Legislative Requirements for Active Ingredients Manufacturers

Under section 47 of the Health Products Act 2007 and the Health Products (Active Ingredients) Regulations 2023, a Manufacturer’s Licence must be granted by HSA before a company can manufacture active ingredients for commercial supply to local or overseas markets.

A Manufacturer’s Licence is needed if a company is involved in any of the following activities:

• Manufacture includes all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage, and distribution of active ingredients and related controls.
• Primary packaging refers to placing and sealing of the active ingredient within the packaging material, which is in direct contact with the active ingredient.
• Secondary packaging refers to placing the sealed primary package within an outer packaging material or container. This includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active ingredients.