Regulatory Bodies and Legislation

Under the COSHH regulations what are practices required to put in place?

A standard operating procedure

What are the 3 regulatory bodies relating to veterinary medicine?

• The VMD

• AMTRA

• The RCVS

What is the VMD?

An executive agency of the government department DEFRA

What are the 6 responsibilities of the VMD

• Issuing marketing authorisations

• Monitoring safety, quality and efficacy of new medications

• Developing, updating and enforcing legislation concerning veterinary medicines

• Inspecting registered premises

• Completing environmental risk assessments of medicines

• Enforcing or prosecuting against illegal marketing or use of unauthorised products

Name 7 enforcement tools of the VMD

• Advisory Letters

• Improvement notices that give the practice a minimum of 14 days to make the required improvements

• Publication of improvement notices

• Seizing products or records

• Destruction of products

• Revocation of authorisation or approvals

• Police cautions

Under which circumstances would the VMD inspect a veterinary practice that is a member of the PSS?

If there is reported or suspected non-compliance with the veterinary medicines regulations

Name 5 responsibilities of AMTRA

• Maintain a Register of RAMAs

• Maintain a Register of registered premises aside from veterinary practices

• Regulate practicing RAMAs

• Authorise training centres for RAMA qualifications

• Monitor CPD for RAMAs

Name 3 responsibilities of the RCVS

• Monitor veterinary professional conduct including the use of medications

• Hold a list of registered premises

• Oversee the practice standards scheme

What are the 4 regulations relating to veterinary medicine?

• Veterinary Medicines Regulations 2013

• Misuse of Drugs Regulations 2001

• Hazardous Waste Regulations 2005

• Control of Substances Hazardous to Health Regulations 2002

What year is The Veterinary Medicines Regulations?

2013

What year is the Misuse of Drugs Regulations?

2001

What year is the Hazardous Waste Regulations?

2005

What year is the Control of Substances Hazardous to Health Regulations

2002

Name 6 things covered under the Veterinary Medicines Regulations

• The issuing and reviewing of marketing authorisations

• Exemptions from authorisations for medicines for small pet animals

• The use of unauthorised products

• The prescribing cascade

• The provision for retail supply

• The advertising of medicinal products

Name 4 things governed by the Veterinary Medicines Regulations

• The sale and supplying of veterinary medicines

• The correct storage of veterinary medicines

• The prescribing of veterinary medicines

• The correct labelling and record keeping of veterinary medicines

Name 3 functions of the Misuse of Drugs Regulations

• Controls the production, possession and storage of controlled drugs

• Deals with the scheduling of controlled drugs

• Promotes education and research into drug dependence and addiction

Name 2 things covered by the Hazardous Waste Regulations

• The classification and disposal of hazardous waste

• Requires any business producing more than 200kg of waste per year to register with the environment agency

Name 3 things covered by the Control of Substances Hazardous to Health Regulations

• The management of risks associated with hazardous substances

• The risk assessment completed for the use of veterinary medicines

• Control measures and standard operating procedures in place to reduce exposure to hazardous substances

What is the purpose of the ‘Exemptions from authorisations for medicines for small pet animals’ scheme?

To allow drugs for small pet animals to be marketed in a cost effective way

What is ‘one health’ ?

An initiative to protect public health by considering the effect of veterinary/animal health and the environment on human health