Dáil Éireann Debate, Wednesday - 5 May 2021
626. Deputy Catherine Murphy asked the Minister for Health the number of Health Products Regulatory Authority audits conducted on veterinary products in each of the years 2017 to 2020 and to date in 2021. [23128/21]
Amharc ar fhreagraThe Health Products Regulatory Authority (HPRA) is the competent authority in Ireland for veterinary medicinal products (VMPs). Under the European Communities (Animal Remedies) (No. 2) Regulations, 2007 (S.I. 786 of 2007, as amended), this role includes inspection and licensing of manufacturers of veterinary medicinal products based in Ireland. A number of inspections of manufacturers, based outside the European Economic Area (EEA), that are supplying VMPs into the EEA are also carried out. During an inspection, the state of compliance of the manufacturer with European Union guidelines on good manufacturing practice is examined.
In Ireland, an inspection is carried out on foot of an application for a manufacturer’s licence, while routine inspections of licensed manufacturers are carried out on a risk basis with the interval being, generally, from 18 – 30 months.
The numbers of inspections of manufacturers of VMPs carried out over the period 2017 – end April 2021 are as follows:
2017 – 20
2018 – 23
2019 – 24
2020 – 23
2021 (to end April) – 6
The current number of licensed manufacturers of VMPs is 30. A list of licensed manufacturers in available on the HPRA website at http://www.hpra.ie/homepage/veterinary/regulatory-information/manufacturers?page=1
