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esubmission.ema.europa.eu/eaf

The word based application forms (AF) have been replaced by electronic application forms (eAF), with new possibilities like electronic data import/export, data population within the form, online access to standardised catalogue terms, built in business rule validation, and support for validation of form, etc. Implementation of mandatory use of the eAF is part of the HMA eSubmission roadmap.

ec.europa.eu/health/documents/eudralex/vol-2_en

EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use. ... in consultation with the competent authorities of the Member States and the European Medicines Agency (EMA) . ... Application form for variation to a marketing authorisation for medicinal products ...

www.ema.europa.eu/en/documents/other/european-medicines-agency-practical...

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations EMA/233564/2014 Page 5/16 . Only the presentation(s) (EU number(s)) affected by the change(s) should be listed.

www.merckgroup.com/en/news/ema-validates-application-for-treatment-08-03-2019.html

Not intended for US, Canada and UK-based media. Darmstadt, Germany and New York, US, March 8, 2019 – Merck and Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO ® (avelumab) in combination with INLYTA ® (axitinib)* for the treatment of patients with advanced renal cell carcinoma (RCC).

www.ema.europa.eu/en/veterinary-regulatory/post-authorisation/variations/type...

Where a variation leads to or is the consequence of other variations, a description of the relation between these variations should be provided in the appropriate section of the application form. MAHs are reminded that the variation application form should be signed by the official contact person. Should the official contact person not be ...

www.gov.uk/.../medicines-apply-for-a-variation-to-your-marketing-authorisation

Medicines: apply for a variation to your marketing authorisation ... (EMA) if any of the MAs ... Submit the variation application form ...

www.hma.eu/96.html

EMA/CMDh explanatory notes on Variation Application Form - Human medicinal products only (December 2014) [Track version] Examples for acceptable and not acceptable groupings for MRP / DCP products (June 2017) [ Track version ]

www.sukl.cz/file/65120_1_1

EMA/CMDh EXPLANATORY NOTES ON VARIATION APPLICATION FORM (Human medicinal products only) Doc. Ref.: CMDh/EMA/133/2010/Rev4 October 2010 INTRODUCTION AND GENERAL COMMENTS This document is intended to provide more clarification on how the new Variation Application Form should be completed. It will be regularly updated as more experience is

www.emea.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000086...

The completed electronic EU variation application form , declaring all variations included in the group in the section ‘type of changes’, as well as a justification for the proposed grouping in the ‘precise scope and background’ section of the application form.

ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/2016-01-01_nta...

3 If the variations are part of a grouped submission including a lin e-extension, this application form should be considered an a nnex to the application form for the extension application. 4 Type II variation submitted under Article 29 of Regulation (EC) No 1901/2006.