Wholesale distribution authorisations
1. The wholesale distribution of veterinary medicinal products shall be subject to the holding of a wholesale distribution authorisation.
2. The holders of a wholesale distribution authorisation shall be established in the Union.
3. Wholesale distribution authorisations shall be valid throughout the Union.
4. Member States may decide that supplies of small quantities of veterinary medicinal products from one retailer to another in the same Member State shall not be subject to the requirement of holding a wholesale distribution authorisation.
5. By derogation from paragraph 1, a holder of a manufacturing authorisation shall not be required to hold a wholesale distribution authorisation for the veterinary medicinal products covered by the manufacturing authorisation.
6. The Commission shall, by means of implementing acts, adopt measures on good distribution practice for veterinary medicinal products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Application and procedures for wholesale distribution authorisations
1. An application for a wholesale distribution authorisation shall be submitted to the competent authority in the Member State in which the site or sites of the wholesale distributor are located.
2. An applicant shall demonstrate in the application that the following requirements are met:
(a)
the applicant has at its disposal technically competent staff and in particular at least one person designated as responsible person, meeting the conditions provided for in national law;
(b)
the applicant has suitable and sufficient premises complying with the requirements laid down by the relevant Member State as regards the storage and handling of veterinary medicinal products;
(c)
the applicant has a plan guaranteeing effective implementation of any withdrawal or recall from the market ordered by the competent authorities or the Commission or undertaken in cooperation with the manufacturer or marketing authorisation holder of the veterinary medicinal product concerned;
(d)
the applicant has an appropriate record-keeping system ensuring compliance with the requirements referred to in Article 101;
(e)
the applicant has a statement to the effect that it fulfils the requirements referred to in Article 101.
3. Member States shall lay down procedures to grant, refuse, suspend, revoke or change a wholesale distribution authorisation.
4. The procedures referred to in paragraph 3 shall not exceed 90 days, starting, if applicable, from the date on which the competent authority receives an application in accordance with national law.
5. The competent authority shall:
(a)
inform the applicant of the outcome of the evaluation;
(b)
grant, refuse or change the wholesale distribution authorisation; and
(c)
upload the relevant information of the authorisation in the manufacturing and wholesale distribution database referred to in Article 91.
