Variation cover letter ema

UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. You can change your cookie settings at any time. For the purposes of operating the Sunset Clause in accordance with regulation 67 Human Medicines Regulations as amended , the period of three years during which the product has not been marketed in Great Britain will be restarted from the date of conversion to a Great Britain MA. In most cases this means that fewer UK MA numbers will be needed in comparison with the number of European Commission authorisations because all pack sizes for a presentation will be covered by a single MA number. If the MAH chooses to opt-out, their product s will no longer be licensed and must not be marketed in Great Britain.
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New variations regulation: Regulatory and procedural guidance

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Updated formatted table template for dossier submission available | European Medicines Agency

From 1 January , the electronic Common Technical Document eCTD is the only acceptable electronic format for all applications and all submission types in the context of the centralised procedure. These include new applications, supplementary information, variations , renewals , follow up measures FUMs , periodic safety update reports PSURs for centralised authorised products, Notifications etc. There is no obligation to submit a full, reformatted eCTD for already authorised products. However, if marketing authorisation holders wish, they may provide EMA with information reformatted as eCTD for their already authorised products. In particular, EMA would encourage the submission of reformatted quality information in eCTD, in order to facilitate the handling of variations and line extensions.
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Medicines: apply for a variation to your marketing authorisation

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Human eSubmission eCTD v3. Industry access. Paediatric submissions.
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