RFI 11-10: Identification of Drugs/Essential Medicines Manufacturers
PFSCM has issued RFI 11-10 DRUGS for the identification of manufacturers of essential medicines. Interested manufacturers are encouraged to submit documentation as specified in the RFI for various dosage forms and strengths of the products.To inquire to receive the documentation, please contact: RFI@nl.pfscm.org
Send inquiries to Mr. Wesley Kreft or Mr. Marcel Hendriks at RFI@nl.pfscm.org and copy Mr. Robert (Butch) Staley at rstaley@pfscm.org or contact Mr.Wesley Kreft and Mr. Marcel Hendriks at +31.348.489.630
Responses to the RFI must be delivered to: The Partnership for Supply Chain Management (PFSCM) Attn. Procurement Department Westdam 3b 3441 GA Woerden Netherlands
-Goods quoted shall comply with the standards of the current edition (or the latest edition in which they are included) of the United States Pharmacopoeia (USP); or, if applicable, with another acceptable pharmacopoeia standards, e.g., EP, BP, or BPC. Where the USP gives no definition of the Goods and no other standards are specified, the Goods shall be manufactured in accordance with tested "in-house" formulations so as to be suitable for human medicine.
-Goods quoted must be produced at manufacturing site approved by:
1. U.S. Food and Drug Administration (FDA) or other Stringent Regulatory Authority (SRA).
2. The World Health Organization (WHO) under their Prequalification of Medicines Programme
RFP 11-06: Identification of ARV Manufacturers
SCMS has issued RFP 11-06 ARV for the identification of manufacturers of ARVs compliant with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and U.S. Agency for International Development’s (USAID) quality assurance policy. Send inquiries to Mr. Marcel Hendriks at RFP@nl.pfscm.org and copy Mr. Robert (Butch) Staley at rstaley@pfscm.org or contact Mr. Marcel Hendriks at +31.348.489.630.
Goods quoted must fully comply with the following technical specifications:
-FDA: fully FDA approved, or
-FDA (tentative): Tentatively approved by FDA, or
-USAID: Approved by USAID under the USAID Blanket ARV Source Waiver (for ARVs of innovator companies manufactured in specific non-US sites)
Background information can be found on:
-FDA’s list of approved and tentatively approved ARVs in association with PEPFAR: http://www.fda.gov/oia/PEPFAR.htm -PEPFAR consolidated list of ARVs Eligible for purchase: http://www.usaid.gov/our_work/global_health/aids/TechAreas/treatment/consolidated_list_arvs.pdf
RFI 11-09: Identification of Essential Medicines International Distributors/Wholesalers
PFSCM has issued RFI 11-09 WHS for the identification of international distributors/wholesalers of essential medicines. PFSCM has the intention to expand its network of prequalified distributors/wholesalers for the supply of essential medicines.
Send inquiries to Mr. Marcel Hendriks at RFI@nl.pfscm.org and copy Mr. Robert (Butch) Staley at rstaley@pfscm.org or contact Mr. Marcel Hendriks and/or Mr. Wesley Kreft at +31.348.489.630.
Eligible international distributors/wholesalers shall:
-hold all required current licenses,
-operate in compliance with GDP,
-preferably ISO 9001-2008 certified, and
-have adequate quality controls systems in place in accordance with pre-qualification and quality assurance according to WHO guidelines: A model quality assurance system for procurement agencies.
Background information can be found on:
http://www.who.int/medicines/publications/ModelQualityAssurance.pdf
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