lecture 1: Licenses Flashcards
5 types of manufacturers license?
- Manufacturer Licence (MIA)*
- Manufacturer ‘Specials’ Licence (MS)*
- Manufacturer licence for investigational medicinal products
- Manufacturer licence exempt advanced therapy products (Hospital exemption licence)
- Manufacturer licence for non-orthodox practitioners
do these exist for veterinary products as well?
yes the equivalent exists ONLY for 1 and 2
what does (1) a manufacturers licence allow the holder to do?
manufacture/ assemble licensed medicinal products- that hold a MA.
import/ export to/ from countries outside the EEA
define manufacture
any process carried out in the course of making the product
what does manufacture not include?
dissolving or dispersing the product in or diluting/ mixing it with a substance used as a vehicle for purpose of administering it
define assembly?
processes of dividing up, packaging and presentation of the product or substance
is assembly included in manufacture?
yes but still regarded as separate
what must the licensing authority be satisfied with before granting a licence?
- operations to be carried out
- where? premises
- how? equipment available
- who? staff qualifications
- records- safekeeping
how long must records be retained?
5 years
do both manufacture and assembly need a manufacturers license?
yes
what does a manufacturers specials licence allow the holder to do?
manufacture unlicensed medicines (specials)
what is a special?
medicines that don’t have a marketing authorisation.
import unlicensed products from outside the EEA
do pharmacies need a specials licence to prepare specials extemporaneously?
no
what is the specials dispensing service?
when patients have special needs for medicines which don’t have MA.
law allows the supply and manufacture of unlicensed medicinal products (specials)
when can specials be dispensed in this way?
rare conditions/ specific circumstances which there’s clinical need for them
when cant specials be used in this way?
if there is already a licensed product for the need
what is needed for a pharmacist to be able to supply a special to a patient in this situation?
an unsolicited order by a
doctor, NIP, PIP, SP, dentist, pharmacist in hospitals, health centres, registered pharmacists.
For use by a patient under that persons direct care
conditions of specials:
who must the medicinal product be supplied to?
TO:
doctor, NIP, PIP, SP, dentist.
Or for use under pharmacist supervisionin hospitals, health centres, registered pharmacists
conditions of specials?
previous AND
no advertising
Adequate supervision and procedure for manufacture
Written records of manufacture or assembly kept- very detailed
Manufacturer MUST hold specials licence
who can prescribe cannabis based specials?
special doctors- not just any doctors.
must be registered on a specialist register
what license does manufacture/ assembler of cannabis based specials require?
specials license
home office license
what does a ‘manufacturers license for investigational medicinal products’ allow the holder to do?
manufacture investigational medicinal products for use in clinical trials
what phases on clinical trials is this licence needed for?
phase 1,2,3 if passed this they have an MA
What does a wholesale dealers license allow the holder to do?
wholesale pharmacy, prescription only, herbals and GSL medicines
import unlicensed medicinal products from countries INSIDE the EEA
does an equivalent exists for veterinary products?
no
WL holder many distribute medicinal products only to?
- Holder of a WL relating to those products
- holder of an equivalent EEA WL
- persons who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retain sale
- person who may lawfully administer those products
conditions for WL regarding handling?
staff, premises and equipment must be suitable for the handling and storage and distribution of the products to maintain quality
conditions for WL regarding records?
records of distribution must be kept for a minimum of 5 years
when are exemptions for MA, ML’s and WL’s applied?
to products prepared for an individual
for products manufactured or assembled FOR holders of authorisations
when are pharmacists exempt from licensing requirements?
providing
- activity takes place on registered premises
- is supervised by a pharmacist
if you are making a p or GSL product up to make something for a patient do you need a license?
NO as long as P or GSL and its for self administration or for someone in the customers care
when aren’t licenses required for preparing/ dispensing a medicinal product?
- a practitioners prescription
- customers recipes AS LONG AS P or GSL!
- counter prescribing- in accordance of pharmacists own judgement
- assembly- as falls under manufacture
- stock mixtures
under the medicines act 1968, when can counter prescribing be done?
only for a patient present in the pharmacy at the time of the request
what is a nostrums?
retail sales ‘own name’ products
where must nostrums be prepared and under what circumstances?
on the premises
under pharmacist supervision
not advertised to anyone
other practitioners exempt from licensing?
doctors and dentists are allowed to manufacture and assemble products intended for individual patient.
Nurses and midwives don’t need a ML to assemble (break bulk and repack) for an individual patient
conditions of this?
supplied to patient in course of their treatment
- not manufactured or assembled on a large scale
do herbal medicinal products need licenses?
no provided that its manufactured or assembled by a herbal practitioner
premises is lockable to the public.
the product is for administration for a present person
product doesn’t contain a listed substance
is a ML needed to market his own products from his licensed premises?
no
does group buying by retailers or practitioners require a wholesaler license? when do they?
no, unless the group is a separate company.
its fine if they are part of the same group
is a WDL needed to import a product specifically for an individual?
no
is a WDL needed for a product intended to be reexported without alteration?
no
according to the HMR 2012 do food and cosmetics need licensing?
no
what vitamins are considered food?
A B B2 B6 C D E
which cosmetics don’t need licensing?
external for cleansing, deodorising, caring or keeping in good condition
which foods don’t need a license?
beverages, confectionary, vitamines above
when do food and cosmetics require a license?
- if promoted to practitioners
- for oral administration with recommendation as beneficial for a particular disease or labelled with a dosage for a medicinal purpose
- vitamins with active ingredients
what dosage of vitamins A needs a ML?
> 2500 units
what dosage of folic acid needs ML?
> 25ug
what dosage of vitamin D needs ML?
> 250 units
what dosage of cyanobalamin needs ML?
> 5ug
no exemption on cosmetics containing?
- any antibiotic
- > 0.004% of any hormone
- hexachlorophane except less than 0.1% and labelled with cautions
- > 1% resorcinol
