Generic and Interchangeable Medicines

The Health (Pricing and Supply of Medical Goods) Act 2013 introduced a system of generic substitution and reference pricing for authorised medicines. The legislation is applied to certain types of medicines which are widely used and can result in significant cost savings.

Under this legislation, interchangeable medicines are defined as those medicines that (1) contain the same active ingredient in the same strength, (2) are in the same pharmaceutical form, and (3) have the same route of administration.

The role of the HPRA under this legislation is to establish, publish and maintain a "List of Interchangeable Medicines" which are suitable for generic substitution. In the list, products are grouped together according to the active substance, strength, pharmaceutical form and route of administration. The first list was published in 2013.

The current list is available at Interchangeable medicines

You can search for groups of interchangeable medicines by entering the active substance.

Consultations and Updates to the List 

The Act requires the HPRA to consult with relevant marketing authorisation holders prior to adding a medicine or a group of medicines to the list of interchangeable medicines.

Full details on the general consultation process and the possible outcomes can be found in our Guide to Interchangeable Medicines.

Receive Updates

Why is the Interchangeable list important?

Previously, when a specific brand of medicine was prescribed for a patient, a pharmacist could only supply that brand, even when less expensive versions of the same medicine were available. Under the Health (Pricing and Supply of Medical Goods) Act 2013, pharmacists may substitute a medicine on the HPRA interchangeable list for another one of lower cost. The person buying the medicine will therefore save money. When lower priced medicines are made available to patients in this way, it is known as generic substitution.

Guide to Interchangeable Medicines

The HPRA published a guide explaining how the ‘interchangeable list’ is prepared. This guide also includes information about:

• Reference and generic medicines.
• Which medicines can be interchanged.
• How medicines are included on the interchangeable list, including the consultation and appeal process.
• Publication and presentation of the interchangeable list.

Following clarification received from the Department of Health that the demonstration of bioequivalence is not required by the Health (Pricing and Supply of Medical Goods) Act 2013. 

Generic Medicines: Information for Patients and Members of the Public

Information for the public on the safety, quality and effectiveness of generic medicines is included on the Generic Medicines webpage.

Reference Pricing

Reference pricing is the setting of a common reimbursement price, (also called reference price), for a group of medicines which are considered interchangeable by the HPRA. The HPRA has no role in setting the reimbursement price of medicines. This is the responsibility of the HSE.