MEP: Classification of medicines Flashcards
Important legislation in the MEP:
The Human Medicines Regulations 2012
Medicines Act 1968
The Veterinary Medicines Regulations 2013
What are the three classes of medicinal products for humans under the Human Medicines Regulations 2012?
General sale medicines
Pharmacy (P) medicines
Prescription only medicines (POM)
What are General Sale Medicines?
Those that can be made available as ‘self-selection’ items for sale in registered pharmacies. They can also be sold in other retail outlets that can ‘close so as to exclude the public’.
When can GSL products be sold?
Within a pharmacy, GSL medicines can only be sold when a pharmacist has assumed the role of responsible pharmacist; however, the pharmacist may be physically absent for a limited period of time while remaining responsible, thus permitting sales of general sale medicines during this absence
What are pharmacy P medicines:
A pharmacy medicine is a medicinal product
that can be sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist. Pharmacy medicines must not be accessible to the public by self-selection.
Together with GSL medicines, P medicines are collectively known as over-the-counter (OTC) or non-prescription medicines. The sale of some of these medicines is associated with additional legal and professional considerations
What are POM’s:
A prescription-only medicine (POM) is a medicine that is generally subject to the restriction of requiring a prescription written by an appropriate practitioner.
An appropriate practitioner includes the following;
• doctors
• dentists
• supplementary prescribers
• nurse independent prescribers
• pharmacist independent prescribers
• EEA and Swiss approved health professionals
• community practitioner nurse prescribers
• optometrist independent prescribers (not for
Controlled Drugs, or parenteral medicines)
• paramedic independent prescribers
• physiotherapist independent prescribers
• podiatrist independent prescribers
• therapeutic radiographer independent prescribers
Can drugs vary between classes?
Some medicines can be classified under
more than one category and this can depend upon formulation, strength, quantity, indication or marketing authorisation.
What are reclassified medicines?
More medicines are being reclassified from POM to P providing pharmacists with a larger range of medicines to select from to treat patients.
