Statutory Instruments

MEDICINAL PRODUCTS (CONTROL OF WHOLESALE DISTRIBUTION) (AMENDMENT) REGULATIONS 2019 | MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) (AMENDMENT) REGULATIONS 2019 | MEDICINAL PRODUCTS (CONTROL OF MANUFACTURE) (AMENDMENT) REGULATIONS 2019

The purpose of these regulations is to enable the holder of a wholesaler’s authorisation to import exempt medicinal product from a third country and to update the subsequent requirements to be met by the holder of that authorisation. The requirement for a mutual recognition agreement to be used as an appropriate arrangement between the European Union and a third country has been removed.

The regulations will result in an increase in the number and type of operators who can import an exempt medicinal product from a third country while still maintaining security and traceability of the supply chain.

The regulations will also result in an improvement in the transparency of the wholesale distribution of medicines and will realign national legislation with the EU Pharmaceutical Directive for the recognition of good manufacturing practice in a third country.

 

S.I. No. 217 of 2019 Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2019:

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S.I. No. 218 of 2019 Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2019

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Read on Irish Statute website here.

 

S.I. No. 219 of 2019 Medicinal Products (Control of Manufacture) (Amendment) Regulations 2019

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Read on Irish Statute website here.