The MAH s will implement the required changes. 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. Paper submissions are not accepted. For groupings where MAs were granted through a national procedure only, you will need to apply for grouped changes through that respective member state. 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. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
They, however, remain part of the Commission Decision in the Community Registry on the Commission’s webpage. Home Health and social care Medicines, medical devices Marketing authorisations, variations and licensing guidance. A new procedure code abbreviation is used for worksharing procedures i. There may be some delay before EMA is able to respond due to the high volume of requests and necessary processing time. The parallel importer should also inform the MAH immediately. In such case, only the amended parts of the SmPC and package leaflet should be provided in track changes and in English language under the EU regional appendix. 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: Variations
Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented. However PSURs should be submitted as specified templaet the conditions vwriation the marketing authorisation for the combination product if anyor otherwise according to the standard submission cycle i.
For more information, see the questions-and-answers below and Periodic safety update report single assessments. If you have multiple products granted by Spain, for example, you would need to cmdhh for grouped changes through their competent authority. Subsequently, where the procedure includes at least one CAP, the Commission will adopt a decision to the MAHs for the centrally authorised products and, as applicable, to the competent authorities of the Member States for nationally authorised products.
The outcome of the PSUR assessment results in a legally binding decision or CMDh position and any action to vary, suspend or revoke the marketing authorisations must be implemented in a harmonised and timely manner for all products within the scope of the procedure across the EU.
The grounds for the re-examination request must be forwarded to the Agency within 60 days of receipt of the opinion. The MAH must submit the variation application for worksharing at the latest by the recommended submission dates published under submission templat. This affects all PSURs irrespective whether they are for centrally or nationally authorised medicinal products and whether they follow the EU single assessment or purely national PSUR procedure. Also see ‘when do I have to submit revised product information?
Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’. Where a marketing authorisation is withdrawn, coger 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.
An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency. Explore the topic Marketing authorisations, variations and licensing guidance. Decision-making process for centrally authorised medicinal products.
Heads of Medicines Agencies: Applications for MA
Upon cmfh of the letter of intent, the Product Lead if the worksharing procedure contains at least one Type II variation will review and decide whether the proposed worksharing procedure is acceptable. 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: The same general principles as for grouped variations applies.
Skip to main content. The response from the Agency on the acceptability of the worksharing application, further to the submission of the letter of intent should be attached to the application form. This means that the MAH may give written notice to the Agency or CHMP that it wishes to request a re-examination within 15 days of receipt of the cmh after which, if it does not appeal, the opinion will be considered final.
For nationally authorised products NAPsplease submit your query using the following web form. This will apply to all procedure types, including national procedures.
Applications for Marketing Authorisation
Based on the evaluation of the cumulative safety data and the risk-benefit analysis, the marketing authorisation holder shall draw conclusions in fover PSUR as to the need for changes to the product information of the products covered by the PSUR.
A new procedure code abbreviation is used for worksharing procedures i. The changes related to the use of ‘submission type’ and the new ‘submission unit type’ will be introduced to the PSUR repository tempplate the next release of the PSUR Repository currently planned for July In such case, only the amended parts of the Temp,ate and package leaflet should be provided in track changes and in English language under the EU regional appendix.
You can see details of this in the annex of the EU guidelines. Annex I scientific conclusions and grounds for variation to the terms of the marketing authorisations Annex II amendments to the product information of the nationally authorised medicinal products Annex III conditions to the marketing authorisationsas applicable Procedures that contain nationally authorised products NAP s Annex C: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.
The details of the applicant where the invoice should be sent to should be clearly stated in the cover letter. You should type the full details of your query in the appropriate space.
The MAH is expected to provide, as applicable, by Day They shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase.
A formal letter with the worksharing applicant and contact person for the worksharing procedure should be provided with the worksharing application.