« Lightened » procedures

Homeopathic veterinary medicinal products shall be authorised before they are placed on the market. By way of derogation, they may benefit from a light procedure: the recording.

Homeopathic medicinal products are defined in Article L. 5141-2 of the Public Health Code (CSP) as veterinary medicinal products obtained from substances called homeopathic strains, using a manufacturing process described by the European Pharmacopoeia, the French

Pharmacopoeia or Pharmacopoes used officially in another Member State of the European Union. The placing on the market of a homeopathic veterinary medicinal product is subject to prior authorisation for the placing on the market of a homeopathic veterinary medicinal product issued by the French Agency for Food, Environmental and Occupational Health Safety (Article L. 5141-5 CSP).

By way of exception, homeopathic medicinal products may be subject to registration if they fulfil the conditions laid down in Article L. 5141-9 (CSP):

• a route of administration described in an official Pharmacopoeia;
• the absence of therapeutic indications on the labelling;
• a degree of dilution ensuring the safety of the medicinal product, in particular such that it does not contain more than one part per 10,000 of the mother dye;
• for homeopathic medicinal products intended for food-producing animals, the strains contained therein are set out in Table 1 of Regulation 37/2010 laying down maximum residue limits.

The labelling of registered homeopathic medicinal products shall contain only the particulars provided for in Article R. 5141-72 (CSP): 

1. the very apparent indication ‘veterinary homeopathic medicinal product without an approved therapeutic indication’; 
2. the scientific name of the strain(s) followed by the degree of dilution using the symbols of the European or French Pharmacopoeia; if the homeopathic veterinary medicinal product consists of more than one strain, the labelling may indicate a novel name in addition to the scientific name of the strains; 
3. the name and address of the holder of the registration and, where applicable, of the manufacturer; 
4. the method of administration and, if necessary, the route of administration; 
5. The expiry date in plain language (month, year);
6. The pharmaceutical form;
7. the capacity of the sales model; 
8. Special storage precautions, where appropriate;
9. Target species;
10. A special warning if it is necessary for the medicinal product; 
11.  The number of the manufacturing lot;
12. The registration number.

Applications for registration of homeopathic medicinal products referred to in Article R. 5141-3 (CSP) shall be submitted to the French agency for veterinary medicinal products, together with the dossier described in Article R. 5141-64 (CSP). Title IV of the Order of 1 September 2009 laying down the nature and procedures for the submission of the administrative information and the scientific documentation provided in support of the applications for marketing authorisation referred to in Articles R. 5141-16, R. 5141-18 and R. 5141-20 of the Public Health Code, specifies the elements of the file applying to registrations of homeopathic medicinal products. Samples of medicinal products are not to be provided at the time of submission, but the French agency for veterinary medicinal products may request the supply of samples where appropriate. The Director-General of Anses shall notify his decision within 210 days of the submission of a complete application and file. Silence by the Director-General shall mean refusal of a marketing authorisation or registration. (Articles R. 5141-28 and R. 5141-65 CSP). An application file must be filed for each veterinary medicinal product or series of veterinary medicinal products. A series of medicinal products is defined as a set of medicinal products consisting of the same constituent(s) in several pharmaceutical forms or dilutions, where appropriate (Article R. 5141-63 CSP). Thus, each unit strain or mixture formula must be the subject of an application for registration, but that application may cover several pharmaceutical forms and include all the dilutions desired subject to compliance with the conditions laid down in Article L. 5141-9 (CSP). 

The amounts of fees are specified in the attached table (PDF) for applications for registration.
All information related to pharmaceutical establishments is available on the website page “Authorisations for the opening of establishments » , since there is no difference between a “classical” veterinary medicinal product manufacturing/distribution establishment and another homeopathic medicine establishment.

To apply for authorisation for a medicinal product  

Decree No 2013-472 allows for a lightening of the documents in the application for marketing authorisation (MA) for herbal veterinary medicinal products. Thus, Article R. 5141-20 of the Public Health Code specifies the possible use of published scientific literature (safety and effectiveness) instead of the usual specific studies. In addition, Decree No 2015-1172 provides for a reduced fee for the investigation of these cases. For each part of the dossier (pharmaceutical quality, safety and residues, efficacy), relief is possible and requirements are specified.

Following the issuance of Decree No 2013-472, Anses self-entered in order to define the possible relief measures. A working group (external and internal experts) of the French agency for veterinary medicinal products met to establish the levels of data and evidence expected for a lighter dossier.

Taking into account this opinion, the main reliefs allowed are as follows:

1. the possible use of a tracer to specify botanical identification with constant quality in the case of a plant veterinary medicinal product of complex composition (necessity of the appropriateness of the tracer characterisation with the requirements of the European Pharmacopoeia);
2. the use of information related to an old use for the bulk of the toxicity data (except for mutagenicity);
3. the use of the bibliography:

• for pre-clinical data, with the possibility of inter-species extrapolation (except for tolerance);
• for clinical data with critical analysis and a synthesis of their admissibility in terms of acceptable levels of scientific evidence.

However, in its opinion, Anses identified three main scientific and regulatory difficulties that would prevent applicants from filing a dossier:

1. the absence of a maximum residue limit (MRL) for a large majority of plants used in veterinary herbal medicinal products intended for food-producing animals (the existence of an MRL being a prerequisite for the submission of a MA dossier);
2. the need for strict identification to characterise the plant or plant parts of the medicinal product;
3. the scarcity of scientific publications with a high standard of proof of the effectiveness of the plant or part of a plant.

It is therefore necessary to lift these brakes. Thus, in its opinion, the Agency proposes work on the setting of MRLs for plants, in particular with the European Medicines Agency.

After expertise, expectations are clarified for applicants and proposals are made to overcome identified issues. The Agency’s conclusions should therefore encourage the submission of MA applications for veterinary herbal medicine, where the therapeutic arsenal is currently very limited.

To apply for authorisation for a medicinal product 

To access the thematic file