For European variation procedures, no further approval letter will be issued by the Medicines Authority and variations can be considered approved in Malta following approval confirmation by the Reference Member State without prejudice to any other national legislation in place e. The cover letter should also indicate a reference to the variation procedure number, as appropriate, and a brief description of the variation. The Product Information SmPC, Package Leaflet and labelling is always the latest approved and should contain the changes as proposed in the scope of the variation application form. Search for medicines Swedish. 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 on the MPA website.

Original scientific papers and study reports referred to if not earlier submitted as an eCTD sequence. Electronic Common Technical Document. The two guidelines are available on the Web page of the European Commission. Further current information is available on the CMD h Web page:. The following remarks may be helpful: We are publishing eCTD submissions for of all types of applications e.

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. The Medicines Authority follows the following system for issuing of approvals for variations, notifications and renewals.

A formal letter with the work-sharing applicant and contact person for the work-sharing procedure should be provided with the work-sharing application.

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. However, in exceptional cases non-critical deviations may be considered on a case-by-case basis. The following documents are needed: 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.


Day 90 is the commencement of national phases.

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. In order to benefit from a work-sharing 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. The two guidelines are available on the Web page of the European Commission.

Heads of Medicines Agencies: Applications for MA

When Sweden is CMS, a national approval is only sent when the Swedish product information is affected. This will allow the Agency and the national competent authorities to update the dossier of each marketing authorisation included in the work-sharing procedure with the relevant amended or new information. Submission information 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.

Ltter 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.

The following is a list of mandatory documents to be submitted to the Medicines Authority for a variation to a nationally authorised product: In order to make it possible for us to process the applications within the narrow timeframes given, it is essential that all supporting documents are submitted with the application.

Urgent safety restriction – Member state standard operating procedure. It varistion be clearly stated in the cover letter, which changes have already been implemented in the product information and the date it occurred.

cmdh cover letter variation

In the national procedure, the procedure is re-started upon receipt of the response. The MAH must submit the variation application for work-sharing at the latest by the recommended submission dates published under submission dates.


For veterinary medicinal products, the RMS can still allocate variation procedure number upon request.

cmdh cover letter variation

To ensure continued availability of a medicinal product on the market in Vriation, batch specific requests can be submitted. Copy of an Approval Letter from a Member State Authority, if available, or the proof of payment, if not available. For further information on electronic submissions see “Electronic submissions “in the left margin.

If you would variatino to talk to us about this issue then please get in touch. When PL and labelling are affected, these should also be submitted in the same format. 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.

A presentation to guide applicants can be found here. Human medicines – Regulatory and procedural guidance – Post-Marketing Authorisation.


Two Commission guidelines have been issued in connection with the a. In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc. Where changes to the outer pack, immediate pack and package leaflet are being proposed, mock-ups with all the differences highlighted should be submitted. 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.

cmdh cover letter variation

In these cases, the variation procedure number needs to be obtained from the Reference Authority.