Medicines Regulation: Manufacturer And Wholesale Licences

Question 1

What does an manufacturers licence allow you to do

Answer 1

Make, assembled or import human medicines

Question 2

How do you qualify for a manufacturers licence

Answer 2

You need to show the mhra that you comply with eu good manufacturing practice (GMP) and pass regular site inspections

Question 3

Define manufacture

Answer 3

Includes any process carried out in the course of making the product
(Doesn’t include dissolving or dispersing in, or diluting or mixing it with a substance used as a vehicle for the purpose of administering it)

Question 4

Define assembly

Answer 4

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

Question 5

Companies must have a manufacturer licence to apply for a ….

Answer 5

Marketing authorisation

Question 6

What are the 5 types of manufactures licences for human medicines

Answer 6

1. Manufacturers licence (MIA)
2. Manufacturers 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 products practitioners

Question 7

What 5 things must the licencing authority be satisfied with before a licence is granted

Answer 7

1. What: operations which will be carried out
2. Where: premises
3. How: equipment available
4. Who: qualifications of supervisory staff
5. Records: arrangements for safekeeping and maintenance of adequate records

Question 8

Define specials in the context of an MA

Answer 8

Specially manufactured or ordered products including cannabis based products for medicinal use in humans (CBPM)

Allows the holder to manufacture unlicensed medicines specials
Import unlicensed medicinal products from outside the EEA

Question 9

What is the exemption surrounding specials licences

Answer 9

Pharmacists can prepare such products extemporaniously without the requirement for a specials licence.

Question 10

When are ‘specials’ prescribed

Answer 10

For patients who have special clinical needs that cannot be met by licenced medicinal products.
They are supplied in response to an unsolicited order for use by a patient under that person’s direct care and responsibility

Question 11

What are some particular regulations surrounding specials

Answer 11

No advertising
Adequate supervision and procedure for manufacture
Written records of manufacture and assembly must be kept
Manufacturer must hold specials licence

Question 12

What other licence must a specials supplier usually hold when supplying cannabis based products

Answer 12

A home office licence (controlled drugs)

Question 13

What does a manufacturer licence for investigational medicinal produces allow the holder to do

Answer 13

Manufacture investigational medicines for use in clinical trials (phases 1-3)

Question 14

What is wholesale dealing

Answer 14

Anything that isn’t direct supply to a patient by a practitioner

Question 15

What does a wholesalers licence allow a person to do

Answer 15

Wholesale sell or supply P, POM, GSL and traditional herbal medicines wholesale
Import unlicensed medicinal products from EEA
export medicines to EEA

Question 16

Who can wholesalers distribute these medicines to

Answer 16

Another wholesaler (in UK or EEA)

A person who may lawfully sell these products by retail or may lawfully supply them in circumstances corresponding to retail sale

Person who may lawfully administer those products

Question 17

What are the regulations surrounding staff and records relating to wholesaler licences

Answer 17

Staff, equipment, premises and facilities must be adequate for the handling, storage and distribution of medicinal products so as to maintain their quality

Records for distribution must be kept for a minimum of 5 years so that products can be recalled from circulation if necessary

Question 18

What are the general exemptions from licencing

Answer 18

Medicinal products specially prepared for an individual

Products manufactured or assembled for holders of authorisations (in this case MAs and WLs are not required)

Question 19

When are pharmacists exempt from needing licencing requirements

Answer 19

When the activity takes place on registered pharmacy premises and the person making the medicine is supervised by a pharmacist

Question 20

Are licences required for preparing / dispensing medicines medicines via practitioners prescription, customer’s recipe or counter prescribing when the patient is in the medicine

Answer 20

No

Question 21

Are pharmacists allowed to assemble stock without a licence

Answer 21

Yes

Question 22

What are nostrums

Answer 22

Products made in a pharmacy premises to a special recipe from the pharmacy which cannot be advertised

Question 23

Which other practitioners are exempt from licensing requirements?

Answer 23

Doctors and dentists - allowed to prepare and assemble products intended for individual patients
Nurses and midwives - don’t need a licence go assemble (break bulk and repack)

Within the course of their professional practice, for the patient in the course of their treatment and not on a large scale or by an industrial process

Question 24

What are the licencing exemptions surrounding herbalists

Answer 24

Herbalists don’t need a manufacturers licence or an MA provided:
The manufacture or assembly takes place on premises which can be locked to exclude the public
If the product is for administration to a sperson, the person is present and the herbalist uses their judgement
The product doesn’t contain certain listed substances

Question 25

Do food and cosmetics need licencing

Answer 25

Not usually if there are no medical claims made.

Question 26

Borderline substances (such as vitamins) foods and cosmetics only need to hold a licence

Answer 26

If promoted to practitioners (need MA)
Products for oral administration as foods is
Written recommendation as beneficial for a particular disease or labelled with dosage for a medicinal purpose

Question 27

What are the maxinum doses of the following vitamins before they need an MA
Vit A
Vit D
Folic Acid 
Cyanocobalamin

Answer 27

2500 units
250 units
25pico g
5pico grams

These in particular are regulated as they are fat soluble so won’t go straight through you