S.L. 437.47 Art. 43Suspension of a manufacturing and import Authorisation.

(1)The Veterinary Services may suspend a manufacturing

Authorisation for such period as it may determine, or may refuse, revoke, or vary the provisions of, any such Authorisation.

(2) The powers vested in sub-regulation (1) shall only be exercisable in any of the following circumstances, where:

(a) the matters stated in the application on which the Authorisation was granted were false or incomplete in an essential manner;

(b) a material change of circumstances has occurred in relation to any of those matters;

(c) any of the conditions of the Authorisation has been contravened;

(d) the requirements in relation to the licences as established by these regulations have not been complied with;

(e) the processes of manufacture or assembly of a veterinary medicinal product are carried out in a manner that is not in compliance with the provisions of the marketing authorisation of that veterinary medicinal product;

(f) the conditions for good manufacturing practice are not being complied with;

(g) there is sale and processing of active substance and veterinary medicinal products under unsanitary conditions or leading to adulteration; and

(h) in any other circumstance as is established under these regulations.

(3) The Veterinary Services shall carry out regular inspections to ensure that the requirements established by these regulations in relation to the manufacture, assembly or modification of a veterinary medicinal product or active substance are complied with.

(4) With respect to the manufacture of veterinary medicinal products or active substance the Veterinary Services or any authorised person carrying out an inspection shall:

(a) inspect the manufacturing establishment and any other location and at any reasonable time the Director may deem necessary;

(b) examine any relevant documents;

(c) take any samples the Director may deem necessary and if necessary submit them to designated laboratories for testing;

(d) open or/and examine or/and seize any article believed to be in violation of these regulations or for obtaining evidence;

(e) draw up a report of the findings and communicate the contents of such report to the Manufacturing Authorisation holder or the applicant for a Manufacturing Authorisation and to the qualified person in relation to such inspection;

(f) carry out any other activity the Director may deem appropriate for the proper execution of his duties and responsibilities as provided by these regulations;

(g) produce, upon request by the inspected part, the designated document containing information on the legal basis and scope of the inspection and the identification of the inspector/s;

(h) at the time of the inspection draw up a list of deficiencies that may have been identified and shall sign this list, and such list shall be countersigned by the holder of the Authorisation or his legal representative;

(i) shall draw up a report of the inspection within thirty

(30) working days of the inspection and shall forward a copy of such report to the holder of the Authorisation.

(5) Except in urgent cases an inspection shall be carried out in the presence of a qualified person or his representative.

(6) Subject to the provisions of these regulations, every licence shall, unless previously renewed or revoked, continue to be valid until such time as it is renewed by the Veterinary Services following an inspection.

(7) The Veterinary Services shall establish the period of validity of any licence.

(8) Following the inspection mentioned in sub-regulation (1), the Veterinary Services:

(a) may renew the licence, with or without modifications, for such a further period as specified; or

(b) if, having regard to the provisions of these regulations, it considers it necessary or expedient to do so, may refuse to renew the licence.