French Public Health Code
In forceI.-When veterinary medicinal products prescribed in accordance with the provisions of article R. 5141-111 are dispensed, the pharmacist or veterinarian must immediately transcribe the dispensing in ink, without blanks or overwriting, onto a register or record it using any appropriate system which does not allow the data contained therein to be altered once the registration has been validated. The recording systems allow the information provided for in this article to be printed out immediately at the request of any supervisory authority, and each printed page must include the name and address of the pharmacy or the professional domicile where the veterinary practice is carried out. The data they contain must appear on a medium which guarantees their permanence and integrity. They must also be duplicated on two separate media, the first used for regular consultation, the second kept in reserve. It must be possible to access, consult and use the archived data for as long as it is kept.
Transcripts or recordings must include the following information for each medicinal product:
1° A serial number ;
2° The surname, first name or company name and address of the keeper of the animals, or the words "professional use";
3° The name or formula of the medicinal product;
4° The quantity dispensed;
5° The name of the prescriber;
6° The date of issue;
7° The batch number of the medicinal product;
8° The words: "medicinal products supplied by... "with an indication of the intermediary who supplies the medicinal products under the conditions of II of this article, in the case of medicinal products other than medicated feedingstuffs.
The veterinarian is exempt from transcribing or recording this information if the prescriptions he writes on sheets of paper from counterfoil books or which he intends to publish electronically are numbered. He must keep duplicates of these prescriptions under the same conditions as the register or record mentioned above.
At least once a year, the pharmacist or veterinary surgeon compares the list of medicines received and dispatched with the list of medicines in stock, and any discrepancies must be recorded in a report.
The registers or computerised records are kept for a period of ten years and are made available to the supervisory authorities for the prescribed period. It must be possible to print out these records on paper and they must be classified by keeper of the animal, by medicinal product and in chronological order. They shall be made available to the inspection authorities on request.
The pharmacist or veterinary surgeon shall immediately record on the prescription given to the animal keeper the date of issue, the serial number under which the issue was transcribed or recorded, the quantity issued and, where appropriate, the words "medicinal products supplied by..." with an indication of the intermediary who supplied them. "with an indication of the intermediary who supplies these medicinal products under the conditions set out in II of this article, in the case of medicinal products other than medicated feedingstuffs, together with his name and address. When dispensing, the veterinarian will indicate, on the duplicate of the prescription which he keeps, the date of dispensing, the quantity dispensed, the batch number of the medicinal products and, where applicable, the words "medicinal products dispensed by..." together with the name of the intermediary who dispensed the medicinal products. "with an indication of the intermediary who supplies these medicinal products under the conditions of II of this article, in the case of medicinal products other than medicated feedingstuffs.
The details mentioned in the previous paragraph are included on the prescription in the event of a renewal.
II - Veterinary medicinal products are dispensed retail by a person mentioned in article L. 5143-2, in compliance with article L. 5143-9 or under the conditions set out in article L. 5143-8, at the pharmacy in the case of pharmacists, at the professional place of practice or the place where the animals are kept in the case of veterinarians, at the place where the medicinal products are stored in the case of groups approved under article L. 5143-6, or at the French veterinary school in the case of those in charge of the school's pharmacy.
For these professionals, the use of an intermediary for the supply of veterinary medicinal products containing poisonous substances is possible for :
1° Medicated feed ;
2° Veterinary medicinal products prescribed as part of the implementation of the animal health programme;
3° Veterinary medicines prescribed under the conditions defined in IV of R. 5141-112-2 by the veterinarian to whom responsibility for monitoring the health of the farm has been entrusted by the owner or keeper of the animals, in accordance with the care protocol;
4° Veterinary medicinal products prescribed by a veterinarian as part of the care he personally provides, provided that the time between this care and delivery does not exceed ten days.
The veterinary medicinal products mentioned in 2°, 3° and 4° are delivered in sealed packets bearing the name and address of the owner or keeper of the animals. By sealed package is meant any opaque package whose closure is such that the recipient can ensure that it has not been opened by a third party. For prescription medicines, the prescription is enclosed inside the pack. It includes the specific information provided for in article R. 5141-111.
For the veterinary medicinal products mentioned in 1° whose volume of packaging does not allow them to be packaged, the veterinarian or pharmacist mentioned in the first paragraph of article R. 5142-54 ensures that the prescription accompanying them accompanies the medicinal products throughout delivery.
The persons authorised to make retail deliveries and the persons under whose control the medicinal products are delivered in accordance with article L. 5143-6 ensure that the transport conditions are compatible with the proper storage of the medicinal products. They shall also ensure that all explanations and recommendations are made available to the user.
