31 January 2017 EMA/827463/2016 Veterinary Medicines Division

Implementation plan for the centralised procedure: QRD template v.8.1 The Quality Review of Documents (QRD) Group, the CMDv and the CVMP have revised the veterinary product information (PI) templates. This revision comes after 4 years of experience with the previous version. The template for each EEA language, as well as an annotated template in English (clean and tracked changes), are available on both the EMA and CMDv websites. A separate implementation plan is published on the CMDv website for MRP/DCP/purely-national MAs. 1) For new initial marketing authorisation (MA) applications via the centralised procedure: Applicants should comply with PI template v.8.1 at time of submission. However, any veterinary medicinal product with a submission scheduled within 2 months of publication of PI template v.8.1 will be allowed to comply during the course of the procedure, see section 2.1 below. 2) For ongoing applications via the centralised procedure: a. Ongoing initial MA applications Any initial MA application already submitted at the time of publication of PI template v.8.1 should switch to it during the course of the procedure, preferably using existing time-points in the procedure when a submission of documents is foreseen (e.g. Day 121 responses to questions) and, at the latest, by Day 181. This applies even if no specific questions are asked on the draft product information during the MA application procedure. However, considering the time constraints, new MA applications with a CVMP opinion scheduled within two months of the date of publication of PI template v.8.1 will not be required to adjust to the new version (unless the applicant wishes to do so). In this case, alignment with PI template v.8.1 should take place post-authorisation, see section 3 below. b. Ongoing post-authorisation applications Marketing Authorisation Holders (MAHs) with post-authorisation applications ongoing at the date of publication of PI template v.8.1 who wish to switch to it before the end of the procedure should request this on a case-by-case basis using the email address: [email protected] Where it is possible to switch within an ongoing post-authorisation affecting the PI, this is strongly encouraged.

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 E-mail [email protected] Website www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

3) For existing MAs granted via the centralised procedure: MAHs should align the PI with template v.8.1 at the next post-authorisation procedure affecting the PI (e.g. variation, line extension) and at the latest by the time of renewal of the MA (if applicable).

Applicants/MAHs wishing to discuss the consequences of PI template v.8.1 for their product(s) may submit any questions to their nominated EMA project manager for initial MA applications or, for post-authorisation procedures, to [email protected]

Implementation plan for the centralised procedure: QRD template v.8.1 EMA/827463/2016

Page 2/2

Implementation plan (veterinary) - European Medicines Agency

Jan 31, 2017 - E-mail [email protected] Website www.ema.europa.eu ... 1) For new initial marketing authorisation (MA) applications via the centralised ...

74KB Sizes 1 Downloads 108 Views

Recommend Documents

Agenda - European Medicines Agency veterinary medicines ...
On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry loung

Veterinary pharmacovigilance 2016 - European Medicines Agency
Feb 16, 2017 - monitoring of several centrally authorised products ..... regulatory tools within the EU that are ... Following to this, a Rapid alert was circulated.

Veterinary - European Medicines Agency - Europa EU
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000171.js p&mid=WC0b01ac058002d9ab). Scientific advice received from the .... The secretariat of the SAWP-V will be in charge of validation and processing of the req

Action plan - European Medicines Agency - Europa EU
5 days ago - Guidelines should include more details on the principles of good information design in which content and layout are ... relevance and importance of the QRD template is also acknowledged in this respect as it is the main tool .... databas

Report - European Medicines Agency
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.

8th annual report veterinary - European Medicines Agency - Europa EU
Mar 15, 2018 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 .... 20. 25. 30. 35. 2009. 2010. 2011. 2012. 2013. 2014. 2015. 2016. 2017. Outcome of MUMS/limited market (re)classification requests ... early stage of development but the pl

Human Medicines Highlights Newsletter - European Medicines Agency
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.

Human Medicines Highlights Newsletter - European Medicines Agency
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.

Public CVMP work plan - 2017 - European Medicines Agency
Dec 8, 2016 - Application of the 3Rs in Regulatory Testing of Medicinal Products (3R's) .................. 9 ... intended to stimulate development of new veterinary medicines for minor species and/or for rare diseases in .... throughout their lifecyc