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. The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e. If a translation is considered not to be of an acceptable quality, the Member State concerned will inform the MAH and the Agency within 3 days of receipt of the translation. Only the worksharing applicant will be invoiced for the worksharing procedure. They shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase.
Applicants belonging to the same mother company or group of companies and applicants having concluded agreements or exercising concerted practices concerning the placing on the market of the medicinal products concerned, have to be taken as ‘the same MAH’ 1. Disagreements should be solved directly with the concerned MS. In such cases, and in cases where any other ongoing procedures may affect the product information annexes, the MAH is advised to contact the Agency in advance of submission or finalisation of the procedure concerned. For more information on the EURD list and answers to frequently-asked-questions, see the following document:. The EMA will check at the beginning of the procedure whether the submission of an RMP has been correctly performed in accordance to the above criteria. The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission.
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: Submission and assessment is expected to take place at national level and, as necessary, be coordinated across the Member States.
Quality Changes to the active-substance master tenplate.
Heads of Medicines Agencies: Renewals
View all 15 ratings. However PSURs should be submitted as specified in the conditions of the marketing authorisation for the combination product if anyor otherwise according to the standard submission cycle i. It should be noted that the responsibility for the quality of the submitted documentation lies with the MAH s and is crucial to the overall assessment. For more information on GVP modules, renedal Good pharmacovigilance practices. This will allow the Agency and the national competent authorities to update the dossier of each marketing authorisation included in the worksharing procedure with the relevant amended or new information.
The same general principles as for grouped variations applies. If the data contained in the PSUR contribute meaningfully to the scientific assessment, these data should be included letger the scope of the PSUR procedure. For CAPs outside the procedure e.
A shorter presubmission phase is envisaged in cases where: Such information and data will not be redacted from the single assessment report with respect to individual products prior to sharing them with all concerned MAHs. For generic products or others not directly involved in the PSUSA procedure itself, renewao changes have to be submitted via a variation procedure according to the timelines indicated in the table below.
The Agency will monitor the quality of the translations, temolate review by the Member States and industry’s compliance with the Member States’ comments as part of the Performance Indicators.
Worksharing: questions and answers
Supporting covdr for each product including the revised summary of product characteristicslabelling and package leafletif applicable. The changes related to the use of ‘submission type’ and the new ‘submission unit type’ will be introduced to the PSUR repository in the next release of the PSUR Repository currently planned for July All EU languages including Norwegian and Icelandic: Renewap on the evaluation of the cumulative safety data and the risk-benefit analysis, the marketing authorisation holder shall draw conclusions in the PSUR as to the need for changes to the product information of the products covered by the PSUR.
Following an expression of interest cove based on a rota system, the Chair of the Committee for Medicinal Products for Human Use CHMP will appoint a rapporteur and co-rapporteur when the application ernewal a new indication for the procedure. Unless otherwise requested by competent authorities, the marketing authorisation holder shall prepare a single PSUR for all its medicinal products containing the same active substance with information covering all the authorised indicationsroute of administrationdosage forms and dosing regiments, irrespective of whether authorised under different names and through separate procedures.
Applications for Marketing Authorisation
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 no changes to the product information are being proposed as part of the PSUR, the MAH should not include any product information within the EU regional appendix. How useful was this page?
If nationally petter medicinal products are part of the worksharing procedure, the MAH should also include a confirmation that reneqal worksharing applications have been submitted to all Member States where the products concerned are authorised twmplate that the relevant national fees have been paid.
If a translation is considered not to be of an acceptable quality, the Member State concerned will inform the MAH and the Agency within 3 days of receipt of the translation.
Heads of Medicines Agencies: Variations
After the translation process Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented. The share payable by each marketing authorisation will be calculated by the EMA. For translations of Annexes QRD templates for each language should be used Make sure that the title pages are adjusted and all brackets i. Procedures that contain templste authorised products CAP s.
The contact information provided in the xml delivery file will always override any information provided in the cover letter. Annex I – Definitions. Guideline on good pharmacovigilance practices GVP: Whilst changes become binding 6 months after publication, there might exceptionally be situations where PSUR submissions rrenewal necessary prior to the new frequency taking effect and this will be indicated in the EURD list as well.
Please refer to the guideline on the processing of renewals in the centralised procedure.