Category: Medicines licensing

Stay informed about medicines licensing, marketing authorizations, specials, and regulations surrounding unlicensed medicines.

Medicines licensing Safe dispensing practices

Expiry dates on medicines

Medicines are supplied with an expiry date that indicates the period during which the manufacturer guarantees the product’s quality, safety, and efficacy, provided it has been stored according to the recommended conditions.

Expiry dates are usually printed on the packaging as month and year (for example, EXP 06/2026). EU medicines legislation requires the expiry date to appear on the packaging in this format (month/year) under Directive 2001/83/EC.

Where the expiry date is expressed as month and year only, the medicine should be considered valid until the last day of that month.

Medicines licensing Over-the-counter (OTC) medicines Pharmacist and technician responsibilities

Medicines licensing and marketing authorisations

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.

Medicines licensing Over-the-counter (OTC) medicines Pharmacist and technician responsibilities

Pseudoephedrine and ephedrine

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.

Medicines licensing Over-the-counter (OTC) medicines Pharmacist and technician responsibilities Record-keeping requirements Safe dispensing practices

Pharmacy medicines (P)

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: