Portal Veterinary medicinal products

Paragraph 13 of Article 58 of European Regulation 2019/06 specifies that the marketing authorisation holder shall without delay inform the competent authority which has granted the marketing authorisation or the Commission, as applicable, of any action which he intends to take in order to cease the marketing of a veterinary medicinal product prior to taking such action, together with the reasons for such action. The planned suspension or withdrawal the marketing marketing authorisation shall be declared to the ANMV as far in advance as possible, if possible 12 to 24 months before the last batches are no longer marketed. This declaration use the reporting template available on the ANSES website. The corresponding email should be sent to DQ_ANMV@anses.fr . Declaration sheet After examining the data provided, the impact of the marketing suspension on the national market is assessed by Anses-ANMV. In the event of a major impact, the search for transitional and alternative measures is continued. At the same time, the SIMV is informed of the withdrawal of MA project, with the agreement of the marketing authorisation holder (or its representative). Manufacturers interested in taking over marketing authorisations can then directly contact the SIMV (contact@simv.org). “ Good practices for the management of these declarations ” specify the actions to be taken by each of the participants as well as the modalities of exchanges. The advance declarations do not replace the official information to the ANMV (enreg@anses.fr) on the abandonment of marketing authorisation, which will be completed in the month preceding the exact date of abandonment.

The issue of medicinal products supply shortages is a major topic for both animal and human health. In veterinary medicine, the holders or their representative (responsible for placing on the market) are obliged to report to Anses any risk of shortage of a veterinary medicinal product which could lead to a risk to human health, animal health or animal welfare.

The combined effects of climate disruption and human activities have created disturbances in the Earth’s ecosystems that are impacting the health of living organisms. Allergenic plants, mosquitoes and ticks have been spreading across France, affecting human and animal health. In forests, gardens and crops, plant pests and other harmful organisms are acclimatising rapidly. This year on the ANSES stand, we invite you to come take a closer look at these invasive species, so you can recognise them and protect yourself. Our programme for this year includes observation of living organisms, games and discussions with our scientists. And in a nod to this year's Olympic Games, ANSES will also provide an opportunity to learn while moving your body.

EU4H11 (Joint Action on quality of medicines and implementation of the pharmaceutical legislation/strategy) is part of the EU4Health programme funded by the European Commission. The total budget of this Joint Action amounts to more than 3 million EUR, 80% of the costs will be co-financed by the European Commission. The project aims at strengthening capacities of EU/EEA GMP/GDP inspectorates in the global vision of mutual reliance of inspection data to better ensure quality of medicinal products and protection of Public Health.

ANSES’s work contributes to the fight against antimicrobial resistance. To mark World Antibiotic Awareness Week, the Agency is publishing the data collected in 2022 from: the monitoring of sales of veterinary medicinal products containing antimicrobials the French surveillance network for antimicrobial resistance in pathogenic bacteria of animal origin (Resapath) the European scheme for monitoring antimicrobial resistance in the food chain The Agency is also offering another look at its expert appraisal work on the transmission of antibiotic-resistant bacteria from animals to humans.

On 2 October 2023, ANSES received a report involving the case of a young girl who was hospitalised in serious condition following the use of insecticides intended for treating parasites in cattle. Every year, the Agency is informed of cases where antiparasitics intended for animals are used to treat head lice in children. It reiterates that antiparasitic treatments for animals should never be used on human beings, especially children.

Three cattle in France have been diagnosed with epizootic haemorrhagic disease (EHD). They are the very first cases to have occurred in this country. They were confirmed on 18 September 2023 by the ANSES Laboratory for Animal Health, which is the reference laboratory for this disease in France and for the World Organisation for Animal Health (WOAH). The cases were reported in the Pyrénées-Atlantiques and Hautes-Pyrénées départéments.