The New EU Animal Health Legislation for Veterinary Medicinal Products (London, United Kingdom – May 12-13, 2020) – ResearchAndMarkets.com
DUBLIN–(BUSINESS WIRE)–The “The New EU Animal Health Legislation for Veterinary Medicinal Products” conference has been added to ResearchAndMarkets.com’s offering.
The new EU Regulation (2019/6) on Veterinary Medicinal Products will be applicable for all EU countries from 28 January 2022 and 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 for supply and use, off-label use and inspection controls will also be covered.
This is a must-attend seminar for all animal health professionals.
Benefits of attending:
- Be prepared for the revolutionary changes to the EU legislation
- Gain essential guidance on the implications of the changes
- Understand how this will affect you and your company
- Hear the implications on variations
- Be aware of the opportunities the changes will create
- Comply with data protection and routes to market
- Understand the post-market measures
- Plan for the impact on supply and use
Agenda:
Day one
Introduction
- Understanding EU legislation
- The EU legal framework
- Current directives and regulations
- Implementation of the new regulation
Overview of EU Regulation (2019/6)
- Goals of the new Regulation
- Highlights of the nine legal chapters
Scope, general provisions and rules
- New definition of VMPs
- 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
Day two
Limited MAs, referrals, homoeopathy, manufacturing
- Limited market and exceptional MAs
- Union interest referral procedure
- Homoeopathic products
- Manufacturing authorisations including public database
Supply and use
- Wholesalers
- Retailers including internet sales
- Veterinary prescriptions
- Use, record-keeping, use of immunologicals
- Vets providing services in the 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
Speakers:
Julian Braidwood
Veterinary Surgeon and R&D Director
Triveritas
Dr Julian Braidwood qualified as a Veterinary Surgeon and worked in mixed practices before spending fifteen years in R&D and Regulatory departments of five leading Animal Health companies.
He has managed clinical trials and regulatory groups, experimental facilities, laboratories, and worked internationally in many countries. Having become an R&D Director within the industry, he formed Triveritas in 2000 which has grown rapidly throughout Europe and North America and has offices in UK, France, Germany, Poland and USA.
For more information about this conference visit https://www.researchandmarkets.com/r/54ycbr
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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