In February 2016, the Regulation of Retail Pharmacy Businesses Regulations were amended (S.I. No. 80 of 2016) to include regulation 5(1)(ea), which puts in place a legal requirement that all pharmacy-only medicines be stored in a part of the pharmacy to which the public does not have access. It states:
5(1)(ea) medicinal products other than medicinal products referred to in sub-paragraph (e), and not being medicinal products on a general sales list, are stored in a part of the premises to which the public does not have access.
A
Regulatory Notice from the PSI was issued in October 2017, which explains that there are a number of ways in which pharmacies can comply with the requirements of the legislation including:
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Storage of pharmacy-only medicines behind the medicines counter/OTC counter.
- Any other arrangements within the premises that ensures that the public does not have direct or physical access to pharmacy-only medicines.
When considering whether you have met the requirements of the legislation, you should ask yourself: Is a member of the public able to self-select (i.e. physically access / pick up) a pharmacy-only medicine from a publicly accessible part of the pharmacy?
The answer to this should be no.