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

Article 123 U.K. Controls

1. Competent authorities shall carry out controls of the following persons:

(a) manufacturers and importers of veterinary medicinal products and active substances;

(b) distributors of active substances;

(c) marketing authorisation holders;

(d) holders of a wholesale distribution authorisation;

(e) retailers;

(f) owners and keepers of food-producing animals;

(g) veterinarians;

(h) holders of a registration for homeopathic veterinary medicinal products;

(i) holders of veterinary medicinal products referred to in Article 5(6); and

(j) any other persons having obligations under this Regulation.

2. The controls referred to in paragraph 1 shall be carried out regularly, on a risk-basis, in order to verify that the persons referred to in paragraph 1 comply with this Regulation.

3. The risk-based controls referred to in paragraph 2 shall be carried out by the competent authorities taking account of at least:

(a) the intrinsic risks associated with the activities of the persons referred to in paragraph 1 and the location of their activities;

(b) the past record of the persons referred to paragraph 1 as regards the results of controls performed on them and their previous compliance;

(c) any information that might indicate non-compliance;

(d) the potential impact of non-compliance on public health, animal health, animal welfare and the environment.

4. Controls may also be carried out on the request of a competent authority of another Member State, the Commission or the Agency.

5. Controls shall be carried out by representatives of the competent authority.

6. Inspections may be carried out as part of the controls. Such inspections may be made unannounced. During those inspections the representatives of a competent authority shall at least be empowered to:

(a) inspect the premises, equipment, means of transport, records, documents and systems, related to the objective of the inspection;

(b) inspect and take samples with a view to submitting them for an independent analysis by an Official Medicines Control Laboratory or by a laboratory designated for that purpose by a Member State;

(c) document any evidence deemed necessary by the representatives;

(d) carry out the same controls on any parties performing the tasks required under this Regulation with, for or on behalf of the persons referred to in paragraph 1.

7. The representatives of the competent authorities shall keep a record of every control that they carry out and where necessary shall draw up a report. The person referred to in paragraph 1 shall be promptly informed in writing by the competent authority of any case of non-compliance identified through the controls and shall have the opportunity to submit comments within a time limit set by the competent authority.

8. The competent authorities shall have procedures or arrangements in place to ensure that staff performing controls are free from any conflict of interest.