LAW Flashcards
Which agency in the UK grants medicines licences and marketing authorisation?
Medicines and Healthcare RegulatoryAgency (MHRA)
for how long should records of private prescriptions be kept for
2 years
what is legally required to be present on dispensing labels
name of the drug
name of the patient
strength
dosage instructions
name and address of the pharmacy
date of dispensinf
advisory labels/ cautionary labels
Keep out of the reach and sight of children
what are the classes of medicinal products for animals
Prescription only medicines - (POM-V) prescribed by veterinarian
Prescription only medicines - (POM-VPS) prescribed by veterinarian, pharmacist and suitably qualified person
Non food producing animal - (NFA-VPS)
prescribed by veterinarian, pharmacist and suitably qualified person
Authorised veterinary medicines (AVM-GSL) available on general sale
describe the cascade under which vetinary medicinal products are prescribed
Where available it is a legal requirement to Supply a licensed veterinary medicine (with a GB or UK marketing authorisation) for the species and condition indicated
When the above is not possible Supply veterinary medicine with a Northen Ireland (NI) marketing authorisation for the species and condition indicated
When the above is not possible Supply licensed GB, NI or UK veterinary medicine for another species or different condition can be considered
When the above is not possible supply a GB, NI or UK licensed human medicine or veterinary medicine authorised outside the UK can be considered
When the above is not possible, Extemporaneous or specially manufactured medicines can be considered
state the law regarding the sale of human medicines for animals in the UK
It is unlawful to sell or supply unauthorised veterinarymedicines (medicines not licensed as veterinarymedicines), including human medicines such as GSL and Pmedicines, for an animal unless this takes place under theveterinary cascade.This applies even if a vet asks the animal owner verbally topurchase an over-the-counter human product from a pharmacy
in addition to the typical requirements on a human dispensary label, what should be present on a vetinary dispensary label
Name of prescribing veterinary surgeon
Name and address of owner
Identification and species of animal
Expiry date of product (unless on container)
Any applicable withdrawal period
The words “for animal treatment only”
for how long must records for vetinary medicines be kept for
at least 5 years
what does the Human Medicines Regulations(HMR) regulate
Containers, packages,identification of medicinal products
Promotion of sales of medicinal products
The advertising of medicines is controlled by a combination of statutorymeasures enforced by the MHRA, and self-regulation through Codes of Practice for the pharmaceutical industry
name some instances in which sales promotion or advertisement of drugs to the general public might be prohibited
there is an exception for approved vaccination campaigns
Advertisements referring to specified diseases
Advertisements for medicinal products on prescription only
Advertisements relating to certain medicinal products e.g. psychotropic ornarcotic drugs
Certain material in advertisements e.g. recommendations by celebrities
Specifies form and content of advertisements
what is required in sales promotions or advertisements to healthcare professionals
must contain:
Contain essential information compatible with the summary of product characteristics
Include information which is accurate, up-to-date, verifiable or sufficiently complete to enable the recipient to form his own opinion of the therapeutic value of theproduct to which the documentation relates
do the standard labelling requirements apply to dispensed medicines
no they do not
the standard labels for relevant medicinal products for human use should have?
Name of the product
Active ingredient (s) and strength Pharmaceutical form
Contents by weight, volume or number of doses i.e. quantity
List of excipients known to have a recognised action.
(If injectable, topical or eye preparations - all excipients to be listed)
Method and if necessary the route of administration
Warning to store out of reach and sight of children
Special warnings required by the MA (if any)
Expiry date
Special storage precautions (if any)* Special precautions for disposal (if any)
Name and address of MA holder
MA number
Manufacturer’s batch reference
If for self-medication, any instructions for use
difference between dispensed labels and standard medicinal labels for drugs UK
dispensed labels are tailored to individual prescriptions, while standard medicinal labels serve as a general information source about the drug itself.
Standard labels also contain manufacturer’s information
where can we find PILs online
MHRA
Electronic medicines compendium(emc)
PILs online
