OTC medicines

MHRA logo

In the UK, the manufacture and supply of over-the-counter (OTC) medicines is tightly regulated to ensure products are safe, effective and of a consistently high quality. 

Products are subject to strict licensing procedures as laid down by the Medicines Act 1968 and EU legislation which can over-ride UK legislation.  These are enforced by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) and in Europe, the European Medicines Agency (EMA) and the Committee for Human Medicinal Products (CHMP). 

A product can only be sold if it has a Marketing Authorisation (MA).  To be granted a Marketing Authorisation, the applicant company has to provide evidence to prove to MHRA that the product meets all the necessary requirements for safety, efficacy and quality.

An important part of the Marketing Authorisation is the Summary of Product Characteristics (SmPC).  This summarises all the product attributes such as the active ingredients, what it can be used for, how it works, warnings and side effects.  It forms the basis for any claims made about the product including those that can be used in advertising.

Products may also be granted a Marketing Authorisation through a European route which can allow a medicine to be launched into more than one European country. 

Once on sale, OTC medicines are continually monitored by MHRA, taking into account the latest scientific evidence and reports of possible side effects from health professionals and patients. 

Many OTC products were initially only available on prescription but have been made available over-the-counter after demonstrating a history of safe use as a prescription medicine.  More information about this can be found on the access to medicines page.

PAGB offers member companies advice on all aspects of the current regulations, guidance and legislation at both UK and European level.