Cap. 437 Art. 49The Director.

(1) Without prejudice to any other obligation relating to the operation of veterinary activities arising out of the provisions of this Act, the Director shall -

(a) be the chief advisor to the Government on any matter relating to animal or veterinary public health or relating to, or in connection with, the veterinary health services;

(b) submit periodical reports, to the Minister, on the situation concerning State veterinary activities;

(c) report to the Minister any information concerning any new scientific evidence or facts, which may directly or indirectly affect State veterinary activities;

(d) submit to the Minister the documentation or data required for the making, by the Minister, of rules and, or, regulations in accordance with the provisions of this Act, and advise the Minister on any matter required to be done by the Minister under this Act;

(e) liaise with other departments or bodies on matters falling under his responsibility;

(f) perform such duties and functions as are assigned to him by or under this Act and, generally, to monitor the running of veterinary activities;

(g) decide upon any request made by the manufacturer, or by a duly authorized representative, of veterinary medicinal products, for the purpose of obtaining authorisation for the marketing of such products in accordance with the provisions of this Act;

(h) where a request under paragraph (g) has been favourably decided upon, issue the authorisation for the marketing of the veterinary medicinal products and include such products in the list of approved Veterinary Medicinal Products, which shall, from time to time, be published by the Veterinary Services;

(i) decide on the continuation or cessation of the manufacture, importation or marketing of a veterinary medicinal product, active substance or veterinary medical device and, or on the recalling of that product, in cases where an undesirable effect has been detected or suspected;

(j) upon a reference made to him for that purpose, determine whether particular substances or active substances have been used in the manufacture of a veterinary medicinal product;

(k) exercise supervision and conduct inspections on the manufacture, importation, introduction, wholesale distribution, brokering, marketing, retail and use of veterinary medicinal products and active substances;

(l) decide on the continuation or cessation of the manufacture, importation or marketing of a veterinary medicinal product, active substance or veterinary medical device in cases where a product or batch defect has been detected or suspected;

(m) decide on the confiscation, sealing, isolation or otherwise of veterinary medicinal products, active substances or veterinary medical devices which are found to be in breach of any of the provisions of this Act or any Regulations made thereunder; and

(n) decide on the taking of temporary measures which shall not have effect for more than six (6) months from their publication by notice in the Government Gazette, unless these are extended by such other notice, and said temporary measures prohibit or limit the introduction, sale, possession or movement of any animal, product of animal origin or any other thing capable of carrying or transmitting pests or diseases.

(2) Without prejudice to the preceding sub-article, the Director may also:

(a) draw up and update assessment reports on the results of analytical and pharmaco-toxicological tests, and on the results of clinical trials of veterinary medicinal products and assessment of dossiers thereof; and

(b) test veterinary medicinal products or any of the ingredients thereof and, where necessary, intermediate products or other constituent materials, or submit such products for testing by a trading partner laboratory or by a laboratory designated for that purpose, with a view to ensuring that the manufacturing and testing methods employed by the manufacturer and described in the application are in accordance with the provisions of this Act or any regulations made thereunder.

(3) The Director may exercise any one or more of his functions either directly or through any of the officers or employees of the Veterinary Services or through the Medicines Authority or any agency authorised for that purpose, or through a contractor or other person with whom an agreement for the performance of any one or more of such functions has been entered into:

Provided that nothing in this sub-article shall authorise the Director to contract out or delegate any:

(a) of his regulatory functions; or

(b) of his authorisation functions, unless such functions are expressly delegated to the Medicines Authority or to another public authority established by law, in particular another national competent authority as defined in this Act.

(4) The Director may approve the entering into contracts and memoranda of understanding between the Veterinary Services and the Medicines Authority for any purpose of cooperation which is deemed beneficial to any of the parties to the contract or memorandum of understanding in the carrying out of any of their functions.

(5) For the purpose of performance of any functions under this Act, the Director or any other such officer or person as may be authorised by the Director may request the assistance of the Malta Police Force, any local council, any department of Government, any agency of Government, any voluntary organisation or private sector entity.

(6) For the purposes of sub-articles (3), (4) and (5) where applicable to the Medicines Authority, these are subject to an agreement between the Medicines Authority and the Director Veterinary Services, such as in the form of a contract or memorandum of understanding.