The Essentials: UK Medicines Regulation – Final Test
This is the final module in the course. This will draw on all the learnings from the course. There is no time limit for this test, and you may attempt is as many times as you like.
After the test, you will receive your final mark. To receive your certificate, you must attain a score greater than 75%.
There is then a short feedback survey to complete before you are issued your certificate.
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Question 1 of 15
1. Question
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency that operates under which of the following government departments?
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Question 2 of 15
2. Question
The MHRA has many responsibilities. Which of the following is not one of them?
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Question 3 of 15
3. Question
Medicines are intended to benefit those who use them, as well as wider public health, but medicines can have side effects and as such there are specific restrictions placed on them. Which set of regulations consolidate UK law concerning medicinal products for human use?
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Question 4 of 15
4. Question
Under HMR 2012, which of the below criteria form part of the definition of a medicine? Select all that apply.
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Question 5 of 15
5. Question
There are three distinct legal categories of medicines, prescription-only medicines (POM), pharmacy medicines (P), and general sales list medicines (GSL). Each legal category has its own characteristics. P and GSL medicines are collectively referred to as ‘over-the-counter’ (OTC) medicines.
Match the following characteristics to the corresponding legal category.
Sort elements
- POM
- P
- GSL
- OTC
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Typically for conditions that are best diagnosed and managed by doctors.
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Usually require more support for consumers to correctly select and use.
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Products which can be self-selected by consumers.
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Available both behind the counter and on retail store shelves, empowering self-care.
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Question 6 of 15
6. Question
A marketing authorisation can be obtained via a number of routes, each tailored to specific circumstances and regulatory requirements. Match the following routes with their definition.
Sort elements
- Pure National Procedure
- International Recognition Procedure
- Reclassification
- Informed Consent
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Full MHRA assessment is conducted in order to achieve the product licence.
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Expedited assessment utilising assessments from other regulatory authorities.
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Changing the status of a medicinal product.
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Marketing a product identical to one already approved, with the permission of the original marketing authorisation holder.
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Question 7 of 15
7. Question
The Common Technical Document (CTD) standardises the presentation of quality, safety, and efficacy information for regulatory review in many countries. At its core, the CTD comprises of five modules, each serving a distinct purpose in presenting comprehensive data to regulatory authorities.
Which of the following modules contains the proposals for the summary of product characteristics (SmPC)?
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Question 8 of 15
8. Question
SmPCs are intended to be the primary source of information for healthcare professionals, providing insights into the safe and effective use of medicines. The SmPC is organised into 10 sections.
Which of the following is not a section of the SmPC?
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Question 9 of 15
9. Question
A well-chosen name assists in the clear communication of the medicine’s identity, its active ingredients, and its therapeutic use. This is especially important for OTC medicines where patients often need to self-select the right medicine.
Which of the following is not required as part of the name of a medicine?
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Question 10 of 15
10. Question
The Patient Information Leaflet, or PIL, is designed to provide patients with accessible, comprehensive information about the medicine. Patient information leaflets must follow the order and content specified in Schedule 27 of the HMR 2012. Which of the following is not specified within Schedule 27 of the HMR 2012?
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Question 11 of 15
11. Question
Marketing authorisation holders (MAHs) are required to notify MHRA of changes to medicines packaging. This can be done via a number of procedures.
Match the route type to the correct description.
Sort elements
- P1
- P2
- P3
- P4
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First approval of mock-ups following the granting of a marketing authorisation.
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Changes to patient information leaflets which include significant changes to content and/or design and layout.
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Changes to pack design and layout. This process normally takes up to 90 days. If approved by PAGB, this process will be reduced to 30 days.
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Changes which MHRA informs the marketing authorisation holder on and for which a full application is required.
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Question 12 of 15
12. Question
There are several benefits to making a medicine available over-the-counter. Select all that apply.
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Question 13 of 15
13. Question
There are different types of procedure to reclassify a medicine. Which of the below is not one of them?
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Question 14 of 15
14. Question
Advertising regulations come from Part 14 of the Human Medicines Regulation 2012. MHRA has produced detailed guidance on advertising and promoting medicines, known as what?
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Question 15 of 15
15. Question
Which of the following services does PAGB offer? Select all that apply.
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