Distribution, administration and prescription of VMP’s Paule Carnat-Gautier French Ministry of agriculture

Regulation Directive 2001/82/EC of the European Parliament and the Council on Community code relating to veterinary medicinal products Title VI Possession, distribution and dispensing of veterinary medicinal products Regulation for veterinary medicinal products is provided in the European Union by directive/ two thousand one/ eighty two on the Community code relating to veterinary medicinal products. Distribution, administration and prescription of VMP’s are described in title six of this directive. It also includes definitions of specific terms. 2

Definitions Wholesale dealing: Any activity including Purchase Sale Import, export Other commercial transaction No matter if a profit is made or not Except for supply by a manufacturer of products manufactured by himself Except for retail supplies Wholesalers are companies dealing which VMP’s, they can make all commercial transactions like purchase, sale, import or export whether or not for profit. The supply by a manufacturer of VMPs manufactured by himself and retail supplies carried out by people entitled to do so are not included in the definition of wholesale dealing. 3

Wholesalers Article 65 of Directive 2001/82/CE Wholesale is subject to the holding of an authorization Granting by a competent authority of the Member State Procedure must not exceed 90 days Supplies of small quantities from one retailer to another can be excluded from the scope of wholesale authorization The article sixty five of the directive two thousand one, eighty two lays down wholesale activities are subjected to autorisation. This authorization is granted by a competent authority of the MemberSstate. Procedure for granting this authorization must not exceed ninety days on and after the day when the competent authority received the application. 4

Wholesalers Authorization : Competent technical staff Suitable and suffisant permits Complying with requirements concerning Storage Handling Wholesalers need to have competent technical staff and suitable and suffisant permits to be granted the authorization. They must also comply with specific requirements laid down in the Member State concerning storage and handling of veterinary medicinal products. 5

Wholesalers Detailed reports for each incoming or out going transaction: Date Accurate identity of VMPs Manufacturer’s batch number, expiry date Quantity received or supplied Name and adress of the supplier or recipient. At least for three years Wholesalers have to keep detailed reports for each incoming or out going transactions. They have to register the following information: date, accurate identity of VMP’s, manufacturer’s batch number and expiry date. For incoming transaction, the quantity received and the name and adress of the supplier. For out going transaction, the quantity supplied and the name and adress of the recipient. These recodrs have to be kept available for inspection by the competent authority at least every three years. 6

Wholesalers Detailed audit Once a year Compares incoming and outgoing medecinal supplies with supplies currently held in stock Discrepancies have to be recorded Wholesalers have to perform a detailed audit, once a year, to compare incoming and outgoing supplies to supplies currently held in stock. All discrepancies have to be recorded. 7

Wholesalers Emergency plan for recall operation Supply only to people allowed to carry out retail activities according to article 66 In case of importation, they have to notify to MAH and to the competent authority MAH marketing authorization holder. Recall operation can be ordered by the competent authority or can be undertaken in cooperation with the manufacturer of the veterinay medecinal products or with the marketing autorization holder. Wholesalers have to have an emergency plant guaranteeing the effective implementation of any recall operation. They can supply veterinary medecinal products only to persons permitted to carry out retail activities according to article sixty six. If they want to import a veterinary medecinal products, they have to notify it to the marketing authorization holder and to the the competent authority of the Member State in wihch the products will be import. 8

Retail supply Only by people allowes to carry out such operations according by the legislation of the Member State. Veterinarian prescription Any prescription of VMP’s issued by a professionnel person qualified to do so.

Retail supply Detailed record (for 5 years): Date Precise identity of veterinary product Manufacturer’s batch number Name and adress of the supplier or recipient Name and adress of the prescribing veterinarian Detailed audit once a year

Retail supply Supply for food producing animals by or under the supervision of a person registered Not for the oral or parenteral treatment of bacteria infections

Veterinary prescription Required for dispensing the following VMP Subject to official restrictions (narcotic or psychotropic substances) VMPs for food producing animals Avoid risk for target species, person administrating to the animal, environnement Interfere with subsequent diagnostics or therapeutic measures Official formula for food producing animals New VMP containinig an active substance authorised for fewer than five years Quantity prescribed and supplied restricted to the minimum amount required for the treatment or therapy concerned.

Administration Only person empowered under national law possess or have under their control VMPs or substances used as VMPs (anabolic, anti-infectious, anti parasitic, anti inflammatory, hormonal or psychotropic properties) Register of manufacturers and dealers in possession of active substances : Detailed records of all dealings At least for 3 years.

Administration Owners and keepers of food producing animals Proff of purchase, possession and administration of VMPs During 5 years after administration Maintenance of record : Date, name of VMP Quantity, name and adress of the supplier Identification of animals treated.

Veterinarians providing services Article 70 Veterinarians providing services in another Member state Take with them and administer to animals small quantities of VMP which are not authorized in the member state

Immunological VMPs Member state can prohibit, to eradicate an animal disease (article 71) : Manufacture, import, possession, supply or use of immunological VMPs Interfere with the diagnosis, control or eredication of animal disease The disease is largely absent