Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Article 101 U.K. Obligations of wholesale distributors

1. Wholesale distributors shall obtain veterinary medicinal products only from holders of a manufacturing authorisation or from other holders of a wholesale distribution authorisation.

2. A wholesale distributor shall supply veterinary medicinal products only to persons permitted to carry out retail activities in a Member State in accordance with Article 103(1), other wholesale distributors of veterinary medicinal products and to other persons or entities in accordance with national law.

3. The holder of a wholesale distribution authorisation shall have permanently at its disposal the services of at least one responsible person for wholesale distribution.

4. Wholesale distributors shall, within the limits of their responsibility, ensure appropriate and continued supply of veterinary medicinal product to persons authorised to supply it in accordance with Article 103(1), so that the needs for animal health in the relevant Member State are covered.

5. A wholesale distributor shall comply with the good distribution practice for veterinary medicinal products as referred to in Article 99(6).

6. Wholesale distributors shall immediately inform the competent authority and, where applicable, the marketing authorisation holder, of veterinary medicinal products they receive or are offered which they identify as falsified or suspected to be falsified.

7. A wholesale distributor shall keep detailed records of at least the following information in respect of each transaction:

(a) date of the transaction;

(b) name of the veterinary medicinal product including, as appropriate, pharmaceutical form and strength;

(c) batch number;

(d) expiry date of the veterinary medicinal product;

(e) quantity received or supplied, stating pack size and number of packs;

(f) name or company name and permanent address or registered place of business of the supplier in the event of purchase or of the recipient in the event of sale.

8. At least once a year, the holder of a wholesale distribution authorisation shall carry out a detailed audit of the stock and compare the incoming and outgoing veterinary medicinal products recorded with veterinary medicinal products currently held in stock. Any discrepancies found shall be recorded. The records shall be available for inspection by the competent authorities for a period of five years.