s2 w1 Flashcards
Labelling RMP Manufacturing and Wholesale Advertising
what legislations underpin labelling of medicines?
• Human Medicines Regulations 2012
– Part 13. Packaging and Leaflets
– Schedule 24. Packaging information requirements
– Schedule 25. Packaging requirements: specific provisions
• NB. Those medicinal products that are CDs must also be labelled in accordance with the Misuse of Drugs Regulations 2001
what are the requirements for labelling of medicinal prodcts?
All labelling of containers and packages of RMP shall be:
i. Easily legible
ii. Comprehensible
iii. Indelible
Either in English only or in English and one or more other languages, provided same particulars appear in all languages
You need to express Braile on outer packaging
TRUE
what is needed on the immediate outer packaging?
- Name
- Strength
- who intended for
- active substance (if more then 3 - common name)
- pharmaceutical form
- method of admin
- warnings
- expiry
- storage
- MA name and address of holder
- batch number
Will POM be in a POM rectangle
TRUE
what is INN?
International non-proprietary name
a blister pack need all the outer packaging requirements?
FALSE
what does a blister pack need on it?
- Name of product
- Strength and form
- Intended for babies, children or adults
- common name of each active substance
- name of MA holder
- expiry date
- batch number
you need to state contains paracetamol
TRUE
- unless it is in the name of the product
what are the four types of manufacturing licenses?
- Manufacturer licence (MIA)
- Manufacturer Specials License
- Manufacturer licence for investigational medicinal products
- Manufacturer licence exempt advanced therapy products (Hospital exemption licence)
what does a manufacturer licence allow holder to do?
– Manufacture and/or assemble licensed medicinal products, including export to a country outside the EEA
– Import licensed medicinal products from countries outside the EEA
manufacturing with a manufacturing licence include dissolving or dispersing the product in, or diluting or mixing it with, a substance used as a vehicle for purpose of administering it
FALSE
what is involved in assembly with manufacturing licence
various processes of dividing up, packaging and presentation of the product or substance
what MUST licensing authority be satisfied with to grant a licence?
- 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
before a product can be manufactured what must it be?
covered by marketing authorisation, held by the manufacturer or by a person ordering the product from a manufacturer.
what does a manufacturers special licence allow holder to do?
- Manufacture unlicensed medicines ‘specials’
* Import unlicensed medicinal products from outside the EEA
what is special dispensing sevice?
allows patient who may have special clinical needs which may not be met by licensed medicinal product
who is allowed to manufacture a special medicinal product?
– doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber
– Pharmacists in hospitals, health centres, registered pharmacies
what are the conditions for manufacturing special medicinal product?
A. Medicinal product is supplied—
a) to a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber; or
b) for use under the supervision of a pharmacist in
centre
B. No advertising
C. Adequate supervision & procedure for manufacture
a) to meet specified requirements
D. Written records of manufacture or assembly kept
a) Available for inspection
E. Manufacturer holds Manufacturer ‘Specials’ Licence
what must m• Manufacturer or assembler of ‘specials’ hold?
– Manufacturers (Specials) Licence
– Home Office Licence (in most cases)
– Comply with requirements of BP – pharmaceutical preparations
what is a wholesale dealer licence (WDL)?
WDL allows holder to:
• wholesale pharmacy, prescription only, traditional herbal and GSL medicines
• import unlicensed medicinal products from countries inside the EEA
what can a WDL distrubte medicinal product to?
a) holder of a WL relating to those products;
b) holder of an equivalent EEA WL;
c) person who may lawfully sell those products by retail or may lawfully supply them in circumstances corresponding to retail sale; or
d) a person who may lawfully administer those products
what are the exemptions to licensing?
- Medicinal products specially prepared for an individual
* Products manufactured (or assembled) for holders of authorisations
when are pharmacists exempt from licensing?
- activity takes place on registered pharmacy premises (hospitals and care homes)
- is supervised by a pharmacist
when are licences NOT required for dispensing and preparing of medicinal products?
a) Practitioner’s prescription
b) Customer’s recipes/ specifications where product is for self-administration or for someone in customers’ care
c) Counter prescribing
d) Assembly
e) Stock mixtures
Herbalist need a license?
FALSE
provided that the product was made by a herbal practitioner and does not contain certain listed substances.
what are exemptions for wholesale dealing licence?
• A manufacturer or MA holder does not need a wholesale dealer licence to market his own products directly from his licensed premises
what are exemptions for imports and exports of WDL?
– to import a product specifically for an individual
– for a product intended to be re-exported without alteration
borderline substances need a MA?
TRUE
- if promoted to practitioners
what is defintion of advertisement?
includes
- door to door
- visits by medical sales reps
- supply of samples
- sponsorship
what includes in advertising/
- Medical journals
- Magazines
- Newspapers
- Notices/posters
- TV or radio
- Internet advertising
- Films/ cine recordings
- Circular or personal letters
- Posters in London underground trains
MHRA handles complaints of advertising
TRUE
