Distribution, administration and

prescription of VMP’s

Paule Carnat-GautierFrench 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

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 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

Wholesalers

Authorization : Competent technical staff Suitable and suffisant permits Complying with requirements

concerning Storage Handling

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

Detailed audit Once a year Compares incoming and outgoing

medecinal supplies with supplies currently held in stock

Discrepancies have to be recorded

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

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