This Quality Policy defines the principles, responsibilities and standards by which Euro Biom Ltd conducts its pharmaceutical wholesale and export activities. It establishes our commitment to protecting patient safety, maintaining medicinal product integrity and meeting the regulatory expectations of the Medicines and Healthcare products Regulatory Agency (MHRA) and the national regulators of the destination countries.
This policy applies to all activities carried out under Wholesale Dealer Authorisation WDA(H) 59239, including procurement of UK-licensed medicinal products, storage at the GDP-compliant contract storage site, Clarity Pharma Ltd (WDA(H) 18036), export distribution, named-patient import supply, shortage medicines supply, institutional tender supply, 2-8°C cold chain supply arranged through partners and all associated documentation and pharmacovigilance obligations. It applies to every member of Euro Biom staff, every contracted partner and every third party acting on behalf of Euro Biom.
Euro Biom operates in compliance with the Human Medicines Regulations 2012 (as amended), the UK Good Distribution Practice guidelines aligned with the EU GDP guidance of 5 November 2013 (2013/C 343/01), the falsified medicines provisions of those Regulations, and the MHRA Green Guide. Export activities additionally comply with the regulatory requirements of the destination jurisdiction, including but not limited to registration, import permit, Certificate of Pharmaceutical Product (CPP) and batch-specific documentation requirements issued by SFDA (Saudi Arabia), EDE / DHA / DoH (UAE), NAFDAC (Nigeria), PPB (Kenya), FDA Ghana, MoPH Qatar, MoH Kuwait (Kuwait), NHRA (Bahrain), MoH Oman, TITCK (Turkey), SAHPRA (South Africa), EFDA (Ethiopia), TMDA (Tanzania), EDA (Egypt), AMMPS (Morocco), Rwanda FDA, NDA (Uganda), DPML (Cameroon), ARP (Senegal), ANARME (Mozambique), MCAZ (Zimbabwe), HPRA (Ireland), BfArM (Germany), ANSM (France), CBG-MEB (Netherlands), FAMHP (Belgium) and other competent authorities.
Overall responsibility for this Quality Policy rests with the Board of Directors of Euro Biom Ltd. Day-to-day responsibility for the Quality System is delegated to the Responsible Person named on the MHRA licence, Mr Brian Lindsay, who has the authority to suspend supply, reject product, initiate recall and represent Euro Biom before the MHRA and other competent authorities in any quality matter. All staff are empowered and expected to raise any quality concern without fear of retaliation.
Euro Biom commits to the following principles in every transaction:
Before any commercial relationship is established, Euro Biom qualifies each supplier and each customer. Supplier qualification includes verification of MHRA authorisation status, GDP or GMP certificate status, corporate standing and regulatory history. Customer qualification includes verification of the customer's wholesale, manufacturing, hospital or institutional authorisation in the destination jurisdiction; Euro Biom does not supply products to unauthorised recipients or to purposes inconsistent with the customer's licence. Qualification records are maintained and reviewed periodically.
Products requiring controlled temperature storage and transport are handled through qualified warehouse partners with storage zones operated by the contract storage site at 2-8°C and 15-25°C under its own licence. 2-8°C shipments are packed by the contract storage site in temperature-controlled packaging with a data logger, arranged with specialist carriers. Where a data logger is shipped, the recipient can use its temperature record together with the batch documentation to assess release at destination against the manufacturer's stability profile.
Euro Biom operates a documented recall procedure designed to retrieve product from customers promptly on receipt of a recall notice at any level (precautionary, Class 1, Class 2, Class 3). Product complaints are logged, acknowledged and investigated within defined timelines. Suspected falsified medicines are quarantined and reported to the MHRA Defective Medicines Report Centre and to the originating marketing authorisation holder. Suspected serious adverse drug reactions are reported to the MHRA Yellow Card scheme and to the equivalent reporting system of the destination country.
The Quality System is subject to internal self-inspection on a scheduled basis and to external inspection by the MHRA and, where applicable, destination regulators. Audit findings, deviations and CAPA are reviewed by management at least annually. This Quality Policy is reviewed at least annually and updated whenever there is a material change in regulations, operations, supplier base or destination markets.
Quality concerns, complaints, recall notifications and regulatory correspondence may be directed to the Responsible Person via work@eurobiom.co.uk or by post to Euro Biom Ltd, Unit-5 Skyport Drive, Harmondsworth, London, UB7 0LJ, United Kingdom. Telephone: +44 7492 670948.
This Quality Policy is published by Euro Biom Ltd and reviewed annually. It applies to all Euro Biom personnel, contracted service providers and parties acting on behalf of the company.