Presented by
Management Forum
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.
★★★★★ "Julian was speaking in clear language and in a nice tempo (not to quick, not to slow). He acted imme... more"
- Format: Bespoke training
- CPD: 12 hours for your records (depending on your requirements)
- Certificate of completion
- A Practical Approach to Veterinary Vaccine Development and Registration in the EU
- Registration of Veterinary Vaccines in the USA and Canada
- The New EU Animal Health Legislation for Veterinary Medicinal Products
- Veterinary Pharmaceutical Submissions in the EU
- Working Through Veterinary Drug Development in the EU and USA
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
The The New EU Animal Health Legislation for Veterinary Medicinal Products course will cover:
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
Julian Braidwood
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. Julian 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 co-founded Triveritas in 2,000 which grew rapidly internationally and became part of knoell in 2021. knoell is one of the leading service providers for worldwide registration and regulatory compliance in crop protection, crop nutrition, chemicals, cosmetics, animal health products, and medical devices. The knoell Group employs almost 600 people worldwide in more than 14 countries.
knoell is the only knowledge-based animal health consultancy and clinical studies specialist with its own technical staff based on three continents: North America, Europe, and Asia. The animal health team offers a full portfolio of services, including start-to-finish product development and ad hoc services – in all domesticated species for pharmaceuticals and biologicals, feed additives, novel, generic and borderline products.
Reviews of IPI's The New EU Animal Health Legislation for Veterinary Medicinal Products training course
Julian was speaking in clear language and in a nice tempo (not to quick, not to slow). He acted immediately if a participant wanted to ask a question...Very good, very comprehensive.
Nov 2 2021
Tonny van Dijk 
Sr. Regulatory Affairs Specialist, Prionics Lelystad B.V.
Nov 2 2021
It was very interesting, thorough and informative. I enjoyed following the course and listening to the presenter.
Rachael Benjamin
Regulatory Affairs Officer, Beaphar B.V.
Nov 2 2021
I really thought Julian was excellent, very engaging, and really informed
Siobhan Crowe 
Pharmacist, Univet Ltd
May 5 2021
Very good!
Ruud Huibers 
Advisor Regulatory Affairs Pharma EU, Elanco Deutschland GmbH
Nov 2 2021
was really good for me as I am just starting my activities on VMP and I need to understand more new regulation
Karine Tanan 
Principal Scientist, Scientific and Regulatory Affairs, Cargill R and D Centre Europe
Nov 2 2021
I wanted to hear about the new animal health legislation - which Julian Braidwood succeeded in doing.
Marianne Valentin Hansen 
Drug Safety Specialist, Pharmacosmos
Nov 2 2021
I wanted to get more familiar with the new legislation, to understand a bit more about its background. This course helped me a lot in understanding more of the thoughts behind the various articles.
Charlotte Jacobs
Regulatory Affairs Officer, Beaphar B.V.
Nov 11 2020
Content = good however some of the points were of little relevance to me. Presentation = excellent. Very clear slides and the speed of delivery was perfect. Speaker = excellent. Very knowledgeable and happy to discuss topics in depth if required
Rodney Cartmill 
Head of Regulatory Affairs - New Products, Norbrook Laboratories Ltd
Dec 9 2019
The main themes of the new Regulation were presented in a precise but detailed manner and this, coupled with the extensive knowledge and sympathetic manner of the speaker, make the course something special.
Heike Luckow
Regulatory Affairs, Bela-Pharm GmbH & Co. KG
Mar 6 2019
Julian was a fantastic presenter, with excellent examples of real-life scenarios making a potentially dry course thoroughly enjoyable.
Jennifer Hynes
Quality Manager, Benchmark Vaccines Limited
Dec 9 2019
An interesting, informative and interactive two-day course which provided a clear overview and explanation of the most important changes that we can expect as a result of the 2019/6 Legislation. It is not easy to keep the audience interested while explaining a new law but Julian managed to do this excellently.
Kitty Ruigrok
DVM, Regivet BV
United Kingdom
- Benchmark Vaccines Limited
- Boehringer Ingelheim Animal Health UK Ltd.
- Boehringer Inghelheim Animal Health Netherlands B.V.
- Cross Vetpharm Group UK Ltd
- Elanco Animal Health
- Norbrook Laboratories Ltd
- Parexel International Ltd.
Netherlands
- Beaphar B.V.
- DADA Consultancy BV
- European Medicines Agency
- Nutreco Nederland BV
- Prionics Lelystad B.V.
- Regivet BV
Germany
- Bela-Pharm GmbH & Co. KG
- Boehrigner Ingelheim VRC GmbH & Co. KG
- Elanco Deutschland GmbH
- Zoetis Deutschland GmbH
Denmark
- Boehringer Ingelheim Animal Health Nordics A/S
- Pharmacosmos
- Pharmacosmos A/S
Belgium
- Cargill R and D Centre Europe
- Delaval NV
Finland
- Vetcare Ltd
- Vetcare Oy
France
- Merial - Boehringer Ingelheim
- VETOQUINOL S.A.
Austria
- Vana GmbH
Ireland
- Univet Ltd
Israel
- biovac
Italy
- Fatro Spa
Poland
- Vetoquinol Biowet Sp. z o.o.
Portugal
- Hifarmax, Produtos e Serviços Veterinários, Lda.
Spain
- Chef du Monde
Run The New EU Animal Health Legislation for Veterinary Medicinal Products Bespoke training for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
