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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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.

10. 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

11. 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

12. 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.

13. 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.

14. 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.

15. 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

16. 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