Practical Guide To Curl Pdf' title='Practical Guide To Curl Pdf' />European Medicines Agency Variations. This page lists questions that marketing authorisation holders MAHs may have on worksharing. It provides an overview of the European Medicines Agencys position on issues that are typically addressed in discussions or meetings with MAHs in the post authorisation phase. Revised topics are marked New or Rev. MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text. Archived content Identification Guide to the Major Diseases of Grapes Archived content. Archived content is provided for reference, research or recordkeeping purposes. What is worksharing and what types of variations can be subject to worksharing Article 2. Commission Regulation EC N 1. Fallout 2 Torrent Iso Psp on this page. Variations Regulation sets out the possibility for a MAH to submit the same Type IB or Type II variation, or the same group of variations affecting more than one marketing authorisation from the same MAH in one application. Applicants belonging to the same mother company or group of companies and applicants having concluded agreements or exercising concerted practices concerning the placing on the market of the medicinal products concerned, have to be taken as the same MAH1. Extensions are excluded from worksharing. Based on Articles 7 and 2. Variations Regulation, when a group of variations only consists of type IA or IAIN variations affecting several marketing authorisations, this is considered as a group of variations and not a worksharing procedure. However, it is possible to include a group of type IA and IAIN variations with a type IB or a type II variation, which is submitted for a worksharing procedure. In electromagnetics and communications engineering, the term waveguide may refer to any linear structure that conveys electromagnetic waves between its endpoints. RLHHK/x360-UEi.jpg' alt='Practical Guide To Curl Pdf' title='Practical Guide To Curl Pdf' />In such cases, the review of the type IA or IAIN variation will be performed as part of the worksharing procedure. In order to avoid duplication of work in the evaluation of such variations, a worksharing procedure has been established under which one authority the reference authority, chosen amongst the competent authorities of the Member States and the Agency, will examine the variation on behalf of the other concerned authorities. Where at least one of the concerned marketing authorisations has been authorised via the centralised procedure, the Agency will be the reference authority. 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. Purely national marketing authorisations can be included in worksharing procedures submitted as of 4 August 2. References. 1See page 4 of the Commission communication on the Community marketing authorisation procedures for medicinal products page 4. What variations would be considered acceptable for worksharingIn 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. Therefore, where the same changes to different marketing authorisations require the submission of individual supportive data sets for each medicinal product concerned, which each require a separate product specific assessment, such changes will not benefit from worksharing. Grouped variations can be subject to a worksharing procedure, provided that the same group of variations applies to all medicinal products concerned by the worksharing procedure. Examples of changes which would be considered suitable for evaluation under worksharing Clinical pharmacovigilance. Changes to multiple generic marketing authorisations MAs containing the same active substance. Changes to a single substance MA and a fixed combination MA containing the same active substance. Proposal for combination use affecting both MAs. Introduction or changes to the pharmacovigilance system. Quality. Changes to the active substance master file. Update of the Certificate of European Pharmacopeia. Revision of test method for the active substance. Additional examples will be regularly included to reflect accumulated experience. Morceau De Concours Pdf on this page. What presubmission steps will apply to a worksharing procedure 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. The letter of intent should provide the following information types and scope of variations overview of MAs concerned explanation that all MAs belong to the same MAH explanation justification for suitability of worksharing rapporteurs reference Member States RMSs and national competent authorities of the medicinal products concerned, if applicable MAH target submission date MAH contact person for the worksharing procedure. A letter of intent template is available. The letter should be sent to pa busema. Upon receipt of the letter of intent, the Agency will appoint a Procedure Manager and will decide whether the proposed worksharing procedure is acceptable. Subsequently, the Agency will initiate the Rapporteur appointment procedure. Following an expression of interest and based on a rota system, the Chair of the Committee for Medicinal Products for Human Use CHMP will appoint a rapporteur and co rapporteur when the application includes a new indication for the procedure. It is expected that the co rapporteur will be one of the rapporteurs of the centrally authorised medicinal products or a CHMP member representing one of the RMSs or national competent authorities for the nationally authorised products. The MAH will be informed accordingly. A shorter presubmission phase is envisaged in cases where a proposed worksharing procedure relates to multiple MAs for the same medicinal product authorised via the centralised procedure only the variations subject to the worksharing procedure concern the implementation of urgent safety related changes the variations subject to the worksharing procedure concern the implementation of changes requested by CHMP. Worksharing procedure for multiple centrally authorised medicinal products duplicatesThe submission of a formal letter of intent is not required, however applicants are advised to request a WS number from PA BUSema. Marketing Authorisation Holders are advised to submit such variations as usual and a procedure manager will be appointed at the time of validation. How should I present a variation application under worksharingRev. December 2. 01. 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 e. CTD sequence per product, covering all variations applied for. This will include a cover letter and electronic application form, together with separate supportive documentation for each medicinal product concerned and revised product information if applicable for each medicinal product concerned. If applicable, the MAH should provide a revised RMP for each medicinal product as part of the application upfront.