On 17 July 2023, the Health Sciences Authority (“HSA“) announced a public consultation on new subsidiary legislation under the Health Products Act 2007 (“HPA“), namely the proposed Health Products (Active Ingredients) Regulations 2023 (“Regulations“).
“Active ingredients” are defined as ingredients that contribute to the intended function of the product, and are pharmacologically active substances that may be used to manufacture health products. At present, active ingredients are regulated under the Poisons Act 1938 (which imposes a licensing requirement on importers and wholesalers), and the Medicines Act 1975 (on application for certification).
To ensure that active ingredients are consistently manufactured, stored and distributed in accordance with appropriate quality standards, HSA seeks to implement risk-based regulatory controls that will be streamlined and consolidated under the HPA by way of the Regulations. Further, the proposed Regulations will provide a fit-for-purpose and risk-based licensing framework for active ingredients that will be aligned with international standards.
Once the proposed Regulations are implemented, the regulatory controls under the Poisons Act 1938 and Medicines Act 1975 will no longer apply. Licensed importers and wholesalers will no longer need to hold a separate Form A Poisons Licence under the Poisons Act.
In this Update, we examine the scope, overview, and licensing framework proposed in the draft Regulations.
For more information, click here to read the full Legal Update.
