Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Law And Ethics > Medication Licensing > Flashcards

Medication Licensing Flashcards

1
Q

Human Medicines Regulation 2012

A
  • a person may not sell or supply or offer a medicinal product unless that product has a UK marketing authorisation
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is the MHRA ?

A
  • Medicines and Healthcare products Regulatory Agency
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What is the MHRA responsible for ?

A
  • ensure safety quality and efficacy
  • promote international standardisation + harmonisation to assure the effectiveness and safety of medicines
  • educate the public about risks and benefits of products + devices
  • research + development
  • influence UK + EU regulatory frameworks so they’re risk proportionate + effective at protecting public health
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Dec 31 st 2020

A
  • EMA licences for CAPs no longer apply to the UK.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What is a Marketing Authorisation (MA) for?

A

An MA permits the holder to:
- Sell, supply, offer for sale or supply, or export a product.
- Procure its sale, supply, or exportation.
- Procure its manufacture or assembly.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

What are the steps to apply for a Marketing Authorisation (MA) ?

A
  • Applicant must be registered with the MHRA.
  • Submit an application with adequate evidence of safety and efficacy.
  • MHRA reviews the risk vs benefit profile of the product.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

What is a Conditional Marketing Authorisation?

A
  • issued for products addressing unmet medical needs or serious/life-threatening conditions
  • allows earlier approval with less comprehensive data, but requires complete data post-approval.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

What is an SPC ?

A
  • contains description of medicinal products + properties + conditions associated with its use
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Jan 1 st 2021

A
  • All CAPs automatically converted to UK Marketing Authorisations (MAs) under a ‘grandfathering’ arrangement.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Dec 31, 2022

A

Grandfathering arrangement ended.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Jan 1st 2023

A
  • CAPs require a valid UK MA to be marketed in the UK
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

What must the Full MA application must include ?

A

• Pharmaceutical form, composition, physical characteristics, and medicinal use.
• Method of manufacture and assembly.
• Quality control procedures.
• Containers and labelling.
• Reports of experimental, biological, and clinical trials, including adverse reactions.
• If made abroad: documentary evidence of authorisation for manufacture and assembly.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What is an abridged Marketing Authorisation (MA) application?

A

• Relevant data already submitted in a previous application.
• Data about a similar product that is well-documented.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

What does manufacture mean ?

A
  • any process carried out in the course of making the product
  • but does not include dissolving or dispensing a product
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What does assembling mean ?

A
  • enclosing the product in a container
  • or labelling a product that is already in a container
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What is a Manufacturer’s Licence (ML) and who issues it?

A

• required to manufacture, assemble, or import medicines (outside approved countries).
• Issued by the MHRA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What is required before applying for a Marketing Authorisation (MA)?

A

• A Manufacturer’s Licence (ML) is required before applying for a Marketing Authorisation (MA).

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What are the requirements for medicines under Good Manufacturing Practice (GMP)?

A
  • be of consistent high quality.
  • be appropriate to their intended use.
  • meet the requirements of the MA or product specification.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

How does the MHRA ensure compliance with Good Manufacturing Practice (GMP)?

A
  • Inspects ML holder’s premises during an initial visit and conducts regular inspections.
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

What must be included in an ML application regarding personnel?

A
  • qualification of the production manager and QP (qualified person)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

What is a Wholesale Dealer’s Licence (WDA)?

A
  • issued by the MHRA
  • for individuals or companies that sell or supply human medicines to anyone other than the patient
  • including medicines imported from the EEA
22
Q

What does a wholesale dealer license allow ?

A
  • Wholesale of pharmacy, prescription-only, traditional herbal, and GSL medicines.
    • Import of unlicensed medicinal products from countries in the EEA.
    • Export of medicinal products to countries in the EEA.
23
Q

What does a Wholesale Dealer’s Licence (WDA) specify?

A

• The premises for distribution.
• The Responsible Person (RP).
• Emergency plans for product recall.
• Record-keeping requirements (e.g., invoices).

24
Q

What does the MHRA consider to approve an ML or WDA ?

A
  • operations to be carried out under the licence
  • the premises where operations will be carried out
  • equipment available on premises for carrying put those operations
  • qualifications of person who supervises the operation
  • arrangements made for safekeeping of records regarding products
25
Q

What is an IMP ?

A
  • investigational medicinal product
  • pharmaceutical form of an active substance or placebo that is being tested or used as a reference in a clinical trial
26
Q

What is a Non- IMP ?

A
  • medicinal product used in a clinical trial but is not being tested or evaluated as part of the study.
27
Q

Who reviews Clinical Trials of Investigational Medicinal Products (CTIMPs)?

A
  • CTIMPs are reviewed by the MHRA and the Research Ethics Committee
28
Q

What are the two types of products involved in clinical trials?

A
  1. Investigational Medicinal Products (IMPs).
  2. Non-Investigational Medicinal Products (Non-IMPs).
29
Q

Who authorises clinical trials of medicinal products in the UK?

A
  • The MHRA authorises clinical trials for medicinal products.
30
Q

Phase I of a clinical trial

A
  • new product tested on small group of healthy adults
  • tests : dosage, safety + side effects
31
Q

Phase II of a clinical trial

A
  • people affected by the disease are included
  • larger group size (up to 500)
  • tests : if treatment is effective, against a placebo + side effects
32
Q

Phase III of clinical trial

A
  • even larger group ( up to thousands )
  • tests = effectiveness + over longer periods and in different countries , tests against existing treatments
33
Q

Phase 4 of a clinical trial ?

A
  • tests over longer periods of time + in different groups of ppl + in combination with other treatments
    -treatments licensed + benefits weighed up against costs + limitations to guide NHS use
34
Q

What is pharmacovigilance under HMR 2012 ?

A

• Capturing and evaluating information about medicines.
• Taking measures to minimise and prevent risks associated with medicines.

35
Q

What are the responsibilities of the Marketing Authorisation (MA) holder under HMR 2012?

A
  1. Operate and maintain a pharmacovigilance system.
  2. Employ a Qualified Person for Pharmacovigilance (QPPV).
  3. Evaluate safety information related to the product.
36
Q

What are the requirements for a Qualified Person for Pharmacovigilance (QPPV)?

A

• Must be permanently available to the MA holder.
• Must reside and operate in the UK or the EU/EEA.
• Responsible for establishing and maintaining the pharmacovigilance system for UK-authorised products.

37
Q

What is the QPPV responsible for?

A

• Overseeing the pharmacovigilance system.
• Ensuring compliance with regulatory requirements for safety monitoring.

38
Q

What is the yellow card scheme ?

A
  • voluntary reporting scheme
  • any member of public or health professional can report suspected issue or adverse effects of a medicine
39
Q

What is the purpose of the yellow card scheme ?

A
  • serves as an early warning of safety issues
40
Q

What are the challenges of the yellow card scheme ?

A
  • unreliable
  • under-reporting
  • complex system
  • 2020 Cumberlege report - outlined reforms needed
41
Q

What should be reported under the Yellow Card Scheme?

A

For established medicines and vaccines, report:
• All serious suspected adverse drug reactions (ADR’S) , especially:
• In children
• In individuals over 65.
• ADRs linked to:
• Biological medicines and vaccines.
• Delayed drug effects or drug interactions.
• Complementary remedies.

42
Q

What is the Black Triangle Scheme?

A

• Applies to new medicines and vaccines.
• Identified by a black triangle (▲) on packaging, SPC, and in the BNF.
• Monitored by the MHRA for around 5 years post-marketing (no fixed limit).

43
Q

What is the purpose of the black triangle ?

A

Aims to:
• Confirm the benefit/risk profile from clinical trials.
• Quickly identify previously unrecognised side effects.

44
Q

What is a National Patient Safety Alert (NatPSA) in medicines recall?

A

• Equivalent to Class 1 Medicines Recall.
• Issued when a defect presents a risk of death or disability.
• Requires immediate action via the Central Alerting System or MHRA website.

45
Q

What are Class 2 and Class 3 medicines recalls?

A

• Class 2: Defect may cause mistreatment/harm (not life-threatening or serious); action within 48 hours.
• Class 3: Defect unlikely to cause harm; recall due to non-compliance with MA or specification; action within 5 days.

46
Q

What is a Class 4 Medicines Notification (Caution in Use)?

A

• No threat to patients, but a minor defect (e.g., packaging or printed materials).
• Recall may not occur due to supply concerns.
• Alerts provide advice to healthcare professionals (HCPs).

47
Q

What is a company-led medicines recall or notification?

A

• Licence holder identifies affected customers and contacts them directly.
• A pan-NHS or healthcare system alert is not necessary.

48
Q

What are falsified medicines?

A
  • fake medicines that mimic real ones
  • may misrepresent identity, source, or history.
  • contain low-quality ingredients, wrong doses, or mislabelled/fake packaging
49
Q

What are counterfeit medicines?

A
  • do not comply with intellectual-property rights or that infringe trademark law
50
Q

Can a medicine be both falsified and counterfeit ?

A
  • yes they can be both

Law And Ethics (11 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions