Two Commission guidelines have been issued in connection with the a. Urgent safety restriction – Member state standard operating procedure. 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. Worksharing procedures have to be applied for at the CMD h. Guideline on fast track procedure for human influenza vaccines. Guideline on categorisation of extension applications EA versus variation.
Further current information is available on the CMD h Web page:. Variations to medicinal products can be classified in different categories, depending on the level of risk to public health and the impact on the quality, safety and efficacy of the medicinal product concerned. 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. No additional paper cover letters or application forms should be sent. Guideline on categorisation of extension applications EA versus variation.
Implementation of variations approved by the Reference Member State where Malta is Concerned Member State can be carried out immediately following official notification by the RMS that the variation is approvable. Application form, procedure number and guidelines 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.
Recommendations 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.
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 Medicines Authority follows the following system for issuing of approvals for variations, notifications and renewals. An invoice on the application fee will be sent upon receipt of the application, so no payment should be made in advance. According to this Directive, the requirements for national applications are similar to those for European procedures and work sharing and grouping of variations is possible. Electronic Common Technical Document. Human medicines – Regulatory and procedural guidance – Post-Marketing Authorisation.
Heads of Medicines Agencies: Variation
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.
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.
It is recommended that the background documents are submitted also in an electronic format to allow an expedite process. Please note that review articles, core data sheets and extracts from texts books are not considered detailed enough for the scientific assessment.
The following documents are needed: The justification for use of the work-sharing procedure is the lefter important part of the letter. So for work-sharing applications there are typically 2 cover letters in variatin submissions. 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.
In this case these variations cannot be submitted with an approval from another country since legal classification is at the discretion of each Member State. Guideline on categorisation of extension applications EA versus variation.
BfArM – Variations – Submission of Variations
Day 90 is the commencement of national phases. Where changes to the outer pack, immediate pack and package leaflet are being proposed, mock-ups with all the differences highlighted should be submitted. 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.
National variations submitted with the relevant approval from another Member State, may be implemented immediately following submission of the variation application.
Marketing authorisation holders cmh strongly discouraged from applying for a BSR when a batch does not comply with the registered finished product specifications. Further current information is available on the CMD h Web page: Even though the main body of the procedure is the work-sharing vadiation 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 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.
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 fee as their assessment is based on the assessment of the RMS.
The MAH should then at the next lether update their package leaflet with this date in accordance with the approved version published on the MPA website.
Over-labelling or re-packaging must be carried out in line with the General guidelines on the repackaging of medicinal products for human use.
Accessibility Sitemap Contact us Svenska. Further current information is available on the CMD h Web page:. No paper applications should be submitted. In the variation application form, use the full German name of the medicinal product as letrer is authorised, and indicate the German marketing authorisation holder as well as the Germanmarketing authorisation number. This Page Recommend page.