Intro to Medical Regulations

Question 1

What are the two major classes of law?

Answer 1

1) Statute Law

2) Civil Law

Question 2

What are the three subtypes of statute law?

Answer 2

1) Criminal law
2) Administrative law
3) Professional law

Question 3

what was the first piece of restrictive legislation?

Answer 3

Arsenic Act 1851

Question 4

what 3 pieces of legislation followed relating to drugs and medicines in the UK?

Answer 4

1) The Medicines Act 1968
2) The Misuse of Drugs Act 1971
3) The Poisons Act 1972

Question 5

When was the medicines act replaced by?

Answer 5

human medicines regulations 2012

Question 6

what are retailed pharmacists covered by?

Answer 6

medicines act 1968

Question 7

what does the HMR 2012 cover?

Answer 7

• Medicines are traded freely across the EU and EU laws cover many aspects of medicines regulation
Consolidated and simplified many changes and
addition/deletions made to the Medicines Act 1968

Question 8

how will pharmacists be affected by brexit?

Answer 8

Licensing of medicines
• Trading in medicines
• Parallel imported medicines
• Free movement of pharmacists
• Dispensing EU prescriptions
• Emergency supply of POMs to EU residents
• Miscellaneous legislation (e.g. waste regulation, employment
legislation etc)

Question 9

whats the key feature of hmr 2012

Answer 9

SINGLE legal framework applicable to ALL medicinal products for human use at EVERY stage of development, production, licensing
and supply to the public
only applies to substances which are sold as medicines or ingredients

Question 10

who operates and enforces the HMR 2012

Answer 10

Medicines and Healthcare Products Regulatory Agency (MHRA)

Some aspects relating to pharmacy by GPC

Question 11

who replaced the Committee on Safety of Medicines (CSM)

Answer 11

Commission on Human Medicines (CHM)

Question 12

what does the CHM do?

Answer 12

Advises ministers on policy matters relating to medicines regulation
• Provides independent advice to MHRA about the safety, quality or efficacy of medicinal products
Promotes the collection and investigation of information relating to
adverse drug reactions

Question 13

who are the Government’s agency which is responsible for ensuring that medicines and medical devices work properly and are acceptably safe ?

Answer 13

Medicines and Healthcare Products Regulatory Agency (MHRA)

Question 14

what do the MHRA do?

Answer 14

• Licensing authority for medicines in the UK
• Regulates clinical trials of medicines
• Collects and investigates information relating to adverse reactions for human
medicines (post-marketing surveillance)
• Monitors the safety and quality of imported unlicensed medicines
• Investigates internet sale of medicines
• Investigates counterfeit medicines
• Issues drug alerts and recalls

Question 15

what do the MHRA publish every month?

Answer 15

drug safety update

Question 16

define a medicinal product

Answer 16

Any substance or combination of substances presented as having properties of preventing or treating disease in human beings

Question 17

define administer

Answer 17

means to administer to a human being -
a) orally, by injection, or by introduction into the body
in any other way; or
b) by external application

Question 18

example of products that are exempt from legislation

Answer 18

food and cosmetics (mostly)

Question 19

what legislation are medical devices regulated under?

Answer 19

Medical Devices Regulation 2002 (as amended)

Question 20

what classifies as a medicinal product?

Answer 20

e.g. contact lenses, dental filling substances, pacemakers, dressings,
artificial hips, BP machines, pregnancy testing kits, blood glucose
monitors, urine testing strips

Question 21

what does CE on a packet mean?

Answer 21

it meets safety and performance requirements (fit for its stated use)