S.L. 437.115 Art. 35Access by the Director.

(1) The persons referred to in Article 123(1) of

Regulation (EU) 2019/6, the holders of authorisation in accordance with regulation 6, the holders authorisation in accordance with Article 5(6) of Regulation (EU) 2019/6, the holders of registration in accordance with Article 116 of Regulation (EU) 2019/6, the dispensers of veterinary medicinal products and the brokers of veterinary medicinal products shall allow the Director to carry out the controls referred to in the same provisions by making the premises, documents, installations and any equipment accessible at any reasonable time for inspection by the Director.

(2) When the Director has valid reason to believe that any of the persons referred to in sub-regulation (1) is acting in contravention of any of the provisions of these regulations or Regulation (EU) 2019/ 6, he shall notify the person concerned in writing through a notice specifying the type of contravention and a time frame during which a valid justification for his actions is to be provided.

(3) When the person concerned fails to provide a valid justification within such time as specified in the notice, or if the reply is unsatisfactory, the Director may suspend the activity of the concerned person by means of a written notice specifying the reasons for such suspension until such person is in compliance.

(4) The Director may also commence administrative or disciplinary measures against the person for failure to fulfil his obligations.

(5) Any authorisation or registration granted under these regulations or Regulation (EU) 2019/6 shall not be renewed unless remedial steps by the person to whom the notice is addressed are taken as specified in the notice.