Pharmacy law- Legislation

Question 1

2 ways public protection was achieved?

Answer 1

1. restricting public access to meds, drugs, poisons- prevents criminal uses
2. ensuring purity, potency, efficacy during manufacture, distribution & sale

Question 2

Medicines Act 1969 & Regulations

Answer 2

• established by MHRA
• Controls medicinal products at all stages
• Veterinary Medicines Reg 2013
• Human medicines Regulations 2012- divided into 17 parts

Question 3

Misuse of Drugs Act 1971 & Regulations

Answer 3

• controls meds and drugs which are addictive or misused

- Misuse of drugs Reg 2001

Question 4

Poisons Act 1972

Answer 4

controls poisons

Question 5

Health Act 2006

Answer 5

• supervision and management of CD

- supervision–> responsible pharmacists

Question 6

Health Act 1999

Answer 6

• As amended by Health & Social care Act 2008
  Pharmacy order 2010
  –> directs the GPhC
  –> controls the pharmacy profession- pharmacist & techs

Question 7

What is Committee of MHRA?

Answer 7

• Medicines Healthcare products Regulatory Agency

Question 8

What is a Medicinal Product?

Answer 8

Substance which can restore, correct or modify a physiological function by exerting a pharmacological action and canmake a medical diagnosis

Question 9

What is an Authorised Medicinal Product?

Answer 9

A product authorised if it holds:

• a marketing authorisation
• a certificate of registration
• traditional herbal registration/ article 126a registration

Question 10

What is a Relevant Medicinal Product?

Answer 10

A product which holds a:
Marketing authorisation - our traditional medicines, or in HMR 2012 terms, a relevant medicinal product
certificate of registration - a homeopathic
traditional herbal registration - is a herbal remedies

Question 11

What is a Medicinal Purpose?

Answer 11

• treating or preventing disease
• diagnosing disease
• contraception
• inducing anaesthesis
• interfering with the normal operation of a physiological function