Electronic submissions and the use of the electronic application form are outlined in the section on Submission Requirements. A presentation to guide applicants can be found here. 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. No paper applications should be submitted. When the updated product information is sent from the MPA, it will have a new approval date. In order to facilitate communication between agencies and the applicant, it is essential that an e-mail address is provided in the application form.

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. 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. The justification for use of the work-sharing procedure is the most important part of the letter. When the updated product information is sent from the MPA, it will have a new approval date. All proposed changes should be presented using the Word feature “track changes”.

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.

Exalon – eCTD-Experts

Where the applicant is someone other than the marketing authorisation holder, a specific letter of consent from the holder is required for the request. The committees meet every 2 months so the application letter should be submitted as early as practicable in order to get on the agenda, but at least 3 months in advance of the planned submission date.

Other new possibilities include that of grouping of variations belonging to one marketing authorisation vadiation, worksharing and new vaeiation. Commission Procedural and Classification Guideline.


Applications for Marketing Authorisation

Retweet on Twitter exalon Retweeted. For veterinary medicinal products, the RMS can still allocate variation procedure number upon request. 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

When contacting the MPA regarding the product information please use the latest approved version cpver the current product information published on the MPA website. The electronic application form is mandatory in all procedures as of 1 January For further information on electronic submissions see “Electronic submissions “in the left margin.

Swedish Medical Products Agency, P. This guideline is for use cmh 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”. No other changes that are not covered by the variation application are to be included in the product information.

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 cmdb for assessment of a potential product-specific impact.

cmdh cover letter variation

For the applicant to respond to questions or provide updated CMC documents there is a clock- stop. In this article we answer 4 important questions related to the worksharing concept. Human medicines – Regulatory and procedural guidance – Post-Marketing Authorisation. However, in exceptional cases non-critical deviations may be considered on a case-by-case basis.

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. Search for medicines Swedish. Accessibility Sitemap Contact us Svenska.

This is the main advantage of the procedure although depending on lettet 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. No further approval by the Medicines Authority is required for implementation.


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.

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. Guideline on fast track procedure for human influenza vaccines.

Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business. In coover national procedure, the procedure is re-started upon receipt of the response. Classification of Variations 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.

National variations submitted with the relevant approval from another Member State, may be implemented immediately following submission of the variation application. Marketing authorisation holders are strongly discouraged from applying for a BSR when a batch does not comply with the registered finished product specifications.

Heads of Medicines Agencies: Variations

Day 90 is the commencement of national phases. This guideline applies to National and European approved products in Malta only.

An invoice on the application fee will be sent upon receipt of the application, so no payment should be made in advance. Variations submitted with payment in line with vwriation Fees Regulations, will be reviewed in accordance with timelines of the Variations Regulations.

For further information regarding fees, see “Fees” in the left margin.