Legal Supply Status and Reclassification of Medicines
This page provides information to members of the public, healthcare professionals, and companies on the legal supply status of medicines. It also provides information on how this status can be changed.
Legal supply status
The supply status of a medicine describes how a medicine can be supplied to a patient legally. It is sometimes called the supply category or classification of a medicine.
Supply category
A medicine that is subject to prescription can only be supplied in a pharmacy with a valid prescription. This supply category is subdivided into the following:
- Non-renewable: dispensed once by the pharmacist unless the doctor directs otherwise.
- Renewable: dispensed for up to six months by the pharmacist unless the doctor directs otherwise.
Classification of a medicine
A medicine that is not subject to prescription can be supplied to a person without a prescription. This supply category is subdivided into the following:
- Pharmacy-only supply: supplied in a pharmacy under the supervision of a pharmacist, but no prescription is needed.
- General sales: supplied in a pharmacy without the supervision of a pharmacist or in a non-pharmacy retail outlet.
Who decides it?
The HPRA is responsible for deciding a medicine legal supply category. It does this by considering criteria that are set out in the following laws:
- Title VI (Articles 70 to 75) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
- Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended.
- The supply category is specific to each medicine and forms part of its marketing authorisation (or licence). You will find the legal supply status of authorised medicines on the HPRA Find a Medicine webpage.
Reclassification
Reclassification is when a medicine legal supply status is changed. Generally, new medicines may only be supplied on prescription. After use of the medicine for a number of years, sufficient information may be available to justify a change in the supply status. This might be a change from being subject to prescription; to not subject to prescription
Companies that hold marketing authorisations can apply to the HPRA to have their medicine supply status changed. These applications are called reclassification,applications. If approved, a change to the condition of the marketing authorisation is made.
The HPRA provides guidance on reclassification applications in its Guide to reclassification (switching) of legal supply status for human medicinal products.
Applicants should also consult the European Commission Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use. This document provides general guidance to applicants on key considerations and data requirements that regulatory authorities expect of reclassification applications.
We strongly encourage applicants to seek HPRA national scientific and regulatory advice before the submission of innovative or first-in-class reclassification applications.