Quality Defects and Recalls

This section provides information for manufacturers, MAHs, etc on how to report a quality defect and requirements for coordinating recall and related actions on the Irish market.

Quality Defects may be defined as attributes of a medicinal product or component which may affect the quality, safety and/or efficacy of the product, and/or which are not in line with the approved Product Authorisation (PA) or Veterinary Product Authorisation (VPA) file, or other marketing authorisation. Quality defects may lead to recall of batch(es) from the market, restriction of supply, or other actions. It is important that suspected quality defects are investigated by the relevant parties and notified to the relevant competent authorities, in a timely manner, so that the requisite actions can be carried out effectively, to protect patient and animal health.

The HPRA’s Quality Defects and Recall (QDR) Section receives notifications of suspected quality defects from, amongst others, the medical professions, patients and consumers, pharmaceutical companies and wholesalers, and from Competent Authorities in other countries. The QDR section works with MAHs and manufacturers to coordinate market actions and to ensure that the relevant other Competent Authorities are informed of the defect issue, where applicable. The QDR section also oversees Corrective and Preventive Action (CAPA) implementation.

How to Determine if a Suspected Quality Defect should be Reported

Upon receipt of a suspected quality defect issue by the MAH and/or manufacturer an initial investigation should be performed. The investigation should determine the extent of the defect and the potential risk associated and, therefore, whether the defect should be reported to the HPRA and/or other relevant Competent Authorities.

Irish legislation states that, where a suspected defect involves an Exempt Medicinal Product, all these cases should be reported to the HPRA.

Further guidance in determining reporting of suspected quality defects can be found in the HPRA Guide to reporting of quality defects.

How to Report a Suspected Quality Defect

Suspected and/or obvious product defects may be reported to the Quality Defects Section of the Health Products Regulatory Authority by post, e-mail, fax or telephone. Email is the preferred method. For potentially urgent defect issues, telephone should be used as the first point of contact. The relevant HPRA contact details are available below.

• The exact name of the medicinal product
• The Product marketing Authorisation Number (PA/VPA/EU Number), if any
• The product dosage form (e.g. Tablets) and Strength (e.g. 75 mg)
• The Batch or Lot Number
• The Expiry Date
• The Name of the Marketing Authorisation Holder
• Where you obtained the product (e.g. the wholesaler or pharmacy name, and their address)
• An exact and full description of the suspected defect (please be as specific and as detailed as possible)
• Your name, address and contact details, including telephone number(s)
• The date on which you are reporting the quality defect

MAHs, manufacturers and/or wholesalers should use the Quality Defect Report Form to report quality defects to the HPRA. Please complete this form as a Word document and submit via email to qualitydefects@hpra.ie.

The requirement for a recall or other market action will largely depend on its associated risk to patient or animal health. The risk associated with a quality defect is dependent on multiple factors, including the nature of the product, the potential patient or animal population and the defect itself. A risk assessment carried out by the MAH should consider these and other factors, as well as the potential risk posed by the defect leading to an out of stock situation.

Classes of Quality Defects

There are three classes (or ratings) of quality defects and these are classified according to their potential risk to patient and/or animal health.

Critical Quality Defects

These are defects which are potentially life-threatening or could cause a serious risk to health

Major Quality Defects

These are defects which could cause illness or mistreatment but are not critical

Minor Quality Defects

These are defects which may not pose a significant hazard to health

For further Information please contact the following:

E-mail: qualitydefects@hpra.ie

Post:

Compliance Department - Quality Defects
Health Products Regulatory Authority
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Ms. Breda Gleeson, Market Compliance Inspector
Office contact no.: +353-1-6764971
Out-of-hours contact details: +353-87-9703559 (mobile)

Mr. Kevin O’Donnell, Market Compliance Manager
Office contact no.: +353-1-6764971 
Out-of-hours contact details: +353-87-9562818 (mobile)

Carrying out Recall and Related Actions on the Irish Market