Regulatory references

Articles R. 5141-2 to R. 5141-12 of the Public Health Code

Content of the declaration

All the elements requested in Article R. 5141-8 of the Code de la santé publique are to be provided:

1. The identity of the promoter; name and address of the company at the initiative of the test and a contact point (mail and/or telephone);
2. The framework of the test:
   
   the title of the purpose of the test, the justification of the test (new MA or amendment of the MA) and the reference of the sponsor’s trial;
   
   the location(s) of the test (specific address of the farm or at least the department concerned and for pet animal tests the contact details of veterinarian investigators are sufficient);
   
   the identity of the investigator(s), their qualifications, experience and duties (application for registration with the College and residence for professional practice);
   
   if separate from the sponsor, the identity of the manufacturer of the test medicinal product and placebo;
   
   where applicable, the identity of the importer;
   
   references to marketing authorisations obtained in another Member State of the European Union or in a third country for the medicinal product being tested and of any decisions to refuse, suspend or withdraw such authorisations;
   
   the date on which it is envisaged to start the test and the likely duration of the trial.
3. The test protocol specifying in particular:
   
   the type of trial (clinical trial for dose confirmation, dose determination, safety, tolerance, etc.);
   
   the therapeutic indication being tested;
   
   the dosage of the medicinal product studied and, if applicable, that of the reference medicinal product;
   
   duration of treatment;
   the number of animals to be included in the test and the main criteria for inclusion.
4. For the veterinary medicinal product tested:
   
   its name as defined in Article R. 5141-1 or its code name;
   The registration status of the medicinal product: whether the medicinal product has been the subject of either a refusal of marketing authorisation or an international suspension or withdrawal of the marketing authorisation within 5 years preceding the application; specify the reasons for this decision;
   
   its pharmaceutical form;
   
   its qualitative and quantitative composition by using, where appropriate, international names where they exist or, failing that, the names of
   the European or French pharmacopoeia;
   
   the possible presence of a new active ingredient;
   
   the indication, if known, of the chemical, pharmacological and clinical classes to which the active substance belongs (the indication of the medicinal product under investigation);
   
   the place of manufacture;
   
   the route of administration;
   
   the animals of destination (species, number, distribution by group and number of animals included in France for international trials);
   
   the situation of the active ingredient(s) with regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin;
   
   the proposed wait time, if any;
   
   In the absence of sufficient documentation to justify a specific waiting period, the standard waiting period provided for by the rules must be applied.
5. For a reference medicinal product:
   
   its name;
   
   its pharmaceutical form;
   
   its qualitative and quantitative composition as an active ingredient;
   
   the status of the active ingredient(s) in relation to the above-mentioned Regulation;
   
   the waiting time, if applicable.
6. For a placebo:
   
   its pharmaceutical form;
   
   its place of manufacture;
   
   its qualitative and quantitative composition.
7. The synthesis of the elements of scientific information the knowledge of which is required for the implementation of the test, according to its nature, in the chemical, technological, pharmaceutical, biological, pharmacological, toxicological and clinical fields, referred to as prerequisites, together with the references of the main works used for this synthesis.

For a chemical medicinal product 

• the ‘TSE’ status: medicinal product concerned or not by the Order of 24/01/01 on the prevention of the transmission of animal spongiform encephalopathies;
• if a different waiting time from the flat-rate wait time (cf. Article 11.2 of Directive 2001/82/EC) is proposed, it must be duly justified by appropriate documentation;
• specific data may be requested when reporting specific clinical trials (e.g.: user safety data for a new external pest control, ecotoxicity data for a medicinal product intended for farmed fish and administered in water).

For an immunological medicinal product

• the ‘TSE’ status: medicinal product concerned or not by the Order of 24/01/01 on the prevention of the transmission of animal spongiform encephalopathies;
• the qualitative and quantitative composition of the product, specifying whether the active ingredient is alive or not, and whether the product contains an adjuvant;
• a brief description of the manufacturing process;
• the list of checks on possible contaminant agents (researched agents — viral, bacterial, fungal, mycoplasmic, possibly parasitic — and mention of the techniques used) carried out on all raw materials of biological origin and the corresponding acceptability standards, together with the corresponding certificates of analysis;
• a description of the safety and activity controls carried out on the finished product and the corresponding standards of acceptability, together with a certification from the manufacturer certifying that the controls meet the standards set. In particular, the manufacturer will have to compare the conformity of the immunological product with a possible monograph of the European Pharmacopoeia, if it exists;
• laboratory demonstration of safety after dose or overdose;
• if necessary, a study of reproductive function and an examination of immunological functions;
• in the case of an immunological substance containing at least one living organism, a study to assess the diffusibility and stability (reversion to virulence) of the strain used as a vaccine.

8. Where applicable, a copy of the authorisations granted under section R. 5132-74 or section R. 5132-83 (if psychotropic or narcotic)

Details of pharmaceutical establishments: 

Whether for the manufacturer, importer, distributor, name, full address and country.

If the manufacturer is not a French establishment, there are two cases:

Recipient of the request

The request must be sent by post to:

Anses – French Agency for Veterinary Medicinal Products
Département décisions administratives
14 rue Claude Bourgelat 
Parc d’activités de la Grande Marche — Javené
CS 70611-35306 FOUGERES- FRANCE
or by email to: enreg@anses.fr

Contact for information :  +33 2 99 94 66 65

Modifications of the test (Amendment)

Any modification of the test (date and duration of the trial, number of animals, investigators, locations of the test, dosage, withdrawal period, etc.) must be declared in advance to the Agency (mail and protocol if necessary).

The mail must refer to the test concerned and explicitly specify what is changed.

Treatment time

The ANMV Anses has 2 months to oppose the implementation of the test. The deadline is one month in the context of an addendum.

Where the application complies with the rules in force, a letter confirming that the Agency has not objected to the implementation of the test shall be systematically sent to the applicant.

In case of missing information, a request for supplement shall be sent to the applicant with a deadline for reply. In the absence of a response within the specified time limits, the opposition to the implementation of the test shall be considered definitive.

Relationship to an import request

The clinical trial declaration may be filed in conjunction with the import application.
Note: the quantities imported must be in line with the quantities necessary to set up the test.

The complete file shall preferably be sent electronically and shall consist of:

• the letter of declaration of establishment of a clinical trial, (see “Clinicaltrials of veterinary medicinal products”);
• the protocol and the technical data provided for in the procedure for the declaration of establishment of a clinical trial, (see “Clinicaltrials of veterinary medicinal products”);
• a technical file intended for the release of GMOs in Article R.533-3 of the above-mentioned Environmental Code containing:

1. General and administrative information relating to the structure requesting authorisation:
   
   a) the name, first name and address of the person responsible for the dissemination in the case of a natural person;

b) the name or business name, the registered office and the person responsible for the dissemination in the case of a legal person;

c) the names, forenames, qualifications and experiments of scientists who will be responsible for the direction, supervision, control and security of the dissemination.

2. Synthetic information on the intended release:

a) the title of the project;

b) the places or sites concerned;

c) the duration of the experiment;

3. the information provided for in the annex to this Order;
4. a declaration assessing the impact and risks to public health and the environment posed by the deliberate release of genetically modified organisms;
5. the summary of the technical file provided for in Article R. 533-9 of the Environmental Code described by Council Decision 2012/813/EC of 3 October 2002 establishing, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, the form for the notification of the deliberate release into the environment of genetically modified organisms for purposes other than their placing on the market, to be transmitted to the European Commission;
6. the information sheet intended for the public as provided for in Article L. 533-3-1 of the Environmental Code.