Licensing Flashcards
What does a manufactures licence (MIA) allow the holder to do?
Manufacture/assemble licensed medicinal products, import and export licensed medicinal products from outside EEA
True or false an MIA holder can dissolve/disperse the product or dilute/mix it with a vehicle for the purpose of administration?
False!
What are specials?
Medicines for patients with special clinical needs that cannot be met by licensed medicinal products
True or false, pharmacists can create specials extemporaneously without the need for a licence?
True
What does a specials licence (MS) allow the holder to do?
To manufacture unlicensed medicines and import them from countries outside EEA
True or false, a holder of a specials licence is allowed to advertise the product?
False-cannot advertise specials
What must the manufacturer of cannabis based products hold?
A specials licence, a home office licence and must comply with BP requirements
What does a manufacturers licence for investigational medicinal products allow the holder to do?
To manufacture investigational medicinal products for use in clinical trials
Which phases of clinical trials is a licence for investigational medicinal products required for and why?
Phase 1, 2 and 3 clinical trials. Not 4 because that’s when product gets MA.
What does a wholesale dealers licence allow the holder to do?
Wholesale P, POM, GSL and traditional herbal medicines and import unlicensed products from countries inside EEA.
Who can a wholesale dealer distribute medicinal products to?
Another wholesale dealer, person who may lawfully sell/supply the products (pharmacist) and person who may administer the products.
True or false, wholesale deal records of distribution must be kept for a minimum of 5 years so that the products can be recalled if necessary?
True
