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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
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2
Q

What is the MHRA ?

A
  • Medicines and Healthcare products Regulatory Agency
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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
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4
Q

Dec 31 st 2020

A
  • EMA licences for CAPs no longer apply to the UK.
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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.

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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.
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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.
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8
Q

What is an SPC ?

A
  • contains description of medicinal products + properties + conditions associated with its use
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9
Q

Jan 1 st 2021

A
  • All CAPs automatically converted to UK Marketing Authorisations (MAs) under a ‘grandfathering’ arrangement.
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10
Q

Dec 31, 2022

A

Grandfathering arrangement ended.

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11
Q

Jan 1st 2023

A
  • CAPs require a valid UK MA to be marketed in the UK
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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.

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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.

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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
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15
Q

What does assembling mean ?

A
  • enclosing the product in a container
  • or labelling a product that is already in a container
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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

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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).

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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.
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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.
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20
Q

What must be included in an ML application regarding personnel?

A
  • qualification of the production manager and QP (qualified person)
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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
What is an IMP ?
- 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
What is a Non- IMP ?
- medicinal product used in a clinical trial but is not being tested or evaluated as part of the study.
27
Who reviews Clinical Trials of Investigational Medicinal Products (CTIMPs)?
- CTIMPs are reviewed by the MHRA and the Research Ethics Committee
28
What are the two types of products involved in clinical trials?
1. Investigational Medicinal Products (IMPs). 2. Non-Investigational Medicinal Products (Non-IMPs).
29
Who authorises clinical trials of medicinal products in the UK?
- The MHRA authorises clinical trials for medicinal products.
30
Phase I of a clinical trial
- new product tested on small group of healthy adults - tests : dosage, safety + side effects
31
Phase II of a clinical trial
- people affected by the disease are included - larger group size (up to 500) - tests : if treatment is effective, against a placebo + side effects
32
Phase III of clinical trial
- even larger group ( up to thousands ) - tests = effectiveness + over longer periods and in different countries , tests against existing treatments
33
Phase 4 of a clinical trial ?
- 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
What is pharmacovigilance under HMR 2012 ?
• Capturing and evaluating information about medicines. • Taking measures to minimise and prevent risks associated with medicines.
35
What are the responsibilities of the Marketing Authorisation (MA) holder under HMR 2012?
1. Operate and maintain a pharmacovigilance system. 2. Employ a Qualified Person for Pharmacovigilance (QPPV). 3. Evaluate safety information related to the product.
36
What are the requirements for a Qualified Person for Pharmacovigilance (QPPV)?
• 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
What is the QPPV responsible for?
• Overseeing the pharmacovigilance system. • Ensuring compliance with regulatory requirements for safety monitoring.
38
What is the yellow card scheme ?
- voluntary reporting scheme - any member of public or health professional can report suspected issue or adverse effects of a medicine
39
What is the purpose of the yellow card scheme ?
- serves as an early warning of safety issues
40
What are the challenges of the yellow card scheme ?
- unreliable - under-reporting - complex system - 2020 Cumberlege report - outlined reforms needed
41
What should be reported under the Yellow Card Scheme?
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
What is the Black Triangle Scheme?
• 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
What is the purpose of the black triangle ?
Aims to: • Confirm the benefit/risk profile from clinical trials. • Quickly identify previously unrecognised side effects.
44
What is a National Patient Safety Alert (NatPSA) in medicines recall?
• 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
What are Class 2 and Class 3 medicines recalls?
• 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
What is a Class 4 Medicines Notification (Caution in Use)?
• 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
What is a company-led medicines recall or notification?
• Licence holder identifies affected customers and contacts them directly. • A pan-NHS or healthcare system alert is not necessary.
48
What are falsified medicines?
- fake medicines that mimic real ones - may misrepresent identity, source, or history. - contain low-quality ingredients, wrong doses, or mislabelled/fake packaging
49
What are counterfeit medicines?
- do not comply with intellectual-property rights or that infringe trademark law
50
Can a medicine be both falsified and counterfeit ?
- yes they can be both

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