Irish Medicines Board (Miscellaneous Provisions) Act 2006

Insertion of new section 15A into Control of Clinical Trials Act 1987 (authorised officers).

24.— The Control of Clinical Trials Act 1987 is amended by inserting the following after section 15:

“Authorised officers.

15A.— (1) The Irish Medicines Board may appoint any of its officers to be authorised officers for the purposes of this Act and any regulations under this Act.

(2) The Irish Medicines Board shall cause an authorised officer to be issued with a warrant identifying the officer as such an officer.

(3) An authorised officer shall, when performing a function or exercising a power in his capacity as an authorised officer, produce the warrant issued under subsection (2) to him or her if requested to do so by a person affected by the performance of the function or exercise of the power, as the case may be.

(4) Subject to subsections (5) and (6), an authorised officer may, for the purpose of ensuring that any provision of this Act or of any regulations under this Act is being complied with—

(a) at all reasonable times, enter and search a premises of any class or description,

(b) inspect any substance or product which is stored, or offered or kept for supply at such premises,

(c) require the production of, inspect and, if he thinks fit, take copies of any prescription, book, invoice, order, record, register, or other document or of any entry in any such book, invoice, order, record, register, or other document at such premises,

(d) inspect and copy or extract information from any data within the meaning of the Data Protection Acts 1988 and 2003,

(e) take (without payment) samples of any medicinal product, medical device or substance stored, or offered or kept for supply at such premises for test, examination or analysis,

(f) seize and detain any medicinal product, medical device, substance or article,

(g) take any document which he has reasonable cause to believe to be a document which may be required as evidence in proceedings under this Act or any regulations under this Act.

(5) An authorised officer shall not other than with the consent of the occupier enter a private dwelling (other than any part of the private dwelling used by a registered medical practitioner or registered dentist for carrying on his or her professional practice) unless he or she has obtained a warrant from a judge of the District Court under subsection (8) authorising such entry.

(6) An authorised officer, for the purpose of exercising any of the powers conferred on him under subsection (4), may require any other person, having authority to do so, to break open any container or package, or to permit him to do so.

(7) Where an authorised officer seizes any medicinal product, medical device, substance, article or document in the exercise of a power conferred on him by subsection (4), he or she shall inform the person from whom it is seized of that fact.

(8) If a judge of the District Court is satisfied, on the sworn information of an authorised officer, that there are reasonable grounds to authorise entry into any of those premises set out at subsection (5), the judge may issue a warrant authorising such an authorised officer, accompanied, if appropriate, by other authorised officers or by a member or members of the Garda Síochána, or any combination thereof, at any time or times within one month from the date of issue of the warrant, on production of the warrant requested, to enter those premises or part thereof and to exercise any of the powers conferred on such an authorised officer under this Act or any regulations under this Act.

(9) A person shall not wilfully obstruct or interfere with the exercise of a power by an authorised officer pursuant to this Act or any regulations under this Act.

(10) A person shall not, without reasonable excuse, fail to comply with any request made by an authorised officer under this Act or any regulations made under this Act.”.