Legal Supply Status and Reclassification of Medicines
The HPRA is responsible for deciding the legal supply category for a medicine. The supply category is specific to the product and is part of the marketing authorisation.
The categories for supply of a medicine are outlined below.
Subject to prescription:
- 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.
Not subject to prescription:
- Pharmacy-only: available under the supervision of a pharmacist.
- General sale: can, with reasonable safety, be sold without the supervision of a pharmacist.
The criteria for deciding legal supply status are included in national legislation, Medicinal Products (Control of Placing on the Market) Regulations 2007, as amended. For further information click here.
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 legal supply category to supply by a pharmacist without a prescription. It may also be possible for medicines previously supplied only by a pharmacist to be supplied on general sale, if appropriate.
Companies which hold marketing authorisations can apply to the HPRA to have the supply categories changed. These applications are called reclassification or ‘switching’ applications. Since the 2007 Regulations came into force, for nationally authorised products this requires an application to the HPRA and no additional change to the Medicinal Products (Prescription and Control of Supply) Regulations is needed.
Reclassification applications are assessed by the HPRA and its experts and if approved, a change to the condition of the marketing authorisation is made.
Guidance on how to make applications to change legal supply status is given in the Guide to Reclassification (Switching) of Legal Supply Status of Human Medicinal Products.
Applicants should also consult the EU guide Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use.
Information on the legal supply status of authorised medicinal products is available on the Medicines Product List.
List of Active Substances Suitable for Reclassification
The HPRA published a list of twelve active substances (or combinations of substances) contained in medicinal products (medicines) currently classified as prescription-only medicines (POM) for which it considers the method of sale and supply (MoSS) classification could be safely switched from POM to over the counter (OTC) (pharmacy sale not subject to medical prescription).
For more information, and to view the list, please visit Legal Classification / Method of Sale and Supply.