In 2020, 13 veterinary medicines were recalled from the Irish market, according to the Health Products Regulatory Authority (HPRA), which has published its 2020 annual report.

In the report the HPRA said in certain cases, withdrawal of a product is necessary to protect animal health and/or public health.

The 13 recalls in 2020 were described as a “substantial increase” when compared to 2019, when that figure was just seven.

Three of the recalls related to stability issues; three related to non-compliances with specifications; two were connected to contamination issues; and two to artwork/non-compliance issues.

Two caution-in-use notifications were also issued for veterinary medicines to mitigate the risks presented by quality defect issues.

The HPRA‘s inspections programme focusses on ensuring compliance with relevant standards and legislation, the HPRA said.

And, in 2020, there were 16 good manufacturing practice (GMP) inspections of sites that manufacture/test veterinary medicines.

Defects

Quality defects relating to 78 veterinary medicines were reported or identified in 2020, representing a 15% increase over the 2019 figure.

The risk classifications assigned, along with the corresponding figures for the previous two years, are outlined below.

Year201820192020
Critical quality defects261012
Major quality defects431936
Minor quality defects563829
Number of reports not justified011
Total number of quality defects1256878
Image source: HPRA

The majority of the reports – 55% – were submitted by pharmaceutical companies, which included manufacturers, distributors and marketing authorisation holders; while 4% of the reports were received from other competent authorities.

The HPRA‘s inspections programme focusses on ensuring compliance with relevant standards and legislation, the HPRA said.

And, in 2020, there were 16 good manufacturing practice (GMP) inspections of sites that manufacture/test veterinary medicines.