First Time Registration

All pharmacies must be operated in accordance with the current legislation and in particular with the provisions of:   

• The Pharmacy Act 2007  
• Section 17 of the Act governs, inter alia, changes in the ownership of a retail pharmacy business. 
• The PSI (Retail Pharmacy Businesses) (Registration) Rules 2008 (S.I. No. 495 of 2008)- these Rules set out the requirements that applicants must comply with and the procedures and timelines which will be followed by the PSI in carrying out its functions in relation to the registration of pharmacies   
• The Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008) (‘the Regulations') made by the Minister for Health under Section 18 of the Pharmacy Act 2007. The Pharmacy Practice Guidance Folder will aid compliance with the Section 18 Regulations.  
• Requirement for a Supervising Pharmacist is contained in the Pharmacy Act, sections 27(c), 28(b) and 29(c) which state that at the premises where a retail pharmacy business is carried on, there must be “a registered pharmacist who has a 3 year minimum post-registration experience in whole time charge of the carrying on of the business there”. 
• Requirement for a Superintendent Pharmacist is contained in the Pharmacy Act, sections 27(b), 28(a) and 29(b) which state that in the carrying on of a retail pharmacy business “the part of the business that consists of the management and administration of the sale and supply of medicinal products is under the personal control of a registered pharmacist who has a 3 year minimum post-registration experience”. 
• Information regarding Superintendent and Supervising Pharmacist as well as requirements details are available on our Superintendent and Supervising Pharmacists page

To begin the registration process an applicant must submit a valid application on the  PSI's registration portal.  

Applications for registration of a Retail Pharmacy Business (RPB) must be submitted at least 60 days before it is due to be registered and open. This timeframe is to enable a thorough review of the application, and to allow any necessary inspection activity to be carried out in a timely manner prior to registration. 

Please note that incomplete applications will not be considered, and you may be required to resubmit your application if sufficient details are not provided. 

Completion of an application to open an RPB is a two-stage process. If you are completing this application and are not the pharmacy owner or a person legally authorised to act on behalf of the pharmacy owner, the nominated person in respect of the pharmacy owner (such as the company secretary or a company director) will have to review and approve Part 1 of the application. They will then need to complete Part 2 and submit payment of the relevant fee.  

The following details will need to be provided during the application process. We recommend you gather all the necessary documents and information before beginning your application: 

• Pharmacy Trading name, address, contact details. 
• Details of the ownership of the pharmacy; this included details of the owning company, company secretary, directors, shareholders etc.  
• Details of the ownership of the proposed pharmacy premises. 
• Pharmacy opening hours and services it intends to provide. 
• Details of Supervising Pharmacists to be appointed at the pharmacy. The nominated Supervising Pharmacists will have to confirm the appointment and complete the required mandatory declarations. 
• Details of Superintendent Pharmacists to be appointed at the pharmacy. The nominated Superintendent Pharmacists will have to confirm the appointment and complete the required mandatory declarations.  
• Details of all pharmacist and pharmaceutical assistant personnel to be employed.  

The following documentation must be uploaded as part your application for first registration of a retail pharmacy business: 

1. Evidence of professional indemnity cover in respect of the operation of the retail pharmacy business 
2. One set of plans of the retail pharmacy business layout  

This plan should:  

• Identify the dimensions of the area of the Retail Pharmacy Business (in m2)   
• Identify the dimensions of the dispensary and the area in which pharmacist supervised medicines are stored (in m2)  
• Identify patient consultation area(s)  
• Clearly demarcate the professional services and retail areas  
• Identify any storage areas where medicinal products or pharmacy records are located  
• Detail the postal address of the building in which the premises is situated   
• Detail any other relevant information  
• Be drawn to scale or be copies of plans drawn to scale    
• Identify the entire premises in which the Retail Pharmacy Business is situated and the use/business use of the other parts of the premises  

3. Site Maps of the location of the retail pharmacy business  

• If the pharmacy is in a shopping centre, please provide a map indicating where the shopping centre is in the locality and another map indicating the location of the pharmacy within the shopping centre.    
• If the pharmacy is on a hospital campus, please provide a map of the location of the hospital pharmacy on the campus and another map indicating the location of the pharmacy within the hospital.   
• If the pharmacy is in an urban area, town or village, please provide a map indicating the location of the pharmacy in the urban area, town or village.  
• In circumstances where there are no street numbers in your area, your location map should be sufficiently accurate to be able to identify the exact location of the proposed retail pharmacy business. 

4. Certificate of Incorporation   

• In the case of a pharmacy which is owned by a company, an applicant must provide the Certificate of Incorporation of the company that will own the pharmacy for which you are applying to register. 

5. The Memorandum and Articles of Association or Company Constitution  

• In the case of a pharmacy which is owned by a company, an applicant must provide The Memorandum and Articles of Association or Company Constitution of the company that will own the pharmacy for which you are applying to register.  

As part of the first-time registration process for a pharmacy, it may be necessary for the pharmacy premises to be inspected.  An inspection cannot be scheduled until a complete and valid application has been submitted to the PSI.  

Once a complete and valid application is received, it will be reviewed, and a PSI Quality Assessor (Authorised Officer) will contact you to arrange a suitable date and time for the inspection to be carried out. The inspection must be carried out at least 10 working days before the pharmacy is due to be registered and open to patients and the public. Please refer to the Inspection Checklist which outlines the requirements that must be in place before an inspection of the pharmacy can be carried out.   

Failure to have such requirements in place at the time of inspection will delay the registration process.  

The PSI has also developed a Security Assessment Template, in conjunction with An Garda Síochána, to aid pharmacy owners and superintendent pharmacists in assessing the security of their pharmacies.  

The PSI Quality Assessor will provide a report after the inspection visit, which will be issued to the nominated Superintendent Pharmacist. The report will indicate the standards and requirements that have been met, and any actions required to be addressed, with a time period for their completion.  

Failure to complete the required actions may delay the registration process.  

When a satisfactory response has been provided to the PSI in relation to all identified required actions and all matters have been addressed, the inspection process is complete. An email is sent to the nominated contact to close off the inspection process and to inform them that the file has been transferred to Registration for final review.    

Note that the completion of the inspection stage does not mean registration is confirmed.  

Please note that the PSI may forego a physical inspection and instead may provide a self-declaration form to be completed by the Superintendent Pharmacist. The PSI will inform you of the inspection method (physical or self-declaration) once we have received a valid application. 

During the online application process at the final step, you will find instructions on how to complete the payment including the amount to be paid.  

The current application fee for First Registration of a Retail Pharmacy Business is as follows: 

• Where an application is made on the PSI Registration portal more than 60 days prior to the proposed opening date the application fee is €3,325. 

Where an application is made on the PSI Registration portal less than 60 days prior to the proposed opening date the application fee is €4,325. This includes the standard fee of €3,325 and an additional late fee of €1,000 for the urgent fast-track processing of a first application for registration as set out in the PSI (Fees) Rules 2014. A fast-track application option is available for exceptional circumstances only. Should you wish to request this option, please contact the PSI Retail Pharmacy Business Registration Team prior to submitting this application (rpbreg@psi.ie). The applicant specifies the ‘proposed opening date’ during the application process. 

The PSI will not review applications until the associated fee has been paid. 

Payment can be made online using a credit/debit card or through an Electronic Fund Transfer (EFT)/Bank Transfer. If you choose to pay by a bank transfer, the Fee Demand Notice (FDN) details will be available to download. This document will include the unique FDN number to be used as a reference, PSI's bank details and the amount required be paid.  

If you do not include the FDN in the payment reference, you must send an email to info@psi.ie with the application number and payment details to prevent any delays in processing your submitted application. 

For further information please visit our PSI fees page. 

We will issue a hard copy certificate of registration to a pharmacy owner as soon as practicable after registration is complete (or continued registration). A digital registration certificate will be available online immediately upon application approval.

The certificate will be valid for 12 months from the date of registration. 

It is a requirement that the registration certificate of both the pharmacy and supervising pharmacist is prominently always displayed in the RPB. 

Following registration of the pharmacy, the following details will appear in the online public register on the PSI website: 

• Name of pharmacy
• Address of pharmacy
• Telephone, fax and website details
• PSI registration number of pharmacy
• Companies' office registration number of the pharmacy
• Name of pharmacy owner
• Name of superintendent pharmacist
• Name of supervising pharmacist
• Date of first registration
• Date of expiry of the current certificate of registration
• Opening hours of the pharmacy

The PSI has produced the following guidelines to facilitate compliance with the requirements of the Regulations:  

• Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business (Version 2, May 2017) 
• Guidelines on the Equipment Requirements of a Retail Pharmacy Business (Version 3, April 2019) 
• Guidelines on the Premises Requirements of a Retail Pharmacy Business (Version, Oct 2017) 
• Guidelines on Patient Consultation Areas in Retail Pharmacy Businesses (Version 2, Jan 2015) 
• Guidelines on the Sale or Supply of Non-Prescription Medicinal Products from a Retail Pharmacy Business (Version 1, November 2018) 
• Guidelines on the Sourcing of Medicinal Products for Sale or Supply by a Retail Pharmacy Business
• Guidelines on the Disposal of Medicinal Products for a Retail Pharmacy Business 
• Guidelines on the Storage of Medicinal Products within a Retail Pharmacy Business