In this article we answer 4 important questions related to the worksharing concept. When applying for a national type II variation for a SmPC change the requirements for documentation is the same as in the mutual recognition procedure. The following is a list of mandatory documents to be submitted to the Medicines Authority for a variation to a nationally authorised product: 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”. In the variation application form, use the full German name of the medicinal product as it is authorised, and indicate the German marketing authorisation holder as well as the Germanmarketing authorisation number. 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. In general, variations submitted for work-sharing 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.
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. 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. In order to facilitate communication between agencies and the applicant, it is essential that an e-mail address is provided in the application form. Where the applicant is someone other than the marketing authorisation holder, a specific letter of consent from the holder is required for the request. Such applications may be required when the product in full compliance with the details of the marketing authorisation cannot be sourced for a short, defined period of time maximum of 6 months.
The approval letter should be translated into the English or Maltese language if it is in another language, with the scope of the variation made clear. No additional paper cover letters or application forms should be sent. Electronic submissions and the use of the electronic application form are outlined in the section on Submission Requirements.
In general, variations submitted for work-sharing will follow the day evaluation timetable of Type II variations and weekly-start timetables may apply to the assessment following the same principles lettdr those applied to the assessment of Type II variations. However, in exceptional cases non-critical deviations may be considered on a case-by-case basis.
The amended German texts are not needed before the national phase is started. In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc.
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You can call us on 52 61 76 or simply complete your details below and we will get straight back to you. Other new possibilities include that of grouping of variations belonging to one marketing authorisation holder, worksharing and new timelines. Over-labelling or re-packaging must be carried out in line with the General guidelines on the repackaging of medicinal products for human use. It is important that application forms for variations are filled in correctly and that all the documents that should be appended to the application form are submitted in accordance with the categorisation guidelines.
Electronic copies of the final proposed SmPC also in editable word formatPL and Labelling, if updated; current and proposed tracked changed versions of variayion product information highlighting the changes resulting from a variation should be submitted as applicable. This is the main advantage of the procedure although depending on the markets, there may also be some cost savings as some competent authorities charge a smaller variatipn as their assessment is based on the assessment of the RMS.
This guideline applies to National and European approved products in Malta only.
Variations – Swedish Medical Products Agency
Not a very wise move: Where the applicant is someone other than the marketing authorisation holder, a specific letter avriation consent from the holder is required for the request.
A copy of the ticked conditions met and documents submitted as per the categorisation guideline if applicable. The 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 the approval letter. Human medicines – Regulatory and procedural guidance – Post-Marketing Authorisation.
Electronic Common Technical Document.
Heads of Medicines Agencies: Variations
This should include a common cover letter and application form, together with separate supportive documentation for each medicinal product concerned and revised product information if applicable for each medicinal product concerned. 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 xmdh comprehensive set of services covering all aspects of the electronic drug regulatory affairs business.
It is recommended that the background documents are submitted also in an electronic format to allow an expedite process.
Total evaluation time excluding clock stop is given within the parenthesis. Allocation of variation procedure number for human medicinal products are handled by the applicant according to Chapter 1 of the CMD h Best Practice Guides for the Submission and Processing of Variations in the Mutual Recognition Procedure. National variations submitted with the relevant approval from another Member Eltter, may be implemented immediately following submission of the variation application.
In addition to the common cover letter a national cover letter is required in the national language. The front page of the Marketing Authorisation document will be revised and sent to the Marketing Authorisation Holder should the details included change as letrer result of a variation.
Applications for Marketing Authorisation
Classification of Variations Variations to medicinal products can be classified in different categories, depending on the level of risk to public health and variatiion impact on the quality, safety and efficacy of the medicinal product concerned. While the first guideline provides detailed operational advice as well as information on the documentation to be submitted, the second provides details of the variation categories i. Copy of an Approval Letter from a Member State Authority, if available, or the proof of payment, if not available.
Such applications may be required when the product in full compliance with the details of the marketing authorisation cannot be sourced for a short, defined period of time maximum of 6 months. This letter will become part of the MA package and must be retained with the formal documents relating to the licence.
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. 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.