11.—(1) An inspector may, upon entering any premises by virtue of article 10 —
(a)inspect the premises and any plant, machinery or equipment at the premises;
(b)search the premises;
(c)inspect and remove from the premises any substance, article or product (whether or not appearing to the inspector to be a medicinal product);
(d)take and remove from the premises samples of any substance, article or product;
(e)carry out any examinations and tests and make any enquiries (including such enquiries of any person as the inspector considers it appropriate to make relating to the fitness to practise of a registrant who is or has been employed on the premises to provide pharmaceutical services);
(f)require any person holding or accountable for any documents or records (whether or not kept at the premises being inspected) to produce them for inspection at the premises.
(2) The power conferred by paragraph (1)(f) includes power to require any documents or records that are kept by means of a computer or other electronic device to be produced in a form in which they are legible and may be taken away.
(3) If an inspector requires documents or records to be produced for inspection by virtue of the power conferred by paragraph (1)(f), the inspector may—
(a)take copies of or extracts from such documents or records;
(b)take possession of the documents or records or of the computer or other electronic device in which the documents or records are stored and retain them for as long as the inspector considers necessary;
(c)require access to any computer or other electronic device or to any associated apparatus or material that is or has been used in connection with the documents or records and inspect and check the operation of the computer, electronic device, apparatus or material.
(4) The power conferred by paragraph (3)(c) includes power to require any person having charge of, or otherwise concerned with the operation of, the computer, device, apparatus or material to afford such assistance as the inspector may reasonably require.
(5) An inspector also has power to do anything which is calculated to facilitate the discharge of the inspector’s functions or which is incidental or conducive to the discharge of those functions.
Commencement Information
I1Art. 11 in force at 10.2.2010 for specified purposes, see art. 1(3)
I2Art. 11 in force at 27.9.2010 in so far as not already in force by S.I. 2010/1621, art. 2(1), Sch.