Human Medicines Regulations 2012 Lecture Part 1 Flashcards
What has changed since the UK left the EU?
- Laws derived from the EU remain in force after the UK’s withdrawal from the EU
- Since leaving the EU the Medicines and Medical Devices Act 2021 was introduced
- Pharmacies do not have to comply with the Falsified Medicines Directive
- MHRA has control over pharmacovigilance
- Medicines which were approved by the EMA’s centralised route (CAPs) were converted into UK MAs when the UK left the EU
What do the Human Medicines Regulations cover?
- The HMR is made up of 17b parts and many schedules
- They regulate the manufacture, distribution and importation of medicines for human use
- The advisory structure is principally the Commission on Human Medicines
- It defines what a ‘medicinal product’ is
- Describes the UK’s obligation in relation to pharmacovigilance
- Enforcement of the Regulations is the responsibility of:
- MHRA
- GPHC
- Local drug authorities
What is a medicinal product?
any substance or combination of substances presented as having properties of preventing or treating disease in human beings
What happened with R v Chapman (Sonny) [2017]
- 4 defendants were found in possession of canisters containing nitrous oxide
- convicted under the Psychoactive Substances Act 2016
- They argued at their appeal that nitrous oxide did not come under the Act as it was classed as a medicinal product
- The nitrous oxide in this case was found not to be a medicinal product
Can a substance for a medicinal product for only one purpose?
yes only one purpose but not for another
What does MA stand for?
Marketing authorisation
What does Homeopathic remedies need?
registration certificates
What does THR stand for?
Traditional Herbal medicinal products
What is a manufacture’s license for?
To manufacture, assemble, or import from a state other than an approved country
What is a wholesale dealer’s license for?
To sell or supply a medicinal product to a person who is NOT the end user
What is Licensed medicine?
A medicine with a UK marketing authorisation which meets acceptable standards of efficacy, safety and quality.
What is Unlicensed medicine?
A medicine which does NOT have a UK marketing authorisation
What is Off-label medicine?
A licensed medicine that is being used outside of the terms of its marketing authorisation e.g. for an alternative indication
What is Pharmacovigilance?
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems (WHO 2006)
Who must operate a pharmacovigilance system?
A MA holder
Can anyone use the MHRA Yellow Card Scheme reporting site?
Yes they can
Is there a dedicated Coronavirus Yellow Card reporting site?
Yes
Where can reports be made?
via the Yellow Card Scheme website, the App or via freephone
What are the Legal classes?
- POM - Prescription Only Medicine
- P - Pharmacy
- GSL - General Sales List
What is the importance of legal classification?
it determines the level of control over the supply
What is the importance of classification?
depends in part on how much input is required from a health professional
Where can GSL be sold?
From almost any outlet and must be able to close so as to exclude the public
Can GSL be sold without pharmacist supervision?
Yes
Where can P medicines be sold?
Only from a Pharmacy
Sale made by a pharmacist or under the supervision of a pharmacist
It must be no less safe and effective than if the pharmacist made the sale or supply
position to intervene
