In all other cases, a national competent authority chosen by the Coordination Group, taking into account the recommendation of the holder, will act as the ‘reference authority’. Clean PDF versions should have all changes ‘accepted’. Expand section Collapse section. Subsequently, the Agency will initiate the Rapporteur appointment procedure. This means that the MAH may give written notice to the Agency or CHMP that it wishes to request a re-examination within 15 days of receipt of the opinion after which, if it does not appeal, the opinion will be considered final. Further current information is available on the CMD h Web page:. The response from the Agency on the acceptability of the worksharing application, further to the submission of the letter of intent should be attached to the application form.
Examples of changes which would be considered suitable for evaluation under worksharing:. 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. Complete set of Annexes for all centrally authorised products CAPs electronically only in Word format highlighted. Complete set of annexes of one CAP electronically only in Word format highlighted. A template cover letter for worksharing procedures including centrally authorised products and nationally authorised products only is available.
The day period may be reduced having regard to the urgency of the matter, particularly for safety issues, or may be extended to 90 days for Type II variations concerning changes or additions to the therapeutic indication.
Heads of Medicines Agencies: Variation
Examples of changes variationn would be considered suitable for evaluation under worksharing: Electronic Common Technical Document. In principle, identical modules will have to be provided for each product included in the worksharing. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. If nationally authorised medicinal products are part of the worksharing procedure, the MAH should also include a confirmation that the worksharing applications have been submitted to all Member States where the products concerned are authorised and that the relevant national fees have coveer paid.
We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry. Leave this field blank.
Marketing Authorisation Holders are advised to submit such variations as usual. Refer to the eCTD variations question-and-answer document for guidance on the submission of variations in eCTD format.
An automated acknowledgement email is sent from the system confirming whether the submission has passed the relevant technical validation criteria and whether it has been uploaded to the Agency’s review tool and made available lrtter the Common Repository.
When submitting the full set of annexes in PDF format, this should be accompanied by the completed remplate checklist and following the user guide on how to generate PDF versions of the product information – human.
Update of the Certificate of European Pharmacopeia. This page lists questions that marketing-authorisation holders MAHs may have on worksharing. This will allow all the involved Parties The Agency, MSs and Committee Members to receive the full data for the worksharing application. In case of comments, it will be up to the MAH to correctly implement the same amendments in the other centrally authorised productsas appropriate.
A letter of temllate template is available.
Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: Skip to main content.
The worksharing application must be submitted at the same time to all relevant authorities, i.
The two guidelines are available on the Web page of the European Commission. The response from the Agency on the acceptability of the worksharing application, further to the submission of the letter of intent should be attached to the application form.
Upon finalisation of the review of the variations subject to the worksharing procedure, the Agency will issue an opinion reflecting the final outcome of the procedure. Not a very wise move: The complete set of annexes must be presented sequentially i. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.
Article 23 1a a provides for a two-month timeframe for amending the decision granting the marketing authorisation for the following variations:.
A new procedure code abbreviation is used for worksharing procedures i. Where a worksharing application is considered invalid i. Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’. One completed electronic EU variation application form, listing all medicinal products concerned and declaring all variations included in the group in the section ‘type of changes’, as well as a justification for the proposed worksharing and grouping if applicable in the ‘precise scope and background’ section of the application form.
All EU languages including Norwegian and Icelandic: 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.
Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business. 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.