S.L. 437.115 Art. 12Manufacturing of veterinary medicinal products and active substances.    Cap. 378.

(1) For the purposes of these regulations, the manufacture of active substances shall include both total and partial manufacture or importation of an active substance, and the various processes of dividing up, packaging or presentation prior to their incorporation into a veterinary medicinal product, including repackaging or re-labelling, as are carried out by a distributor.

(2) For the purposes of Article 89 of Regulation (EU) 2019/6, the applicants shall submit an application in the manner provided by the Director to obtain the manufacturing authorisation referred to in Article 88(1) of Regulation (EU) 2019/6 and shall pay the relevant fees.

(3) A manufacturing authorisation shall not be required for preparation, division, changes in packaging or presentation where these processes are carried out solely for retail directly to the public by pharmacists in veterinary pharmacies, or by other persons legally authorised to supply veterinary medicinal products to the public.

(4) The manufacturing authorisation shall only be granted by the Director when the requirements provided for in Article 89 of Regulation (EU) 2019/6 are satisfied.

(5) The Director may, upon a request by the holder of authorisation for a change in the manufacturing authorisation, vary the condition of the authorisation if he is satisfied that such change will not adversely affect the standard of good practice in manufacture as may be prescribed.

(6) For the purposes of Article 133 of Regulation (EU) 2019/ 6 and when the Director considers that circumstances may exist which necessitate the consideration of whether the authorisation should be varied, suspended or revoked, the Director may serve on the holder of a manufacturing authorisation a notice requiring him, within such period as may be specified in such notice, to obtain any information specified in the notice.

(7) The Director may, at his own discretion, suspend, revoke or vary the conditions of a manufacturing authorisation if:

(a) the information stated in the application on which the authorisation was granted was false or incomplete in an essential manner;

(b) a material change of circumstances has occurred in relation to any of such information;

(c) any condition of the authorisation has been contravened;

(d) the requirements in relation to the authorisation as established by these regulations and Regulation (EU) 2019/6 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 exists the sale and processing of active substance and veterinary medicinal products under unsanitary conditions or leading to adulteration; and

(h) there occurs any of the other circumstances established under these regulations.

(8) The Director may 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.

(9) With respect to the manufacture of veterinary medicinal products and active substance, the Director may:

(a) inspect the manufacturing establishment and any other premises at any reasonable time;

(b) examine any relevant document;

(c) take any sample deemed necessary and if necessary, submit it 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 as he 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;

(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; and

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

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

(10) Except in urgent cases, an inspection shall be carried out in the presence of a qualified person responsible for manufacturing and batch release referred to in Article 97 of Regulation (EU) 2019/6, or his representative.

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

(12) 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.

(13) Following an inspection the Director may renew the authorisation, with or without modifications, for such a further period as specified.

(14) The holder of the manufacturing authorisation, or the manufacturer of active substance shall:

(a) verify the authenticity and quality of the excipients;

(b) keep a record of all suspected adverse reactions and adverse reactions on humans relating to the use of veterinary medicinal products that are brought to his attention and report them promptly to the Director in no later than fifteen days (15) following receipt of the information;

(c) implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time the veterinary medicinal products or the active substance in the distribution network;

(d) record and investigate any complaint concerning quality defects; and

(e) perform other responsibilities as may be established by the Director from time to time.

(15) Manufacturing authorisation holders shall be regarded as producers and therefore shall be held liable for damages in cases and under the conditions set forth in the Consumer Affairs Act.

(16) The Director may require from the applicant further information concerning the particulars supplied pursuant to Article 89(2) of Regulation (EU) 2019/6 and the qualified person referred to in Article 97 of Regulation (EU) 2019/6: Provided that before the applicant provides the requested information, the manufacturing authorisation shall be suspended.