Licensing System Flashcards
What do licenses and certificates permit?
Permit a person or company to engage in specific, controlled activities e.g. efficacy, safety and quality
Marketing Authorisation (MA) is granted by the MHRA to authorised what?
- Sell, supply and export product
- Procure its sale, supply and exportation
- Procure its manufacture
How often does MA need renewed?
every 5 years
What must medicinal products have?
An MA
What is an ML and what does it authorise?
Manufacturers License
- Authorises manufacture and assembly of medicinal product.
What is a WDL and what does it authorise?
Wholesale dealer’s license
- Authorise re-selling of a medicinal products by wholesale dealing.
What are the licensing exemptions for pharmacist/ those under their suspension?
- Dispensing medicines on Rx
- Dispensing medicines in the course of counter prescribing
- Preparing a product to a formula provided by purchaser for admin
- Preparing a stock of products for use
- Preparing a stock medicines for sale from pharmacy
- Assembling a medicine for retail sale without advertisement from the pharmacy
What is a special?
Unlicensed products prepared by a special’s license holder ordered by an appropriate prescriber for a patient
How long do you keep the records for a special?
5 years
What are the requirements for a special?
- Patient name
- Drug name and quantity
- Batch No.
- Date of supply
Who do you report adverse reactions to and how?
MHRA via yellow card scheme
How do you know if a medicine is unlicensed? Name two examples of unlicensed medicines.
- They have no MA/Summary Of Product Characteristics (SPC)
- Extemporaneous and specials
What would you do in the case of unlicensed medicines?
- Unlicensed use due to dose, age, indication, form
- Pharmacists should inform prescriber it is unlicensed and suggest alt if there is one
- Inform patient it is unlicensed and what this means
What is off-label use?
Prescribing licensed medicines outside of their license
What are you required to do in the case of off-label use?
Inform prescriber and patient of unlicensed use
What are parallel imports?
Medicines imported from another member state of the EU
True or False, Parallel imports are cheaper than UK imports?
TRUE
What are the requirements of Parallel imports?
- Must be branded version of UK product with an MA from the country of manufacture.
- Must be labelled in english and english PK
- Prescribe exact brand on Rx
- Can apply for shortened application for a product license - PL rather than full MA
What must be licensed under the THR scheme?
Herbal medicines
What does THR stand for?
Traditional herbal registration
What does the THR scheme do?
Quality, safety, THR logo/no, regulated manufacturing standards, no data required an efficacy
