Generic and Interchangeable Medicines
The Health (Pricing and Supply of Medical Goods) Act 2013 provides for the introduction of a system of generic substitution and reference pricing for authorised medicines. This legislation was commenced on 24 June 2013.
The role of the HPRA under this legislation is to establish, publish and maintain a "List of Interchangeable Medicines" on our website. Products are grouped together according to their active substance, strength, pharmaceutical form and the route of administration.
View and search the list
The legislation will apply first to certain types of medicines such as those for high cholesterol, high blood pressure, acid reflux and stomach ulcers as these medicines are widely used and result in significant costs.
Initial List containing Atorvastatin products published on 7 August 2013
On commencement of the legislation, the HPRA began a consultation process (as per the legislation) in respect of atorvastatin. Following completion of this consultation, the initial list was published on 7 August 2013.
Ongoing Consultations and Updates to the List
The HPRA will be adding further active substances to the list on a continual basis. We will update the Consultations and Updates to the List section of our website as consultations are both commenced and completed.
Guide to Interchangeable Medicines
The HPRA has published a detailed guide outlining the process involved in establishing a list of interchangeable medicines and includes information about:
• Reference and generic medicines;
• The criteria for interchangeability;
• Publication of the interchangeable list;
• Process for inclusion on the interchangeable list including the consultation and appeal process.
Generic Medicines: Information for Patients and Members of the Public
The HPRA information leaflet Our Advice on Generic Medicines provides members of the public with details on the safety, quality and effectiveness of generic medicines. This is one of a number of HPRA consumer leaflets providing advice on the safe purchase and use of medicines.
The Health (Pricing and Supply of Medical Goods) Act 2013 also provides for the introduction by the Health Service Executive (HSE) of a system of reference pricing, which involves the setting of a common reimbursement price, or reference price, for a group of medicines which are deemed interchangeable by the HPRA. The HPRA has no role in reimbursement or in setting prices of medicines. This is the responsibility of the HSE.
About the Legislation
Under the Health (Pricing and Supply of Medical Goods) Act 2013, medicines on the interchangeable list may be substituted for each other to help save money for those who pay for medicines and/or the health service. When lower priced medicines are made available to patients in this way, it is known as ‘generic substitution’.
The publication of an interchangeable list by the HPRA will facilitate increased levels of generic substitution by assisting pharmacists to safely dispense a lower cost version of a medicine where a specific brand has been prescribed. Previously, when a specific brand of medicine was prescribed for a patient, a pharmacist could only supply that particular brand, even when less expensive versions of the same medicine were available. This legislation allows pharmacists to substitute medicines which have been confirmed as interchangeable by the HPRA.