The Regulation is applicable for centrally authorised, MRP/DCP and national marketing authorisations.
The use of the eAF (electronic application form) is mandatory from 1st January 2016 for all applications (human and veterinary MRP, DCP and national procedure applications for marketing authorisation, renewal and variations). Further details can be found on: http://esubmission.ema.europa.eu/eaf/index.html and CMDh website.
How to submit a variation for Transfer of Marketing Authorisation?
Type of procedure
A Transfer of Marketing Authorisation (MA) from the existing Marketing Authorisation Holder (MAH) to a new MAH has to be submitted nationally (also for MRP or DCP) as variation requiring assessment (VRA) under category E.z – Transfer of marketing authorisation to different legal entity, following standard timetable of 60 days.
Documents to be provided
- Declaration stating the date on which the Transferor and the Transferee finalise the transitional organisational arrangements and the Transferee takes over all responsibilities (must be signed by both the Transferor and the Transferee).
- Contact details of the person responsible for communication between the MAH and State Agency of Medicines and letter of authorisation.
- Information on whether the phamacovigilance system master file (PSMF) and Qualified Person for pharmacovigilance (QPPV) remain the same or are changed.
- Revised product information and the implementation date of the variation.
- Proof of establishment of the MAH in the EEA.
Follow up requirements
Evidence must be provided that a Pharmacovigilance System Master File (PSMF) is in place for the new MAH and a variation to replace or change an existing summary of the PSMF, or introduce a new summary of the PSMF has been/will be submitted according to the current legislation. See also CMDv Q&A - List for the submission of variations according to Regulation (EU) 2019/6.
Submission of safety variations following signal and PSUR assessment outcome
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for the analysis, prioritisation and assessment of validated signals, resulting in a PRAC recommendation.
More information: Signal management
The EMA publishes PRAC recommendations every month under: PRAC recommendations on safety signals
You can find the Excel table at the bottom of the page (List of safety signals discussed since September 2012), where list of all signals discussed at PRAC is published. Last column of the table (Update of product information recommended by PRAC) contains information whether Product Information has to be updated or not (No/Yes). In the second column from the right (PRAC meeting) the date of PRAC meeting and link to the PRAC protocol is given (NB! You cannot find the updated wording of the Product Information there). To find the Product Information updated wording, you should go one step backwards, where Excel table is at the bottom of the page and pdf files of PRAC Recommendations on adopted signals can be found (PRAC recommendations on safety signals: monthly overviews). You should choose the pdf file „New product information wording” with the date and year given in the Excel table and choose ET= Eesti keel language.
NB! In preparing the variation the translation given in PRAC recommendations should be used.
Depending on whether the PSUSA (Periodic safety update report single assessments) involved only centrally authorised, centrally and nationally, only nationally authorised active substances or whether the active substance is included in the EURD list (List of European Union reference dates) or it not (yet) included there the outcomes of PSUR assessments are published on different websites:
More information: Periodic safety update report single assessments
1. PSUSA procedure involves only centrally authorised products
The outcomes of PSUR assessments are published as part of each medicine's EPAR: European public assessment report
2. PSUSA procedure involves both centrally and nationally authorised products
The outcome can be found on the Community Register maintained by the European Commission.
3. PSUSA procedure involves only nationally authorised products
The outcomes of the PSUR single assessments are published on EMA website „Outcomes of periodic safety update report single assessments”
In the second column from the right (Regulatory outcome) it is stated whether variation has to be submitted or not (Variation/Maintenance) following PSUR single assessment. In case variation has to be submitted in the last column named “Documents” you can find in addition to the list of medicines the pdf file named “CMDh scientific conclusions ...”, where you can find the conclusion and updated wording also in Estonian language. Product information must be updated according to this document.
NB! In preparing the variation the translation given in CMDh conclusion should be used.
4. Active substance is not in the EURD list and PSUR assessment is carried out within Work-sharing (WS) procedure
Following CMDh monthly meeting the outcomes of informal PSUR WS procedures are published on CMDh website.
Summaries of PSUR Assessment Reports are published on CMDh website Pharmacovigilance site
Updates of Product Information are given in the Assessment Report. Marketing Authorisation Holder (MAH) has to organise the translation of the Product Information.
MAH should make sure (even if the active substance is in the EURD list), that all Product Information updates published on CMDh website in the list of active substances are implemented into Product Information. Usually, the timetable of implementation is provided within the CMDh press release.
Last updated: 15.05.2022