447. Deputy Colm Burke asked the Minister for Health to clarify the current legal position regarding the sale of over the counter paracetamol products to persons under 18 years-of-age; and whether any statutory minimum age currently applies in pharmacies or non-pharmacy retail outlets. [67822/26]

There is no prohibition, on age grounds, as regards the retail sale of paracetamol-containing products. The sale of medicines is governed by the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended, with specific provisions which apply exclusively to the sale of medicines that consist of, or contain, paracetamol. These regulations provide that paracetamol may only be supplied, without prescription, from pharmacies and non-pharmacy outlets, subject to certain restrictions on presentation and quantities that may be supplied.

The Health Products Regulatory Authority 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.

In non-pharmacy outlets the pack sizes available are restricted under the legislation to:

- 12 or fewer dosage units, each of which contains more than 120mg of paracetamol but not more than 500mg of paracetamol

- 10 or fewer dosage units, each of which contains more than 500mg of paracetamol but not more than 600mg of paracetamol

In the case of a medicine intended for use in children under 6 years of age:

- Packs must contain 12 or fewer dosage units, each of which contains no more than 120mg of paracetamol

- Pack size of liquid forms should contain 60ml or less with no more than 120mg of paracetamol contained in 5ml

In addition to these requirements, a non-pharmacy retailer may only supply one pack of a paracetamol medicine per sales transaction.

In 2015, a national strategy, Connecting for Life, was launched by the Department of Health aimed at reducing suicide. One of its key goals is to limit access to medicines that are commonly used in intentional overdoses, such as paracetamol.

As a result, retailers must be especially careful when selling any product containing paracetamol. There are specific legal requirements to follow, and all staff must be aware of the restrictions.

Any specific concerns about the sale of paracetamol products can be raised directly with the HPRA via reportacase@hpra.ie.