In principle, identical modules will have to be provided for each product included in the worksharing. There is a day deadline to respond to a NWG otherwise the variation will be withdrawn or refused, this also applies if only a partial response has been received by the day deadline. 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. Applicants are strongly advised to use the pre-submission checklist below which will reduce the likelihood of the submitted application being invalidated or rejected. Variations related to safety issues, including urgent safety restrictions , must be implemented within a timeframe agreed by the marketing authorisation holder and the Agency. The Quality Review of Documents QRD linguistic check will be performed on one set of annexes of one centrally authorised medicinal product.
If you have multiple products granted by Spain, for example, you would need to apply for grouped changes through their competent authority. Highlighted changes should be indicated via ‘Tools — Track changes’. In the web form you will be asked to provide your name, the name of your employer or organisation, contact details and the subject of your enquiry. 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. Since January it has become mandatory for new marketing authorisation, renewal and variation application submissions to be made using electronic application forms eAFs. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. It is important that changes proposed to the product information which are based on the submitted PSUR data are not submitted in parallel via a separate variation procedure.
Composite coordination collection CCC – national pilot scheme If you want to apply for changes to one or more product licences licence for vagiation product under a marketing authorisation that would affect the product information you can submit a composite coordination collection CCC.
Unless otherwise requested by competent authorities, vraiation marketing authorisation holder shall prepare a single PSUR for all its medicinal products containing the same active substance with information covering all the authorised indicationsroute of administrationdosage forms and dosing regiments, irrespective of whether authorised under different names and through separate procedures. You can see details of this in the annex of the EU guidelines.
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Periodic safety update reports (PSURs)
Use this form to work out what the fee for your CCC submission will be. It should be either a:. For nationally authorised medicinal products i. Additionally, product information should be kept up-to-date by the MAH by submitting the appropriate variations taking account of the latest scientific knowledge or conclusions of assessments and recommendations made civer by cmrh of the EMA and national competent authority websites. 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 well-established substance, a homeopathic or herbal medicinal product?
See the list of fees.
Heads of Medicines Agencies: Variation
National competent authorities can also request PSUR for generic medicinal products at any tempate on the grounds detailed in Article c 2 of the Directive. The worksharing application must be submitted at the same time to all relevant authorities, i. You will need to include this in your application form. The QRD convention should be followed.
The list overrules the ‘standard’ PSUR submission cycle and any conditions related to the frequency of PSUR submission included lettter a marketing authorisation. Start of the procedure according to the published timetable. 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.
This will apply to all procedure types, including variarion procedures. The frequency of submission shall be in accordance with the conditions specified in the marketing authorisation MAor otherwise according to the standard submission schedule of PSURs i.
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 variiation for a new MA.
Only one centrally authorised medicinal product will undergo a linguistic check. Proposals for worksharing applications should be sent to: Type IA changes have little or dover impact on the quality, safety or efficacy of the product, for example administrative modifications such as:.
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. Thank you for your feedback. You can apply for: This can result in having to submit a large number of sets of tracked change product information tempate the additional burden of providing translations.
Periodic safety update reports (PSURs) | European Medicines Agency
Such opinions will also list any variations e. 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 covee mutual cmdb or decentralised temmplate. Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised medicinal products: Once MHRA have all the necessary documents, it will usually take 60 days to assess applications although it could take up to days if the variation s are more complex or up to 30 days if urgent.
Submission requirements and EU reference dates: