2-Day Seminar: The New EU Animal Health Legislation for Veterinary Medicinal Products (London, United Kingdom - March 6-7, 2019) - ResearchAndMarkets.com
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.
Programme Day 1
Welcome and introductionUnderstanding EU legislation The EU legal framework Current directives and regulations Implementation of the new regulation
Overview of the new regulationGoals of the new regulation Highlights of the nine legal chapters
Scope, general provisions and rulesNew definition of VMPs Marketing authorisation (MA) submissions Dossiers: full, abridged, limited and exceptional applications New clinical trial authorisation issues Labelling, package leaflet, pictograms
General rulesApplications: examination, withdrawal Classification as Rx or not SPC requirements MA granting and refusals Antimicrobial exclusions and restrictions
Data protection and routes to marketProtection periods: generics, prolongations and patents New centralised MA National, DCP and MRP Coordination group and re-examination
Post-marketing measuresUnion product database, initial sales Antimicrobial data collection MA holder responsibilities National help desks for SMEs New additional countries after MRP and DCP
VariationsAssessment or not, groups, work sharing Harmonisation of similar old national SPCs (high/low risk) Union PV system and database, public access, reporting
Programme Day 2
Limited MAs, referrals, homeopathy, manufacturingLimited market and exceptional MAs Union interest referral procedure Homeopathic products Manufacturing authorisations including public database
Supply and useWholesalers 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 useFor food and aqua species Withdrawal periods Antimicrobials
VariousListed diseases Exemptions for certain pets Immunologicals from third countries Advertising
Inspections and controlsCommission checking Member States systems Restrictions and sanctions
Regulatory networkCompetent authorities International organisations outside the EU CVMP CMDv including majority voting
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/
Laura Wood, Senior Press Manager
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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