Overview
Since 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. This register is published online and is accessible on this website via the ‘Search our Registers’ button.
You can contact the RPB section of the Registration unit by emailing rpbreg@thepsi.ie or by phone (++353)(01) 2184000 should you require any clarification in relation to this process.
Regulations made under Section 18 of the Pharmacy Act 2007, the Regulation of Retail Pharmacy Businesses Regulations 2008 govern the operation of pharmacies. These regulations cover the staff, premises, equipment, record-keeping and procedures of a pharmacy and include regulations in relation to the supply and counselling of both prescription and non-prescription medicines.
Policy on the Safe Keeping of Medicines and Associated Records during Pharmacy Cleaning and/or Merchandising provides clarifications to pharmacy owners and pharmacists regarding the conditions and circumstances where cleaning and merchandising may take place outside normal opening hours and when the pharmacy is closed to the public, and in particular the conditions attaching where it is impracticable for a pharmacist to be physically present while these specific activities are being undertaken.
The Registrar/CEO of the PSI has issued a Memorandum of Advice on possible public health risks and other concerns arising from certain commercial practices in the establishment and development of retail pharmacy businesses.
This Memorandum of Advice was approved by the Council of the PSI on 10 February 2011 and deals in particular with planning issues, finance and investments, valuation of retail pharmacy businesses and Sections 63 and 64 of the Pharmacy Act 2007.
The PSI hopes that this memorandum will be of use to members of the profession in identifying certain aspects of commercial relationships or practices which the PSI apprehends may adversely impact on patient health and safety.
Superintendent and Supervising Pharmacists
Each pharmacy must have a superintendent pharmacist and a supervising pharmacist, each of whom must have at least three years’ appropriate
The PSI provides forms for the purposes of the appointment of a Superintendent Pharmacist for a Corporate Body or a Sole Trader/Partnership and for the appointment of a Supervising Pharmacist as well a form for payment of the fee of €85.00 that must accompany either of these appointments”.
The management and administration of the sale and supply of medicines is under the personal control of the superintendent pharmacist who is essentially the person in overall control of the management of a pharmacy, including its professional and clinical management.
The supervising pharmacist is in whole-time 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 pharmacy.
The certificates of registration of the retail pharmacy business and of the supervising pharmacist must be on conspicuous display in the pharmacy.
Further information about the roles and responsibilities of superintendent and supervising pharmacists is available here.
Pharmacy Ownership
A pharmacy may be owned by a registered pharmacist, a partnership of registered pharmacists, a representative (in the case of a deceased pharmacist) or a corporate body such as a limited company.
A company cannot lawfully operate a pharmacy without having a formal legal agreement with a superintendent pharmacist. Anyone wishing to open a new pharmacy must have it registered with the PSI, in accordance with statutory rules, before it can operate.
For further information on the application process, see First-Time Registration.
Change of Pharmacy Ownership
Any change in ownership of a pharmacy may have the effect of cancelling its registration and the pharmacy owner must immediately notify the PSI of any such change. A change of ownership will apply in the case of a transfer of more than 50% of shares within a company.
As a change of ownership of the pharmacy cancels its registration, it is necessary for the pharmacy owner to apply for registration as a new opening under the process outlined in First-Time Registration.
Queries regarding changes of ownership should be sent to rpbreg@thepsi.ie
Permanent Relocation of a Pharmacy
If a pharmacy is relocating to a new premises, the registration of the existing pharmacy will be cancelled and the owner must apply for registration of the new premises as a new opening under the process outlined in First-Time Registration.
Queries regarding the permanent relocation of a pharmacy should be sent to rpbreg@thepsi.ie
Temporary Relocations
Where a pharmacy owner wishes to relocate temporarily, for a maximum period of one year, to allow for the renovation or refurbishment of its registered premises, a relocation fee of €1000.00 will be charged - PSI (Fees) Rules 2008
This fee covers both the move to the temporary premises and the move back to the refurbished premises, provided the relocation is for a period less than twelve months. However, the continued registration fee of €2250.00 remains payable, when it becomes due, and is not affected by the temporary relocation.
If the business does not move back to the original premises within 12 months, the retail business may then become classified as a new pharmacy and, as such, be required to become the subject of a new application for registration which would also involve the payment of a first registration fee of €3500.00.
Queries regarding the process of temporary relocation should be sent to rpbreg@thepsi.ie
Cancelling the Registration of a Pharmacy
The procedure for cancelling the registration of a pharmacy is outlined in “cancelling your registration” (link to cancelling your registration), There are also certain safeguards that must be put in place regarding the medicines and patient records held in the pharmacy.
Queries regarding the process of cancelling the registration of a pharmacy should be sent to rpbreg@thepsi.ie