Cap. 458 Art. 102Power to inspect, take samples and seize goods and documents.

(1) For the purpose of ascertaining whether there is or has been or there is likely to be a contravention of this Act or of any regulations or rules made thereunder, an authorised officer shall have a right to inspect:

(a) any substance or article appearing to him to be a medicinal product;

(b) any article used or intended to be used to contain any medicinal product or to be a label or leaflet used or intended to be used in connection with a medicinal product;

(c) any plant or equipment appearing to him to be used or intended to be used in connection with the manufacture or assembly of medicinal products, and any process of manufacture or assembly of any medicinal products and the means employed, at any stage in the process of manufacture or assembly, for testing the materials after they have been subjected to those processes; or

(d) any premises, records, documents and pharmacovigilance system master file of the marketing authorisation holder or any firms employed by the marketing authorisation holder to perform pharmacovigilance activities as established under article 31A: Provided that an authorized officer may also carry out inspections of starting material manufacturers after a specific request for the purpose is made by such manufacturer himself:

Provided further that the samples that may be collected may be analysed at a designated laboratory identified by the Authority.

(2) An authorised officer may, for the purpose specified in the preceding subarticle, take a sample, including with a view to independent tests being carried out by an Official Medicines Control Laboratory or a laboratory designated for that purpose by an European Union Member State, of any:

(a) substance or medicinal product sold or supplied or intended to be sold or supplied; or

(b) substance or article used or intended to be used in the manufacture of a medicinal product.

(3) For the purposes of subarticle (1), an authorised person shall have the right:

(a) to inspect any records, in whatever form they are held, related to the manufacture, assembly, sale or supply of a medicinal product and, where such records are kept in electronic form:

(i) may have access to, and inspect and check the operation of any computer, any associated apparatus or material which is or has been in use in connection with the records; and

(ii) may require any person having charge of, or otherwise connected with the operation of, the computer, apparatus or material to afford him such assistance as he may reasonably require;

(b) to take copies of any entry in any book or document produced in pursuance of the preceding paragraph and where the records are kept electronically, by means of a computer or otherwise, require the records to be produced in an intelligible form which may be taken away;

(c) to take photographs of any equipment, premises, records and documents.

(4) Any authorised officer shall have a right to seize, remove and detain any substance or article which he has reasonable cause to believe to be a substance or article in relation to which, or by means of which, an offence under this Act is being or has been committed, and any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings under this Act.

(5) For the purpose of subarticle (4), any authorised person may, so far as is reasonably necessary in order to secure compliance with the provisions of this Act and any regulations or rules made thereunder, require any person to break open any container, package or machine, or to permit him to do so: Provided that where a person seizes any substance or article, including any document, for the purposes specified in subarticle (4), he shall inform the person from whom it is seized and give him a receipt thereof.

(6) Without prejudice to the preceding provisions of this article, any authorised person shall have the same rights conferred by those provisions in relation to things belonging to, or any business carried on by, an applicant for an authorisation or certificate under Part III of this Act, and may exercise such rights for the purpose of verifying any statements or information contained in the application for the authorisation or certificate; and, where by virtue of the provisions of this subarticle a person exercises any such right as is specified in subarticle (4), he shall be subject to the duty imposed by subarticle (5).

(7) Notwithstanding anything in the preceding provisions of this article, where a person claiming to exercise a right by virtue of the provisions of this article is required to produce his authorisation or credentials, the right shall only be exercisable by him on the production of the authorisation or credentials.

(8) After every inspection the authorized officer shall report on whether the manufacturer complies with the principles and guidelines of good manufacturing practice or, where appropriate, with the requirements relating to pharmacovigilance. The content of such reports shall be communicated to the manufacturer or marketing authorisation holder who has undergone the inspection.

(9) Within ninety days of an inspection a certificate of good manufacturing practice shall be issued to a manufacturer if the outcome of the inspection shows that the manufacturer complies with the principles and guidelines of good manufacturing practice as provided for by legislation in force at the time.