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The New EU (European Union) Animal Health Legislation for Veterinary Medicinal Products Training Course
The programme will offer a comprehensive introduction to the new EU Regulation (2019/6) and will address the changes and implications to the industry including marketing authorisations, submissions and dossiers.
*INCLUDES: Interactive discussion sessions*
Details
Course overview
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
Who should attend?
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
- Personnel who are new to the animal health industry and all those needing an overview of the new legislation
Programme
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
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
- 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
Presenter
Julian Braidwood (More...)
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. Triveritas provides specialist contract services to Animal Health and related companies. Triveritas develops veterinary vaccines and medicines by providing comprehensive services in veterinary regulatory affairs, regulatory maintenance, international clinical trials, QA, project/study management, and training. A tailored start to finish service takes client projects from proof of concept through to multi-national registrations.
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5-6 May 2021 Live webinar |
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5-6 May 2021 Live webinar |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,63 Until 24 Mar* |
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to attend Live webinar |
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2-3 Nov 2021 Live webinar |
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2-3 Nov 2021 Live webinar |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,63 Until 21 Sep* |
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to attend Live webinar |
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4-5 Nov 2021 Face-to-face, (venue not yet confirmed) |
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4-5 Nov 2021 Face-to-face (venue not yet confirmed) |
GBP 1,399 1,199 EUR 1,959 1,679 USD 2,182 1,87 Until 23 Sep* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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* Note the early booking discount cannot be combined with any other offers or promotional code