Vendredi 15 Février 2008
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POST 01226E: COLD CHAIN EQUIPMENT: COMPETITIVE PRICING 14 FEBRUARY 2008 Follow-up on posts: 01225E 01221E, 01218, 01216, 01214E ******************************************* I would like to submit the following in response to Vikram Singh. *********************************************************** Dear members, As PQS secretariat, I would like to make the following clarification in regards to Vikram Singh's contribution (01221E). WHO has not moved to PQS fully. Currently, the active categories are E08 and E13 (since 30 June 2005) and E06 (since 1 October 2007). E01 and E03 categories are in the transition period, which means the new PQS performance specifications and verification protocols have been announced and a deadline given to currently listed articles' manufacturers to comply with new requirements. E01 deadline has been announced as 31 March 2008, while E03 deadline is 31 March 2009. If WHO does not receive a dossier for a PIS listed E03 product before this date, the item will automatically be disqualified and will no longer be recommended for purchase by UN agencies for use in immunization programmes. E03 section of the PIS will also be shut down on 31 March 2009. Effective 14 September 2007, all new applications for prequalification of refrigerators and freezers for storing vaccines and freezing icepacks must follow PQS procedures. Therefore, Vikram's point that "only two manufacturers supply the major quantity of WHO prequalified equipment" is not correct. First of all, it is not clear to which category Vikram is referring to. If he is referring to E03 category, for the above explained reasons, we do not have any prequalified E03 products yet. Vikram's point 2 is not clear to me, which "two" (products) he is referring to that are not competitive. We would appreciate any efforts from the countries in bringing local products to the use of UN procurement services. I would suggest that regarding the procedures, all follow published PQS guides that can be found and downloaded from the following link: http://www.who.int/immunization_standards/vaccine_quality/pqs_reference_docs/en/index.html Regarding the competition, I am not clear whether WHO prequalification will be enough when a wide variety of products are available at competitive prices. I would like to ask Vikram, why during the last UNOPS tender in India, non-WHO prequalified AD syringes were also invited to bid. I am asking this because, by the time of this tender, WHO had a total of 55 E08 and E13 syringes both from industrialized and developing countries, including India at a very competitive prices. Since the tender was open to non-WHO prequalified AD syringes, it means there is something beyond the competitive market that I am missing. I agree that currently we have a very limited number of laboratories. However, the PQS system is flexible compared to PIS and we can add new laboratories very easily if they meet the published criteria. Practically, all tests could be done in-country without manufacturers sending the equipment to laboratories abroad. There are ILAC accredited laboratories (almost) in all countries. When a manufacturer approaches us with a product for prequalification, local laboratories are the first thing we inquire with, to expedite the testing process, and secondly to expand the PQS accredited testing laboratories. NEMKO from Germany, METAS from Switzerland and CEMAFROID from France were accredited through such a process in 2007. Cheers, [log in to unmask]">Dr Umit Kartoglu PQS secretariat All members of the TechNet21 e-Forum are invited to send comments on any posting or to use the forum to raise a new discussion or request technical information in relation to immunization services. The comments made in this forum are the sole responsibility of the writers and do not in any way mean that they are endorsed by any of the organizations and agencies to which the authors may belong. Visit the TECHNET21 Website at http://www.technet21.org You will find instructions to subscribe, a direct access to archives, links to reference documents and other features. To UNSUBSCRIBE, send a message to : [log in to unmask]">[log in to unmask] Leave the subject area BLANK In the message body, write unsubscribe TECHNET21E The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. It is moderated by Padmini Menon and is hosted in cooperation with IT Power India (www.itpi.co.in)
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