AP NEWS

2-Day Seminar: The New EU Animal Health Legislation for Veterinary Medicinal Products (London, United Kingdom - March 6-7, 2019) - ResearchAndMarkets.com

January 22, 2019

DUBLIN--(BUSINESS WIRE)--Jan 22, 2019--The “The New EU Animal Health Legislation for Veterinary Medicinal Products” conference has been added to ResearchAndMarkets.com’s offering.

The new EU animal health legislation (EU Regulation 2019/6) for veterinary medicinal products will have massive implications for all animal health companies operating in, or wanting to operate in the EU. This seminar will provide essential insight into these revolutionary changes and enable participants to plan their regulatory strategies going forward.

The programme will offer a comprehensive introduction to the legislative changes and will address the new issues, marketing authorisation (MA) submissions and dossiers. Data protection and routes to market will be discussed, as will post-marketing measures and variations. The implications on supply and use, off-label use and inspection controls will also be addressed.

Agenda

Programme Day 1

Welcome and introduction

Understanding EU legislation The EU legal framework Current directives and regulations Implementation of the new regulation

Overview of the new regulation

Goals of the new regulation Highlights of the nine legal chapters

Scope, general provisions and rules

New definition of VMPs Marketing authorisation (MA) submissions Dossiers: full, abridged, limited and exceptional applications New clinical trial authorisation issues Labelling, package leaflet, pictograms

General rules

Applications: examination, withdrawal Classification as Rx or not SPC requirements MA granting and refusals Antimicrobial exclusions and restrictions

Data protection and routes to market

Protection periods: generics, prolongations and patents New centralised MA National, DCP and MRP Coordination group and re-examination

Post-marketing measures

Union product database, initial sales Antimicrobial data collection MA holder responsibilities National help desks for SMEs New additional countries after MRP and DCP

Variations

Assessment or not, groups, work sharing Harmonisation of similar old national SPCs (high/low risk) Union PV system and database, public access, reporting

Discussion

Programme Day 2

Limited MAs, referrals, homeopathy, manufacturing

Limited market and exceptional MAs Union interest referral procedure Homeopathic products Manufacturing authorisations including public database

Supply and use

Wholesalers Retailers including internet sales

Supply and use (continued)

Veterinary prescriptions Use, record-keeping, use of immunologicals Vets providing services in other Member States

Off-label use

For food and aqua species Withdrawal periods Antimicrobials

Various

Listed diseases Exemptions for certain pets Immunologicals from third countries Advertising

Inspections and controls

Commission checking Member States systems Restrictions and sanctions

Regulatory network

Competent authorities International organisations outside the EU CVMP CMDv including majority voting

Discussion

For more information about this conference visit https://www.researchandmarkets.com/research/bphqgl/2day_seminar?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20190122005554/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Animal Healthcare/Veterinary

KEYWORD: UNITED KINGDOM EUROPE

INDUSTRY KEYWORD: EDUCATION HEALTH TRAINING VETERINARY

SOURCE: Research and Markets

Copyright Business Wire 2019.

PUB: 01/22/2019 08:52 AM/DISC: 01/22/2019 08:52 AM

http://www.businesswire.com/news/home/20190122005554/en

AP RADIO
Update hourly