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Veterinary medicine - ANMV

The French Agency for Veterinary Medicinal Products (ANMV), within ANSES, is the Competent Authority in France for risk assessment and management with regard to veterinary medicinal products.

In this capacity, the Government was keen for the ANMV to strive for constant improvement of its services with a view to protecting public health as well as the health and welfare of animals.

To this end, the ANMV must enforce the current applicable legal provisions in an independent, competent and impartial manner. Click here to find out more about the Agency’s history.

The ANMV is located in Javené, near Fougères (Ille-et-Vilaine) and has 80 staff members, mainly specialised scientists.

 

 

 

 

Declaring an adverse effect that may be due to a veterinary medicinal product (in French)

Sector professionals

List of veterinary pharmaceutical manufacturers and wholesalers (in French)

 

Marketing authorization (AMM) no./National Working Group (GTIN) code correspondence table (in French)

News

To limit environmental exposure to antibiotics in veterinary medicine treatments
22/06/2022
News

To limit environmental exposure to antibiotics in veterinary medicine treatments

Many antibiotics are used in both humans and animals. As part of the One Health approach, the Veterinary Medicines Monitoring Committee, attached to the Director of Anses-ANMV, has just published an article on the impact of antibiotics on the environment.
Storage of veterinary medicines and recommendations during heatwaves
21/06/2022
News

Storage of veterinary medicines and recommendations during heatwaves

Veterinary medicine quality is vital and must be ensured throughout the pharmaceutical chain, from design until use. Each participant in the chain has an influence on one or more parameters and needs to take precautions to guarantee and maintain veterinary medicine quality. During the summer, especially in cases of high heat, the storage of veterinary medicinal products may be affected; beyond 40 °C, there are risks of irreversible degradation (quality, effectiveness) or even toxicity (formation of degradation products). The French Agency for Veterinary Medicinal Products also makes recommendations for storage of medicinal products and storage conditions during transport. The Agency's recommendations Storage +2°C to +8°C: Store in a refrigerated cabinet with temperature monitoring. Vaccines should be stored in a refrigerated cabinet unless specifically stated otherwise. <25°C to 30°C: In the event of hot weather, avoid prolonged exposure to high temperatures. If there are no specific instructions, store at room temperature. The same precautions should be applied during hot weather. Store medicines in their packaging, away from light and moisture. Store medicines away from other products in order to limit the risk of confusion and/or cross-contamination (if possible in separate refrigerated cabinets): plant protection products, biocides, medicines for human use, nutritional supplements, food, etc. Transport The storage conditions specified in the package leaflet or label should be observed during transport until the veterinary medicine is used. Medicines to be stored between +2°C and +8°C: Transport under conditions that comply with the cold chain but do not cause the product to freeze (refrigerated insulated container without direct contact between the eutectic plates and the medicine's packaging). Medicines to be stored below 25°C or 30°C and medicines to be stored at room temperature: Avoid prolonged exposure to high temperatures. Limit stock kept in cars to what is strictly necessary for immediate use, if possible. Recommandations during heatwaves Generally speaking, temperatures above 40°C expose a drug to the irreversible deterioration of its quality and effectiveness, or even to risks of toxicity due to the formation of degradation products. Medicines to be stored between +2°C and +8°C: These sensitive drugs should be used promptly after removal from the refrigerator, unless the instructions state that the product should come to room temperature before administration. They should be transported under conditions that comply with the cold chain but do not cause the product to freeze (refrigerated insulated container without direct contact between the eutectic plates and the medicine's packaging). The refrigerator temperature should be checked regularly (if possible with a min/max temperature measurement system in case there is a power failure or breakdown). Medicines to be stored below 25°C or 30°C and medicines to be stored at room temperature: During transport, limit exposure to high temperatures such as those frequently encountered in car boots or passenger compartments exposed to direct sunlight. As a precautionary measure, they should be transported in an unrefrigerated insulated container. Where it is not possible to guarantee storage under optimum conditions, exposed products should be replaced regularly. In each case, the product's appearance should be examined when it is opened, as any alteration indicates a change in the properties of the pharmaceutical form and/or a risk of degradation of the active substances. Products that are degraded or exposed to high temperatures must be replaced. The ANMV can offer advice in the event of any doubt and on a case-by-case basis regarding veterinary medicine quality in relation to any adverse storage conditions.
Overview of the European conference on the use of plants in veterinary medicine
20/05/2022
News

Overview of the European conference on the use of plants in veterinary medicine

The conference was organised in several sessions. In the first session, the context of the use of plants in veterinary medicine in the European Union was presented and the various stakeholders (farmers, veterinarians and pharmaceutical industries) were able to share their expectations and problems with the use of veterinary herbal medicines. Secondly, two experts from the Human Committee on Herbal Medicinal Products presented a feedback on the problems encountered in the authorisation of herbal medicinal products for human use compared to conventional chemical medicinal products. Then, the Anses-ANMV gave a feedback on the work carried out by France, in particular on the referral 2014-SA-0083 . Finally, these sessions continued with the presentation of the perspectives at European level by the EMA and the European Commission and the sharing of the views of the participants. Conference overview
Birth control pills for female cats and dogs must be prescribed by a veterinarian
19/05/2022
News

Birth control pills for female cats and dogs must be prescribed by a veterinarian

Birth control pills for pets can have serious side effects. They should therefore only be dispensed on prescription by a veterinarian and used in accordance with a number of recommendations.
PFUE — European Conference on the Use of Plants in Veterinary Medicine
08/04/2022
News

PFUE — European Conference on the Use of Plants in Veterinary Medicine

As part of the French Presidency of the Council of the European Union (PFUE), the French agency for veterinary medicinal products (Anses-ANMV) organised a European conference on the use of plants in veterinary medicine on 29 March. The conference, intended for the competent European authorities, was held remotely and attended 54 participants from outside the Anses.
Meeting of Heads of Agency (HMA) from 4 to 6 May 2022
12/05/2022
News

Meeting of Heads of Agency (HMA) from 4 to 6 May 2022

The French agency for veterinary medicinal products (Anses-ANMV) organised with Ansm (French agency for human medicines) the second meeting of Heads of Agency (HMA) from 4 to 6 May. The meeting was held at the Palais du Grand Large in Saint Malo with 90 participants from the competent European authorities, the European Commission and the European Medicines Agency (EMA). On the first day, a meeting was organised with stakeholders: representatives of the veterinary medicine industry, veterinarians, farmers and the veterinary diagnosis industry. Among other things, the meeting provided an opportunity to discuss the implementation of the Veterinary Regulations. On May 5th and 6th, the heads of medicines agencies met for a day and a half. At the veterinary session, the European strategy HMA-EMA 2021-2025 on “Big Data” was adopted as well as the Action Plan of the Network of Agencies’ 2025 Strategy. Part of this event was dedicated to medical devices for human use.
A new process for monitoring adverse reactions to veterinary medicines
04/05/2022
News

A new process for monitoring adverse reactions to veterinary medicines

A new EU-wide pharmacovigilance scheme has been launched with the new EU Regulation on veterinary medicinal products. It aims to manage the adverse effects of veterinary medicines and applies to all medicines authorised in at least one European Union country. We put three questions on this new process to Sylviane Laurentie, deputy director of the French Agency for Veterinary Medicinal Products, responsible for inspection, surveillance and pharmacovigilance.
Three new databases for greater transparency on veterinary medicinal products in Europe
07/03/2022
News

Three new databases for greater transparency on veterinary medicinal products in Europe

The new Regulation (EU) No 2019/6 on veterinary medicinal products provides for the creation of three databases, designed to improve access to and sharing of information on these products. Here is an overview of their objectives.
Human hormonal treatments: be careful not to expose your pets
21/01/2022

Human hormonal treatments: be careful not to expose your pets

In dogs and cats, repeated contact with their owner’s topical hormone replacement therapy can cause hormonal problems. Following reports of adverse effects in several European countries, ANSES-ANMV (French Agency for Veterinary Medicinal Products) is inviting owners to apply these medications with the necessary precautions to avoid exposing their pets.
What does the new European regulation on veterinary medicinal products change?
28/01/2022
News

What does the new European regulation on veterinary medicinal products change?

The new European regulation on veterinary pharmaceuticals came into force on 28 January 2022. The Director of the French Agency for Veterinary Medicinal Products (ANMV), Jean-Pierre Orand, assesses what will change.
ANSES at the 2022 Paris International Agricultural Show
26/02/2022

From 26/02/2022 to 06/03/2022

ANSES at the 2022 Paris International Agricultural Show

Tous les jours de 9h à 19h
Parc des expositions - Porte de Versailles, Paris - Hall 4, Allée B, stand n°118
Public : oui
Porte de Versailles, Paris 15e
Food is one of the pillars of our health. And yet an imbalanced diet or contaminated food can expose us to immediate risks and chronic diseases. As France's leading health agency on this topic, ANSES looks forward to seeing you at the 2022 Paris International Agricultural Show, at its stand dedicated to safe and healthy food. You will have the opportunity to discover how ANSES’s researchers and scientific experts work to protect us from risks ‘from farm to fork’, and help us adopt good daily hygiene and nutrition practices.
Phytotherapy and aromatherapy: adapting risk assessment in veterinary medicine
24/01/2022

Phytotherapy and aromatherapy: adapting risk assessment in veterinary medicine

Herbal preparations (phytotherapy) and essential oils (aromatherapy) are increasingly being used as alternatives to other “allopathic” medicinal products for the treatment of animals. This is true even for food-producing animals. If the products used have a therapeutic purpose, they are considered veterinary medicinal products.This means it should be possible to guarantee there is no risk to consumers of foods derived from treated animals. However, it is complicated to implement the current regulations to assess this risk for herbal medicinal products. ANSES therefore issued an internal request to propose a specific assessment methodology for herbal veterinary medicinal products.

Decryption

Use of mesenchymal stromal cells in horse medicine
07/05/2021

Use of mesenchymal stromal cells in horse medicine

Mesenchymal stromal cells as advanced therapies in veterinary medicines may have a therapeutic use in the treatment of osteo-articular degenerative affection in horses. Other therapeutic interests have yet to be discovered. A centralized marketing authorization was delivered for two veterinary medical product based on allogenic mesenchymal stromal cells, veterinarians also perform autologous ones. However, products based on autologous mesenchymal stromal cell, have to be produced by the veterinarian on expert platform, with all the necessary safety and quality controls because of the lack of standardized procedure. This article is available in the version of the authors above or in the technical supplement of the journal La Dépêche Vétérinaire n° 180 of October 2020.
Veterinary medicinal product marketing authorisation (MA)
07/05/2021

Veterinary medicinal product marketing authorisation (MA)

All pharmaceutical products must receive a Marketing authorisation (MA) before they can be sold in Europe. Pharmaceutical products are drugs that have been prepared in advance by a pharmaceutical company in accordance with good manufacturing practices (active ingredients and excipients). These products may be produced in one or several different forms (tablet, syrup, capsule, etc.).

For France, marketing authorisations are delivered by:

 

  • The French Agency for Food, Environmental and Occupational Health & Safety (ANSES), based on an opinion issued by the French Veterinary Medicinal Products Committee
  • the European Commission, based on an opinion issued by the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Agency (centralised procedure only).

MAs are delivered following an assessment of the benefit/risk ratio and the pharmaceutical quality of the drug (which must be found to be satisfactory), based on a dossier submitted by the requestor (future MA holder). The benefit/risk ratio takes into account the risks to human and animal health as well as risks to the environment.

Decisions concerning national MAs (authorisation, refusal, variation, renewal, suspension, transfer, withdrawal) are made by the Director General of ANSES based on an opinion issued by the French Veterinary Medicinal Products Committee. These opinions are the result of a technical and scientific assessment process based on the data from a dossier which is generally submitted by a pharmaceutical laboratory. This dossier contains the results of pharmaceutical and biological, pharmacological, toxicological and ecotoxicological studies, as well as clinical studies.  ANSES's assessment aims to evaluate the quality and safety of the medicinal product for the animal, the consumer, the user, the environment, as well as its efficacy.  

TABLE OF CONTENTS

1/ Export certification

2/ OCABR (Official batch releases of immunological products)

3/ Clinical trials

4/ Electronic submission of MA application dossiers for veterinary medicinal products

5/ Vaccination PRRS in pigs: the recommendations of the Anses to limit recombination of vaccine strains

6/ Use of mesenchymal stromal cells in horse medicine

Market surveillance
12/01/2021

Market surveillance

Quality control of authorised veterinary medicinal products is carried out by the ANMV laboratory. Every year, a control programme is drawn up based on a risk analysis. Medicinal products on the market are taken from wholesalers and analysed to ensure that they comply with the specifications validated in the MA. Leaflets and labels for authorised medicinal products, as well as updates, are also checked.
Reported quality defects are managed and monitored by means of a risk analysis, which may lead to batch recalls at the various stages of the distribution chain.
Stock shortages of veterinary medicinal products are reported to the Agency by manufacturers for a joint assessment of their criticality, monitoring and the identification of possible alternatives.
Advertisements for veterinary medicinal products must be systematically submitted to the ANMV and some of them may be subject to prior authorisation.
Legal classification of "borderline" products on the market serves to identify whether products fall within the scope of veterinary medicinal product regulations or other regulations such as those on biocides, animal feed, etc.
Work on the mapping of therapeutic gaps by animal species is continuing, with the organisation of meetings by sector to monitor developments. The aim is to seek therapeutic solutions to resolve these gaps by working with all stakeholders within the French animal health network (RFSA).
Each year, ANMV publishes an annual overall report on surveillance of the veterinary medicinal product market in France (see annual report 2018), and presents the results obtained from inspection of veterinary pharmaceutical establishments, pharmacovigilance and market surveillance.
The surveillance system for veterinary medicinal products developed in recent years by ANMV ensures that the veterinary medicinal products placed on the French market meet criteria relating to quality, safety and effectiveness. In this respect, the detection tools and systems developed have now proved their worth.
However, these tools can only function with the active participation of all the players in the veterinary medicinal product chain, and require the mobilisation and contribution of all.
To contact the Market Surveillance unit: usm@anses.fr
 
Contents - Market surveillance
•    Quality control of veterinary medicinal products
•    Quality defects 
•    Batch recalls
•    Stock shortages 
•    Advertising
•    Legal classification of "borderline" products

Antimicrobial resistance: a major issue for animals and humans
08/01/2021

Antimicrobial resistance: a major issue for animals and humans

Antimicrobial resistance is a major issue for both human and animal health. The emergence and spread of antibiotic-resistant bacterial strains call into question the efficacy of these treatments. Preserving the efficacy of antibiotics is therefore a genuine public health challenge, requiring an integrated approach according to the One Health concept covering both humans and animals.
Electronic submission of MA application dossiers for veterinary medicinal products
08/01/2021

Electronic submission of MA application dossiers for veterinary medicinal products

Since 1 January 2010, ANSES-ANMV has accepted electronic submission of applications for marketing authorisation (MA), as well as for modifications, transfers and renewals of MA. This submission method is optional. Paper applications are still accepted.
Pharmacovigilance for veterinary medicinal products
04/12/2020

Pharmacovigilance for veterinary medicinal products

Veterinary medicinal products only receive marketing authorisation if the assessment of the data concerning their quality, safety and efficacy shows that the benefits linked to their use are greater than the risks incurred. The clinical trials conducted in the context of MA applications highlight a certain number of adverse effects which may occur when using medicinal products. However, these trials are conducted on a limited number of animals under standardised conditions of use. The large-scale use of a drug under real-life conditions once an MA is granted then makes it possible to precisely pinpoint  the possible adverse effects of a product and to identify any potential risk factors (species, breed, age, pre-existing ailments, etc.).

Pharmacovigilance therefore aims to detect any emerging signs as quickly as possible, both unexpected adverse effects and known adverse effects with an unexpected frequency or severity. This post-MA monitoring sometimes results in adjusting risk management measures, which may include providing additional precautions for use on the package leaflet, or in certain cases withdrawal of the MA.

Here is a glimpse of the Agency's work on the topic. 

 

Monitoring sales of veterinary antimicrobials
27/11/2020

Monitoring sales of veterinary antimicrobials

Antimicrobial resistance is a major public health issue concerning both human and veterinary medicine. Monitoring of sales of veterinary antimicrobials is one of the main sources of information used to assess and manage the risks associated with antimicrobial resistance. These sales have been monitored annually by the Agency since 1999, based on the recommendations of the World Organisation for Animal Health (OIE).
Clinical trials of veterinary medicinal products
22/04/2020

Clinical trials of veterinary medicinal products

Regulatory reminder In accordance with the provisions of Article R.5141-2 of the Public Health Code, pursuant to sub-paragraph 6 of Article L.5141-16, clinical trials of veterinary drugs constitute one of the stages in the experimentation of veterinary medicinal products. The procedures for declaring such clinical trials to the Director General of the French Agency for Food, Environmental and Occupational Health & Safety are defined in Articles R. 5141-8 and R. 5141-9 of the same Code. Articles L. 5142-7 and R. 5141-123 also lay down the conditions for importing these drugs into France. It therefore appears necessary to clarify which medicinal products are covered by this obligation. A distinction needs to be made between products regarded as medicinal products for use in clinical trials covered by these laws and regulations, and those which do not fall within the scope of the aforementioned Articles. Definitions Veterinary medicinal products for use in clinical trials These medicinal products are active substances or placebos presented in a refined pharmaceutical form with an established formula and defined characteristics and specifications. Their preparation is mass-produced in significant quantities in a pilot or industrial production unit. These may be medicinal products already possessing a marketing authorisation, but used, presented or packaged differently from the authorised product, or used for a different indication from the authorised product. The following are therefore excluded from this definition and from the scope of the aforementioned legislative and regulatory provisions: active substances, in a form or formulation under development, whose formula, characteristics and specifications are being defined and may be subject to change as studies progress; preparations that are not mass-produced, but most often formulated in small quantities and in a formulation laboratory; products used in laboratory studies conducted in non-clinical and pre-clinical fields to study their physico-chemical characteristics, preliminary stability, or behaviour in animals; products used in laboratory studies to determine their properties and to improve then optimise the formula in order to define the composition of a final formulation. Clinical trials of veterinary medicinal products containing or consisting of genetically modified organisms (GMOs) Any veterinary medicinal product containing genetically modified organisms must, prior to field trials, obtain authorisation for deliberate release of genetically modified organisms from the Director General of the French Agency for Food, Environmental and Occupational Health & Safety. This authorisation is issued taking into account the opinion of the High Council for Biotechnology (HCB) and after a public consultation. > Procedure for notifying establishment of a clinical trial (PDF)
Export certification
09/04/2020

Export certification

ANSES-ANMV can issue certificates at the request of pharmaceutical establishments exporting veterinary medicines to third countries (Public Health Code, Article R.5141-127) or medicated feeding stuffs to other European Union Member States or to third countries (Public Health Code, Article R.5141-128).
Application for official release of a batch of inactivated or live rabies vaccines for veterinary use
09/04/2020

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

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
08/04/2020

Stock shortages of veterinary medicinal products

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
08/04/2020

Quality control of veterinary medicinal products

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

Publications

Document PDF
Thematique
Veterinary medicine - ANMV
Date de mise en ligne
18/11/2021
Document PDF
Thematique
Veterinary medicine - ANMV
Date de mise en ligne
09/02/2022
Numéro de saisine
Antibiotiques2020
Document PDF
Thematique
Veterinary medicine - ANMV
Date de mise en ligne
12/05/2021
Document PDF
Thematique
Veterinary medicine - ANMV
Date de mise en ligne
19/02/2021
Numéro de saisine
Antibiotiques2019
Document PDF
Thematique
Veterinary medicine - ANMV
Date de mise en ligne
01/12/2020
Numéro de saisine
Pharmacovigilance2019