MHRA have confirmed that claims against mycobacteria are considered in scope of medicines regulations
Article 2 of the Biocidal Product Regulation (BPR), sets out the scope of biocides regulations, including where products are considered out of scope because they are covered by other relevant regulations.
For example, it is generally the case that medicines regulations will apply where products make claims to be effective against “specifically named pathogens”.
In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) determine which products, claims and uses are in scope of medicines regulations.
MHRA have recently confirmed that product type (PT) 1 products (applied directly to humans) will be in scope of medicines regulations where they make claims against mycobacteria.
The BPR defines PT 1 as: disinfectants – human hygiene – products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.
Typically, products in this product type are hygienic hand rubs, hand sanitisers and hand washes.
This means applications for BPR product authorisation for the GB and NI markets which make claims against mycobacteria cannot be accepted for PT 1 uses (disinfectants used directly on humans).
Please note HSE has no involvement in Union authorisations granted by the EU Commission as a mechanism to place products on the NI market.
This change does not affect applications for product authorisation in other use areas (PTs 2, 3, 4 and 5) where claims against mycobacteria can continue to be submitted.
HSE is unable to advise on medicines regulations. If you wish to discuss this change or are unsure if this applies to your BPR product, contact the MHRA using their advice form.
We are aware that the existing efficacy guidance contains reference to mycobacteria claims in PT 1. We aim to update this guidance to reflect this change as soon as possible.
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