Chapter 9 - General advice on due diligence Northern Ireland

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the legal obligations for manufacturers and importers of electronic cigarettes and refill containers. This guidance is based on the Tobacco and Related Products Regulations 2016 (TRPR) and the Tobacco Products and Nicotine Inhaling Products (Amendment) (EU Exit) Regulations 2020. While no specific company or inspection date is cited, the document addresses general industry compliance and the 'due diligence' defense under Regulation 50. To meet safety and quality standards, companies must go beyond simple product notification. They are required to maintain a comprehensive technical dossier for every product, proving that production standards are monitored for every batch. Key required actions include documenting product specifications, conducting regular batch testing, and performing stability studies to ensure product quality throughout its shelf life. Furthermore, the dossier must contain a detailed list of ingredients, including Safety Data Sheets and toxicological risk assessments. Manufacturers must validate their production processes and maintain rigorous records of batch data, safety checks, and risk assessments. For ongoing monitoring, the MHRA mandates the tracking of customer complaints and Adverse Drug Reaction (ADR) reports, including any corrective actions taken. Failure to comply with these regulations and maintain documented evidence of due diligence may result in criminal prosecution. The MHRA advises businesses to seek specialized legal or compliance advice to ensure full adherence to these safety standards.