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. 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. Implementing variation needed, type and classification. See annex 1 of the regulations for more information on extensions. After the translation process Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented.

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. For nationally authorised products NAPs , please submit your query using the following web form. Revised topics are marked ‘New’ or ‘Rev. For more details on PSUR submissions for generics, products containing well-established substances, homeopathic or herbal medicinal products , please 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? Use this form to work out what the fee for your variation submission will be. Quality Changes to the active-substance master file. Good quality of the translations and compliance with the Member States’ comments is required to facilitate the process.

Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. Unless otherwise requested by competent authorities, the 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 varation, irrespective of whether authorised under different names and through separate procedures.

Explore the topic Marketing authorisations, variations and licensing guidance. 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.

Heads of Medicines Agencies: Variations

The PSUR assessment under a PSUSA procedure is as follows, regardless whether it refers to one or more centrally authorised medicinal productsa mix of centrally authorised medicinal products and nationally authorised productsor nationally authorised products only. A template cover letter for worksharing procedures including centrally authorised products and nationally authorised products only vwriation available.

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If your variation eg change of manufacturer affects details of the labels, leaflets and or packaging also known as livery of the product, you will need to include the updated versions with your submission to be assessed.

cmdh variation cover letter template

This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application. For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and ttemplate. See annex 1 of the regulations for more c,dh on extensions. Periodic safety update reports PSURs. Examples of changes which would be considered suitable for evaluation under worksharing:.

cmdh variation cover letter template

A PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect public health e.

References The linguistic review process of product information in the centralised procedure — Human. Marketing-authorisation-updating process for nationally authorised medicinal products if applicable. In case of CMDh position by consensus, Member States may perform a voluntary linguistic review in the translation process, therefore the following timelines apply:. Refer to the eCTD variations question-and-answer document for guidance on the submission of variations in eCTD format.

Complete set of annexes of one CAP electronically only in Word format highlighted.

Worksharing: questions and answers

Once MHRA has all the necessary documents, it takes up to 30 days to process your initial application. If the change is more significant than a IA change but is not a type II change or an extension, it is considered a type IB change. 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.

The MAH of centrally authorised medicinal products should submit a clean and a tracked version of the agreed amended product information prior to fover adoption of the PRAC recommendation. Type IA changes have little or no impact on the quality, safety or efficacy of the product, for example administrative modifications such as:. Clean versions should have all changes ‘accepted’. The MAH s will implement the required changes. Marketing Authorisation Holders are advised to submit such variations as usual.


The Agency will allocate a ‘high-level’ cross-products procedure number, which will be used for the handling of worksharing procedures affecting more than one medicinal product.

The EMA has published further guidance on how the fees are calculated and teplate. For such procedures, a linguistic review will take place in parallel to the scientific assessment. 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 lftter 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’.

Heads of Medicines Agencies: Variation

However as the reference product information might be different for the various EU product informationit 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.

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.

You can submit grouped changes to an MA with multiple product licences under the European procedure. 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.

No specific template needs to be followed for the responses to the request for supplementary information RSI. For groupings where MAs were granted through a national procedure only, you will need to apply for grouped changes through that respective member state. It addresses specific challenges in the EU single assessment procedure for nationally authorised productsbut the issues may also apply to centrally authorised products:

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