Certification services for good distribution practices for medicinal products

Summary

The contract is for GDP (Good Distribution Practice) certification for ETSA Global Logistics, covering the requirements applicable to its transport of radiopharmaceuticals. The provider will carry out an audit tailored to ETSA’s activities, prepare the audit report and issue the certificate; the scope also includes up to two optional annual follow-up audits. The audit schedule will be agreed with ETSA, and the work will take place at ETSA’s offices; ETSA has no medicine warehouses. The report is due within one month of the audit, and the certificates within a further month, in Spanish, English and French. The initial contract lasts six months. ETSA may exercise up to two one-year extensions for follow-up audits in 2027 and 2028. The maximum price is EUR 3,000 for the initial certification and EUR 1,500 for each extension, excluding VAT. The price must include travel and subsistence costs and, if needed, the certification transfer audit. Price carries up to 98 points and energy-efficiency measures up to 2 points. Bids are due by 13 October 2026 at 16:00. To participate, the bidder must be a certification body accredited by ENAC or an eligible equivalent body and provide the required evidence of financial and technical capacity. The audit team must include at least one lead auditor, and all auditors must be qualified and have more than two years of experience. The bid must include, among other items, current tax and social security certificates and the required declarations and completed forms for financial and technical capacity, quality requirements, the bid and the contract coordinator.