For nationally authorised medicinal products eCTD strongly recommened. From 1 March , the use of the eSubmission Gateway or web client is mandatory for all electronic Common Technical Document eCTD submissions through the centralised procedure. By analogy to the implementation of referral procedures, the respective variations for the NAPs have to be submitted to the relevant NCA within 10 days after publication of the Commission Decision on the EC website. Expand section Collapse section. Introduction or changes to the pharmacovigilance system. References Fees payable to the European Medicines Agency.
The regulatory activity ‘PSUR’ can only be used for the ‘initial’ PSUR submission due to the built-in business rules linking to the submission deadline. The Quality Review of Documents QRD linguistic check will be performed on one set of annexes of one centrally authorised medicinal product. The Agency will monitor the quality of the translations, the review by the Member States and industry’s compliance with the Member States’ comments as part of the Performance Indicators. No specific template needs to be followed for the responses to the request for supplementary information RSI. For more information on how to use the PSUR repository, see:
If the data contained in the PSUR contribute meaningfully to the scientific assessment, these data should be included in the scope of the PSUR procedure.
An automated acknowledgement email is sent from the system confirming whether the submission has passed the relevant technical validation criteria and whether it has been uploaded to the Agency’s review tool and made available via the Common Repository. The regulatory activity ‘PSUR’ can only be used for the ‘initial’ PSUR submission due to the built-in business rules linking to the submission deadline.
Start of temllate procedure according to the published timetable.
Points highlighted in this document may nevertheless also apply to the assessment of centrally authorised products and hence it is recommended that all MAHs consult the document prior to finalisation of their PSUR. Revision of test method for the active substance. See grouping of variations: Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure.
The explanatory note will form the basis of the upcoming revision of GPV VII; this update, once finalised, will therefore supersede this guidance document. Submission requirements and EU reference dates: The request and its grounds should be considered by the PRAC and the CHMP if it concerns at least one marketing authorisation granted in accordance with the centralised procedure or the CMDh otherwise, which will either approve or deny the request.
Extensions are excluded from worksharing. For such procedures, a linguistic review will take place in parallel to the scientific assessment.
Worksharing procedure for type-II variations. Any information included in this section, will be discussed by the CMDh for nationally authorised products with the aim of agreeing on any necessary action, which will then be transmitted to MAHs either in the CMDh minutes or as a press release dependent on the issue.
Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’ The submission of a formal letter of intent is not required, however applicants are advised to request a WS number from Remewal ema.
Applications for Marketing Authorisation
When submitting the full set of annexes in PDF format, this should be accompanied by the completed formatting checklist and following the user guide on how to generate PDF versions of the product information – human. An advice note will be generated at the data lock point DLP date and sent accordingly to the relevant QPPVs in order to ensure the accurate identification of the chargeable units for the products involved in the procedure. The share payable by each marketing authorisation will be calculated by the EMA.
Where a marketing authorisation is withdrawn, revoked or not renewed, the former marketing authorisation holder is encouraged to continue to collect spontaneous reports of suspected adverse reactions occurring in the EU see GVP Module VI to, for example, facilitate review of delayed onset adverse reactions or of retrospectively notified cases of adverse reactions.
If amendments are requested by the Agency as a result of the validation, updated documentation should also be submitted to the MSs. The EURD list is a living document, meaning that it can be amended whenever considered necessary by the PRACCHMP or CMDh in response to the emergence of relevant new safety information, newly authorised substances or requests from the marketing authorisation holders.
Where applicable, revised product information Annexes including Annex A, if applicable should be included in electronic Word and PDF format in the same eSubmission Gateway or eSubmission Web Client package within a folder called ‘working documents’. Reference SME declaration Data submission for authorised medicines. An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency.
Heads of Medicines Agencies: Renewal
For more information on the EURD list and answers to frequently-asked-questions, see the following document: MAHs should contact the relevant Risk Management Specialist in case of such requests if there is a need for initial clarification on the process.
In case of incomplete or incorrect data in the web form, the request may not be processed. Worksharing procedures for type-IB variations At submission day 0: The total of chargeable units in the procedure will be identified from the Art.
The agreed changes should be included in the annexes of any subsequent regulatory procedures. Clean versions should have all changes ‘accepted’. For the submission of responses to the PSUR Repository, the xml delivery file is filled in the same way as the original PSUR submission apart from the selection of ‘response’ as a regulatory activity submission unit.
The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure. Marketing authorisation holders are not required to systematically include listings of individual cases, including case narratives, in the PSUR. By analogy to the implementation of referral procedures, the respective variations for the NAPs have to be submitted to the relevant NCA within 10 days after publication of the Commission Decision on the EC website.
Only one centrally authorised medicinal product will undergo a linguistic check.