One significant advantage of the work-sharing procedure is that there is a time-table. Welcome to Exalon Your partner for high quality eCTDs, regulatory submission services and EVMPD support Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business. Search for medicines Swedish. Not a very wise move: This guideline is kept updated by the European Commission. 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. All proposed changes should be presented using the Word feature “track changes”.
In such instances where the variation has been approved and the Marketing Authorisation Holder cannot meet the required timeline for implementation of the change an extension may be sought via submission of a batch specific variation. For changes not covered by the variation regulation, please see links in the left margin leading to pages for Article 61 3 notifications, MAH transfer, changes to the local representative or change in legal status OTC. If the applicant finds it necessary to implement IA and IAIN variations in the product information before the MPA has sent out approval letters, applicants can enter a new date of revision in the product information. Navigation and service Go to: The following is a list of mandatory documents to be submitted to the Medicines Authority for a variation to a nationally authorised product: Total evaluation time excluding clock stop is given within the parenthesis. When Sweden is CMS, a national approval is only sent when the Swedish product information is affected.
The Worksharing Procedure for Variations for National Marketing Authorisations in the EU
You can call us on 52 61 76 or simply complete your details below and we will get straight back to you. Electronic Common Technical Document. This new Variation Regulation establishes new rules avriation the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, granted in Centralised Procedures CPDecentralised Procedures DCP or the Mutual Recognition Procedures MRP.
In addition to cutting down on un-necessary work by the competent authorities, it encourages the MA holder to harmonise the Chemistry, Manufacturing and Controls Section of the dossier where possible in EU markets. The product information in the context of variations When contacting the MPA regarding the product information please use the latest approved version of the current product information published coover the MPA website.
If the applicant finds it necessary to implement IA and IAIN variations in the product information before the MPA has sent out approval letters, applicants can enter a new date of revision in the product information.
Accessibility Sitemap Contact us Svenska. Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of lether drug regulatory business. Under “Application form and Regulatory Guidance” in the right margin you will find links to the application form and guidelines from the Commission and the CMD. The front page of the Marketing Authorisation document will be revised and sent to the Marketing Authorisation Holder should the details included change as a result of a variation.
Retweet on Twitter exalon Retweeted. Day 90 is the commencement of national phases.
Lletter applicant must ensure that the approval letter where applicable from another member stated pertains to the variation being submitted, that is, the scope of the variation must be covered by variatuon approval letter.
Cover letter and Variation application form. The amended German texts are not needed before the national phase is started. Even though the main body of the procedure is the work-sharing the approvals still have to be issued nationally, and it is in this national phase that any printed packaging materials and updated SmPCs would be submitted.
In this article we answer 4 important questions related to the worksharing concept. Electronic copies of the final proposed SmPC also in editable word formatPL and Labelling, if updated; current and proposed tracked changed versions of the product information highlighting the changes resulting from a variation should be submitted as applicable. In addition to the common cover letter a national cover letter is required in the national variationn.
For further information regarding fees, see “Fees” in the left margin. In such instances where the variation has been approved and the Marketing Authorisation Holder cannot meet the required timeline for implementation of the change an extension may be sought via submission of a batch specific variation. We provide consulting and training regarding eCTD coger xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry.
If the applicant has a harmonised dossier in more than one EU market they could request the dossier to be converted to a de-centralised rather than nationally approved dossiers in the relevant markets. The justification for use of the work-sharing cmd is the most important part of the letter. The response from the Agency on the acceptability of the work-sharing application, further to the submission of the letter of intent should be attached to the application form.
Original scientific papers and study reports referred to if not earlier submitted as an eCTD sequence. Over-labelling or re-packaging must be carried out in line with the General guidelines on the repackaging of medicinal products for human use. Other new possibilities include that variatiln grouping of variations belonging to one marketing authorisation holder, worksharing and new timelines. If you would like to talk to us about this issue then please get in touch.
BfArM – Variations – Submission of Variations
In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc. This guideline applies to National and European approved products in Malta only. The following is a list of mandatory documents to be submitted to the Medicines Authority for a variation to a nationally authorised product: The following documents are needed: Type II extended e. This guideline is for use by marketing authorisation holders applying for a national change in the legal classification for supply of a medicinal product from “subject to a medical prescription” to “not subject to a medical prescription”.
Not a very wise move: Total evaluation time excluding clock stop is given within the parenthesis.