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LAST Ireland > Implementation of 2010/63/EU > Flashcards

Implementation of 2010/63/EU Flashcards

1
Q

Role of HPRA (5)

A
  1. Human and veterinary medicines
    2.Clinical trials
  2. Protection of animals for scientific purposes
  3. Medical devices
  4. Cosmetic products
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2
Q

What is the HPRA

A

Health products regulatory authority (2013) - competent authority for scientific animal protection legislation

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3
Q

3 Levels of Authorisation

A

Establishment, Project, Individuals

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4
Q

Details of Establishment Authourisation

A

Need site master file = activities, key personnel, animals used
Inspection = animal welfare, health monitoring, record keeping and training of key personnel
Lasts 3 years

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5
Q

Animal Welfare Body People

A

AWO, Scientist, Vet

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6
Q

What are the named people in AWO

A
  1. Compliance officer
  2. Information officer
  3. Designated vet
  4. Training officer
  5. Animal care and welfare officer
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7
Q

What are the types of individual authorisation?

A
  1. Project management
  2. Carry out procedures
  3. Perform euthanasia
    A. Short term = 2 months or less for trainee human surgeons and expert trainers
    - Lasts 5 years
    - Pay fees
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8
Q

What do you need when applying for individual authorization?

A
  • Form
  • CV
  • LAST certificate
    Compliance officer signature
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9
Q

What is a project?

A

Program of work having a defined scientific objective and involving one or more procedures

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10
Q

What are procedures?

A

Any use of animals which may cause the animal a level of pain, suffering, distress, or lasting harm equivalent to or higher than that caused by the introduction of a needle in accordance with good veterinary practice

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11
Q

What is a project authorization?

A

Any length of time with a max of 5 years but need ethics committee approval letter and 40 day project evaluation

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12
Q

What is involved in a project evaluation?

A
  • likelihood of achieving its goal
  • proposed benefits and likelihood of success
  • Analysis of harms including animal no. severity, humane endpoints, analgesia, anesthesia
  • non-technical summary
  • Email applicant with queries
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13
Q

What are the responsibilities of the project authorization holder?

A
  1. Keep register of people working on project
  2. Read T&Cs
  3. Ensure compliance w/ authorization
  4. Adhere to monitoring arrangements
  5. Report to animal welfare officer/vet
  6. Apply 3R’s
  7. Submit annual statistical returns to the HPRA
  8. Complete end-of-project report
  9. Submit retrospective assessment to HPRA
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14
Q

What is compliance?

A

Following the rules and regulations, the responsibility of everyone in animal research

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15
Q

HPRA Compliance Policy

A
  1. Fair, proportionate, and dissuasive
  2. Risk based
  3. Consistent
  4. Responsibility escalated to find root
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16
Q

What is involved in HPRA inspections?

A

Un/announced inspections in 1/3 establishments which is a legal requirement. Focuses on project, training and functioning of AWB

17
Q

What tools are used to ensure compliance?

A
  1. Initial action - report, letter
  2. Notices - compliance notice, fixed penalty notice
  3. Suspension and revocation - take away individual, project, or establishment authorization
  4. Other - prosecution, animal welfare notice, seize and dispose, closure order
18
Q

What is a culture of care?

A

A commitment to improving animal welfare, scientific quality, care of staff and transparency for stakeholders. It involves going beyond the minimum requirements and having an active commitment to the 3Rs, improving welfare and science

19
Q

What does the European Commission do?

A

Constantly monitoring the translation of directive throughout EU states and updating position on topics

20
Q

What does the national committee do?

A

Advise HPRA and AWB on care and use of animals, ensuring sharing of best practice
Exchange info on operation of AWB and project evaluation
HPRA = secretariat to committee but not member

LAST Ireland (11 decks)

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