Importation & Batch Release
Importing medicinal products from third countries into the UK and EEA requires strict compliance with regulatory frameworks. Products must be certified by a Qualified Person (QP) before they can be released to the market. Our team provides comprehensive importation services, ensuring that all human and veterinary medicines entering these territories meet legal requirements and maintain the highest quality standards.
We hold the necessary licenses issued by regulatory authorities such as the MHRA and HPRA, allowing us to act as importers and manage batch releases efficiently. This includes coordinating with manufacturers, verifying documentation, and ensuring compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
Our services cover the entire supply chain, from the supplier to the point of release. We conduct audits and inspections of APIs, raw materials, packaging facilities, and distribution networks. By monitoring each step, we maintain the integrity of products, prevent deviations, and ensure regulatory compliance throughout the import process.
Batch release is a critical step in guaranteeing product safety. Our in-house QPs review all production and quality control documentation, certify batches for release, and manage the associated paperwork. This meticulous oversight reduces risks and ensures that all products entering the market are safe, effective, and fully compliant.
In addition to operational management, we provide strategic advice on importation procedures, risk mitigation, and regulatory updates. Our team works closely with clients to optimize import strategies, ensuring that products are released efficiently while fully adhering to all legal and regulatory requirements.
Ready to bring your products to market with confidence? Get in touch today.
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