In case no changes to the product information are being proposed as part of the PSUR, the MAH should not include any product information within the EU regional appendix. Worksharing procedures for type-IB variations At submission day 0: Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Explore the topic Marketing authorisations, variations and licensing guidance. For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5.

There is a day deadline to respond to a NWG otherwise the variation will be withdrawn or refused, this also applies if only a partial response has been received by the day deadline. You can submit grouped changes to an MA with multiple product licences under the European procedure. A template cover letter for worksharing procedures including centrally authorised products and nationally authorised products only is available. In case of CMDh position by consensus, Member States may perform a voluntary linguistic review in the translation process, therefore the following timelines apply: This format is a legal requirement for both nationally authorised products and centrally authorised products. How useful was this page?

The PSUR frequency as published on the EURD list for a given active substance or combination of active substances overrules the standard submission cycle i. In this communication the MAH should indicate whether they templxte wish to make use of the opportunity of an oral explanation to defend their position before the PRAC. Submission to the Rapporteur and Committee members.

Worksharing: questions and answers

For more information, see: Variations related to safety issues, including urgent safety restrictionsmust be implemented within a timeframe agreed by the marketing authorisation holder and the Agency. However, the parallel importer will not become party to the PSUR procedure and will not receive a copy of the assessment templatf and outcome documentation as a MAH would.

For more information on GVP modules, see Good pharmacovigilance practices. Please refer to the guideline on the processing of renewals in the centralised procedure.


Heads of Medicines Agencies: Applications for MA

In the latter case, a justification should be provided for the appropriate language s stating why certain comments are not reflected in the final texts. The MAH of centrally authorised medicinal products should submit a clean and a tracked version of the agreed amended product information prior to the adoption of the PRAC recommendation. Any changes not listed will not be considered as part of the variation application.

This system is available from the Heads of Medicines Agencies HMA and provides a simple and secure mechanism for exchange of information between applicants and regulatory agencies. If considered necessary, an oral explanation can be held within this day timeframe. Annex I – Definitions. If the change is more significant than a IA change but is not a type II change or an extension, it is considered a type IB change.

For more information, see the questions-and-answers below and Periodic safety templahe report single assessments. For nationally covsr medicinal products i.

Additional examples will be regularly included to reflect accumulated experience.


Upon finalisation of the review of the templxte subject to the worksharing procedure, the Agency will issue an opinion reflecting the final outcome of the procedure. This is a legally binding requirement from the EU pharmaceutical legislation.

See the list of fees. Once MHRA has all the documents, it will take 30, letfer or days to assess your application depending on how urgent or complex the changes are, excluding time taken to answer questions.

No specific template needs to be followed for the responses to the request for supplementary information RSI.

cmdh variation cover letter template

Additionally, product information should be kept up-to-date by the MAH by submitting the appropriate variations taking account of the latest scientific knowledge or conclusions of assessments and recommendations made public by means of the EMA and national competent authority websites.

The CHMP will appoint a different co- rapporteur to coordinate the re-examination procedure. Submission requirements and EU reference dates: The list will then be amended accordingly cmfh appropriate and published on the European medicines website. Start of the procedure according to the published timetable.


If nationally authorised medicinal products are part of the worksharing procedure, the MAH should also include a confirmation that the worksharing applications have been submitted to all Member States where the products concerned are authorised and variaton the relevant national fees have been paid. Use this form to work out what the fee for your variation submission will be. The Agency will monitor the quality of the translations, the review by the Member States and industry’s compliance with the Member States’ comments as part of the Performance Indicators.

In such cases, and in cases where any other ongoing procedures may affect the product information annexes, the MAH is advised to contact the Agency in advance of submission or finalisation of the procedure concerned.

Heads of Medicines Agencies: Variations

It variatioj expected that the co- rapporteur will be one of the rapporteurs of the centrally authorised medicinal products or a CHMP member representing one of the RMSs or national templage authorities for the nationally authorised products.

Therefore, where the ‘same’ changes to different marketing authorisations require the submission of individual supportive data sets for each medicinal product concerned, which each require a separate product-specific assessment, such changes will not benefit from worksharing.

cmdh variation cover letter template

You can apply for: Where relevant, data relating to a particular indicationdosage form, and route of administration or dosing regimen, shall be presented in a separate section of the PSUR and any safety concerns shall be addressed accordingly.