COVER LETTER CMDH VARIATION

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’. Submission to the National Competent Authorities Where nationally authorised medicinal products are part of the worksharing , the same application as submitted to the Agency should be submitted to all Member States, even if some products are not relevant to some MSs. 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 , 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 or within one year for the other variations. Revised topics are marked ‘New’ or ‘Rev. 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. Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’. Introduction or changes to the pharmacovigilance system.

All EU languages including Norwegian and Icelandic: A PDF version of the entire post-authorisation guidance is available: Upon receipt of the final opinion, the Member States concerned shall approve the final opinion, inform the Agency accordingly and where necessary, amend the national marketing authorisations within 60 days. Extensions are excluded from worksharing. Annex B includes information on the nationally authorised medicinal products included in the worksharing application if applicable. A formal letter with the worksharing applicant and contact person for the worksharing procedure should be provided with the worksharing application. Additional examples will be regularly included to reflect accumulated experience.

In the cases where the changes to the product information may vary between products, the product with the most complex changes will generally be the one subject to linguistic check. If the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows: Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.

  ESSAY KRITIKAN TERHADAP PEMIMPIN BANGSA DARI ASPEK MORALITAS DAN RELIGIUSITAS

Decision-making process for centrally authorised medicinal products Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisationthe 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 or within one year for the other variations.

variattion

cover letter cmdh variation

Such applications may be required letter the product in letter compliance with the details of the marketing authorisation cannot be sourced for a short, defined period of cmdh maximum of 6 months.

The letter of intent should provide the following information: However, in exceptional cases non-critical deviations may be considered on a case-by-case variation. Only the worksharing applicant will be invoiced for the worksharing procedure.

If the variations subject to worksharing affects the summary of product characteristics SmPClabelling or package leafletthe revised product information annexes must be submitted as follows:.

Heads of Medicines Agencies: Variations

The request to bring the batch into compliance with the marketing authorisation can be submitted using the appropriate application form. If nationally authorised medical products are part of the worksharing procedure, relevant product and Member State cndh should be provided as annex B to the application form using the template for annex B.

A PDF version of the entire post-authorisation guidance is available: Extensions are excluded from worksharing. Worksharing procedure for multiple centrally authorised medicinal products ‘duplicates’. Upon receipt of the letter of intent, the Product Lead if the worksharing procedure contains at least one Type II variation will review and decide whether the proposed worksharing procedure is acceptable.

Vvariation submission types e. Where the outcome of the procedure is favourable and the Commission decision granting the marketing authorisation requires amendments, the Agency will inform the Commission accordingly. How useful was this page? National variations submitted with the relevant approval from another Member State, may be implemented immediately variation submission of vraiation variation application.

Clean PDF versions should have all changes ‘accepted’.

New variations regulation: Regulatory and procedural guidance

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 variations applied for.

  GRAMSCI LYONS THESIS

Worksharing procedures for type-IB variations. This excludes letters to change legal classification prescription status.

The Agency applies the existing post-opinion timeframes, as set-out in the linguistic review process of product information in the centralised procedure — human.

cover letter cmdh variation

Any co-packed component, as for example a variation device, should also be provided. Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:. This applies to all applications for human medicines. Revised topics are marked ‘New’ or ‘Rev. Upon receipt of a favourable CHMP opinion that requires amendments to the decision granting the marketing authorisationthe 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 or within one year for the other variations.

When submitting the full set of annexes in PDF format, this should be accompanied by the completed formatting checklist and following the user guide on how to generate PDF versions of the product information – human.

cover letter cmdh variation

Avoid submitting documents in several different formats, variatoin they are cmdh called working documents which should be submitted in MS Word in a separate folder.

Icelandic and Norwegian language versions must always be included. In order to benefit from a worksharing procedure, it is required that the same changes will apply to the different medicinal products concerned, with either no or limited need for assessment of a potential product-specific impact.

Applications for Marketing Authorisation

The box containing the Cover Letter should cmdh easily identified. 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.

A formal letter with the worksharing applicant and contact person for the worksharing procedure should be provided with the worksharing application.