Over-The-Counter (OTC) Medicines

Over-The-Counter (OTC) medicines are products which are available to patients without the need for a prescription. Generally they are medicines where:

• their benefits outweigh their risks
• the potential for misuse and abuse is low
• the patient can use them for self-diagnosed ailments
• they can be adequately labelled, and
• doctors are not needed for the safe and effective use of the medicine.

The Better Regulation of OTC Medicines Initiative (BROMI) was set up in 2005 to look into how to ease the regulatory burden on OTC medicines. Their objectives are:

• to assess the regulatory process in relation to the Over-The-Counter (OTC) medicines sector to identify areas of overlap and duplication where control could be exercised through different mechanisms.
• to identify areas where a simplified approach to the operation and delivery of the regulation of OTC medicines would benefit all stakeholders.
• to determine what measures need to be in place to enable a proportionate approach to OTC medicines regulation while maintaining safeguards to protect public health.
• to identify and make proposals to facilitate change and tackle barriers to achieving it, and produce an action plan.
• to agree criteria for a successful outcome and monitor the impact of action.¹

The regulations surrounding OTC medicines are changing and, as a result, the regulatory process should be simplified for the benefit of all.

Please refer to our regulatory services for further information or contact us with your specific regulatory compliance requirements.

1. Source: MHRA