Medicines Regulation: Manufacturer And Wholesale Licences Flashcards
What does an manufacturers licence allow you to do
Make, assembled or import human medicines
How do you qualify for a manufacturers licence
You need to show the mhra that you comply with eu good manufacturing practice (GMP) and pass regular site inspections
Define manufacture
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)
Define assembly
Various processes of dividing up, packaging and presentation of the product or substance
Companies must have a manufacturer licence to apply for a ….
Marketing authorisation
What are the 5 types of manufactures licences for human medicines
- Manufacturers licence (MIA)
- Manufacturers specials licence (MS)
- Manufacturer licence for investigational medicinal products
- Manufacturer licence exempt advanced therapy products [hospital exemption licence]
- Manufacturer licence for non orthodox products practitioners
What 5 things must the licencing authority be satisfied with before a licence is granted
- What: operations which will be carried out
- Where: premises
- How: equipment available
- Who: qualifications of supervisory staff
- Records: arrangements for safekeeping and maintenance of adequate records
Define specials in the context of an MA
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
What is the exemption surrounding specials licences
Pharmacists can prepare such products extemporaniously without the requirement for a specials licence.
When are ‘specials’ prescribed
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
What are some particular regulations surrounding specials
No advertising
Adequate supervision and procedure for manufacture
Written records of manufacture and assembly must be kept
Manufacturer must hold specials licence
What other licence must a specials supplier usually hold when supplying cannabis based products
A home office licence (controlled drugs)
What does a manufacturer licence for investigational medicinal produces allow the holder to do
Manufacture investigational medicines for use in clinical trials (phases 1-3)
What is wholesale dealing
Anything that isn’t direct supply to a patient by a practitioner
What does a wholesalers licence allow a person to do
Wholesale sell or supply P, POM, GSL and traditional herbal medicines wholesale
Import unlicensed medicinal products from EEA
export medicines to EEA
Who can wholesalers distribute these medicines to
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
What are the regulations surrounding staff and records relating to wholesaler licences
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
What are the general exemptions from licencing
Medicinal products specially prepared for an individual
Products manufactured or assembled for holders of authorisations (in this case MAs and WLs are not required)
When are pharmacists exempt from needing licencing requirements
When the activity takes place on registered pharmacy premises and the person making the medicine is supervised by a pharmacist
Are licences required for preparing / dispensing medicines medicines via practitioners prescription, customer’s recipe or counter prescribing when the patient is in the medicine
No
Are pharmacists allowed to assemble stock without a licence
Yes
What are nostrums
Products made in a pharmacy premises to a special recipe from the pharmacy which cannot be advertised
Which other practitioners are exempt from licensing requirements?
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
What are the licencing exemptions surrounding herbalists
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
Do food and cosmetics need licencing
Not usually if there are no medical claims made.
Borderline substances (such as vitamins) foods and cosmetics only need to hold a licence
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
What are the maxinum doses of the following vitamins before they need an MA Vit A Vit D Folic Acid Cyanocobalamin
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
