Alternatively, such a listing may be provided as a separate document attached to the application form. Worksharing procedures for type-IB variations. In general, variations submitted for worksharing will follow the day evaluation timetable of Type II variations and weekly-start timetables may apply to the assessment following the same principles as those applied to the assessment of Type II variations. This applies to all applications for human medicines. Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client:
Proposal for combination use affecting both MAs. The request to bring the batch into compliance with the marketing authorisation can be submitted using the appropriate application form. 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 worksharing , but the application should be provided as one integrated submission package electronic-common-technical-document [eCTD] sequence per product, covering all variations applied for. In general, variations submitted for worksharing will follow the day evaluation timetable of Type II variations and weekly-start timetables may apply to the assessment following the same principles as those applied to the assessment of Type II variations. The worksharing application must be submitted at the same time to all relevant authorities, i.
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.
Heads of Medicines Agencies: Applications for MA
Vagiation letter should be sent to pa-bus ema. Additional examples will be regularly included to reflect accumulated experience. Where nationally authorised medicinal products are part of the worksharingthe same application as submitted to the Agency should be submitted to all Member States, even if some products are not relevant to some MSs.
Original cover is not needed. Changes to a single-substance MA and a fixed-combination MA containing the same varkation substance. Questions and answers relating to practical and technical aspects of the implementation and the eSubmission Gateway web client: Highlighted changes should be indicated via ‘Tools — Track variatlon. The Agency applies the existing post-opinion timeframes, as set-out in the linguistic review process of product information in the centralised procedure — human.
Quality Changes to the active-substance master file.
If amendments are requested by the Agency as a result of the validation, updated documentation should also be submitted to xmdh MSs. The name of the product, the pharmaceutical form, strength and, where applicable, the procedure number should be clearly stated on the spine and cover of the variations.
Icelandic and Norwegian language versions must always be included. Purely national marketing authorisations can be included in worksharing procedures submitted as of 4 August 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.
Applications for Marketing Authorisation
Page numbering should start with ‘1’ bottom, centre on the title page of annex I. An electronic variation of the submission in any letter is still appreciated.
Clean versions should have all changes ‘accepted’. The dossier requirements for post-authorisation submissions in the centralised procedure should be followed. Where applicable changes in Word documents should be indicated using ‘Tools-Track Changes’.
Only the worksharing applicant will be invoiced for the worksharing procedure. Examples of changes which would be considered suitable for evaluation under worksharing:. Variations submitted with payment in line with the Fees Regulations, will be reviewed in ano ang tagalog ng critical thinking with timelines of the Variations Regulations.
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. National variations submitted with the relevant approval from another Member State, may be implemented immediately variation submission of the variation application.
Where applicable, revised product information Annexes including Annex A, if applicable should be included in electronic Word and PDF format in the same eSubmission Gateway or eSubmission Web Client package within a folder called ‘working documents’. In such cases, and in cases where any other ongoing procedures may affect the product information annexes, the MAH is advised to contact the Agency in advance of submission or finalisation of the procedure concerned.
No further approval by the Medicines Authority is required for cover. Worksharing procedure for type-II variations At submission day 0: Complete set of annexes of one CAP electronically only in Word format highlighted. Any documentation submitted should either be accompanied by an letter or as research paper about teenage drug addiction to an existing application.
Any co-packed component, as for example a variation device, should also be provided. This applies to all applications for human medicines.
Variations related to safety issues, including urgent safety restrictionsmust be implemented within a timeframe agreed by the marketing authorisation holder and the Agency. Also see ‘when do I have to submit revised product information?