the licensing system Flashcards
what is the licensing system
Licensing system was the main novel feature of the Medicines Act (now replaced by the HMR 2012) and remains at the centre of all control over medicines
what are the 3 types of licenses you can get?
Marketing Authorisation (MA)
•Manufacturer’s Licence (ML)
•Wholesale Dealer’s Licence (WDL)
what are the 2 types of certificates you can get?
- Clinical Trials Certificate (CTC)
* Clinical Trials Exemption Certificate (CTX)
true or false- it is an offence to preform any of these without a license
true
what are the 3 key criteria in licensing a new medicine?
safety
quality
efficacy
what was the marketing authorization formally known as?
product license (PL)
what must all commercially available products have?
a marketing authorization -MA
Who is usually the MA holder?
the manufacture of the medicinal product
what does the MA allow the holder to do?
- Sell, supply or export a medicinal product
- Procure its sale, supply or exportation
- Procure its manufacture
how long are MAs usually issued for?
5 years
what does the MHRA have the power to do to an MA?
withdraw or ammend it
what does the manufactures license allow?
Authorises the holder to manufacture or assemble a medicinal product (unless an exemption applies)
what does the manufactures license not allow them to do?
Manufacture does not include dissolving, diluting or mixing with some other substance used as a vehicle for administration
what is assembled defined as?
Assemble is defined as “enclosing a product in a container which is labelled before the product is sold or supplied, or simply re-labelling a product”
what does the MA describe?
Licence describes premises, equipment, people, records and qualifications of people involved
what is a wholesalers license?
Required by any person who sells a medicinal product by way of wholesale dealing
what must a wholsaler have an emergency plan for?
the recall of medicines
do you need a license to import?
No license is required to import:
•A product for administration to the importer or a member of his household (i.e. for personal use)
•A product imported by a doctor or dentist for administration to a particular patient
in what cases do you need a license to export?
(except some biological products e.g. antigens, antibodies, vaccines
do pharmacists need a license?
Pharmacists do not require a license for anything done by or under the supervision of a pharmacist in a registered pharmacy
are specials licensed?
all specials are unlicensed
what must the specials manufacturer have?
- Hold a “specials” manufacturer’s licence
- Not advertise or solicit orders for the product
- Carry out the manufacture under certain conditions to ensure the quality of the product
- Maintain written records
what is an unlicensed medicine?
An unlicensed medicine has no MA and it does not have a SPC. It does not have a monograph in the BNF
•All extemporaneous medicines are unlicensed and so are ‘specials’
when should unlicensed medicines be prescribed?
when there is no licensed form- patient should be infomred
