Search results with tag "Marketing authorisation"
VOLUME 2A Procedures for marketing authorisation …
ec.europa.eumarketing authorisation in a Member State, the applicant/marketing authorisation holder must submit an application in the Member States concerned using the procedure of mutual recognition. The Member States concerned should then recognise the marketing authorisation already granted by the reference Member State and
EudraVigilance User Manual Marketing Authorisation …
www.ema.europa.euSection 6 updated to reflect the marketing authorisation status within the active substance grouping reports outputs . Section 8.3.3 updated to clarify the ‘hide columns’ functionality. Section 9.1 updated to clarify the use of the eRMR in relation to the frequency of monitoring . Section 9.3.1 created to describe the considerations
Timetable: Initial (full) marketing authorisation ...
www.ema.europa.euThe timetables in this document may be subject to revision Initial (Full) Marketing Authorisation application accelerated assessment timetables¬
My medicine: Licensing (marketing authorisation) …
www.mhra.gov.ukBy law, before a medicine can be placed on the market, it must be given a marketing authorisation (product licence) by a medicines regulator. The UK regulator is the Medicines and Healthcare products Regulatory Agency
Timetable: Initial (full) marketing authorisation …
www.ema.europa.euThe timetables in this document may be subject to revision Initial (Full) Marketing Authorisation application assessment timetables: Assessment of initial submission (120-day timetable)
VICH and its role for authorisation of veterinary ...
www.oie.intPage 3 What should be included in an application ‘dossier’? A full application for a marketing authorisation would normally comprise a comprehensive data package with quality documentation, safety data (including target animal safety
Timetable: Initial (Full) Marketing Authorisation ...
www.ema.europa.eu(¬) This timetable is not applicable to Advanced Therapy Medicinal Products (ATMPs); for these the applicant should refer to the timetable for initial …
Practical user guide for electronic Application Forms (eAF ...
esubmission.ema.europa.euPage 7 of 83 1.3. Application for a change to existing marketing authorisation leading to an extension as referred to in Annex I of Regulation (EC) no …
BEST PRACTICE GUIDE For Type IB Variations …
www.hma.eu1.5 A marketing authorisation holder (MAH) may also submit several Type IB and/or Type II variations to one or more of their products in a single
Arnicare Arnica 30c pillules NR 01175/0181 UKPAR - GOV.UK
www.mhra.gov.ukMHRA PAR; ARNICARE ARNICA 30C PILLULES, NR 01175/0181 4 INTRODUCTION The MHRA granted a homeopathic marketing authorisation for the homeopathic
e-Voke 10mg Electronic Inhaler PL 42601/0003 e …
www.mhra.gov.ukUKPAR e-Voke 10 & 15mg Electronic Inhaler PL 42601/0003-4 4 granted on 19 November 2015, the current marketing authorisation holder is Nicovations
CMD(h) BEST PRACTICE GUIDE ON THE …
www.hma.euBPG on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures Rev.5, November 2008 Page 2/11 The principle applies that the marketing authorisation holder may apply for a renewal earlier than
Harmonised Technical Guidance for Non-eCTD …
esubmission.ema.europa.euThis guidance does not apply to the electronic submission of p-marketing authorisation (re MA) information such as scientific advice, clinical trial applications, orphan drug designations, PIP submissions and related submission
EU COMMUNITY REGISTER OF MEDICINAL …
ec.europa.eucontents eu community register of medicinal products - frequently asked questions..... 1 what is a marketing authorisation?
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