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Asthma: Medical Equipment

Asked by Ayoub KhanIndependentDepartment of Health and Social CareTabled Answered 10 July 2025UIN 65185

The question

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 3 July 2025 to Question 62444 on Asthma: Medical Equipment, what recent discussions his Department has had with pharmaceutical companies on encouraging them to become marketing authorisation holders for dosage counters in emergency inhalers.

Answered by Karin Smyth

The Medicines and Healthcare products Regulatory Agency (MHRA) has not approached any pharmaceutical company to encourage them to become a marketing authorisation holder (MAH) for short-acting beta agonist (SABA) pressurised metered-dose inhalers (pMDIs) with integrated dose counters. As the United Kingdom’s independent regulator for medicines and medical devices, the MHRA does not have the remit to proactively approach pharmaceutical companies with requests to become MAHs for specific products.

However, the MHRA provides scientific and regulatory advice to support any pharmaceutical company that wishes to develop and seek authorisation for SABA pMDIs that incorporate integrated dose counters. Through scientific advice meetings and regulatory interactions, the MHRA can offer support on the design, development, and licensing requirements for these products.

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