Written answers

Wednesday, 8 October 2008

Department of Health and Children

Medicinal Products

9:00 pm

Photo of James ReillyJames Reilly (Dublin North, Fine Gael)
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Question 228: To ask the Minister for Health and Children her views on the packaging of prescription medicines; the regulations that exist in regard to packaging; if all such medicines should be provided in child-proof bottles rather than in foil blister packs or cardboard boxes; and if she will make a statement on the matter. [34013/08]

Photo of Mary HarneyMary Harney (Dublin Mid West, Progressive Democrats)
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The Irish Medicines Board is the statutory body responsible for the regulation of medicinal products in Ireland. The Board, in cooperation with its European counterparts, keeps the status and other safety issues of all medicinal products under review and any issues arising are examined and appropriate regulatory action taken if required.

National and EU law require medicinal products to be labelled with a statement on medicinal products to "Keep out of reach of children". The only specific legislation relating to child-resistant proof containers is in the Medicinal Products (Control of Paracetamol) Regulations 2001 which specify use of blister packs in certain circumstances. The regulatory authorities in Europe are generally assessing products on the basis of specific need and as such the needs of elderly and those with mobility-related illness also need to be part of the assessment.

I also understand that the Pharmaceutical Society of Ireland published guidelines for Dispensing Prescriptions in June 1997 which encourage pharmacists to use where possible child-resistant containers.

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