For nationally authorised products , interim results, if requested, need to be submitted to the relevant competent authority unless specified otherwise. For nationally authorised medicinal products i. Periodic safety update reports PSURs. The procedural start dates is published in the PSUR assessment timetable. 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. 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.
However as the reference product information might be different for the various EU product information , it 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. Based on Articles 7 and 20 of the Variations Regulation, when a group of variations only consists of type-IA or -IA IN variations affecting several marketing authorisations , this is considered as a ‘group’ of variations and not a ‘ worksharing ‘ procedure. Since January it has become mandatory for new marketing authorisation, renewal and variation application submissions to be made using electronic application forms eAFs. Product information includes the summary of product characteristics, leaflets and labels. This will allow the Agency and the national competent authorities to update the dossier of each marketing authorisation included in the worksharing procedure with the relevant amended or new information. Depending on the date of the EC decision on the revocation or withdrawal, or the date of expiry of the marketing authorization in case of non- renewal , marketing authorisation holders may still be required to submit a PSUR:. 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.
Worksharing: questions and answers | European Medicines Agency
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. Schematic structure of the CHMP opinion and annexes for an application under worksharingconsisting of centrally and nationally authorised medicinal products: Once MHRA has all the necessary documents, it takes up to 30 days to process your initial application.
Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’ The submission of a formal letter of intent is not required, however applicants are advised to request a WS number from PA-BUS ema.
If relevant, the summary of product characteristic fragments SPC should be submitted to MHRA in the correct format using the templates below. Submission requirements and EU reference dates: A template cover letter for worksharing procedures including centrally authorised products and nationally authorised products only is available.
Guideline on good pharmacovigilance practices GVP: Where relevant, data relating to a particular indicationdosage form, and route of administration or dosing regimen, shall be presented in a separate section of the PSUR and any safety concerns shall be addressed accordingly. If you are making a submission using the portal, you will have to submit using the portal forms as well as submitting the eAF.
The worksharing application must be submitted at the same time to all relevant authorities, i. The parallel importer should also inform the MAH immediately. Do not leave sections out, do not update the Annex III, e. National competent authorities can also request PSUR for generic medicinal products at any time on the grounds detailed in Article c 2 of the Directive. A shorter presubmission phase is envisaged in cases where: However, the parallel importer will not become party to the PSUR procedure and will not receive a copy of the assessment report and outcome documentation as a MAH would.
For example, you can make a change to the manufacturing site of the finished product, change in batch size and the manufacturing process to 1 product. Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: If the implementation period passes 12 months without a variation being made, a default Type 1B should be submitted.
A PDF version of the entire post-authorisation guidance is available: Based on the evaluation of the cumulative safety data and the risk-benefit analysis, the marketing authorisation holder shall draw conclusions in the PSUR as to the need for changes to the product information of the products covered by the PSUR.
Heads of Medicines Agencies: Variation
Worksharing procedures for type-IB variations. 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. A single decision will be issued for each centrally authorised medicinal product. Find out more about cookies or hide this message.
Decision-making process for centrally authorised medicinal products Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisation vraiation, the 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 templaye within one year for the other variations.
The submission requirements for responses to requests for supplementary information are the same as those for the submission of the PSURs.
Applications for Marketing Authorisation
Procedures that contain centrally authorised products CAP s. No specific template needs to be followed for the responses to the request for supplementary information RSI. A full fees list and further information about fees, can be found in the section fees for licence variation applications.
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. Cmxh 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 of the translation.
The contact information provided in the xml delivery file will always override any information provided in the cover letter. 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.
Standards of translation of Annexes The structure of the English Annexes has to be strictly followed and should be exactly translated as per the adopted English version i.