Tim O'Malley (Limerick East, Progressive Democrats)

Amendment No. 52 extends the definition of authorised officer to include officers of the Customs and Excise. This is an important extension in view of the amount of medicinal products passing through our ports, which are supervised by officers of the Customs and Excise. It will increase the effectiveness of their surveillance, particularly with regard to areas of counterfeit medicines and the importation of prescription medicines, often sourced via the Internet, for uses other than those under medical supervision.

Amendment No. 54 excludes officers of the Customs and Excise from having to produce warrants for inspection under this provision. Customs officers have their own authority under their own legislation which sufficiently identifies them for that purpose.

Amendments Nos. 55 and 56 are technical amendments which permit the addition of further paragraphs to subsection 3 of new section 32(b)(3) of the Irish Medicines Board Act.

Amendment No. 57 proposes the insertion of three new paragraphs — (l), (m) and (n) — into section 32B(3) of the Irish Medicines Board Act. These new paragraphs are necessary for the appropriate enforcement of provisions of any regulations that may be made under the Act. Paragraph (l) enables the inspection of data within the meaning of the Data Protection Acts 1988 and 2003. Under this power, it is likely that the examination of medical prescriptions will be necessary and will include the names of identifiable individuals.

The new paragraph (m) requires a person having authority to do so to break open any container or open any vending machine to permit inspections as required. The new paragraph (n) requires persons making facilities such as post office boxes, telecommunications or electronic mail addresses to render assistance and provide information as may be required for the enforcement of the provision of regulations made under the Act.

Amendment No. 58 is a consequential amendment that is necessitated by the insertion of the new paragraphs — (l) (m) and (n) — in subsection 3. Amendment No. 62 is a technical correction of the text where the original reference should have referred to subsection 8 rather than subsection 9.