Quality defects and recalls of veterinary medicines
What is a quality defect in a medicine?
A quality defect is an attribute of a medicine, or component, affecting the quality, safety and/or efficacy of the product. Or it may be that the medicine is not in line with the approved product authorisation (PA), veterinary product authorisation (VPA), or other marketing authorisation.
It is important that suspected quality defects with medicines are notified to the HPRA in a timely manner, so that the required actions can be carried out effectively, to protect patient and animal health. Quality defects may lead to recall of batch(es) from the market, restriction of supply, or other actions.
Who reports suspected quality defects to the HPRA?
Reports of quality defects are received from several sources including medicine agencies in other countries, product authorisation holders, manufacturers, pharmacists, other healthcare professionals and members of the public.
Reports to the HPRA should relate only to medicines on the Irish market or medicines manufactured at an Irish manufacturing site.
How to report a suspected quality defect
Veterinarians can use this online form to report a quality defect.
MAHs, manufacturers, wholesalers, product registration holders and CT sponsors should complete this report form as a Word document and submit it via email to the address provided..
Suspected quality defects may also be reported by e-mail, by post, or by telephone at the contact details below. Urgent issues, where market action (e.g. recall) may be required, may be initially reported by phone while the investigation is ongoing.
Further guidance for industry in determining when to report suspected quality defects can be found in our Guide to reporting and investigation of quality defects in human and veterinary medicinal products.
Recalls of medicines
Once a medicine has been released for marketing, has left the control of the manufacturing facility, and has been made available for sale on the stock management system of the pre-wholesaler/primary wholesaler that batch of medicine is considered to have been placed onto the market.
A recall is the retrieval from the marketplace of a batch or batches of a medicine, due to a quality defect, a non-compliance with the product authorisation, or a safety or efficacy issue.
Recalls should not be initiated by a company without prior consultation with the HPRA.
Different types of recall
Medicines recalls are classified according to the potential impact of the defect on patient or animal health.
The seriousness of the defect determines how far down the supply chain the medicine needs to be recalled from.
- wholesale level recall
- pharmacy/retail level recall
- patient level
Most recalls from the Irish market extend to wholesale level or pharmacy level.
A targeted recall is where a quality defect affects a batch distributed only to a limited, identifiable number of customers. Communications will be sent to those customers only.
A blanket recall is where all customers are difficult to identify individually and so recall communications are sent to all potential customers.
For further information, please consult our Guide to recall of medicinal products for human and veterinary use.
Patient level recall
Where a potential serious risk to patient or animal health exists, the recall may extend to patient/user level. In such cases, communications are sent to all potentially affected groups.
- medicines wholesalers
- community and hospital pharmacists
- doctors / veterinary surgeons
- users/patients
Patients may be contacted by phone by their pharmacist or doctor and asked to return affected packs for replacement, free of charge.
Rapid electronic communications can be used, including website, social media, and press statements, to relay the recall message to patients who are not contactable by other means.
For large-scale patient level recalls, the HPRA can utilise patient groups, to forward recall communications to their members.
Return of recalled packs
A recall will usually only occur if replacement stock or an alternative medicine is available for the patient.
Recalled packs are returned through the original supply chain, for replacement or refund.
Pharmacists should carefully read the instructions on recall letters, to ensure that affected packs are identified, quarantined, and returned in a timely manner.
Publication of recall notices
Recall notices for pharmacy and patient level recalls are published HPRA recalls webpage.
HPRA contacts for quality defects & recalls
Email:
Telephone:
HPRA Office Contact No (office hours): +353-1-676-4971
HPRA Quality Defects and Recalls Emergency Number (24 hours): +353-1-634-3560
Post:
Compliance Department - Quality Defects
Health Products Regulatory Authority
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2