S.L. 437.115 · Veterinary Medicinal Products (S.L. 437.115)
S.L. 437.115 Art. 26Renewal, validation, suspension or revocation of a wholesale distribution authorisation.
(1) Every authorisation granted under these regulations shall, unless previously renewed or revoked remain valid until such time as it is renewed by the Director.
(2) Unless otherwise determined by the Director based on the conclusions of an inspection, the authorisation shall be valid for a period of three (3) years.
(3) The Director may renew the authorisation with or without modifications for such a further period as specified by the Director, or refuse to renew the authorisation:
Provided that in the case that the authorisation is not renewed, the Director shall stipulate corrective measures as necessary, and he may suspend the authorisation until it is confirmed that the holder of the authorisation is in compliance with these regulations and Regulation (EU) 2019/6.
(4) The Director may suspend or revoke the authorisation granted under these regulations for such period as it may be determined in any of the following instances:
(a) where the information stated in the application on which the authorisation was issued was false or incomplete in a particular detail;
(b) where a material change of circumstance has occurred in relation to any of that information;
(c) where any condition of the authorisation has been contravened;
(d) where the requirements in relation to the authorisation as provided for by these regulations and Regulation (EU) 2019/6 have not been complied with; and
(e) where conditions of good practice in wholesale distribution, particularly those established by the Commission in the implementation of Regulation (EU) 2021/1248 are not being complied with:
Provided that the Director may revoke or suspend the authorisation for any other matter that he deems appropriate.