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 authorisations , as applicable Procedures that contain nationally authorised products NAP s Annex C: For translations of Annexes QRD templates for each language should be used Make sure that the title pages are adjusted and all brackets i. CMDh best practic guide Purely nationally authorised medicinal products are considered those which contain substances or a combination of actives substances which are only authorised in one Member State. 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. 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.
The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product. 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. Annex I – Definitions. For more information on GVP modules, see Good pharmacovigilance practices. Start of the procedure according to the published timetable. The 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 authorisations , authorised in more than one Member State.
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.
For centrally authorised products interim results not impacting on the product information or on the condition as stated in the Annex II of the marketing authorisation can be submitted as a post-authorisation measure PAM as described in question How and to whom shall I lettef my PAM data see Post-authorisation measures: For generic products or others not directly involved in the PSUSA procedure itself, the changes have to be submitted via a variation procedure according to the timelines indicated in the table below.
This should be clearly discussed in both the conclusions and actions section of the body of the PSUR as well as in the EU regional appendix. The fee will be due to the EMA within 30 calendar days from the date of the invoice. The Agency uses this information to support the analysis of data, regulatory activities and communication. Before submitting covet request, EMA encourages stakeholders to carefully consult the Letter cover note.
For more information on how to use the PSUR repository, see: MAHs should translate all relevant Annexes for each procedure. CMDh best practic guide Purely nationally authorised medicinal products are considered those which contain substances or a combination of actives substances which are only authorised in one Member State.
The European Union reference date EURD corresponds to the date of the first or the earliest known date of the marketing authorisation in the EU of a medicinal product containing the active substance or combination of active substances.
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.
In cases renwal the wording has to be adapted, a type IB under category C. MAHs should contact the relevant Risk Management Specialist in case of such requests if there is a need for initial clarification on the process. The MAH s will implement the required changes. In the absence of a reply within two days, the EMA will assume that no oral lefter is requested. 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.
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 cmh the translation. 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.
In case of a 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.
In the latter case, a justification should be provided for the appropriate language s stating why certain comments are not reflected in the final texts. Day days after cmdn The MAH s will implement the required changes. This format is a legal requirement for both coover authorised products and centrally authorised products.
For more details on PSUR submissions for generics, products 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 cmxh substance, a homeopathic or herbal medicinal product?
Following receipt of the final compiled translations, the Commission will start the day Standing Committee consultation, addressing only legal and public health matters which means in principle no further linguistic review. Day 15 15 days after the position: Periodic safety update reports PSURs.
The PSUR frequency as published on the EURD list for a given active substance or combination of active substances overrules the standard submission cycle i. This aims to harmonise and strengthen benefit-risk review of medicines across covver European Economic Area.
Procedures that contain nationally authorised products NAP s. Within the PSUR, the marketing cmvh holder is required to consider the impact of the data and evaluations presented within the report, on the marketing authorisation. 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 coger in the procedure.
The MAH of centrally authorised medicinal products should submit a clean rrnewal a tracked version of the agreed amended product information prior to the adoption of the PRAC recommendation. In this communication the MAH should indicate whether they would wish to make use of the opportunity of an oral explanation to defend their position before the PRAC.
Heads of Medicines Agencies: Renewal
In the absence of a reply within lettsr 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.
The Agency will inform the MAH of the insufficient quality of the cmdy and the transmission to the Commission will be delayed until receipt of the amended translation which would be expected within 1 week. Guideline on good pharmacovigilance practices GVP: