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Template - European Medicines Agency
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- Health and social care
- Medicines, medical devices
- Herbal and homeopathic medicines
Cancel a medicine's marketing authorisation or other licence
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
You must cancel your marketing authorisation ( MA ), parallel import product licence and/or traditional herbal remedy registration, before a product can be removed from the market.
If your application for these types of licences is pending and you no longer wish to proceed, you need to withdraw it.
Cancellations
To cancel a marketing authorisation for a medicine or a traditional herbal remedy so it can be removed from the market, you need to:
Follow the European requirements on the European Medicines Agency (EMA) website completing and submitting their cover letter template and notification report table.
Complete the cancellation form ( MS Word Document , 33.5 KB ) if you’re a UK applicant as well as following the European process at step 1.
Or if you need to cancel a parallel import product licence, complete the cancellation form ( PDF , 525 KB , 3 pages ) .
Please ensure that you limit bulk cancellations to a maximum of 10 product licenses showing per application form.
Submit your forms
Submit the relevant forms above to MHRA via the MHRA portal if you’re a UK applicant. You will need to register if you haven’t already.
Or you can submit the forms to us by email to [email protected]
You can also submit the forms via the Central European System Platform (CESP) .
Withdrawals
If you have submitted an application for a new MA , traditional herbal remedy and/or a parallel import product licence and you no longer want to proceed with application, you need to submit a withdrawal form. You should also use this form if you want to withdraw a variation application or amendment for an existing MA .
Complete the application to withdraw a pending application ( MS Word Document , 35 KB ) for and email it to us with ‘withdrawal’ as your subject line.
More information
Visit the European Medicines Agency website for more information on the European requirements for cancellations or email the MHRA for UK requirements.
Updates to this page
You must cancel your marketing authorisation or other licence by 31 December if you want it to be cancelled by 31 March 2016. This will ensure you are not charged a periodic fee for the period 1 April 2016 to 31 March 2017.
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All companies submitting procedural information to the European Medicines Agency are reminded to insert the formatted table template in their cover letter. The formatted table template is used by companies when they submit information on a medicine to the Agency. It is intended to systematically structure and label the information provided.
Forms and templates; Forms and templates. Pre-submission interaction letter of intent form. Legal effective date: 22/04/2015 Reference Number: Version 1.0.4 Summary: ... European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands. Tel: +31 (0)88 781 6000.
This page lists templates applicants may need for the preparation of their marketing authorisation application with the European Medicines Agency (EMA). ... GLP compliance: Non-clinical studies GLP compliance (annex to the cover letter) Reference Number: Revision 1.1. ... European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam The ...
template table cover letter - European Medicines Agency. advertisement. 05 February 2016. Information Management Division, Version 4. Formatted table template. To be inserted in each procedural submission cover letter. 1*. Applicant/MAH Name. 2*.
Variation applications. Cover letter for Variation Applications in the Mutual Recognition Procedure (December 2022) Worksharing procedure to RMS according to Article 20 of Commission Regulation (EC) No 1234/2008. Template of letter of intent for the submission of a worksharing procedure (June 2019) Link to EMA website for Template cover letter ...
The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials. The project is currently in grant management phase and will run for 36 months (with a retrospective start date from 01/05/2022 to 30/04/2025). The first Annual SAFE-CT Safety Assessor Event ...
Letter. The EMA's strategy for the electronic submission of applications aims to improve efficiency and streamline processes for all stakeholders. The use of the Formatted Letter Template will become obsolete as of 1st January 2019. This will concern all EMA Human and Veterinary submission (including PSUSA procedures) and companies should then ...
therefore specific European legal terms such as "active substance", "medicinal product", and "marketing authorisation" were not used in its development. Applicants are reminded that the term "medicinal product" covers both pharmaceutical and biological medicinal products.
The Table of Changes should be included as a separate document to the main Submission Cover Letter. The ASMF holder should use the following example templates for the table. If the changes have been previously authorised in a National or European procedure, the ASMF holder should annotate the table with the procedure number.
Assessment templates and guidance. Human Regulatory and procedural guidance. The Committee for Medicinal Products for Human Use (CHMP) and Committee on Advanced Therapies (CAT) should use the assessment report templates and documents listed below for the assessment of any new application in the centralised procedure.
Within the submission dossier table templates are provided up to section 5.1. Table templates for the following sections (Section 5.2 et seq.) are provided in a separate file with table ... EMA European Medicines Agency EU European Union HaDEA European Health and Digital Executive Agency HTA Health Technology Assessment HTAR Regulation (EU ...
Template for applicants to prepare report on similarity with authorised orphan medicinal products. Template: Similarity report (September 2022) For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.
Dear Sirs, We are pleased to submit our Application Dossier(s) for a <Mutual Recognition> / <Decentralised> procedure for which the details are as follows : Name of the medicinal product(s) (in the RMS) : Pharmaceutical product. Immunological. product. Pharmaceutical form(s) and strength(s) : INN/active substance(s) :
The European Medicines Agency has published a new that all companies need to insert in the cover letters of selected applications for veterinary medicines from now on. The table should be inserted in the cover letters of the applications in the following procedures: ... The formatted table template is intended to systematically structure and ...
Complete the cancellation form (MS Word Document, 33.5 KB) if you're a UK applicant as well as following the European process at step 1. Or if you need to cancel a parallel import product ...
Updated formatted table template for dossier submission available. News 24/01/2013. All companies submitting procedural information to the European Medicines Agency represent reminded to insert one formatted table template in their cover letter. ...
Member States, the European Medicines Agency (EMA) and the Commission services on how those requirements may be met. ... 3 Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance, OJ L 299 of 27.10.2012, p. 1 and Regulation
When notifying EMA, please use the Cover letter template for notification of "withdrawn products" by marketing authorisation holders and the Template to be used to notify the European Medicines Agency and concerned Member States of 'withdrawn products' report table. For detailed guidance, see Notifying a change of marketing status.
31 January 2022 3 of 22 pages General questions Q 1.1 - When did the amended Variation Regulation 1234/2008 (as amended by Regulation 712/2012) enter into force? Variation Regulation (EU) No. 1234/2008 entered into force on 1 January 2010 and was
Template for Active Substance Master File (ASMF) Assessment Report (Applicant's Part) (July 2019) Template for Active Substance Master File (ASMF) Assessment Report (Resctricted Part) (July 2019) For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the ...
The European Medicines Agency policy on the publication of clinical data for medicinal products for human use1 (hereafter referred to as 'Policy 0070') was developed by the European Medicines Agency (EMA), in accordance with Article 80 of Regulation (EC) No 726/2004. Policy 0070 was adopted by the
For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.