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.
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(LAAAF) 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.
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An investigation by the DGCCRF in 2021 led to the penalization of 6.6 million euros for illegal practices by the URGO group.
Medical device law
An amendment to the WDR has just been proposed by the European Commission to postpone the entry into force of the WDR.