In order to facilitate the planning of a worksharing procedure, MAHs are advised to inform the Agency at least two months in advance of the submission of a variation or group of variations to be subject to a worksharing procedure, together with an explanation as to why the holder believes that a worksharing procedure is suitable, by means of a ‘letter of intent’. In case of CMDh position by consensus, Member States may perform a voluntary linguistic review in the translation process, therefore the following timelines apply: For more information on the EURD list and answers to frequently-asked-questions, see the following document:. Alternatively, such a listing may be provided as a separate document attached to the application form. Minor changes are either type 1A or 1B.
Guideline on good pharmacovigilance practices GVP: An automated acknowledgement email is sent from the system confirming whether the submission has passed the relevant technical validation criteria and whether it has been uploaded to the Agency’s review tool and made available via the Common Repository. Before submitting a request, EMA encourages stakeholders to carefully consult the Introductory cover note. 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. At start of the procedure, the invoice will be sent to each MAH with the relevant chargeable units calculation. The MHRA will take up to 30 days to process your application.
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. The submission requirements as set out in the post-authorisation-guidance sections for the different types of variations will also apply to variations subject to worksharingbut the application should be provided as one integrated submission package electronic-common-technical-document [eCTD] sequence per product, covering all vmdh applied for.
One original cover letter addressed to the Agency and national competent authorities, if nationally authorised medicinal products are part of the worksharing procedure, clearly indicating that the application is submitted for a worksharing procedure together with a short overview of all medicinal products concerned, with their respective rapporteursRMSs and national competent authorities, as applicable, as well as an overview of the submission format for the different products, if applicable e.
PSURs of centrally authorised product s ; Gariation of any mix of centrally authorised products and nationally authorised products including through the mutual recognition and decentralised procedures ; PSURs of nationally authorised products. View all ratings. For variations that affect annex A e.
Periodic safety update reports (PSURs) | European Medicines Agency
The contact information provided in the xml delivery file will always override any information provided in the cover letter. The total of chargeable units in the procedure will be identified from the Art. Send a dispatch date list detailing when you intend to dispatch the products to all member states before submitting your application if your MA was granted through the mutual recognition or decentralised procedures. Applicants must not send any accompanying hard media or separate paper cover letter as the cover letter will be in the relevant part of eCTD module 1 in PDF format.
Worksharing: questions and answers | European Medicines Agency
If the variations subject to worksharing affects coveg summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows: For more information on GVP modules, see Good pharmacovigilance practices. Use this form to work out what the cove for your variation submission will be.
Coveer MAH s will implement the required changes. For queries relating to the presentation of the application, please contact the Agency. Day 1 — 14 variztion to 14 days after position: Templats recommend that you use a validation tool to check your submission. Type-II variations listed in Article 23 1a a may only be implemented once the Commission has amended the marketing authorisation and has notified the MAH accordingly.
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.
In case the PRAC recommends any regulatory action i. If you do not use these templates your submission will be rejected. Type-IB variations approved via a worksharing procedure may be implemented upon receipt of the favourable CHMP opinion.
The Agency aims to respond to your query within 5 working days. Guideline on good pharmacovigilance practices GVP: Skip to main content. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments in the texts e.
Variations related to safety issues, cmvh urgent safety restrictionsmust be implemented within a timeframe agreed by the marketing authorisation holder and the Agency. The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure. 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.
Periodic safety update reports (PSURs)
For such procedures, a linguistic review will take place in parallel to the scientific assessment. Extensions Although extensions are still considered a type of variation, their impact on a product is so significant that you will need to follow the application process to apply for a new MA. If the data contained in the PSUR contribute meaningfully to the scientific assessment, these data should be included in the scope of the PSUR procedure.
Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’. If the contact details you provide are incomplete or inaccurate this may ccmdh the Agency from communicating with you.
If considered necessary, an oral explanation can be held within this day timeframe. Such opinions will also list any variations e.
Following receipt of the final compiled translations, the Commission will start the day Standing Committee consultation, addressing only legal and public coverr matters which means in principle no further linguistic review.