In all other cases, we ask the applicant to await the approval letter with updated product information prior to the amendment in question is implemented in the product information. The following remarks may be helpful: 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. Marketing authorisation holders are strongly discouraged from applying for a BSR when a batch does not comply with the registered finished product specifications. Search for medicines Swedish.
SmPC in Word format with changes marked using the function “track changes”. Please note that review articles, core data sheets and extracts from texts books are not considered detailed enough for the scientific assessment. We work with clients assisting them with issues just like this all of the time. Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business. Search for medicines Swedish.
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.
No other changes that are not covered by the variation application are to be included in the product information. All proposed changes should be presented using the Word feature “track changes”. The justification for use of the work-sharing procedure is the most important part of the letter. Grouping including more than one MA in the mutual recognition procedure type IA only Worksharing In these cases, the variation procedure variwtion needs to be obtained from the Reference Authority.
No additional paper cover letters or application forms should be sent. Type II extended e. The following variatiom may be helpful: For type IA variations that affect the product information, only changes resulting from the variation applied for will be considered.
The following documents are needed: SmPC in Word format with changes marked using the function “track changes”.
When contacting the MPA regarding the product information please use the latest approved version of the current product information published on the MPA website.
If Type IA or IB variations include alterations of the Variatuon texts, submit highlighted and clean versions along with the initial application; this applies to electronic submissions as well see the AMG -Submission Ordinance.
Heads of Medicines Agencies: Variation
Other new possibilities include that of grouping of variations belonging to one marketing authorisation holder, worksharing and new timelines. For further information regarding fees, see “Fees” in the left margin.
The electronic application form is mandatory in all procedures as of 1 January In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc. Please note that review articles, core data sheets and extracts from texts books are not considered detailed enough for the scientific assessment.
CMD v Procedural guidance, Variations. Recommendations In order to lettef 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.
Total evaluation time excluding clock stop is given within the parenthesis. A batch specific variation can be submitted covver an extension to the implementation time for an approved variation is required. This excludes variations to change legal classification prescription status.
An invoice on the application fee will be sent upon receipt of the application, so no payment should be made in advance. The Medicines Authority follows the following system for issuing of approvals for variations, notifications and renewals. 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. Over-labelling or re-packaging must be carried out in line with the Clver guidelines on the repackaging of medicinal products for human use.
We work with clients assisting them with issues just lettrr this all of the time.
The cmdu letter should be translated into the English or Maltese language if it is in another language, with the scope of the variation made clear.
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. Accessibility Sitemap Contact us Svenska.
The Worksharing Procedure for Variations for National Marketing Authorisations in the EU
Commission Procedural and Classification Guideline. This Page Recommend page. 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. Requirements for electronic submissions are available on the CMDh website.
A formal letter with the work-sharing applicant and contact person for the work-sharing procedure should be provided with the work-sharing application. 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.