MHRA Confirms Mycobacteria Claims In PT 1 Biocide Products Fall Under Medicines Regulations

On 21 October 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that biocidal products in PT 1, which are applied directly to human skin, must comply with medicines regulations if they make claims against mycobacteria. This change impacts the authorisation process for products like hand sanitisers and disinfectants in Great Britain and Northern Ireland.

Mycobacteria Claims And Regulatory Scope

The clarification from MHRA stems from Article 2 of the Biocidal Product Regulation (BPR), which governs the scope of biocides regulations in the UK. Traditionally, products making claims to be effective against specifically named pathogens, such as mycobacteria, fall under the purview of medicines regulations. PT 1 products, used for disinfecting human skin or scalp, are now subject to these rules if such claims are made.

Implications For Product Authorisation

Manufacturers seeking product authorisation under the BPR for PT 1 products in the GB and NI markets must now adhere to medicines regulations when making mycobacteria-related claims. As a result, applications for these products will no longer be accepted under the BPR framework. This change, however, does not affect biocides in other product types (PTs 2, 3, 4, and 5), where mycobacteria claims remain valid under BPR.

Guidance And Next Steps

The Health and Safety Executive (HSE), responsible for biocides regulation in GB and NI, is aware that current efficacy guidelines reference mycobacteria claims for PT 1 products. The agency plans to update these guidelines in accordance with the MHRA’s clarification. Manufacturers unsure whether their products are affected by this change are advised to contact MHRA through their advice form.

While this adjustment streamlines the classification of mycobacteria-related claims in biocidal products, manufacturers will need to ensure compliance with medicines regulations to continue selling in the GB and NI markets.