446. Deputy Colm Burke asked the Minister for Health whether her Department will examine the introduction of a statutory minimum age for the purchase of over the counter paracetamol products, having regard to safeguarding concerns relating to children and adolescents. [67823/26]

There is currently no statutory minimum age for the purchase of paracetamol-containing products in Ireland. The sale and supply of paracetamol is regulated under the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended, which place specific restrictions on the pack sizes and quantities of paracetamol that may be supplied without prescription.

The Health Product Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland and is responsible for determining the method of sale and supply of a medicine. The HPRA may determine the classification of a medicine as suitable for supply without prescription having regard to the maximum single dose of the product concerned, the maximum daily dose; the strength of the product; its pharmaceutical form; its packaging; or any other circumstances relating to its use as the HPRA may consider appropriate, for example, for a particular indication only.  In determining if a product should be classified as available on general sale in non-pharmacy outlets, the HPRA must have regard to the nature and purpose of the product and must be satisfied that the product concerned can, with reasonable safety, be sold other than under the supervision of a pharmacist.

The legislation already limits the quantity of paracetamol that may be supplied in a single transaction and places strict controls on the pack sizes that may be sold in pharmacies and non-pharmacy outlets. In non-pharmacy outlets, only one pack of a paracetamol-containing medicine may be supplied per sales transaction.

The Department of Health recognises the importance of safeguarding children and young people and of reducing access to medicines that may be used in intentional overdose. This objective is reflected in Connecting for Life, Ireland's national strategy for suicide prevention, which includes measures aimed at limiting access to commonly used means of self-harm, including medicines such as paracetamol.

The Minister has no current plans to introduce a statutory minimum age for the purchase of over-the-counter paracetamol products. However, the Department and the HPRA keep medicines legislation and patient safety measures under ongoing review. Any concerns regarding the sale of paracetamol products can be raised with the HPRA, which has responsibility for oversight and enforcement of the relevant regulatory requirements.