The New EU Animal Health Legislation for Veterinary Medicinal Products

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. This is a must-attend seminar for 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
• Be aware of the opportunities the changes will create
• Comply with data protection and routes to market
• Understand the post-market measures
• Hear the implications on variations
• Plan for the impact on supply and use

This seminar will be beneficial to all those working in the animal health industry including:

• Regulatory affairs managers
• R&D associates
• Manufacturing professionals
• Sales and marketing managers
• Directors and CEOs
• New personnel to the animal health industry and all those needing an essential overview of the new legislation

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

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