Last updated: 28 June 2023
See updates at the end of the post.
Procedural advice on publication of information on withdrawals of applications for marketing authorisation and variations/extensions to marketing authorisations
Revision 2 (of 27 June 2023) of the above guideline has been published. You can view it here.
As stated in Revision 2, it was updated in 05-2023 to align it with the Guide to information on human medicines evaluated by EMA.
Flash report – Member State Coordination Group on HTA (HTACG) (13 June 2023)
The fourth meeting of the Member State Coordination Group on Health Technology Assessment (HTACG) set up by Regulation (EU) 2021/2282 was held on 13 June 2023 in Brussels. You can view the flash report here.
You can read more about the Regulation on Heath Technology Assessment here.
Source: European Commission
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 5-8 June 2023
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines including:
- assessment of safety signals,
- risk management plans,
- periodic safety update reports
- post-authorisation safety studies.
Information on all topics discussed by the PRAC is available in the 67 page agenda.
Report and minutes from the CMDh meeting held on 23-25 May 2023
The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each meeting and are usually published in the week following the CMDh meeting. The reports therefore only contain a subsection of the complete CMDh agenda and are used for a more timely communication of the most important outcomes. The CMDh minutes are a full record of the CMDh meetings (minus redaction of confidential content). They are adopted at the following CMDh meeting and subsequently published.
The report and minutes from the above meeting include (but are not restricted to) the following items:
1) Regulation (EC) No 1234/2008 on variations
The CMDh agreed an update of its Questions and Answers on Variations.
- The main change is the introduction of a new Q&A (3.30) to provide guidance to MAHs of generic/hybrid medicinal products on how to keep the product information updated, when the MA of the reference product in the initial MA application has ceased to be valid.
- Additional amendments to Q&As 2.3, 2.5, 3.23 and 4.16. The CMDh adopted the proposed changes of the Variations Q&A.
- The updated document has been published on the CMDh website under “Questions & Answers”. Here, you can view the track changed (May 2022) and clean (May 2023) versions of the document.
2) CMS Validation Checklist for Human Medicinal Products in MRP
The CMDh agreed an update of the CMS Validation Checklist in MRP.
- The checklist has been aligned with the RMS validation checklist to make reference to the use of the CMDh “Module 1.7.1. Similarity report” template in the comments section, in case the template has not been used.
- The updated document has been published on the CMDh website under “Procedural Guidance > Application for MA”. You can download it here.
3) Update to the Best Practice Guides on (1) Introduction of substances/ combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU Reference Date is not yet legally binding
The CMDh agreed an update of the following Best Practice Guides:
(1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU Reference Date is not yet legally binding.
It has been included that for the assessment of PSURs of newly authorised products not covered by the EU single assessment procedure, the submission via the PSUR Repository should be to the P-RMS and the involved CMSs.
The updated document has now been published on the CMDh website under “Pharmacovigilance > PSUR > Informal PSUR Worksharing”. Here, you can view the track changed (May 2017) and clean (May 2023) versions of the document .
4) CMDh Guidance document for Submission of Summary of the Pharmacovigilance System
The CMDh agreed an update of its Guidance document for the submission of the summary of the Pharmacovigilance system (sPhVS).
- The timelines for changes to the future MAHs have been aligned with the CMDh BPG on the compilation of the dossier for new applications submitted in MRP/DCP.
- The updated document has been published on the CMDh website under “Procedural Guidance > Application for MA”. Here, you can view the track changed (July 2015) and clean (May 2023) versions of the document.
5) Meetings with representatives of Interested Parties
The CMDh convened a meeting with Interested Parties on 16 May 2023 to exchange views on how the variations framework could be revised. A further, general meeting with Interested Parties was held on 31 May 2023. The topics on the agenda include, amongst others, the folllowing:
- resources,
- renewals,
- telematics
- RMS transfers
All presentations have been published on the CMDh website under “About CMDh > Contact with Representative Organisations”. You can view them at the links below:
- CMDh Multilingual Packaging Group – update May 2023
- Improvement of the renewal process
- Availability of updated PI following safety reviews
- CMDh IP Meeting – 31 May 2023 (Medicines for Europe)
- Europharm SMC
6) DCP RMS request form
The CMDh discussed an update of the DCP RMS request form.
- Comments received before and during the meeting were discussed.
- It was agreed to include a field to confirm if the PI is harmonised in case the RefMP is nationally authorised.
- It was further agreed that information that is only relevant to one or some MSs could be asked at national level but should not be included in the CMDh form.
- The rapporteur will prepare an updated version including the comments received for further discussion/agreement in June.
- MSs were asked to comment on the updated form before the June meeting.
7) User testing of the package leaflet
With reference to the March 2020 CMDh press release, in which flexibilities in relation to user
testing during the pandemic period were introduced (mainly to allow digital consultation), the
CMDh discussed if such flexibilities are still acceptable.
- It was noted that the flexibilities for user testing were independent of the regulatory flexibilities introduced during the COVID-19 pandemic (to be further discussed by MSSG, see 2.5).
- It was further noted that COVID-19 is no longer declared a public health emergency of international concern (PHEIC) by WHO and the flexibilities regarding user testing would in theory no longer be needed.
- However, several MSs stressed that under certain conditions digital user testing could be further allowed as long as a paper PL is provided for the testing.
- However, the relevant guidance would need to be updated.
- The question will be further discussed in the QRD WG.
- The discussion will return to CMDh once QRD feedback is available.
8) Legal requirements of Art. 10(5)
The CMDh noted the EC response to the CMDh question on the requirements for granting a
one-year period of data protection for new indications of well-established substances
according to Art. 10(5) of Directive 2001/83/EC.
- The EC stated that “new indication” as mentioned under Art. 10(5) is to be understood literally (i.e. the proposed indication has not yet been approved for other medicinal products with the same active substance authorised in the EU) and interpreted in line with the Guidance on a new therapeutic indication for a well established substance.
- The CMDh stressed the difficulties to establish if the same indication has already been authorised for another product with the same active substance, as no central database for nationally authorised products with this information is available.
- The CMDh agreed to include the EC feedback in the CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity and to further discuss this document in June.
9) Changing legal basis during assessment phase of a DCP
The CMDh discussed a proposal to allow a change of the initial legal basis of a MAA until day
105 of the DCP in case it becomes clear during the assessment that the medicinal product
cannot be approved with the legal basis chosen by the applicant, under the condition that no
extensive data is needed to complete the dossier.
- The CMDh agreed by majority that it is the applicant’s responsibility to choose the correct legal basis and to present a dossier according to the requirements of the chosen legal basis.
- It was agreed that a change of the legal basis during the procedure should therefore not be allowed.
- During assessment, only data relevant to the chosen legal basis should be considered. If such data, provided or requested during assessment, is not sufficient to grant an MA under the chosen legal basis, the application should be withdrawn or concluded negatively.
10) Acceptance of parallel imported medicinal products as comparators in BE studies
The CMDh discussed if parallel imported medicinal products can be used as RefMPs in BE
studies.
- The majority of the CMDh agreed that parallel imported medicinal products would have to be accepted as RefMP in BE studies.
- Some MSs declared that they could not accept them due to legal reasons.
- If they are used in an abridged application, the information related to the product authorised in the origin EU/EEA MSs should be included in the AF.
- Due to the different ways parallel imports are handled in MSs, it could be difficult to clearly identify from which MS the product has been imported, based on the packaging only.
- Due to the different handlings in MSs and anticipated difficulties, the CMDh recommends that parallel imported medicinal products should be avoided as RefMP in BE studies. Such applications could lead to invalidations.
Updates:
| Date | Update(s) |
|---|---|
| 28 June 2023 | 1) New heading Procedural advice on publication of information on withdrawals of applications for marketing authorisation and variations/extensions to marketing authorisations plus relevant content added. 2) Heading Report from the CMDh meeting held on 23-25 May 2023 updated to Report and minutes from the CMDh meeting held on 23-25 May 2023 and link added to the minutes from the meeting. -Point no 1 under this heading updated to add information on additional amendments to Q&As 2.3, 2.5, 3.23 and 4.1. – New points no 6-10 have been added. |
| 20 Jun 2023 | Link added for Best Practice guides, item 3 under the heading Report from the CMDh meeting held on 23-25 May 2023 |
| 14 Jun 2023 | Link added to Flash report – Member State Coordination Group on HTA (HTACG) (13 June 2023. |
| 10 Jun 2023 | Added information on Meeting highlights from the PRAC meeting of 5-8 June 2023. |