Health (Miscellaneous Provisions) Act 2024

PART 3

Amendment of Act of 1995

Amendment of section 1 of Act of 1995

8. Section 1 of the Act of 1995 is amended by the insertion of the following definitions:

“ ‘authorised medicinal product’ means a medicinal product that is authorised under the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ) or Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 20041 , as amended;

‘medicinal product shortage’ means where the current or anticipated supply of an authorised medicinal product or products that is placed on the market does not meet the current or, as the case may be, anticipated demand for that medicinal product or products;

‘medicinal product that is in short supply’ means, in relation to a medicinal product shortage, the authorised medicinal product or products that is the subject of the medicinal product shortage;

‘protocol’ means a protocol issued by the Minister under section 32G;

‘registered pharmacist’ means a person registered in the register of pharmacists established under section 13 of the Pharmacy Act 2007 ;

‘substitutable medicinal product’ means the medicinal product or products that registered pharmacists are authorised under a protocol to supply in substitution for the medicinal product that is in short supply;”.

1 OJ No. L136, 30.4.2004, p. 1