Statutory Instruments

MEDICINAL PRODUCTS (SAFETY FEATURES ON PACKAGING) REGULATIONS 2019

The purpose of these Regulations is to designate the Health Products Regulatory Authority (and in some cases also the Pharmaceutical Society of Ireland) as the competent authority responsible for enforcing Commission Delegated Regulation (EU) 2016/161 of 2 October 2015. In addition, these Regulations provide for the verification and decommissioning of the unique identifier of a medicinal product by a wholesaler before supply in certain circumstances. Finally, these Regulations amend the Medicinal Products (Control of Manufacture) Regulations 2007, the Medicinal Products (Control of Placing on the Market) Regulations 2007 and the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to take account of Commission Delegated Regulation (EU) 2016/161.

S.I. No. 36 of 2019, MEDICINAL PRODUCTS (SAFETY FEATURES ON PACKAGING) REGULATIONS 2019:

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