Cap. 458 Art. 101ARequirements for testing and inspections of manufacturers, importers, brokers and distributors of medicinal products,including APIs, excipients and other starting materials.

(1) The Licensing Authority shall, in cooperation with the European Medicines Agency, ensure that the legal requirements governing medicinal products are complied with, by means of inspections, if necessary unannounced, and, where appropriate, by asking an Official Medicines Control Laboratory or a laboratory designated for that purpose to carry out tests on samples. This cooperation shall consist in sharing information with the European

Medicines Agency on both inspections that are planned and that have been conducted as well as in the coordination of inspections in third countries.

(2) The inspections shall include but not be limited to the ones mentioned in paragraphs (a) and (b) as follows:

(a) manufacturers, located in the European Union or in third countries, and wholesale distributors of medicinal products shall be subject to repeated inspections;

(b) the Licensing Authority shall have a system of supervision including by inspections at an appropriate frequency based on risk, at the premises of the manufacturers, importers, or distributors of active substances, located in Maltese territory, and effective follow-up thereof.

(3) Whenever it considers that there are grounds for suspecting non-compliance with the legal requirements laid down in this Act and subsidiary legislation made thereunder, including the European Union principles and guidelines of good manufacturing practice and good distribution practices, the Licensing Authority may carry out inspections at the premises of:

(a) manufacturers or distributors of active substances located in third countries;

(b) manufacturers or importers of excipients.

(4) Inspections referred to in sub-articles (2) and (3) may also be carried out in the European Union and in third countries at the request of a European Union Member State, the European Union Commission or the European Medicines Agency.

(5) Inspections may also take place at the premises of marketing authorisation holders and of brokers of medicinal products.

(6) Inspections shall be carried out by officials representing the Licensing Authority who shall be empowered to inspect the premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform any pharmacovigilance activities.

(7) Inspections shall be carried out in accordance with the guidelines and provisions referred to in articles 101 to 104.

(8) After every inspection, the Licensing Authority shall report on whether the inspected entity complies with the European Union principles and guidelines of good manufacturing practice and good distribution as applicable, or on whether the marketing authorisation holder complies with the pharmacovigilance requirements laid down in this Act and subsidiary legislation made thereunder.

(9) The Licensing Authority shall communicate the content of those reports to the inspected entity. Before adopting the report, the Licensing Authority shall give the inspected entity concerned the opportunity to submit comments.

(10) Without prejudice to any arrangements which may have been concluded between the European Union and third countries, a Member State, the European Union Commission or the European Medicines Agency may require a manufacturer established in a third country to submit to an inspection as referred to in this article.

(11) Within ninety days of an inspection as referred to in sub-article (1), a certificate of good manufacturing practice or good distribution practices shall, when applicable, be issued to the inspected entity if the outcome of the inspection shows that it complies with the principles and guidelines of good manufacturing practice or good distribution practices as provided for by European Union legislation.

(12) If inspections are performed as part of the certification procedure for the monographs of the European Pharmacopoeia, a certificate shall be drawn up.

(13) Certificates of good manufacturing practice and good distribution practices issued shall be entered in the European Union database managed by the European Medicines Agency on behalf of the European Union. Information shall also be entered in that database regarding the registration of importers, manufacturers and distributors of active substances.