Resources
Practical guides and reference documents for health product brands navigating UK, EU and international regulatory requirements. Contact us to request the resources relevant to your product category and market, or to discuss which guidance applies to your situation.
Preview note
The resources listed below are being updated to reflect the UK and EU regulatory frameworks. Where a UK or EU edition is still in preparation, please request the resource most relevant to your product by email, and we will share the correct UK/EU material for your situation. As a temporary reference, the current Australian edition of the Product Launch Guide is available to download; it covers TGA and ARTG requirements and does not describe UK or EU regulatory pathways.
The current Australian edition of the HealthREG Product Launch Guide, provided here as a temporary reference while the UK and EU edition is in preparation. It covers launching a health product in Australia, from initial classification through to TGA and ARTG listing and retail readiness, and does not describe UK or EU regulatory pathways.
A summary of the legal and regulatory obligations of a UK and EU marketing authorisation holder under the Human Medicines Regulations and EU medicines legislation, and of a UK and EU Responsible Person under the UK Cosmetics Regulation and EU Cosmetic Products Regulation (EC) No 1223/2009, including pharmacovigilance, adverse-reaction reporting, Serious Undesirable Effects reporting, recall procedures and ongoing compliance requirements.
An overview of the MHRA THR and EU THMP regulatory pathways for herbal medicinal products, and of the food supplement route under the Food Supplements (England) Regulations 2003 and Directive 2002/46/EC, including GMP requirements, evidence standards and post-market compliance obligations.
A guide to the regulatory requirements for health product brands entering the UK and EU markets, including MHRA and EU notification and authorisation processes, Responsible Person, Food Business Operator and Authorised Representative requirements, and UK and EU labelling standards.
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We will discuss your product, your market and which resources are most relevant to your regulatory situation.
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