Reg of medicine licences

Question 1

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?

Answer 1

False - manufacture and assemble

Question 2

Manufacture Licence only allows the export to a country outside the EEA but not the import from countries from outside EEA. True or false?

Answer 2

False - export to countries outside EEA and also import from countries outside EEA

Question 3

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?

Answer 3

False - doesn’t include dissolving/dispersing

Question 4

Before a manufactures licence is granted, the licensing authority must be satisfied with the qualifications of supervisory staff. True or false?

Answer 4

True

Question 5

A product can be manufactured before being covered by a MA. True or false?

Answer 5

False - must be covered by a MA by the manufacturer or by a person ordering from a manufacturer BEFORE it is manufactured

Question 6

Manufacture requires a Manufacturer’s licence but assembly doesn’t. True or false?

Answer 6

False - manufacture and assembly do

Question 7

A manufacturer Licence allows the holder to manufacture unlicensed medicines ‘specials’. True or false?

Answer 7

False - require a manufacturer ‘specials’ licence

Question 8

A manufacturers ‘specials’ licence allows the holder to import unlicensed meds from inside the EEA only. True or false?

Answer 8

False - outside the EEA

Question 9

Pharmacies are able to prepare unlicensed products extemporaneously but require a manufacturer ‘specials’ licence. True or false?

Answer 9

False - they are exempt from requiring a specials licence

Question 10

‘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?

Answer 10

True

Question 11

The manufacture of a ‘special’ medicinal product is supplied in response to an unsolicited order. True or false?

Answer 11

True

Question 12

A prescriber can request a ‘special’ if an equivalent licensed product exists. True or false?

Answer 12

False

Question 13

A manufacturer licence for investigational medicinal products allows the holder to manufacture investigational products for use in what?

Answer 13

Clinical trials

Question 14

A manufactures licence for investigational medicinal products is required for phase 1, 2, 3 and 4 of clinical trials. True or false?

Answer 14

False - phase 1, 2 and 3 only (pre-marketing)

Question 15

A wholesale dealers licence allows the holder to wholesale deal POMs only. True or false?

Answer 15

False - P, POMs, traditional herbal and GSL

Question 16

A wholesale dealers licence allows the holder to import unlicensed meds from countries outside EEA. True or false?

Answer 16

False - inside EEA

Question 17

A wholesale licence holder may distribute medicinal products only to a holder of a WL relating to those products. True or false?

Answer 17

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

Question 18

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?

Answer 18

False - 5 years

Question 19

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?

Answer 19

True

Question 20

A pharmacist is exempt from holding a licence for counter prescribing (i.e. extemp prep) provided patient is present in pharmacy. True or false?

Answer 20

True

Question 21

Pharmacist are exempt from licencing for assembly of meds and stock mixtures in pharmacy. True or false?

Answer 21

True

Question 22

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?

Answer 22

True

Question 23

Doctors and dentists are able to manufacture and assemble products intended for individual patients without need for a licence. True or false?

Answer 23

True

Question 24

Nurses and midwives need a manufacturers licence to assemble (break bulk and repack) in the course of their action. True or false?

Answer 24

False - exempt from licence requirement

Question 25

A manufacturer or MA holder does not need a WL to marker his own products directly from his licensed premises. True or false?

Answer 25

True

Question 26

Group buying by retailers or practitioners does not require a wholesale dealer licence, unless the group is a separate company. True or false?

Answer 26

True

Question 27

A WDL is not necessary to import a product specifically for an individual. True or false?

Answer 27

True

Question 28

A WDL is need for a product intended to be re-exported without alteration. True or false?

Answer 28

False - not needed

Question 29

Food and cosmetics are generally exempt from licensing under HMR 2012. True or false?

Answer 29

True

Question 30

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?

Answer 30

True

Question 31

There is no exemption for licensing for cosmetics containing antibiotics. True or false?

Answer 31

True

Question 32

There is no exemption for licencing for cosmetics containing 0.004% or above of any hormone. True or false?

Answer 32

True