Wk 26 - Licensing Flashcards
What are the types of license?
- Marketing authorisation
- Manufacturer’s license
- Wholesale dealer licence
Outline the licensing process
- Clinical trials in patients suffering disease
- Assemble data about drug (MA)
- Plan to prod large batches, assemble + pack (ML)
- Plan to store + distribute product by wholesale (WDL)
- Market + distribution
What are the key criteria in licensing a new medicine?
- Safety
- Quality
- Efficacy
Which organisation give authority to license a product?
MHRA
How long til you have to reapply for an MA license?
5 yrs
When would a product be defined as a generic medicinal product?
- Same qualitative + quantitative composition in active substance
- Same form
- Bioequivalence w/ RMP demonstrated
How long is the data exclusivity period?
8 years
When can a biosimilar be marketed?
After patent of OG biologic has expired
Which group of medicines needed to be prescribed by brand name?
Biologics + biosimilars
What must herbal medicines be registered under?
THR scheme
What is the THR scheme?
- Quality + safety
- THR logo + no.
What is pharmacovigilance?
- Post marketing surveillance of the safety of medicines
- Focused on black triangle meds
What does it mean if a medicine has a black triangle?
- Contains active substance
- Biological med: vaccine
- Conditional approval
- Approved under exceptional circumstances
Does an MA holder require a wholesale dealer’s license?
No
Give examples of licensing exemptions
- Imported by doctor/dentist for admin to a particular patient
- Manufactured or assembled by doctor or dentist for particular patient
- Assembled by nurse or midwife
- Mixing as part of CMP
Registered pharmacy:
- Dispensing prod on prescription
- Dispensing OTC
- Wholesale dealing
What is the difference between unlicensed product + unlicensed use?
- Prod: no MA
- Use: not usual indication
What is required in order to prepare specials?
- Manufacturers license
- Don’t advertise
- Carry out under certain conditions
- Written records
When dispensing a specials product, how long must the record be kept + what should be included?
5 years: patient details, name + quantity of product, who manufactured, batch no. + date supplied to patient
What are the reasons a product may be considered unlicensed?
- Dose
- Age
- Route
- Indication
- Crushing
What is a parallel imported medicine?
Med imported from another country where a version is already available in UK + has UK marketing authorisation
What are counterfeit medicines?
- Med deliberately + fraudulently mislabeled w/ respect to identity or source
