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 on the Generic / Interchangeable list page

Ongoing Consultations and Updates to the List

The list is continuously updated with the addition of new active substances. Information on ongoing consultations and updates can be found on our Consultations and Updates to the List page.

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.
  

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 webpage Our advice on generic medicines

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.