This site or third-party tools used by it make use of cookies necessary for its operation. By closing this banner, scrolling this page, clicking on a link or continuing navigation in any other way, you consent to the use of cookies

European Commission

EUROPEAN CIVIL PROTECTION AND HUMANITARIAN AID OPERATIONS

WORKING WITH DG ECHO AS AN NGO PARTNER | 2021 - 2027

MEDICAL SUPPLIES

In DG ECHO’s documents, the term “medical supplies” refers to:

FINISHED PHARMACEUTICAL PRODUCTS MEDICAL DEVICES THERAPEUTIC FOOD TO ADDRESS ACUTE MALNUTRITION

Medical supplies do NOT include veterinary products and food supplies. 

Irrespective of the value of the contract to be awarded, the Partner must procure medical supplies: 

  1. through a Humanitarian Procurement Centre (HPC), or 
  2. through pre-certified suppliers. 

To know more, see also FAQs 35, 106 and 107

A supplier is pre-certified where it has demonstrated that its premises, facilities and processes comply with the European Commission Guidelines on Good Distribution Practice of medicinal products for human use or the WHO Good Distribution Practices for pharmaceutical products (GDP).  The pre-certification of a supplier does not constitute an assurance with respect to the quality of individual products and services provided by the pre-certified supplier or with respect to the supplier’s compliance with contractual obligations towards third parties. 

Proof of pre-certification of a supplier must be recorded in the procurement file and may be issued by a Stringent Regulatory Authority (supplier license) or by a qualified expert  (MQAS or GDP report). 

A qualified expert is any entity or individual that has the necessary competences and experience to provide expertise on pre-certification of suppliers and/or pre-qualification of medical supplies

 

When assessing offers provided by pre-certified suppliers, the Partner must take a life-cycle costing approach, including aspects to uphold the required quality such as transportation charges, storage requirements and shelf-life. 

The Partner also has to demonstrate that the purchased supplies are pre-qualified. A medical supply is pre-qualified if compliant with the following criteria. 

PRE-QUALIFICATION FOR FINISHED PHARMACEUTICAL PRODUCTS PRE-QUALIFICATION OF MEDICAL DEVICES

All medical supplies must respect any intellectual property rights and patent regulation applicable in the country of operation. 

DEROGATIONS

While no derogation from the minimum quality assurances for medical supplies may be granted, where the Partner, for circumstances beyond its control, is unable to demonstrate compliance with internationally accepted product standards, it may demonstrate instead that the supplies offer the best quality available

This includes a risk-based approach and compliance with standards accepted by the national regulatory authorities (national market authorisation). DG ECHO must be informed of, and consulted on, these exceptional cases without unjustified delay. 

DESTRUCTION OF MEDICAL SUPPLIES

When procuring medical supplies, the Partner must ensure that adequate provisions are in place to ensure respect of national regulation and, when possible, internationally recognised best practices in the destruction of any contract-related supplies that are recalled or expired. 

Provisional Annotated Annex 5 (DG ECHO) - SPECIFIC RULES FOR CARRYING OUT THE ACTION, 4. Quality standards for medical and food supplies

EN

Provisions on medical and food supplies applicable to actions funded under the EU Humanitarian Partnership Certificate 2021 – 2027 – Chapter 2

EN

PuntoSUDMDFParticipURIECAH