You can see details of this in the annex of the EU guidelines. A letter of intent template is available. Introduction or changes to the pharmacovigilance system. All the other variations will follow a yearly timeframe for update of the respective Commission decision. If your variation eg change of manufacturer affects details of the labels, leaflets and or packaging also known as livery of the product, you will need to include the updated versions with your submission to be assessed.
Applications for Marketing Authorisation
Reference SME declaration Data submission for authorised medicines. In principle, identical modules will have to be provided for each product included in the worksharing. The changes proposed to the labelling can be based on the reference product information. Where relevant, data relating to a particular indicationdosage form, and route of administration or dosing regimen, shall be presented in a separate section of the PSUR and any safety concerns shall be addressed accordingly.
Quality Changes to the active-substance master file. The MAHs of such medicinal products should use alternative mechanisms such as signal management and emerging safety issues channels to communicate relevant new safety information to regulatory authorities see GVP Module VI and Module IX. Proposal for combination use affecting both MAs.
In the absence of a reply within two days, the EMA will assume that no oral explanation is requested The MAH of centrally authorised medicinal products should submit a clean and a tracked version of the agreed amended product information prior to the adoption of the PRAC recommendation.
See grouping of variations: For nationally authorised medicinal products eCTD strongly recommened. Worksharing procedure for type-II variations At submission day 0: The official contact person for the PSUR procedure is the one provided in the xml delivery file.
Subsequently, the Agency will initiate the Rapporteur appointment procedure.
This will, where appropriate, allow one single assessment of PSURs cofer products containing the same active substance. The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure.
Worksharing: questions and answers
An electronic copy containing the relevant eCTD sequence for each product, should be submitted to the Agency. You will need to include this in your application form. This deadline is legally binding and must be adhered to.
All the other variations will follow a yearly timeframe for update of the respective Commission decision.
If the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows:. You could be given a further 30 days to respond to letrer requests for information letter, which for Type IB are referred to as Notification with Grounds letters NWG.
The explanatory note highlights and addresses challenges specific to the Ckdh single assessment for nationally authorised products.
Heads of Medicines Agencies: Variations
Periodic safety update reports are pharmacovigilance documents intended to provide a safety update resulting in an evaluation of the impact of the reports on the risk-benefit balance of a medicinal product. Please note that late submissions can no longer be accepted once the procedure has started. Do not leave sections out, do not update the Annex III, e. Composite coordination collection CCC – national pilot scheme If you want to apply for changes to one or more product licences licence for each product under a marketing authorisation that would affect the product information you can submit a composite coordination collection CCC.
These templates should not be altered in any way, other than inserting the relevant information. For purely nationally authorised medicinal productscontaining substances or combination of actives substances not included in the EURD listfor which no PSUSA procedure has been established, the assessment of the PSURs will remain at national level.
Overview Variations are either: If nationally authorised medical products are part of the worksharing procedure, relevant product and Member State details should be provided as annex B to the application form using the template for annex B.
Periodic safety update reports (PSURs) | European Medicines Agency
The data presented in the submissions should be intended exclusively for the purposes of the concerned procedure. Periodic safety update reports PSURs. Worksharing procedure for type-II variations. It will take only 2 minutes to fill in.
Start of the procedure according to the published timetable. Day 15 15 days after the position: