
Regulation (EC) No 1234/2008 on variations
The CMDh has agreed an update of the Questions and Answers on variations. Question 3.8 has been updated to bring it in line with the outcome of the Art. 5 recommendation discussed in November 2015.
The updated document will be published under "Questions & Answers”.
The CMDh has further agreed an update of the examples for acceptable and not acceptable groupings for MRP/DCP products. A general comment has been included that type IA or IAIN variations for the implementation of safety relevant changes may not be grouped together with type IB or type II variations as this would delay the implementation of the safety information. Further minor editorial changes have been included. The updated document will be published under "Procedural Guidance, Variation”.
The CMDh has also agreed an update of the BPG (Chapter 4) for the processing of Type IB Minor Variations (Notifications) in MRP to clarify that an assessment report is generally not foreseen for the evaluation of type IB variations, except for ASMFs included in the ASMF worksharing procedure. The updated document will be published under "Procedural Guidance, Variation”.
News from the CMDh December meeting are available on the CMDh/HMA webpages.
