Internet Supply List: Legislative Basis
The EU common logo was brought in by the Falsified Medicines Directive.
The Falsified Medicines Directive was adopted by the EU in July 2011.The objective of the Directive is to strengthen the EU legal framework which regulates medicines to prevent falsified (counterfeit) medicines being supplied to patients through the legal supply chain.
The purpose of Article 85c of the Directive is to introduce regulatory controls on the supply of medicines over the internet in order to reduce the risks associated with the supply of counterfeit medicines, thereby protecting public health. In Ireland this will apply to pharmacies and other non pharmacy retailers involved in the internet supply of non-prescription medicines only.
In order to transpose Article 85c of the Falsified Medicines Directive into Irish Law the following amendments to legislation have been made:
- The European Union (Amendment of the Pharmacy Act 2007) Regulations 2015 (S.I. No. 86 of 2015) make it a principle function of the PSI to establish and maintain a list of persons entitled to supply non-prescription medicinal products via internet supply (entitled the ISS (Information Society Service) supply list or Internet Supply List)
- The Medicinal Products (Prescription and Control of Supply)(Amendment) Regulations 2015 (S.I. No. 87 of 2015) will require all pharmacies and other entities engaged in internet supply of non prescription medicines to notify the PSI of their internet activities.