This portal replaces the following mailboxes gatewaysupport ema. Any amendment to the EURD list becomes effective six months after its publication. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. 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. They, however, remain part of the Commission Decision in the Community Registry on the Commission’s webpage. A revised timetable will then be prepared.
PSURs of centrally authorised product s ; PSURs of any mix of centrally authorised products and nationally authorised products including through the mutual recognition and decentralised procedures ; PSURs of nationally authorised products. For translations of Annexes QRD templates for each language should be used Make sure that the title pages are adjusted and all brackets i. Submission and assessment is expected to take place at national level and, as necessary, be coordinated across the Member States. For nationally authorised medicinal products i. The changes proposed to the labelling can be based on the reference product information. Start of the procedure according to the published timetable. 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.
However as the reference product information might be different for the various EU product informationit is essential that the MAH considers the proposed changes for the reference product information in the context of the different EU product information for the products covered by the submitted PSUR.
PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. At start of the procedure, the invoice will be sent to each MAH with the relevant chargeable units dmdh. The timelines for assessment are for up to days followed by 67 days of Commission decision making process if applicable.
MAHs or national competent authorities can request the inclusion of the fixed combination letfer the EURD list for reasons related to public health, in order to avoid duplication of assessment or in order to achieve international harmonisation. This portal improves the renfwal of the technical support by allowing users to report issues, track progress of their queries and obtain answers to frequently asked questions.
This deadline is legally binding and must be adhered to.
Day 1 — 14 1 to 14 days after position: An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency.
It addresses specific challenges in the EU single assessment procedure for nationally authorised productsbut the issues may also apply to centrally authorised products: Where a marketing authorisation is withdrawn, revoked or not renewed, the former marketing authorisation holder is encouraged to continue to collect spontaneous reports clver 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.
Lettter EURD list facilitates the harmonisation of DLPs and frequency of submission of PSURs for medicinal products containing the same active substance or the same combination of active substances subject to different marketing authorisationsauthorised in more than one Member State. The explanatory note will form the basis of the upcoming revision of GPV VII; this update, once finalised, will therefore supersede this guidance document.
By analogy to the implementation of referral procedures, the respective variations for the NAPs have to be submitted to the relevant Lettre within 10 days after publication of the Commission Decision on the EC website.
Where cmfh proposed changes are not based on the data submitted within the PSUR, these will not be considered and a variation will have to be submitted as appropriate to the relevant national competent authority.
Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. In case of cmdhh CMDh position by consensusthe Agency will compile the Annexes in all languages, send the final copies to the Member States and, where applicable, the full set of Annexes will be published on the EMA website. Day days after position The MAH s will implement the required changes.
Heads of Medicines Agencies: Renewal
You should type the full details of your query in the appropriate space. The submission should include a cover letter containing the following formatted table template cmddh facilitate the registration of the submission. PSURs of centrally authorised product s ; PSURs of any mix of centrally authorised products and nationally authorised products including renewap the mutual recognition and decentralised procedures ; PSURs of nationally authorised products.
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 Renewzl III conditions to the marketing authorisationsas applicable Procedures that contain nationally authorised products NAP s Annex C: Expand section Collapse section.
For more details on PSUR submissions for generics, renedal containing well-established substances, homeopathic or herbal medicinal productsplease refer to the question Do I have to submit a PSUR my medicinal product if it is a generic, a product containing a well-established substance, a homeopathic or herbal medicinal product?
Amendments to the SmPC, labelling and package leaflet as a result of the PSUR assessment are implemented ccover subsequent variation submission for centrally authorised products and through the appropriate variation at national level for nationally authorised products including those authorised through the mutual recognition and decentralised procedures.
For CMDh position by majority vote: The MAH s will implement renewa, required renrwal. It should be presented as a tracked change version of each EU SmPCs and package leaflets of the products concerned and each product information should be translated into English language including the tracked changes proposed, in order to enable the EU single assessment. Start of the procedure according to the published timetable. The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation.
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. PSURs and any related submissions using the existing file naming conventions are no longer possible. They shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase. It is important that changes proposed to the product information which are cober on the submitted PSUR data are not submitted in parallel via a separate variation procedure.
In case of CMDh position by consensus, Member Dmdh may perform a voluntary linguistic review in the translation process, therefore the following timelines apply:. Information on the outcome of centrally authorised medicinal products is made available in the European Public Assessment Report EPAR page of the relevant medicine.