Reg of medicine licences Flashcards
A manufacturer licence allows the holder to manufacture but not assemble licensed medicinal products, including export to a country outside the EEA. True or false?
False - manufacture and assemble
Manufacture Licence only allows the export to a country outside the EEA but not the import from countries from outside EEA. True or false?
False - export to countries outside EEA and also import from countries outside EEA
The term manufacture includes any process carried out in the course of making the product and includes dissolving or dispersing the product in a substance used as a vehicle for purpose of administering it. True or false?
False - doesn’t include dissolving/dispersing
Before a manufactures licence is granted, the licensing authority must be satisfied with the qualifications of supervisory staff. True or false?
True
A product can be manufactured before being covered by a MA. True or false?
False - must be covered by a MA by the manufacturer or by a person ordering from a manufacturer BEFORE it is manufactured
Manufacture requires a Manufacturer’s licence but assembly doesn’t. True or false?
False - manufacture and assembly do
A manufacturer Licence allows the holder to manufacture unlicensed medicines ‘specials’. True or false?
False - require a manufacturer ‘specials’ licence
A manufacturers ‘specials’ licence allows the holder to import unlicensed meds from inside the EEA only. True or false?
False - outside the EEA
Pharmacies are able to prepare unlicensed products extemporaneously but require a manufacturer ‘specials’ licence. True or false?
False - they are exempt from requiring a specials licence
‘Specials’ are for patients who may have special clinical needs that cannot be met by licensed medicinal products that cannot be met by licensed medicinal products. True or false?
True
The manufacture of a ‘special’ medicinal product is supplied in response to an unsolicited order. True or false?
True
A prescriber can request a ‘special’ if an equivalent licensed product exists. True or false?
False
A manufacturer licence for investigational medicinal products allows the holder to manufacture investigational products for use in what?
Clinical trials
A manufactures licence for investigational medicinal products is required for phase 1, 2, 3 and 4 of clinical trials. True or false?
False - phase 1, 2 and 3 only (pre-marketing)
A wholesale dealers licence allows the holder to wholesale deal POMs only. True or false?
False - P, POMs, traditional herbal and GSL
A wholesale dealers licence allows the holder to import unlicensed meds from countries outside EEA. True or false?
False - inside EEA
A wholesale licence holder may distribute medicinal products only to a holder of a WL relating to those products. True or false?
False - or holder of an equivalent EEA WL, a person who may lawfully sell those products by retail or may lawfully supply them in circumstance corresponding to retail sale or a person who may lawfully adminster those products
Records of distribution of wholesale deal must be kept for a minimum of 2 years so that products can be recalled from circulation if necessary. True or false?
False - 5 years
Pharmacists are exempt from licencing requirements provided activity (extemp) takes place on registered pharmacy premises, hospitals and care homes. Pharmacist must be supervising. True or false?
True
A pharmacist is exempt from holding a licence for counter prescribing (i.e. extemp prep) provided patient is present in pharmacy. True or false?
True
Pharmacist are exempt from licencing for assembly of meds and stock mixtures in pharmacy. True or false?
True
Pharmacist exempt from licence for “own name” products and these products cannot be advertised to anyone i.e. for specific patient cases and must be prepared on registered premises with pharmacist supervision. True or false?
True
Doctors and dentists are able to manufacture and assemble products intended for individual patients without need for a licence. True or false?
True
Nurses and midwives need a manufacturers licence to assemble (break bulk and repack) in the course of their action. True or false?
False - exempt from licence requirement
A manufacturer or MA holder does not need a WL to marker his own products directly from his licensed premises. True or false?
True
Group buying by retailers or practitioners does not require a wholesale dealer licence, unless the group is a separate company. True or false?
True
A WDL is not necessary to import a product specifically for an individual. True or false?
True
A WDL is need for a product intended to be re-exported without alteration. True or false?
False - not needed
Food and cosmetics are generally exempt from licensing under HMR 2012. True or false?
True
Vitamin preparations are subject to licensing if for oral administration as a food and there are no written particulars/directions for dosage. True or false?
True
There is no exemption for licensing for cosmetics containing antibiotics. True or false?
True
There is no exemption for licencing for cosmetics containing 0.004% or above of any hormone. True or false?
True
