RFQ for Supply & Delivery of Pharmaceutical Products for Gaza, oPt.

New clarification added: Dear Sir,Please find below the inquiries received from some potential bidders, along with UNOPS’s responses.CLARIFICATION 1: Palestinian Ministry of Health Registration : Section 3 of the Schedule of Requirements states that the valid Palestinian Ministry of Health (MoH) registration number is a mandatory requirement for all offered medicines.a) Is Palestinian MoH registration mandatory for all 21 items listed in the Schedule of Requirements without exception, including items for which no approved exception has been granted under Section 3.2? UNOPS Reply: Yes. A valid Palestinian MoH registration number is a mandatory requirement for all 21 items listed in the Schedule of Requirements without exception. The provisions under Section 3.2 allow for exception regarding the Marketing Authorisation framework, and do not waive the mandatory requirement for local Palestinian MoH registration for any offered item.b) If a product is registered with the Palestinian MoH but does not yet hold a Marketing Authorisation from a Stringent Regulatory Authority (SRA), a WHO Listed Authority (WLA), or an ML3/ML4-assessed authority, will the Palestinian MoH registration alone satisfy the Marketing Authorisation requirement under Section 3.1 for items not listed under Section 3.2?     UNOPS Reply: No. For items not listed under Section 3.2, Palestinian MoH registration alone does not satisfy the requirements of the RFQ. To be deemed technically compliant, an offered product must concurrently fulfill both criteria under Section 3.1: it must possess a valid Palestinian MoH registration and hold a valid Marketing Authorisation from a recognised Stringent Regulatory Authority (SRA), WHO Listed Authority (WLA), or an ML3/ML4-assessed authority.c) For items listed under Section 3.2 (the five approved-exception medicines), does a valid Israeli Ministry of Health Marketing Authorisation fully satisfy the Marketing Authorisation requirement under this RFQ, provided that a valid Palestinian MoH registration number is also submitted?    UNOPS REply: Yes. For the five approved-exception medicines listed under Section 3.2, a valid Israeli Ministry of Health Marketing Authorisation fully satisfies the primary Marketing Authorisation requirement under this RFQ, provided that it is submitted alongside a valid Palestinian MoH registration number. d) If a product holds a valid Israeli MoH Marketing Authorisation and a valid Palestinian MoH registration, but does not hold an SRA/WLA/ML3+ authorisation, is it eligible to be offered for items outside the Section 3.2 approved exception scope?   UNOPS REPLY: No. A product holding only an Israeli MoH Marketing Authorisation and a Palestinian MoH registration (but lacking an SRA, WLA, or ML3/ML4 authorisation) is ineligible to be offered for any of the items outside the Section 3.2 approved exception scope.CLARIFICATION 2: Eligibility of Israeli-Registered Companies :Section I states that bidders may have the nationality of any country "with the exception of the nationalities, if any, listed in the Tender Particulars section."We wish to confirm eligibility prior to preparing our submission:a) Are companies registered and operating under Israeli law eligible to submit a quotation under this RFQ? UNOPS REPLY: Yes.b) If yes, are Israeli companies classified as "Local Bidders (In-Country)" for the purposes of delivery requirements under Section II.2, with Kerem Shalom as their designated delivery point?  UNOPS REPLY: Yes, Israeli companies are classified as local bidders for the purposes of delivery requirements under Section II.2, with Kerem Shalom as their designated delivery point.c) Are there any nationality-based restrictions in the Tender Particulars that would exclude Israeli-registered entities from participating?UNOPS REPLY: No, there is no nationality-based restriction on the participation. We welcome any submission that meets the all listed requirements. CLARIFICATION 3: UNOPS Coordination at Kerem Shalom Border Crossing: Section II.2 states that for Local Bidders (In-Country), delivery is CIP Kerem Shalom border crossing, and that UNOPS will arrange further logistics from the designated delivery point to the final end-user inside Gaza. UNOPS will also obtain COGAT approval and facilitate the COGAT approval process.a) Does UNOPS coordinate the physical receipt and handling of goods at Kerem Shalom upon delivery by the successful Local Bidder? Or is the Local Bidder responsible for managing the handover process at the crossing?UNOPS REPLY: UNOPS will coordinate the physical receipt and handling of goods at Kerem Shalom upon delivery by the successful local bidder.b) Who is the designated contact or consignee at Kerem Shalom, and will this information be shared with the successful bidder prior to shipment?UNOPS REPLY: UNOPS is the consignee at Kerem Shalom; the contact details will be shared with the successful bidder prior to shipment.c) Is the bidder required to coordinate directly with any Israeli authority at or prior to delivery to Kerem Shalom, or does all coordination pass through UNOPS?UNOPS REPLY: UNOPS will facilicate coordination with Israeli authority at or prior to delivery to Kerem Shalom.d) Does UNOPS provide a standard checklist or template of the COGAT supporting documents required from the bidder (e.g., product specifications, pictures, catalogs), and what is the typical processing timeline for COGAT approval?UNOPS REPLY: UNOPS will provide a standard checklist or template that the successful bidder is requested to fill in. COGAT approval timeline is unpredictable, based on our previous experiences.CLARIFICATION 4: Storage Pending COGAT Approval and Impact on Liquidated Damages: Section II.2 requires the successful bidder to store goods at their own cost until COGAT approval is issued and UNOPS issues a formal shipment notification.a) What is the estimated timeframe between purchase order signing and issuance of the formal UNOPS shipment notification? UNOPS REPLY: As COGAT approval timeline is unpredictable, it is difficult to estimate timeframe between PO signature and issuance of the formal shipment noficiation from UNOPS. UNOPS will send a request for entry of goods to Gaza immediately after PO signature.b) If COGAT approval is delayed beyond the control of the bidder, will UNOPS grant a corresponding extension to the delivery timeline, and will liquidated damages be suspended for the duration of such delay?UNOPS REPLY: UNOPS will grant a corresponding extension to the delivery timeline and will not apply any liquidated damages (LDs) due to the delay in obtaining approval from Israeli authorities.CLARIFICATION 5: Rerouting to the West Bank: Section II.2 states that if COGAT approval is not granted for goods to enter Gaza, the successful Local Bidder must reroute the shipment to the West Bank border crossing at no additional cost.a) Which specific West Bank border crossing would apply in such a scenario? UNOPS REPLY: West Bank border corssing is to be ditermined.b) Will the CIP delivery terms and the agreed unit prices remain unchanged in the event of rerouting to the West Bank?UNOPS REPLY: Yes, CIP delivery terms and the agreed unit prices remain unchanged in the event of rerouting to the West Bank.