Management Forum courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

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.

16-17 May 2022

& 3-4 Nov 2022

Book now

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...)

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.

Book now

Book now

16-17 May 2022
Live webinar
16-17 May 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 11 Apr 22*
Enrol now
to attend
Live webinar
3-4 Nov 2022
Live webinar
3-4 Nov 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 29 Sep 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Beaphar B.V.
  • Bela-Pharm GmbH & Co. KG
  • Benchmark Vaccines Limited
  • Boehrigner Ingelheim VRC GmbH & Co. KG
  • BOEHRINGER INGELHEIM - ANIMAL HEALTH FRANCE
  • Boehringer Ingelheim Animal Health Nordics A/S
  • Boehringer Ingelheim Animal Health UK Ltd.
  • Cargill R and D Centre Europe
  • Chef du Monde
  • Cross Vetpharm Group UK Ltd
  • Delaval NV
  • Elanco Animal Health
  • Elanco Deutschland GmbH
  • European Medicines Agency
  • FATRO S.p.A.
  • Hifarmax, Produtos e Serviços Veterinários, Lda.
  • Norbrook Laboratories Ltd
  • Nutreco Nederland BV
  • Pharmacosmos
  • Pharmacosmos A/S
  • Prionics Lelystad B.V.
  • Regivet BV
  • Research and Markets
  • Univet Ltd
  • Vana GmbH
  • Vetcare Ltd
  • Vetcare Oy
  • Vetoquinol Biowet
  • VETOQUINOL S.A.
  • Zoetis Deutschland GmbH

Very good!

Ruud Huibers, Advisor Regulatory Affairs Pharma EU, Elanco Deutschland GmbH, May 21

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, Nov 20

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, Dec 19

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, Dec 19

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, Mar 19