Implementation of Directive 2010/63/EU Lecture by HPRA Inspector EU Modules 1

Question 1

What is the role of the HPRA?

Answer 1

• State agency answer to the department of health
• Regulate human and veterinary medicines, clinical trials, medical devices, blood and blood components, tissues and cells, cosmetics, organs for transplantation, and the protection of animals used for scientific purposes.
• Implements scientific animal protection legislation
  o scientific animal protection section – 2 vets, 3 scientists and support staff
  o Applications assessed by vets and scientists and inspections by vets.
  o Taken over regulation in 2013 was previously department of health.
• Implementing authorisations and inspections using 3 rs

Question 2

How long does an establishment authorsiation last?

Answer 2

Three years and then they must be renewed.

Question 3

What are the 3 types of individual authorisations?

Answer 3

 Project management
 Carry out procedures
 Euthanasia

Question 4

How long do individual authorisations last?

Answer 4

5 years

Question 5

For what reasons can you get a short term authorisation?

Answer 5

o Can get short term if want to do ani work for 2 months or less
 E.g. human surgeons who must practice on animals before humans
 Foreign trainers/experts to demonstrate or aid here.

Question 6

What is a procedure?

Answer 6

Any use of an animal that may cause the animal a level of pain, suffering, distress or harm equivalent too or higher than, that caused by the introduction of a needle in accordance with good vet practice.

Question 7

How long is the maximum period a project can last for?

Answer 7

Up to 5 years.

Question 8

Does euthanasia require a project authorisation?

Answer 8

any use of an animal that may cause the animal a level of pain, suffering, distress or harm equivalent too or higher than, that caused by the introduction of a needle in accordance with good vet practice.

Question 9

what is the function of the national committee?

Answer 9

Ensure the sharing of best practices in Ireland and with other national committees of Member States within the European Union.
Advise the HPRA and institutional animal welfare bodies on matters dealing with the acquisition, breeding, accommodation, care and use of scientific animals.

Question 10

Can animals be used for cosmetic testing in the EU?

Answer 10

Never.