lecture 1: Licenses

Question 1

5 types of manufacturers license?

Answer 1

1. Manufacturer Licence (MIA)*
2. Manufacturer ‘Specials’ Licence (MS)*
3. Manufacturer licence for investigational medicinal products
4. Manufacturer licence exempt advanced therapy products (Hospital exemption licence)
5. Manufacturer licence for non-orthodox practitioners

Question 2

do these exist for veterinary products as well?

Answer 2

yes the equivalent exists ONLY for 1 and 2

Question 3

what does (1) a manufacturers licence allow the holder to do?

Answer 3

manufacture/ assemble licensed medicinal products- that hold a MA.
import/ export to/ from countries outside the EEA

Question 4

define manufacture

Answer 4

any process carried out in the course of making the product

Question 5

what does manufacture not include?

Answer 5

dissolving or dispersing the product in or diluting/ mixing it with a substance used as a vehicle for purpose of administering it

Question 6

define assembly?

Answer 6

processes of dividing up, packaging and presentation of the product or substance

Question 7

is assembly included in manufacture?

Answer 7

yes but still regarded as separate

Question 8

what must the licensing authority be satisfied with before granting a licence?

Answer 8

• operations to be carried out
• where? premises
• how? equipment available
• who? staff qualifications
• records- safekeeping

Question 9

how long must records be retained?

Answer 9

5 years

Question 10

do both manufacture and assembly need a manufacturers license?

Answer 10

yes

Question 11

what does a manufacturers specials licence allow the holder to do?

Answer 11

manufacture unlicensed medicines (specials)

Question 12

what is a special?

Answer 12

medicines that don’t have a marketing authorisation.

import unlicensed products from outside the EEA

Question 13

do pharmacies need a specials licence to prepare specials extemporaneously?

Answer 13

no

Question 14

what is the specials dispensing service?

Answer 14

when patients have special needs for medicines which don’t have MA.
law allows the supply and manufacture of unlicensed medicinal products (specials)

Question 15

when can specials be dispensed in this way?

Answer 15

rare conditions/ specific circumstances which there’s clinical need for them

Question 16

when cant specials be used in this way?

Answer 16

if there is already a licensed product for the need

Question 17

what is needed for a pharmacist to be able to supply a special to a patient in this situation?

Answer 17

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

Question 18

conditions of specials:

who must the medicinal product be supplied to?

Answer 18

TO:
doctor, NIP, PIP, SP, dentist.
Or for use under pharmacist supervisionin hospitals, health centres, registered pharmacists

Question 19

conditions of specials?

Answer 19

previous AND
no advertising
Adequate supervision and procedure for manufacture
Written records of manufacture or assembly kept- very detailed
Manufacturer MUST hold specials licence

Question 20

who can prescribe cannabis based specials?

Answer 20

special doctors- not just any doctors.

must be registered on a specialist register

Question 21

what license does manufacture/ assembler of cannabis based specials require?

Answer 21

specials license

home office license

Question 22

what does a ‘manufacturers license for investigational medicinal products’ allow the holder to do?

Answer 22

manufacture investigational medicinal products for use in clinical trials

Question 23

what phases on clinical trials is this licence needed for?

Answer 23

phase 1,2,3 if passed this they have an MA

Question 24

What does a wholesale dealers license allow the holder to do?

Answer 24

wholesale pharmacy, prescription only, herbals and GSL medicines

import unlicensed medicinal products from countries INSIDE the EEA

Question 25

does an equivalent exists for veterinary products?

Answer 25

no

Question 26

WL holder many distribute medicinal products only to?

Answer 26

- 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

Question 27

conditions for WL regarding handling?

Answer 27

staff, premises and equipment must be suitable for the handling and storage and distribution of the products to maintain quality

Question 28

conditions for WL regarding records?

Answer 28

records of distribution must be kept for a minimum of 5 years

Question 29

when are exemptions for MA, ML's and WL's applied?

Answer 29

to products prepared for an individual | for products manufactured or assembled FOR holders of authorisations

Question 30

when are pharmacists exempt from licensing requirements?

Answer 30

providing - activity takes place on registered premises - is supervised by a pharmacist

Question 31

if you are making a p or GSL product up to make something for a patient do you need a license?

Answer 31

NO as long as P or GSL and its for self administration or for someone in the customers care

Question 32

when aren't licenses required for preparing/ dispensing a medicinal product?

Answer 32

- 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

Question 33

under the medicines act 1968, when can counter prescribing be done?

Answer 33

only for a patient present in the pharmacy at the time of the request

Question 34

what is a nostrums?

Answer 34

retail sales 'own name' products

Question 35

where must nostrums be prepared and under what circumstances?

Answer 35

on the premises under pharmacist supervision not advertised to anyone

Question 36

other practitioners exempt from licensing?

Answer 36

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

Question 37

conditions of this?

Answer 37

supplied to patient in course of their treatment | - not manufactured or assembled on a large scale

Question 38

do herbal medicinal products need licenses?

Answer 38

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

Question 39

is a ML needed to market his own products from his licensed premises?

Answer 39

no

Question 40

does group buying by retailers or practitioners require a wholesaler license? when do they?

Answer 40

no, unless the group is a separate company. | its fine if they are part of the same group

Question 41

is a WDL needed to import a product specifically for an individual?

Answer 41

no

Question 42

is a WDL needed for a product intended to be reexported without alteration?

Answer 42

no

Question 43

according to the HMR 2012 do food and cosmetics need licensing?

Answer 43

no

Question 44

what vitamins are considered food?

Answer 44

``` A B B2 B6 C D E ```

Question 45

which cosmetics don't need licensing?

Answer 45

external for cleansing, deodorising, caring or keeping in good condition

Question 46

which foods don't need a license?

Answer 46

beverages, confectionary, vitamines above

Question 47

when do food and cosmetics require a license?

Answer 47

- 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

Question 48

what dosage of vitamins A needs a ML?

Answer 48

>2500 units

Question 49

what dosage of folic acid needs ML?

Answer 49

>25ug

Question 50

what dosage of vitamin D needs ML?

Answer 50

>250 units

Question 51

what dosage of cyanobalamin needs ML?

Answer 51

>5ug

Question 52

no exemption on cosmetics containing?

Answer 52

- any antibiotic - >0.004% of any hormone - hexachlorophane except less than 0.1% and labelled with cautions - >1% resorcinol