Cap. 458 Art. 42Inspection in relation to manufacturers, etc.

(1) The Licensing Authority shall carry out regular inspections to ensure that the requirements established by or under this Act in relation to the manufacture, assembly or modification of a medicinal product are complied with.

(2) The Licensing Authority or any person carrying out an inspection shall:

(a) inspect the manufacturing establishment and any other location he may deem necessary;

(b) examine any relevant documents;

(c) take any samples he may deem necessary;

(d) draw up a report of the findings and communicate the contents of such report to the licensee or the applicant for a licence in relation to such inspection and to the qualified person;

(e) carry out any other activity he may deem appropriate for the proper execution of his duties and responsibilities as provided for by or under this Act.

(3) Except in urgent cases an inspection shall be carried out in the presence of a qualified person or his representative, if any.