UNICEF Standards for Supplies

Technical standards

As part of efforts to ensure that supplies are of a high quality, UNICEF purchases supplies that comply with recognized international standards.

Standards for medical devices

Suppliers are required to meet the following technical standards for medical equipment and consumables, medical and hygiene kits, laboratory supplies and diagnostic testing equipment.

Quality
Suppliers have to certify that the items are manufactured in accordance with Good Manufacturing Practices (GMP) for Medical devices and that the items conform to the EEC directive: Council Directive 93/42/EEC of 14 June 1993 concerning Medical devices. Suppliers must provide the following certificates:
- EN ISO 9001 / EN 46001
- EN ISO 9002 / EN 46002.

Documentation
The supplier must provide:
- Catalogue of products (with product reference / photo)
- Complete technical specifications for each product offered.

Samples
UNICEF reserves the right to request free, non-returnable samples for evaluation and testing of the product and / or of the packing and packaging by UNICEF (or its representative), prior to any award. Samples will be subject to technical review and laboratory testing and analysis.
UNICEF reserves the right to request suppliers to provide copies of internal quality control test results or certificates of analysis conducted at independent laboratories, and / or certificates of approval by governments, health ministries or local authorities for the manufacture and / or sale of the product.

Shelf life for sterile medical devices
At the time of delivery to UNICEF, the medical devices must not have been manufactured earlier than four months prior to receipt by UNICEF. Any medical device having an expiry date of less than three (3) years from date of delivery to UNICEF will not be accepted.

Standards for Pharmaceutical Products

UNICEF concentrates mainly on drugs listed in the World Health Organization’s (WHO's) Essential Drugs List www.who.int/medicines/ (WHO technical report series 882). The essential drugs available from the Copenhagen warehouse are listed in the Supply Catalogue.

Any product offered must generally be authorized for marketing in the country of origin.

UNICEF normally buys directly from manufacturers.

Products should be supplied with generic labelling in English and French. Upon request, a proof of compliance with WHO's Good Manufacturing Practice (GMP) guidelines must be sent to Supply Division's Quality Assurance Centre in the form of a certificate issued by an internationally recognized authority, such as the United States Food and Drug Administration. Alternatively, a GMP inspection may be carried out by UNICEF or a representative chosen by UNICEF. The local drug authorities will normally be invited as observers in the inspection and UNICEF may charge a fee for the inspection.

Potential new suppliers are requested to complete the attached Technical Questionnaire for Pharmaceutical Manufacturers (attached below) and indicate which products on our Product List they are able to supply, including the indicative price at which they can supply these products.

Technical Questionnaire for Pharmaceutical Manufacturers [Word]

UNICEF is an Observer to PIC/S

UNICEF became an Observer to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on January 1, 2006, after its quality system for Good Manufactering Practices (GMP) inspections was evaluated by PIC/S to comply with its “Recommendation on Quality System Requirements for Pharmaceutical Inspectorates” (PIC-S PI 002-2 October 2004).

The regulatory environment in many countries exporting pharmaceutical products is weak. To ensure that pharmaceuticals supplied to UNICEF are manufactured in accordance with WHO GMP Guidelines, UNICEF conducts on-site GMP Inspections. However, UNICEF does not issue GMP licences nor GMP certificates following these inspections.

While UNICEF does not publish its list of pre-qualified suppliers of pharmaceutical products,  the UNICEF Supply Division Annual Report lists all pre-qualified suppliers who have received orders above $ 100,000 from Supply Division.

More information about PIC/S can be found on http://www.picscheme.org/

Standards for Vaccines, Syringes and Cold-Chain Equipment

All vaccines and biologicals should conform to both Good Manufacturing Practices (GMPs) and World Health Organization (WHO) standards and requirements, available from WHO's Division of Vaccines and Biologicals at: www.who.int/vaccines-access/.

All syringes, safety disposal boxes and cold-chain equipment should conform to the relevant WHO specifications and test procedures, also available from WHO at: www.who.int/vaccines-access/.

Standards for Nutrition Supplies

Manufacturers of infant formula and related products must comply with the International Code of Marketing of Breastmilk Substitutes. In addition, all manufacturers of nutrition supplies must conform to Good Manufacturing Practice (GMP) standards. Furthermore, manufacturers must comply, except when otherwise specified, with the Standards and Guidelines on Foods for Infants and Children of the Codex Alimentarius (Vol. 4, 2nd Ed., FAO Rome 1994.)