Legislative Basis

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 to reduce the risks associated with the supply of counterfeit medicines, thereby protecting public health.  

In Ireland this applies to pharmacies and non-pharmacy retailers involved in the internet supply of non-prescription medicines only. 

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) made it a principal function of the PSI to establish and maintain a list of persons entitled to supply non-prescription medicinal products via the Internet (entitled the ISS supply list (Information Society Service) 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.

You can find more information here about regulatory requirements, record keeping, Medicinal Product requirements, inspections etc.