S.L. 437.47 Art. 72Repeated inspections.

(1) The Veterinary Services shall ensure, by means of repeated inspections and, if necessary, unannounced inspections, and where appropriate, by asking an Official Medicines Control

Laboratory or a laboratory designated for that purpose to conduct tests on samples, that the legal requirements relating to veterinary medicinal products in any place where active substances and veterinary medicinal products are manufactured, distributed, imported, exported or used are complied with.

The Veterinary Services may also carry out at any reasonable time unannounced inspections at the premises of manufacturers of active substances used as starting materials for veterinary medicinal products, and of the premises of the marketing authorisation holder whenever it considers that there are grounds for suspecting non-compliance with the provisions of regulation Article 51 of European Union Council Directive 2004/28/EC or any provisions of these regulations. Such inspections may also be carried out at the request of another Member State, the Commission or the Agency. In order to verify whether the data submitted in order to obtain a conformity certificate comply with the monographs of the European Pharmacopoeia, the standardization body for nomenclatures and quality norms within the meaning of the Convention relating to the elaboration of a European Pharmacopoeia (European Directorate for the Quality of Medicines) may ask the Commission or the Agency to request such an inspection when the starting material concerned is the subject of a European Pharmacopoeia monograph.

The Veterinary Services may carry out inspections of starting material manufacturers at the manufacturer’s own request. Such inspections shall be carried out by authorized representatives of the Veterinary Services who shall be empowered to -

(a) inspect manufacturing or trading establishments and any laboratories entrusted by the holder of the manufacturing authorisation with the task of carrying out control tests pursuant to regulation 24;

(b) take samples including with a view to an independent analysis by an Official Medicines Control Laboratory or by a laboratory designated for that purpose by Malta;

(c) examine any documents relating to the object of the inspection, subject to the provisions in force in Malta placing restrictions on these powers with regard to the description of the manufacturing method;

(d) inspect the premises, records and documents of marketing authorisation holders or any firms performing the activities described in Title VII, and in particular regulations 67 and 68 thereof, on behalf of a marketing authorisation holder.

(2) The Veterinary Services shall take all appropriate measures to ensure that in the Director, the manufacturing processes used in the manufacture of immunological veterinary medicinal products are completely validated and batch-to-batch consistency is ensured.

(3) The authorised representatives of the Veterinary Services shall report after each of the inspections mentioned in subregulation (1) on whether the principles and guidelines on good manufacturing practice referred to in Article 51 of European Union Council Directive 2004/28/EC or, where appropriate, the requirements set out in Title VII, are being complied with. The inspected manufacturer or market authorization holder shall be informed of the content of such reports.

(4) Without prejudice to any arrangements which may have been concluded between the European Union and a third country, Malta, the European Commission or the Agency may require a manufacturer established in a third country to undergo an inspection as referred to in subregulation (1).

(5) Within ninety days after an inspection as referred to in subregulation (1), a certificate of good manufacturing practice shall be issued to the manufacturer if the inspection established that the manufacturer in question is complying with the principles and guidelines on good manufacturing practice as provided for by Union law. In the event of an inspection carried out at the request of the European Pharmacopoeia, a certificate of compliance with the monograph shall be issued, if appropriate.

(6) Malta shall enter the certificates of good manufacturing practice which they issue in a Union database managed by the Agency on behalf of the Union.

(7) If the outcome of the inspection as referred to in subregulation (1) is that the manufacturer does not comply with the principles and guidelines of good manufacturing practice as provided for by Union legislation, the information shall be entered in the Union database as referred to in subregulation (6).

(8) the persons responsible for the premises mentioned in this regulation shall allow entry to the authorised representatives of the veterinary services to carry out their duties.