Home Office - Key Answers Flashcards
Prepare for the Home Office Licence Inspection and Ongoing
What SOPs reference the CD Register WI and AOs delegated staff?
022 (Import Procedure)
023 (In-Market Release)
024 (Receipt of Pharmaceutical Products)
025 (Storage, Stock Rotation and Regular Stock Takes)
027 (Sales Procedure)
029 (Picking, Packing and Despatch)
037 (Medicines Destruction)
Summarise the Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001
- Misuse of Drugs Act 1971: Primary legislation purpose to prevent the misuse of controlled drugs. Outlines the penalties for unlawful possession.
- Misuse of Drugs Regulation 2001: Outlines the lawful use of controlled drugs. Defines the types of people authorised to handle CDs and defines the 5 schedules for lawful use as medicines/research.
What is your role as Quality Manager?
Support the LH and RP to ensure the QMS is effective and compliant to GDP and the regulations and guidelines.
What does DFLU stand for, and what is this entity used for?
- Drugs and Firearms Licensing Unit.
- Home Office application for Import License for Controlled Drugs can be made on the National Drug Control System (NDS) website at:
https://dflu.homeoffice.gov.uk/#/home
How long are HO Import License valid from date of receipt?
Do you ask the supplier to get an export license after or before the Import License is granted?
3 months.
Export License can be applied for after the Import License is granted.
Name 4 types of falsified representation that can raise suspicions of falsified medicines
- Its identity, this includes packaging, labelling, ingredients, THC/CBD ratio
- Source, country of manufacturer, or MA
- History including documentation and distribution channels used
- Product that has been lost or stolen
Define ‘Unlicensed Medicines’
Unlicensed Medicines are not licensed in the country it is intended to be used (does nit hold an MA in that county).
For it it be supplied, there must be a valid special clinical need of an individual patient where there is no authorised equivalent available on the national market.
True or False?
Medical Cannabis must be prescribed on a named patient basis.
True
Where do you report suspected falsified medicines?
MHRA Yellow Card Scheme
Upon an inbound delivery from a supplier, a product is suspected as falsified and placed in Quarantine. Who should Hologram contact to verify the products authenticity and support with product disposition?
The manufacturer, who will verify if the product, batch is falsified.
what is the difference between according to the mhra between unlicensed medicine and special?
An unlicensed medicine is any medicinal product that does not have a valid UK marketing authorisation.
Specials are defined as specific type of unlicensed medicinal products that are:
i) Manufactured in the UK by the holder of a “Specials” Manufacturing Authorisation (MS) licence, or imported medicines without a UK Marketing Authorisation.
ii) Specially prepared to meet a prescription ordered for individual patients.
iii) Manufactured or imported to meet the special clinical needs of an individual patient when no suitable licensed alternative is available.
The key distinction is that all specials are unlicensed medicines, but not all unlicensed medicines are specials. Specials represent a specific subset of unlicensed medicines that are custom-made or imported to address particular patient needs
How fast must you action a class 2 recall?
48 hours
What classification of recall must you recall immediately?
Class 1
How many days should you take to action a class 3 recall?
5 days
