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 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
