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From 01 January 2009, a pharmacy must be registered as a retail pharmacy business in the register kept by the PSI in order to operate and comply with the Pharmacy Act 2007. The Register of retail pharmacy businesses is published online and are accessible and available to view on this website via the ‘Search our Registers’ button on the top right hand corner of this page.
Regulations made under Section 18 of the Pharmacy Act 2007, the Regulation of Retail Pharmacy Businesses Regulations 2008 [SI 488 of 2008], govern the operation of pharmacies. These regulations cover the staff, premises, equipment and procedures and include regulations in relation to the supply and counseling of both prescription and non-prescription medicines.
The sale and supply of all medicinal products in a retail pharmacy business must be by or under the personal supervision of a pharmacist. Each retail pharmacy business must have a superintendent pharmacist and a supervising pharmacist, each of whom must have at least three years’ appropriate experience. The management and administration of the sale and supply of medicinal products is under the personal control of the superintendent pharmacist who is essentially the person in overall control of the legal, professional and clinical policies pursued in the retail pharmacy business.
The supervising pharmacist is in wholetime charge of the carrying on of the business and is essentially the person responsible for the day-to-day management and operation of the pharmacy. While a superintendent pharmacist can act in respect of more than one pharmacy, a supervising pharmacist can only act in respect of one retail pharmacy business.
The certificates of registration of the retail pharmacy business and of the supervising pharmacist must be on conspicuous display in the pharmacy.
The PSI would like to strongly encourage all superintendent and supervising pharmacists who have not already supplied an email address to the PSI to do so. This is to facilitate the speedy dissemination, to every registered retail pharmacy business, of urgent patient/medication safety alerts or practice updates/information from the PSI. In the near future, an online system will be available for all registrants that will allow for online updating of personal details, such as contact details, including email addresses and telephone numbers.
While the PSI takes every care to ensure the accuracy of these registers, Section 22(4) of the Pharmacy Act 2007 provides that: “A person to whom an entry in a register relates shall notify the Council in writing of – (a) any error that the person knows of in that entry, or (b) any change of circumstances that is likely to have a bearing on the accuracy of the entry, as soon as may be after the person becomes aware of that error or change in circumstances.”
Therefore any registrant who finds an error in their details as published on the online public register or on their certificate should inform the PSI of that error.
In the near future, an online system will be available for all registrants that will allow for online updating of personal details, such as addresses (the PSI (Registration) Rules 2008 require a practice address for publication in the public register and a residential address which is not made publicly available) and contact details, including email addresses and telephone numbers. Registrants will be informed of the new system in due course.
In the application to register a Retail Pharmacy Business, the pharmacy owner must provide details of the ownership of the pharmacy, the services it provides and details of all personnel, particularly the pharmacists employed or engaged.
The pharmacy owner must complete forms nominating the supervising and superintendent pharmacists of the pharmacy. In addition, contact details for the pharmacy and the supervising and superintendent pharmacists are also required to facilitate communication with the PSI, especially in relation to urgent alerts and patient safety information.
All pharmacy owners must complete and sign a declaration which includes an undertaking that the sale and supply of medicinal products will be conducted under the supervision of a pharmacist at all times, that the Retail Pharmacy Business will be conducted in accordance with the Regulation of Retail Pharmacy Businesses Regulations (Section 18 Regulations) and that appropriate arrangements are established to ensure that pharmacists can obtain and maintain appropriate experience and undertake continuing education and continuing professional development.
In addition, pharmacy owners undertake to immediately notify the PSI of any change of ownership of the pharmacy (a change of ownership of a Retail Pharmacy Business cancels its registration), and of changes in personnel, particularly the supervising and superintendent pharmacists.
In nominating the superintendent and supervising pharmacists, details of their three years’ post-registration experience must be detailed.
Following registration of the Retail Pharmacy Business, the following details will appear in the online public register on the PSI website:
• Name of Retail Pharmacy Business
• Address of Retail Pharmacy Business
• Registration Number of Retail Pharmacy Business
• Name of Pharmacy Owner, (and where the pharmacy owner is a company, the registered address of the company and Companies Registration Office registration number)
• Name of Superintendent Pharmacist
• Name of Supervising Pharmacist
• Date of expiry of the Retail Pharmacy Business Certificate of Registration
As soon as practicable, the PSI will issue a certificate of registration to a pharmacy owner whose Retail Pharmacy Business has been registered. This certificate will be valid for 12 months from the date of issue of the certificate. This certificate of registration will contain the name and address of the pharmacy, its registration number, the certificate number, the name of the pharmacy owner, as well as the dates of issue and expiry of the certificate of registration, and must be displayed to the public in the Retail Pharmacy Business to which it pertains.
From 2009 onwards for continued registration, and for all new Retail Pharmacy Businesses applying to register from now on, the procedures and timelines outlined in the statutory rules for registration (Pharmaceutical Society of Ireland Retail Pharmacy Businesses (Registration) Rules) will apply.
From 2009, for continued registration, it is envisaged that in cases where there is no change in the registration details of a Retail Pharmacy Business, a statement of no change, accompanied by the appropriate fee, is all that will be required for continued registration.
Further information on this process will be made available early in 2009.
The commencement of these parts of the Act and the establishment of the Register of Retail Pharmacy Businesses also means that any person now wishing to open a Retail Pharmacy Business must apply to register that pharmacy at least 60 days before it is opened, and have the application processed (including inspection), and registered in accordance with the new statutory rules (Pharmaceutical Society of Ireland Retail Pharmacy Businesses (Registration) Rules), before it may operate.
It should be noted that there is a provision for the urgent or ‘fast-track’ processing of such an application, where the processing of the application is undertaken by the PSI in less than 60 days. This process incurs an additional fee of €1000, as well as the €3500 application fee.
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