The timelines for assessment are for up to days followed by 67 days of Commission decision making process if applicable. 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. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. The list will then be amended accordingly when appropriate and published on the European medicines website. For all worksharing procedures, including those which contain nationally authorised medicinal products , the ‘high-level’ procedure number should be systematically obtained from the Agency shortly before submission by sending your request with a letter of intent to: 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. Leave this field blank.
In order to avoid duplication of work in the evaluation of such variations , a worksharing procedure has been established under which one authority the ‘reference authority’ , chosen amongst the competent authorities of the Member States and the Agency, will examine the variation on behalf of the other concerned authorities. It is the responsibility of the marketing authorisation holder to check regularly the list of EU reference dates and frequency of submission published in the European medicines web-portal to ensure compliance with the PSUR reporting requirements for their medicinal products. Worksharing procedure for type-II variations At submission day 0: The worksharing application must be submitted at the same time to all relevant authorities, i. The changes proposed to the labelling can be based on the reference product information. The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation. The submission requirements for responses to requests for supplementary information are the same as those for the submission of the PSURs.
If the above does not apply, the updated RMP should be submitted as a stand-alone variation. Worksharing procedures for type-IB variations At submission templatte 0: A new procedure code abbreviation is used for worksharing procedures i. Introduction or changes to the pharmacovigilance system. 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 involved in the procedure.
Upon finalisation of the review of the variations subject to the worksharing procedure, the Agency will issue an opinion reflecting the final outcome of the procedure. Skip to main content. Examples of changes which would be considered suitable for evaluation under worksharing:. In this communication the MAH should indicate whether they would wish to make use of the opportunity of an oral explanation to ,etter their position before the PRAC.
An agreement on the procedural details of the PSUR submission should be reached between the marketing authorisation holder and the Agency. The QRD convention should be followed. Timeframe for submission of variation. Where the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly.
One completed electronic EU variation application form, listing all medicinal products concerned and declaring all variations included in the group in the section ‘type of changes’, as well as a justification for the letrer worksharing and grouping if applicable in the ‘precise scope and background’ section of the application form.
From 1 Marchthe use of the eSubmission Gateway or web client is mandatory for all electronic Common Technical Document eCTD submissions through the centralised procedure. 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 authorisationsauthorised in more than one Member State.
The Agency aims to respond to your query within 5 working days. 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.
Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisationthe Commission shall amend the marketing authorisation for each centrally authorised medicinal product to reflect the approved variations within two months, for the variations listed under Article 23 1a a or within one year for the other variations.
Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised medicinal products: This can result in having to submit a large number of sets of tracked change product information with the additional burden of providing translations.
The request and its grounds should be considered by the PRAC and the CHMP if it concerns at least one marketing authorisation granted in accordance with the centralised procedure or the CMDh otherwise, which will either approve or deny the request.
For civer full overview of dossier requirements for National Competent Authorities of Co- Rapporteur and Committee members, including delivery addresses, please refer to the following document: For more information on the EURD list and answers to frequently-asked-questions, see the following document:.
Submission to the Rapporteur and Committee members. The parallel importer should also inform the MAH immediately. For more information on GVP modules, see Good pharmacovigilance practices.
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 CMDh position by consensus: Within the PSUR, the marketing authorisation holder is required to consider the impact of the data and evaluations presented within the report, on the marketing authorisation. It is the responsibility of the marketing authorisation holder to check regularly the list of EU reference dates and frequency of submission published cmvh the European medicines web-portal to ensure compliance with the PSUR reporting requirements for their medicinal products.
PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of reneqal medicinal product at defined time points after its authorisation. In case of comments, it will be up to the MAH to correctly implement the same amendments in the other centrally authorised productsas appropriate. Marketing authorisation holders are not required to systematically include listings of individual cases, including case narratives, in the PSUR.
Heads of Medicines Agencies: Variations
However, the parallel importer will not become party ocver the PSUR procedure and will not receive a copy of the assessment report and outcome documentation as a MAH would. For nationally authorised medicinal products i. Such opinions will also list any variations e.