S.L. 437.47 Art. 44Obligations of the holder of manufacturing authorisation and manufacturer of active substance.

(1)The holder of the Authorisation or the manufacturer of active substance shall:

(a) comply with the EU principles and guidelines of good manufacturing practice and any annexes thereof for veterinary medicinal products and use only active substances which have been manufactured in accordance with the EU guidelines on good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances. To this end, the holder of the manufacturing authorisation shall verify compliance by the manufacturer and distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances. The holder of the manufacturing authorisation shall verify such compliance either by himself or, without prejudice to his responsibility as provided for in these regulations and in the Act, through an entity acting on his behalf under a contract;

(b) inform the competent authority and the marketing authorisation holder immediately if he obtains information that veterinary medicinal products which come under the scope of his manufacturing authorisation or the active substance are, or are suspected of being, falsified irrespective of whether those veterinary medicinal products were distributed within the legal supply chain or by illegal means, including illegal sale at a distance by means of information society services;

(c) verify that the manufacturers, importers or distributors from whom he obtains active substances are registered with the competent authority of the Member State in which they are established;

(d) verify the authenticity and quality of the active substances and the excipients.

(e) have at his disposal the services of staff complying with the legal requirements set by the Veterinary Services as regards both manufacture and controls

(f) dispose of the veterinary medicinal products only in accordance with the legislation of the territory of Malta;

(g) give prior notice to the Veterinary Services of any changes which he may wish to make to any of the particulars supplied pursuant to regulation 40 or other significant changes or of conditions which may affect the quality, safety or efficacy of the veterinary medicinal product. The Veterinary Services shall, in any event, be immediately informed if the qualified person referred to in regulation 46(1) is replaced;

(h) enable the qualified person referred to in regulation 46(1) to carry out his duties, particularly by placing at his disposal all the necessary facilities;

(i) keep detailed records of all veterinary medicinal products supplied by him, including samples, in accordance with the laws of the countries of destination:

(i) date;

(ii) name of the veterinary medicinal product;

(iii) quantity supplied ;

(iv) name and address of the recipient;

(v) batch number;

These records shall be available for inspection by the Veterinary Services for a period of at least three (3) years.

(j) the following information at least shall be recorded in respect of each transaction, whether or not it is made for payment;

(k) record all suspected serious adverse reactions and human adverse reactions relating to the use of veterinary medicinal products that are brought to his attention and report them promptly to the Veterinary Services in no later than fifteen days following receipt of the information;

(l) 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;

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

(n) other responsibilities as may be established by the Veterinary Services from time to time;

(2) For the purposes of this regulation, manufacture of active substances used as starting materials shall include both total and partial manufacture or import of an active substance used as a starting material as defined in the Schedule Part 2. Section C of these regulations, and the various processes of dividing up, packaging or presentation prior to its incorporation into a veterinary medicinal product, including repackaging or re-labelling, such as are carried out by a distributor of starting materials.

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

(4) It shall be the duty of the importer to ensure that:

(a) in the case of veterinary medicinal products and investigational veterinary medicinal products imported from third countries, these have been manufactured in accordance with standards which are at least equivalent to the good manufacturing practice standards laid down in the Good Manufacturing Practice for Veterinary Medicinal Products Rules;

(b) in the case of veterinary medicinal products, such products have been manufactured by manufacturers duly authorised for the purpose; and

(c) in the case of investigational veterinary medicinal products, such products have been manufactured by a manufacturer notified to the competent authorities and accepted by them for that purpose.