The licensing system Flashcards
What are the different types of licences?
- Marketing authorisation
- Manufacturer’s licence
- Wholesale dealer’s licence
What are the 2 types of certificates?
- Clinical trials certificate
- Clinical trials exemption certificate
Outline the licensing process
Clinical trials ( CTC/CTX) ->
Assemble drug properties/formulation data (MA) ->
Plan to produce in large batches, assemble + pack (ML) ->
Plan to store + distribute product by wholesale (WDL) ->
Marketing + distribution
What are the key criteria in licensing a new medicine?
- Safety
- Quality
- Efficacy
What is the other name for a marketing authorisation?
Product licence
Which products need a marketing authorisation?
All commercially available medicinal products
A MA authorises the holder to what?
- Sell, supply + export product
- Procure sale, supply + exportation
- Procure manufacture
Is it lawful to supply/manufacture a medicinal product without an MA?
No
How long is a MA issued?
5 years
After 5 years, MA holders must do what?
Apply for licence renewal
Which organisation has power to withdraw or amend a MA?
MHRA
What must be submitted in order to obtain a MA for a medicinal product? And to who?
- Info on product
- MHRA
What happens when a product is new and must obtain an MA?
- Full info about manufacturing + testing
- Clinical trials result available to MHRA
- Summary of product characteristics submitted
What is a manufacturer’s licence?
- Authorises holder to manufacture or assemble medicinal product
- Describes premises, equipment, people, record + qualifications of people involved
In a manufacturer’s licence, what does ‘manufacture’ not include?
Doesn’t include dissolving, diluting or mixing
Define assemble
Enclosing a product in a container which is labelled before the product is sold or supplied, or re-labelling a product
In the manufacturer’s licence, what must the manufacturer comply with?
Principles for good manufacturing practice
Who requires a wholesale dealer’s licence?
Any person who sells a medicinal product by way of wholesale dealing
What does a wholesale dealer’s licence authorise?
Authorises holder to re-sell to anyone other than the end user
Does an MA holder require a wholesale dealer’s licence?
No
Outline the requirements for a wholesale dealer’s licence?
- Records for medicines received + dispatched
- Emergency plan for recall of medicines
- MHRA visits to inspect premises
Outline the licensing exemptions when importing medicinal products
- Product for administration to importer or member of household
- Product imported by doc/dentist for admin to particular patient
Most cases require no license for the export of a product. Which products require a licence?
Biological products:
- Antigens
- Antibodies
- Vaccines
Pharmacists don’t require a licence when under the supervision of a pharmacists in a registered pharmacy which consists of…
- Preparing/dispensing product on prescription of practitioner
- Preparing/dispensing product to formula provided by purchaser for administration
- Preparing/dispensing product in course of counter prescribing
- Preparing stock that is not advertised
- Assembling product for retail sale w/o advertisement
What are specials?
- Unlicensed products prepared by Special’s licence holder
- Made on the order of doc, dentist, nurse prescriber, pharmacist prescriber
- For patient they’re treating
What are the requirements of a specials manufacturer?
- Holds specials manufacturer’s licence
- Not advertise/solicits orders for products
- Carry manufacture under certain conditions
- Maintain written record
How long is a specials record kept at a pharmacy and what must it include?
- 5 years
- Patient details
- Name + quantity
- Who manufactured it
- Batch no.
- Date supplied
Any adverse drug reaction to a special must be reported to who?
MHRA via yellow card scheme
Does an unlicensed medicine have an MA?
No
Why are extemporaneous medicines classed as specials?
Because they are unlicensed
When should unlicensed medicines be prescribed?
If no equivalent licensed product exists
What are the requirements when prescribing + dispensing an unlicensed medicine?
- Ensure prescriber realise med is unlicensed + inform prescriber of suitable licensed alternative
- Patients informed med is unlicensed
What is unlicensed use?
Prescribing of a licensed medicine outside its license
What may unlicensed use be due to?
- Dose
- Age
- Route of admin
- Indication
What are the requirements when prescribing + dispensing an unlicensed use of product?
- Ensure prescriber is aware of the unlicensed use of a product + inform prescriber of suitable licensed alternative
- Patient informed of unlicensed use + what this means
Herbal medicines which are for sale to public must have which licenses?
- Licensed as medicine
- Registered under traditional herbal registration scheme
What does the traditional herbal registration scheme ensure?
- Quality
- Safety
- Regulated manufacturing standards
- No data required on efficacy
- Must provide patient w/ PIL
- THR logo + no.
