Your guide to Pharmacy Law and Ethics
Stay informed about medicines licensing, marketing authorizations, specials, and regulations surrounding unlicensed medicines.
In the UK, a medicinal product may only be sold or supplied in accordance with its marketing authorisation.
The marketing authorisation (also referred to as the product licence) sets out the legally binding conditions under which a medicine may be marketed, sold and supplied.
Compliance with a product’s marketing authorisation is a legal requirement under the Human Medicines Regulations 2012.
Pseudoephedrine and ephedrine are active ingredients found in certain pharmacy (P) medicines, commonly used as decongestants.
Due to their potential use in the illicit manufacture of methylamphetamine (a Class A controlled drug), the sale and supply of pseudoephedrine- and ephedrine-containing medicines are subject to specific statutory restrictions under the Human Medicines Regulations 2012.
These restrictions apply in addition to the general legal requirements for pharmacy medicines.
Pharmacy medicines (P medicines) are medicinal products that may be sold or supplied only from registered pharmacy premises and only under the supervision of a pharmacist.
The legal classification, supply restrictions and supervision requirements for P medicines are set out in the Human Medicines Regulations 2012.
Under the Human Medicines Regulations 2012, a pharmacy medicine is a medicinal product that: