The guidance also states that the cover letter should mention if the product information is being provided as PIM data. Guideline on categorisation of extension applications EA versus variation. 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. To help in the management of responses over the lifecycle of the eCTD, the responses relating to a particular regulatory activity should be grouped under a node-extension in the eu-regional. Note that bookmarks will not be required as there will be no further internal structure.

Human medicines – Regulatory and procedural guidance – Post-Marketing Authorisation. In the event of submission on a CD or DVD an original, signed paper copy of both the cover letter and, if applicable, the application form must be submitted. This not only applies to new applications, but also to correspondence rounds, variations, PSURs, etc. Urgent safety restriction – Member state standard operating procedure. Explicit forbidding of cross-application references.

The MAH should then at the next printing update their package leaflet with this date in accordance with the approved version published on the MPA website. Guidance Cancel a medicine’s marketing authorisation or other licence.

In the Netherlands it is obligatory to submit an electronic dossier for medicinal products for human use. Sequences numbers should normally follow the order of submission but EMEA vmdh most NCAs are able to accept and view sequences submitted out of numerical order.

cover letter cmdh

CMD letrer Procedural guidance, Variations. Swedish Medical Products Agency, P. 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.


You should use the leaf title to identify the particular set of responses e. For changes not covered by the variation regulation, please see links in the left margin leading to pages for Article 61 3 notifications, Cove transfer, changes to the local representative or change in legal status OTC.

Applications for Marketing Authorisation

Two Commission guidelines have been issued in connection with the a. An invoice on the application fee will be sent upon receipt of the application, so no payment should be made in advance.

Please note that review articles, core data sheets and extracts from texts books are not considered detailed enough for the scientific assessment. The electronic application form is mandatory in all procedures as of 1 January It is possible to submit the response to each question in a separate file but if you choose to do so then you must use node-extensions and leaf titles to group and identify the responses under the top level node-extension. Guideline on categorisation of extension applications EA versus variation.

Variations – Swedish Medical Products Agency

SmPC lwtter Word format with changes marked using the function “track changes”. This new Variation Regulation establishes new rules for 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.

Or if you need to cancel a parallel import product licence, complete the cancellation form PDFKB3 leter.

cover letter cmdh

Human medicines – Regulatory and procedural guidance – Post-Marketing Authorisation. National Competent Authorities have been strongly recommended to adopt this guidance as the basis for their dealings with applicants.


The title of the node-extension should identify the regulatory activity e. Follow Synchrogenix on Twitter My Tweets. If responses to more than one question are submitted in a single file then you should use bookmarks within the PDF file to clearly identify each response. Submit a Comment Cancel reply You must be logged in to post a comment.

An entire annex addresses best practices in the structure of Module 3. It is recommended that you provide a full copy of the list of questions received from the agencies as the first leaf in this section. Modular Nonclinical Study Reports. Organization of Module 3.

BfArM – Variations – Submission of Variations

The following documents are needed:. Organization of Clinical Studies. Total evaluation time excluding clock stop is given within the parenthesis. The guidance sates that granular reports created for the US can be submitted without re-organization in Europe.

Draft EU eCTD Guidance Covers Cover Letter, Sequence Numbers

Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission. 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.

cover letter cmdh

Further current information is available on the CMD h Web page: Note that bookmarks will not be required as there will be no further internal structure.

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