Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2019

• Jurisdiction: Ireland
• Citation: IR SI 217/2019
• Year: 2019

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 21th May, 2019.

I, SIMON HARRIS, Minister for Health, in exercise of the powers conferred on me by section 32 (as amended by section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006)) of the Irish Medicines Board Act 1995 (No. 29 of 1995), and for the purpose of giving further effect to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20011 , hereby make the following regulations:

1. (1) These Regulations may be cited as the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2019.

(2) The collective citation “the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2019” includes these Regulations.

2. In these Regulations—

“Principal Regulations” means the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 ( S.I. No. 538 of 2007 );

“Regulations of 2019” means the Medicinal Products (Safety Features on Packaging) Regulations 2019 ( S.I. No. 36 of 2019 ).

3. Regulation 4(1) (as amended by Regulation 7(a) of the Regulations of 2019) of the Principal Regulations is amended by deleting the definition of “exempt sourced medicinal product”.

4. Schedule 2 (as amended by Regulation 7(b) of the Regulations of 2019) to the Principal Regulations is amended—

(a) in paragraph 2(1), by inserting “and paragraph 2A” after “subparagraph (2)”,

(b) by inserting after paragraph 2 the following...