CMDh & EC updates – October 2021

This post will be updated on an ad hoc basis.

Report from the CMDh meeting held on 12-13 October 2021

Some items of note in this report include the following:

  • CMDh Best Practice Guide on Multilingual Packaging
    • The CMDh has agreed an update of the Best Practice Guide on multilingual packaging (MLP), prepared by the working group on MLP. The update takes into account the experience from discussions on issues arising, feedback from Member States collected in a survey earlier this year, concerns raised by Interested Parties and requests from Member States for clarification on practical aspects of the pilot on multilingual packaging
    • The CMDh also adopted an update of the cover letter template for new MAAs submitted through MRP/DCP, which now includes the option for the applicant to inform about their interest to participate in the pilot on multilingual packaging as described in the BPG
    • The updated BPG will be published on the CMDh website
  • Publication of updated electronic Application Forms (eAF) – Applicants are reminded that a new version ( of the eAFs is available for immediate use since. Further information is available in this post below.
  • Call for review for chemically synthesised and biological medicinal products regarding nitrosamine impurities
    • The CMDh and EMA agreed an update of the joint EMA/CMDh Q&As for MAHs/applicants on the CHMP Opinion for the Article 5(3) referral on nitrosamine impurities in human medicinal products. Questions 8 and 14 have been updated to provide advice on step 2 testing rationalisation for certain cases (e.g. product available in multiple strengths of the same dosage form with the same risk factors). Guidance has also been included for cases, where, despite extensive efforts, a reference standard of the relevant nitrosamine impurity cannot be synthesised.
    • The updated document will be published on the EMA website and linked from the CMDh website

Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures (Jan – June 2021)

The above statistics can be viewed in this presentation.

Overview of timetables 2022 – CMDh 60-day procedures for MRP/DCP applications
  • This document was produced by the CMDh as guidance to inform Applicants of the possible timetables for the applications referred to the CMDh, in accordance with Article 29(1) of Directive 2001/83/EC, as amended and Article13 of Regulation (EC) No 1234/2008.
  • The starting date for the 60 days procedure should be, in principle, no later than 30 days after Day 90 or Day 210 of the Mutual Recognition or Decentralised Procedures, respectively, or the final day of the Variation procedure.
  • However due to the calendars of CMDh meetings, it might not be possible to comply with the 30-day rule in all situations.

Source: HMA website

EU electronic application forms (eAF) v1.25.0.0 now available
  • New version of all eAFs (MAA, variation and MA renewal) is now available for immediate use.
  • The main changes in this version of the forms relate to the implementation of the Medical Device Regulation Art 2(1) of Regulation (EU) 2017/745 and include other changes as implemented in the latest version of the NTA application forms.
  • In summary, the changes are:
    • Human MAA form: an updated section on Medical Devices
    • Variation form: addition of a new section on Medical Devices and addition of new sections on parallel variations and on Harmonisation relating to National Variations.
    • Renewal form: An incorrect business rule relating in the Renewal form for excipients has also been fixed in this version.
  • The version can be used immediately and it strongly recommended that it should be used as soon as possible for applications for products containing medical devices. However, the one-month transitional period will run until end of October 2021 after which the use of version of the forms will become mandatory.
  • The version has now been removed from the eAF website however users can continue to submit applications using this version until the end of October 2021.
  • Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

You can download all the new forms and view presentations on the changes in each form here

Source: Europa website

Q and A on regulatory expectations for medicinal products for human use during the Covid-19 pandemic

This Q & A has been updated from Revision 4 of July 2021 to Revision 5 of September 2021.

There are new and updated Q & As in the document.

Updated Q & As

Responses to the following questions have been updated:

2. Manufacturing, importation of finished products and active pharmaceutical ingredients and GMP and GDP issues

  • Q 2.2 Which measures will be taken in respect of GMP certificates and authorisations to manufacture/import in the light of difficulties to conduct on-site GMP inspections due to restrictions linked to the Covid-19 pandemic? (pages 9-10)

New Q & As

The following are new Q&As:

4 Pharmacovigilance

  • Q 4.2 Is there any impact on corrective and preventive actions management under the pharmacovigilance provisions? (page 14)
  • Q 4.3 is there any flexibility in the planning and conduct of pharmcovigilance audits?(Pages 14-15)
  • Q 4.4 Which measures will be taken in the light of difficulties to conduct on-site pharmacovigilance during the Covid-19 pandemic? (Page 15)

Article 45 and 46 – Paediatric Regulation – EU Worksharing Procedure (Best practtice guide)

The above guide has been updated from the version of February 2019 CMDh/394/2019 to the version of September 2021 CMDh/394/2019, Rev. 1

There are notable changes to the following sections:

Section 2.3 Content and submissions (Pages 6 and 7):

The changes to this section concern the following:submission of documentation to Rapporteur and to each competent Authority where the product is authorised and, upon request, to other Member States following the eCTD format, if available.

Also, in the case of older studies, it may be necessary to submit an extended synopsis instead of a clinical study report when this is not available.

Section 3.3 Submissions of Art. 45 and/or Art. 46 paediatric studies (pages 8 and 9)

The changes to this section concern the submission of documentation to Rapporteur and to each competent Authority where the product is authorised and, upon request, to other Member States.

Here, you can view the clean and track changed versions.

Source: HMA website

Questions and answers on the Paediatric Regulation (Regulation of the European Parliament and of the Council (EC) no 1901/2006, as amended)

This Q&A has been updated from the version of March 2021 CMDh/007/2007, Rev. 10 to the version of September 2021 CMDh/007/2007, Rev. 11

The changes are as follows:

Q 7 about MA Holders having to submit proposals to amend the product information together with the line listings has now been deleted.

Q 15 Which format should the Marketing Authorisation Holders use? (page 4) – The response to this question has been updated.

Here, you can view the clean and track changed versions.

Source: HMA website