Submit a Statutory Complaint to the PSI

What is a statutory complaint ? 

A statutory complaint may be made against a pharmacist or a pharmacy.  

A statutory complaint follows a statutory process meaning there is a legal basis which governs the processing of the complaint. In this case, that is Part 6 of the Pharmacy Act 2007 

What happens when I submit a statutory complaint? 

All complaints received by the PSI are considered by an independent complaints screening committee called the Preliminary Proceedings Committee (PPC). The role of the PPC is to decide whether further action is necessary in relation to complaints received. When the PPC has reviewed the information, it will advise the PSI Council what steps to take.  

It will recommend one of the following:  

1. The PPC may decide there is a case for further action and refer the complaint to either a Committee of Inquiry or to mediation. 
2. The PPC may decide there is insufficient cause to take further action. If the PSI Council agrees with the advice of the PPC, the complaints process ends and no further action will be taken on the complaint. If the Council does not agree, it will send the complaint back to the PPC, who will refer the complaint to mediation or to a Committee of Inquiry.  

How is my statutory complaint processed? 

• When the PSI receives the complaint we will acknowledge receipt of it to the complainant
• We will then send the details of the complaint to the pharmacist and/or pharmacy (the respondents) that are named in the complaint.
• We will invite an initial response, called observations, from the respondent(s)
• Any observations received from the respondents will then be shared with , the person who submitted the complaint (complainant).
• The complainant and respondent have a further opportunity to respond to each other’s observations.
• The PSI will then advise all parties that no further observations are due, and confirms that the file will now be prepared for the PPC .
• The complaint file will then be considered by the PPC and the next available meeting.
• The PPC, having considered the matter, may:

1. Request further information from either party,
2. Decide that no further action is required
3. Decide that further action is required, and recommends the Committee of Inquiry which should further consider the matter,

• All parties will then be advised of the decision by PPC. 

Withdrawing a complaint 

Sometimes a complainant changes their mind and decides that they wish to withdraw the complaint.  Please note that as it is a statutory complaint process, while you may apply to withdraw your complaint, it will still need to be decided by the PPC, with the Council’s agreement, whether no further action is needed or whether to proceed with the complaint as if it had not been withdrawn.  

How to make a complaint  

Please use our online complaint form when submitting a complaint.  This will help you to give us all relevant details that we need to process your complaint.  Your complaint must be sent to us in writing.  We cannot accept complaints made over the telephone.    

If you are unable to complete the online form, you can access our Complaint Form below, which you can download and then send to us by email or by post.   

• Complaint form in English (Word) 
• Complaint form in English (PDF) 
• Foirm gearán i nGaeilge  

Your complaint in writing must include:  

• your full name, address and daytime telephone number; 
• as much information as possible about the circumstances of your complaint, including names, dates and places; 
• as much information as possible about the pharmacist and/or pharmacy, such as name and place of work; 
• any supporting documents that you have, including copies of prescriptions or letters; 
• the name and contact details of anyone, such as a witness, who can confirm the detail/order of events you describe in your complaint.  

Send your complaint form and your supporting documents by:  

• email to complaints@psi.ie, or 
• post to Complaints Officer, PSI, The Pharmacy Regulator, PSI House, 15-19 Fenian Street, Dublin 2, D02 TD72.  

We understand that making a complaint can be stressful, so we will try to consider your complaint as quickly as we can. However, some complaints are complex and it may take some time to gather all the information needed to reach a fair decision. We will keep you informed as much as possible at each stage of the complaints process.  

Sometimes we receive complaints that relate to the work or the responsibility of another organisation. When this happens, we have a duty to let them know about it. For example, if your complaint raises a concern about the protection of children or a vulnerable person, we are obliged to tell the relevant authority such as the Child and Family Agency, Tusla and/or the Gardaí Siochána.  

We have Access Officers appointed at the PSI to assist people with disabilities who need support to use our information and services. If you need help from the PSI’s Access Officers, please phone (01) 218 4000 or email accessofficer@psi.ie.