A sector with great potential and strategic stakes, the market for veterinary products, medicinal products and medicated feeds, has been subject to major regulatory changes in recent years, driven by the ambition to strengthen the single market. The adoption of the veterinary pharmaceutical package in December 2018 led to the adoption of a specific regulatory framework for veterinary products, which had long been treated as medicinal products for human use.

A cross-sectional view of veterinary products and medicines

Thanks to the experience of its partners in health authorities, laboratories and firms dedicated to the health industries, ELSI has developed specific expertise and a recognised practice in regulatory issues and problems, in their economic, commercial and competitive context, thus giving it a cross-sectoral approach and mastery of the pharmaceutical sector, both human and veterinary.

As a player in pharmaceutical law, ELSI has extensive experience in the health industry and works on behalf of its clients in the development, negotiation, implementation and protection of their commercial policy and economic activities.

Thanks to its particular expertise in administrative law applied to health products, ELSI also intervenes on issues related to market access, anti-gift system and advertising of health products as well as all procedures related to pharmaceutical establishments (inspections, etc.) and assists operators, pharmaceutical laboratories, in their dealings with the health authorities.

veterinary products, Our main areas of intervention

  • Regulatory support to national and European health authorities (ANMV, ANSES, inspection, health policy decisions (DPS), etc.)
  • Compliance, Anti-Gift & Health Transparency Law (AGLT)
  • Establishments (opening, ANMV inspection, ANSES)
Contract & commercial policy (Drafting, proofreading, follow-up and advice)
  • Contracts related to pharmaceuticalsupply: Research & Development (R&D), manufacturing, processing, subcontracting, purchasing and supply
  • Contracts related to marketing: operation, licence, distribution, single agreement, commercial agency, commission on sale, mandate, promotion, co-promotion, co-marketing, vigilance, etc.
  • Other commercial contracts: services, partnership agreements, cooperation agreements, market research, confidentiality agreements (NDA), general terms and conditions of sale (GTC) and use (GTU)
  • Unfair competition: free-riding, denigration, violation of advertising rules
Litigation and liability
  • Product liability
  • Negotiation & transaction
  • Appeals against decisions of health authorities
  • Commercial litigation
Health data
  • Identification of personal data
  • GDPR compliance
  • Personal data policy
  • Securing contracts
  • Support for digital projects

A specific legal framework for veterinary products and medicinal products

Three European regulations were successively adopted on 11 December 2018: Regulation (EU) No. 2019/6 on veterinary medicinal products and repealing Directive 2001/82/EC, Regulation (EU) No. 2019/4 on the manufacture, placing on the market and use of medicated feedingstuffs, and Regulation (EU) No. 2019/5 on the centralised marketing authorisation procedure in order to dissociate it from the procedure applicable to medicinal products for human use.

With regard to veterinary medicinal products, these texts have clarified and simplified the marketing authorisation(MA) procedures and strengthened pharmacovigilance, in particular through the signal detection mechanisms. As a corollary to simplification, transparency has also been strengthened by the establishment of the central EU database listing all authorised medicines in the EU. Specific measures for the sale of veterinary medicines now constrain the sector, limiting online sales to non-prescription medicines and banning the advertising of veterinary prescription medicines to the general public, with the exception of certain vaccine campaigns in the agricultural press. The fight against antibiotic resistance is also at the heart of these new challenges, and imposes specific measures such as limiting the use of certain antibiotics and banning their use for prevention.

The regulation of medicated feeds has also undergone major changes, impacting on theapproval of operators in the animal feed sector and their obligations regarding manufacture. The use of medicated feed for prophylactic purposes is also prohibited.

The submission of veterinary medicinal products to the provisions of the anti-fraud law since Law No. 2014-1170 on the future of agriculture, food and forestry(LFAFF) of 14 October 2014, imposes constraints and particular vigilance in relations with veterinarians, veterinary establishments and MSEs.

Other issues are also driving the sector, such as animal welfare and the optimisation of breeding conditions, which are changing the practices and strategies of laboratories. This constrained regulatory framework places veterinary medicines and products at the heart of new strategies, for which the use of a lawyer specialising in pharmaceutical and veterinary product law makes it possible to secure and carry out all of your projects at each stage of the life cycle of your products.

Discover our other expertise

regulatory affairs

Marketing, advertising, health police, establishments, anti-gift & transparency


Business law

Contract law, commercial, advertising, distribution, restrictive practices, anti-competitive practices


Litigation and liability disputes

Commercial litigation, defective products, appeals against authorities' decisions, communication & crisis management


Personal data - Health data

GDPR, CNIL methodology, health data hosting
securing contracts, support for digital projects



Legal and regulatory updates, skills upgrading, find out about all our tailor-made offers


anti-gift & transparency

Our outsourcing offer, the subcontracting of your anti-gift activities & health transparency


consulting & subcontracting subscriptions

Subscriptions to regulatory advice, audit packages, find out about all our subscription and subcontracting offers


interim management

Transformation, temporary surge, implementation of new processes, crisis management



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