Manufacturing/Wholesale Licenses Flashcards
What are the 4 different types of MANUFACTURER’S licenses?
- Manufacturer’s License (MIA), where pharmaceutical companies want to manufacturer products at a large scale
- Manufacturer’s Specials License (MS), where they are allowed then to make up specials
- Manufacturer’s for Investigational Medicinal Products, where the product is not yet on the market, but needs to be produced for trials etc.
- Manufacturer License Exempt Advanced Therapy Products
What is a manufacturer’s license (MIA) ?
allows the manufacturer to manufacture and/or assemble LICENSED medicinal products
allows export of these products to countries outside the EEA
allows the import of licensed materials from countries outside the EEA
(we are a part of the EEA and all laws are harmonised across the countries, so this is already allowed)
What is the definition of ‘manufacture’?
includes any process carried out in the course of MAKING the product
this DOESN’T include dissolving/dispersing/diluting/mixing a substance - otherwise you would need a license to make up a paediatric antibiotic suspension - so this is excluded!
What is the definition of ‘assembly’?
the various processes of dividing up/packaging/presentation of the product or substance
some companies only do this part of the process - but still require a license
What does the MHRA need to be satisfied with to grant a Manufacturer’s License (MIA)?
- What the operations are that the manufacturing is carrying out
- Where the premisses is and that things are safe and secure
- How they’re going to carry out the manufacturing with the equipment
- Who are the people that will be manufacturing
- Record arrangements for safekeeping - kept for 5 years in order to be able to recall batches
The product itself HAS to hold an MA that is held by
- the manufacturer themselves OR
- the person ordering the product from the manufacturer
What is a Manufacturer’s Specials License? (MS)
allows the manufacturer to manufacture and/or assemble UNlicensed medicinal products (these products DON’T carry a marketing authorisation)
allows export of these products to countries outside the EEA
allows the import of licensed materials from countries outside the EEA
(we are a part of the EEA and all laws are harmonised across the countries, so this is already allowed)
Do pharmacies need a manufacturer’s special license in order to prepare products extemporaneously?
NO - we are exempt from the license
When would you need a special product?
for when clinical needs of patients cannot be met by a product that is currently on the market and is licensed
if there IS a product that DOES meet the clinical need - this product should always be prescribed
this is only for SPECIAL circumstances
What is an UNSOLICITED ORDER?
an unsolicited order is a prescription for a special by a prescriber
Conditions for an unsolicited order?
- Appropriate Prescriber - no one else except:
- Doctor
- Dentist
- Nurse IP
- Pharmacist IP
- Supplementary Prescriber - Supply for use under the supervision of a pharmacist in a registered pharmacy/hospital/health centre
- There is NO advertising
- Manufacturer holds a manufacturer’s ‘specials’ license
- Adequate supervision and procedure for manufacture which will be stated in the licence
- Written records of the manufacture/assembly are kept and are available for inspection
Manufacturing Licenses for Cannabis-based Products for Medicinal Use
there is NO licensed products currently available so all of these products are specials -
- Manufacturer’s License
- Home Office License
- Comply with the requirements of the BP
Only SPECIAL registered doctors are able to prescribe these and it has to be for a particular individual patient with a particular need
What is a Manufacturer’s License for Investigational Medicinal Products?
allows the holder to manufacture investigational medicinal products for the use in clinical trials of Phase 1, 2 & 3
Phase 4 - is for AFTER the product has a license
What is a wholesale dealer’s license?
wholesale dealing is where the end recipient of that product is NOT the patient, it allows the holder to
- Wholesale GSL, P, POM, Traditional Herbal medicines
- Import UNlicensed medicinal products from countries INSIDE the EEA
Who can a wholesale deal supply be made to and under what circumstances?
- another holder of a wholesale dealer’s licence
- another holder of an EEA equivalent of the wholesale dealer’s licence
- a person who can lawfully sell the products (pharmacies/retailers, GSL only)
- a person who may lawfully administer the products
AS LONG AS
- Staff/Premises/Equipment/Facilities are adequate for the handling/storage/distribution of products
- Records of the distribution must be kept for a minimum of FIVE years so that products can be recalled from circulation if necessary (manufacturer’s licenses also require them to keep records for 5 years)
Do pharmacist’s need to hold a wholesale dealer’s license?
NO, they are exempt
- as long as it is a one off basis
- keep records of the supplies for 2 years
When is a pharmacist exempt from licensing requirements?
pharmacist’s are exempt from licensing requirements as long as
- the activity takes place on a registered pharmacy premises
- is supervised by a pharmacist - if not actually being carried out by one
What is counter prescribing?
is a product that is recommended by a pharmacist that is then actually made up by them
Medicines Act 1968 - pharmacist can only do this if the patient is actually PRESENT
What activities are pharmacists able to do because they are exempt from the licensing requirements?
ASSEMBLY - falls under the manufacturing licenses usually but pharmacists need to be able to break bulk and repackage medicines
STOCK MIXTURES - preparations for dispensing purposes on the premises belonging to the same business
Retail Sale Products OWN NAME - outdated rule that allows pharmacists to make products on the premises that is not advertised to anyone
What other practitioners are exempt from licensing requirements?
Doctors and Dentists - able to prepare and assemble products intended for an individual patient
Nurses and Midwives - able to assemble as long as they are acting in the course of their profession
This can happen as long as the product is supplied to the patient in the course of their treatment and that the product is not being manufactured on a large scale
What are the herbalist exemptions and conditions for exemption from the licensing requirements?
No license of marketing authorisation needed for herbal remedies AS LONG AS
- the herbal medicinal product is manufactured or assembled BY a herbal practitioner
- if this is carried out on a premise that is OWNED by the herbal practitioner
- if the product is for administration to a person and the person is PRESENT
- and if the product doesn’t contain certain ingredients
Can a holder of a manufacturer’s license or marketing authorisation holder go on to distribute their own products?
Yes, they can do this WITHOUT the need for a wholesale dealer’s license
Only if it is a separate company that wish to carry out the wholesale dealing
What PRODUCTS are exempt from licensing under the HMR 2012?
- Food (inc. Vit A/B/B2/C/D/E)
- Cosmetics
When ARE borderline substances, food and cosmetics subject to the licensing requirements under HMR 2012?
- If the product is promoted to practitioners - then it requires an MA
- If the product for oral administration and has a written recommendation as beneficial for a particular disease or is labelled with dosage for medicinal purpose
- If the product is a vitamin preparation and:
- is for oral administration as a food and there are no written particulars or directions for dosage
- is for oral administration as a food and the recommended daily adult dose exceeds 2500 units of Vit A and 250 units of Vit D (fat soluble vitamins)
- is a fortified foodstuff with added vitamins above the daily dosage - There are no exemptions to any cosmetic that contains
- Any antibiotic
- over 0.004% of any hormone
- Hexachlorophene over 0.1%
- Over 1% of Resorcinol
