So, you’re looking to open a new pharmacy, relocate an existing one or perhaps take over an established retail pharmacy business (RPB) in Ireland? That’s exciting! However, before you can dispense a single prescription, there’s a crucial step: first-time registration with the Pharmaceutical Society of Ireland (PSI), the official Pharmacy Regulator.
This process ensures that all pharmacies operate legally and adhere to the high standards required for patient safety and public health. Let’s break down what you need to know.
When is a first-time registration required for a pharmacy?
You’ll need to submit a first-time registration application in three primary scenarios:
- A brand new opening. This is for completely new pharmacy businesses.
- A permanent relocation. If you’re moving an existing RPB to a new address.
- A change of ownership. When an existing RPB is acquired by new owners. (For more specific details on changes in ownership, the PSI website has a dedicated resource).
The legal framework of the pharmacy first-time registration
Operating a pharmacy in Ireland is governed by legislation designed to uphold professional standards and protect the public. Key legislation you’ll need to be familiar with includes:
- The Pharmacy Act 2007: This act outlines many of the requirements for operating a pharmacy, including provisions for changes in ownership (Section 17).
- The PSI (Retail Pharmacy Businesses) (Registration) Rules 2008 (S.I. No. 495 of 2008): These rules detail the application requirements, procedures, and timelines for the PSI’s registration functions.
- The Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008): Made under Section 18 of the Pharmacy Act 2007, these regulations are crucial for daily pharmacy operations.
The Pharmacy Act also mandates the appointment of two key roles:
- Supervising Pharmacist: This registered pharmacist must have a minimum of three years post-registration experience and be in whole-time charge of the business at the premises.
- Superintendent Pharmacist: This registered pharmacist, also with at least three years of post-registration experience, is responsible for the overall management and administration of the sale and supply of medicinal products within the RPB.
Detailed requirements for both roles can be found on the PSI’s ”Superintendent and Supervising Pharmacists” page.
The journey to registration begins on the PSI’s online registration portal.
Submit your application at least 60 days before your proposed opening date. This allows the PSI ample time for thorough review and any necessary inspection activities. Be aware that submitting less than 60 days in advance incurs a higher «late» fee.
Incomplete applications will not be processed and may require re-submission, leading to delays. Gather all your necessary documents and information beforehand.
The online application is a two-stage process. If you’re not the pharmacy owner or legally authorised to act on their behalf, the nominated person (for example, the company secretary or the director) will need to approve Part 1 of the application and then complete Part 2, including payment.
What information and documents will you need to register your pharmacy?
Prepare to provide a comprehensive set of details and documents:
Information:
- Pharmacy trading name, address, and contact details.
- Full details of the pharmacy’s ownership (company, secretary, directors, shareholders etc.).
- Details of the proposed pharmacy premises ownership.
- Pharmacy opening hours and planned services.
- Details of both the proposed Supervising and Superintendent Pharmacists (they will need to confirm their appointments and make mandatory declarations).
- Details of all pharmacist and pharmaceutical assistant personnel to be employed.
Documents:
- Evidence of professional indemnity cover.
- Detailed plans of the RPB layout. These plans must identify dimensions (m²), delineate professional service and retail areas, mark consultation and storage areas, and be drawn to scale.
- Site maps of the pharmacy’s location. Provide clear maps for shopping centers, hospital campuses, or urban areas, ensuring precise identification of the pharmacy’s exact spot.
- Certificate of Incorporation (if the pharmacy is company-owned).
- Memorandum and Articles of Association or Company Constitution (if the pharmacy is company-owned).
The inspection phase of the first-time registration process of your pharmacy
As part of the first-time registration, your pharmacy premises may undergo an inspection by a PSI Quality Assessor (Authorised Officer).
An inspection can only be scheduled once your complete and valid application is received.
The inspection must occur at least 10 working days before your proposed opening and registration date.
To ensure all requirements are in place before the inspection and avoid delays, refer to the PSI’s Inspection Checklist. The PSI also provides a Security Assessment Template to aid with pharmacy security evaluations.
Following the inspection, a report will be issued to the Superintendent Pharmacist. This report will outline any required actions and timelines for their completion. Addressing these actions promptly is crucial for the registration process.
In some cases, the PSI may opt for a self-declaration form from the Superintendent Pharmacist instead of a physical inspection. You will be informed of the chosen method.
Important: The successful completion of the inspection stage does not automatically confirm registration.
First-time registration application fees
The application fee for first-time registration varies based on your submission timeline:
- More than 60 days prior: €3,325
- Less than 60 days prior: €4,325 (includes a €1,000 late fee for urgent processing, typically reserved for exceptional circumstances. Contact rpbreg@psi.ie if you believe this applies to you).
The PSI will not review your application until the associated fee has been paid. You can pay online via credit/debit card or through an Electronic Fund Transfer (EFT)/Bank Transfer. Always include the unique Fee Demand Notice (FDN) number in your reference or email info@psi.ie with your application and payment details to avoid delays.
For more information about the fees please visit this page.
Receiving your certificate of registration of your pharmacy
Once your application is approved and all conditions are met, you’ll receive a hard copy certificate of registration, valid for 12 months. A digital certificate will be available online immediately upon approval.
Both the pharmacy’s and the Supervising Pharmacist’s registration certificates must be prominently displayed in the RPB at all times.
Public transparency
Following registration, your pharmacy’s details will be published on the PSI’s online public register, including:
- Pharmacy name, address, contact details, and PSI registration number.
- Companies’ office registration number.
- Name of the pharmacy owner, Superintendent Pharmacist, and Supervising Pharmacist.
- Date of first registration and expiry date of the current certificate.
- Pharmacy opening hours.
Conclusion
While the first-time registration process for a retail pharmacy business in Ireland involves several steps and detailed requirements, it’s a vital part of ensuring the highest standards of pharmaceutical care. By understanding the legislative background, preparing thoroughly, and adhering to the PSI’s guidelines, you can navigate this process smoothly and establish a successful and compliant pharmacy operation. Good luck!