B6 Medicines licensing Flashcards
1
Q
what is a medicine?
A
- medicinal product: any substance or combo of substances presented as having properties of treating disease in human beings
- may be used or administered by humans to restore, correct or modify physiological function or exerting pharmacological, immunological effects
2
Q
why do we need a license for medicines?
A
- illegal to manufacture, assemble, import or distribute without a license, certificate or exemption
- provides standards of quality and safety
- regulation and licensing introduced under the Medicines Act
3
Q
what is the licensing organisation for medicines?
A
Medicines and Healthcare products Regulatory Agency (MHRA)
4
Q
what is a Marketing Authorisation (MA)?
A
- name given to the license with full regulatory approval in UK
- place restrictions on products (can’t use everything in everyone!)
- defines the legal classification of the medicine (GSL, P, POM)
5
Q
what does an MA allow for?
A
- sale, supply, import and export of a medicinal product
- procurement for sale, supply, export, manufacture or assembly
6
Q
what does Clinical Trial Authorisation permit?
A
- license for first use of drug / product in humans
- permits use of a medicinal product only in trials / tests
- sale or supply of a medicinal product
- manufacture or assembly for sale or supply
- import into the UK
7
Q
what is the Early Access to Medicines Scheme (EAMS)?
A
- gives patients with life threatening or seriously debilitating conditions, access to medicinal products that are not licensed where no suitable alternative exists
- permits ordering, manufacture and distribution if MHRA are satisfied certain criteria are met
- requirements for pharmacovigilance (safety monitoring)
- advertising is prohibited
8
Q
what is an MIA?
A
- Manufacturer’s and Import Authorisation
- required for manufacturing or assembling relevant products
- manufacturers license needed for a process resulting in a medicinal product
9
Q
general labelling requirements for medicinal products
A
- be legible, comprehensible and indelible
- English
- include standard labelling particulars (specific info)
- from 2025 - ‘UK only’
10
Q
what must PILs have?
A
- be legible, clear and easy to use
- be written in accordance with SmPC
- include specified particulars (specific info)
11
Q
what are the standard labelling particulars for medicinal products?
A
- detailed requirements for labelling of containers/packages
- name of product in Braille on outer packaging
- legal classification (POM, P in a rectangle)
- may include symbols, diagrams or pictograms to clarify information (not for promotion)
12
Q
what is wholesale dealing?
A
- sale of a medicinal product to a person who buys it to:
- sell or supply to someone else
- administer or cause to be administered to someone else
- in the course of a business carried on by the purchaser
- wholesale is never to the patient, it is from one company to another which then provides it to the patient
13
Q
state 4 things that are exemptions for a MIA or WDA license
A
- practitioners
- pharmacists
- named patient supply
- specials
14
Q
what must be considered during the supply of unlicensed, off-label medicines as to whether the pharmacist is liable?
A
- duty of care to patient
- shared responsibility with prescriber
- does the prescriber know it is unlicensed?
- is there a licensed alternative?
- weigh up risks and benefits
- breaches of confidentiality when seeking information
15
Q
describe the licensing of herbal remedies
A
- from dried / crushed / powdered plant materials
- label only states actual contents
- no recommendation for use
