Implementation of 2010/63/EU Flashcards
Role of HPRA (5)
- Human and veterinary medicines
2.Clinical trials - Protection of animals for scientific purposes
- Medical devices
- Cosmetic products
What is the HPRA
Health products regulatory authority (2013) - competent authority for scientific animal protection legislation
3 Levels of Authorisation
Establishment, Project, Individuals
Details of Establishment Authourisation
Need site master file = activities, key personnel, animals used
Inspection = animal welfare, health monitoring, record keeping and training of key personnel
Lasts 3 years
Animal Welfare Body People
AWO, Scientist, Vet
What are the named people in AWO
- Compliance officer
- Information officer
- Designated vet
- Training officer
- Animal care and welfare officer
What are the types of individual authorisation?
- Project management
- Carry out procedures
- Perform euthanasia
A. Short term = 2 months or less for trainee human surgeons and expert trainers
- Lasts 5 years
- Pay fees
What do you need when applying for individual authorization?
- Form
- CV
- LAST certificate
Compliance officer signature
What is a project?
Program of work having a defined scientific objective and involving one or more procedures
What are procedures?
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
What is a project authorization?
Any length of time with a max of 5 years but need ethics committee approval letter and 40 day project evaluation
What is involved in a project evaluation?
- 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
What are the responsibilities of the project authorization holder?
- Keep register of people working on project
- Read T&Cs
- Ensure compliance w/ authorization
- Adhere to monitoring arrangements
- Report to animal welfare officer/vet
- Apply 3R’s
- Submit annual statistical returns to the HPRA
- Complete end-of-project report
- Submit retrospective assessment to HPRA
What is compliance?
Following the rules and regulations, the responsibility of everyone in animal research
HPRA Compliance Policy
- Fair, proportionate, and dissuasive
- Risk based
- Consistent
- Responsibility escalated to find root
What is involved in HPRA inspections?
Un/announced inspections in 1/3 establishments which is a legal requirement. Focuses on project, training and functioning of AWB
What tools are used to ensure compliance?
- Initial action - report, letter
- Notices - compliance notice, fixed penalty notice
- Suspension and revocation - take away individual, project, or establishment authorization
- Other - prosecution, animal welfare notice, seize and dispose, closure order
What is a culture of care?
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
What does the European Commission do?
Constantly monitoring the translation of directive throughout EU states and updating position on topics
What does the national committee do?
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
