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What are the health and environmental challenges presented by herbicide-tolerant varieties?

Published on 18/06/2021

Herbicide-tolerant varieties (HTVs) are crop varieties that have been developed to be intentionally tolerant to a specific herbicide. In France, HTVs of sunflower and rapeseed have been growing in popularity since the early 2010s. In a changing regulatory context and in order to address public concerns, the Agency has conducted several studies to assess the farming practices reshaped by the use of HTVs and identify their potential risks for farmers, consumers and the environment. We provide an overview of the challenges that need to be overcome to improve the traceability and monitoring of HTVs in France.

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Application for official release of a batch of inactivated or live rabies vaccines for veterinary use

Updated on 19/01/2021

In accordance with the provisions of Article R. 5141-81 of the Public Health Code, ANSES-ANMV carries out official batch releases of immunological products (OCABR) for rabies vaccines. Batches of inactivated or live rabies vaccines for veterinary use placed on the market in France are subject to an official batch release by the ANMV, which is the competent national authority. This official batch release includes an analysis of the documents relating to the batch manufacture and analytical controls carried out at ANSES's Nancy Laboratory.

Stock shortages of veterinary medicinal products

Updated on 12/01/2021

A stock shortage is defined as a situation in which it is impossible for a beneficiary to obtain supplies of a veterinary medicinal product on the national market. A stock shortage is assessed as critical when it is likely to induce a risk to human health, animal health and welfare.

Quality control of veterinary medicinal products

Published on 08/04/2020

Each year, within its laboratory, the ANMV's Market Surveillance Unit verifies a series of veterinary medicinal products marketed in France.

Quality defect in a veterinary medicinal product

Published on 08/04/2020

The veterinary medicinal product manufacturer ensures the quality of each batch before placing it on the market. However, there may be occasions when the manufacturer only becomes aware of an incident that occurred during manufacture or distribution after the medicinal product has been marketed. If the medicinal product does not comply with its marketing authorisation, this is known as a quality defect.

Advertising of veterinary medicinal products

Updated on 22/04/2020

ANSES-ANMV is responsible for controlling the advertising of veterinary medicinal products. For this reason, all advertising documents must be submitted to the Agency, and some even require authorisation, before being distributed. 

COVID-19 cannot be transmitted by either farm animals or domestic animals

Published on 01/04/2020

Keywords : COVID-19

The emergence in China in late 2019 of a new coronavirus disease, COVID-19, and its rapid spread around the world have led researchers and health authorities to take prompt and widespread action to better understand the virus involved and how we can protect ourselves from it. It soon emerged that this virus, named SARS-CoV-2, is transmitted from person to person. In France, ANSES was asked to review the available scientific knowledge and assess the possibility of COVID-19 being transmitted via domestic animals or contaminated food. ANSES published its report on 11 March 2020. On the basis of the scientific knowledge available at the time, it concluded that there was no evidence that pets or farmed animals played any role in the spread of the disease. Furthermore, there is nothing to suggest that consumption of contaminated food can lead to infection via the digestive tract.

URGENT : the French agency for veterinary medicinal products works remotely as of March 17th, 2020

Published on 23/03/2020

Considering the rapidly changing health situation in France, all the staff of the French agency for veterinary medicinal products works remotely as of March 17th, 2020. Therefore, core safety functions shall remain available remotely. You can reach your regular contacts at  the French agency for veterinary medicinal products by e-mail or telephone. See the list of your contacts on the attached link.  

Legal classification of "borderline" products

Updated on 08/04/2020

The French Agency for Veterinary Medicinal Products (ANSES-ANMV) is regularly called upon to qualify the legal status of products with regard to French and EU regulations and to determine whether these products, their placing on the market, their production and distribution fall within the scope of the regulations on veterinary medicinal products. To do this, ANSES-ANMV relies on the definition of a veterinary medicinal product according to European Directive 2001/82/EC as amended, which has been transposed into Articles L. 5111-1 and L. 5141-1 of the Public Health Code.

Batch recall of a veterinary medicinal product

Updated on 08/04/2020

A batch recall is considered following identification of a quality defect or pharmacovigilance problem, or following a decision to suspend/revoke a marketing authorisation or temporary authorisation for use.

Good Laboratory Practice (GLP)

Updated on 08/04/2020

The aim of good laboratory practice is to guarantee the quality and integrity of data obtained in non-clinical trials carried out on veterinary medicinal products with a view to obtaining marketing authorisation, so that these data can be recognised internationally (in particular by OECD Member States) without the need to duplicate studies. GLP is a quality assurance system covering the way in which non-clinical safety studies relating to human and animal health and the environment are organised and the conditions under which these studies are planned, performed, monitored, recorded, reported, archived and disseminated.  

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