Provision of a range of Finished Pharmaceutical Products to UNSMIL HQ, Janzour Tripoli Libya. (Албания - Тендер #69144414)

Description

1.1. United Nations Support Mission in Libya (UNSMIL) intends to engage qualified vendor(s), to provide a range of Finished Pharmaceutical Products (FPPs) to UNSMIL in Tripoli, Libya. This Statement of Requirements (SOR) details the qualification requirements for potential vendor(s) and establishes the technical specifications and compliance criteria of the items to be provided to the UNSMIL HQ, Janzour, Tripoli, Libya. Specific Requirements/Information Vendor(s) shall demonstrate, (submit information/supporting documentation) that they can meet the mandatory requirements and presented briefly below: 2.1. Previous Experience: 2.1.1. Valid Certificate of registration as a pharmaceutical manufacturer or distributor, Certificate of Incorporation: Vendor shall provide valid license(s) required under national legislation in the country of operation and issued by the national regulatory authority or other relevant entity, in the English Language or a valid/certified translation. 2.1.2. Evidence of minimum three (3) years of experience in manufacturing/provision/supply of the items requested in Appendix B.2 or related/similar items. Vendor shall provide a list of minimum three (3) references from reputable entities/clients within the last 3 years (international, outside the country of vendor operation), with full contact details (name, job title, email, phone number), to which the Vendor is/was (during the last 3 years) supplying the requested items, or items of a similar nature. The UN reserves the right to contact such referees to request information on the Vendors’ level of service and quality of goods. 2.2. Quality Management Certification: Vendor shall present evidence of compliance with national or WHO Good Distribution Practices (GDP) / Good Storage Practices (GSP)/ Good Manufacturing Practice (GMP) or have a valid and certified Quality Management System: ISO 9001:2015 or an equivalent industry specific QMS standard issued by independent accreditation bodies.: 2.2.1. In case the vendor is a manufacturer: Vendor shall present a valid GMP Compliance Certificate, or an internationally accepted equivalent issued by WHO, a Stringent Regulatory Authority or a National Regulatory Authority (NRA) which is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or by other NRA considered acceptable to the UN. GMP Certificates shall be presented for all relevant manufacturing sites and stipulate the types of activities that are authorized in the production facilities. 2.2.2. In case the vendor is NOT a manufacturer: Vendor shall, where relevant, comply with national or WHO Good Distribution Practices (GDP) / Good Storage Practices (GSP) and/or have a valid certified Quality Management System (QMS) e.g., ISO 9001:2015, or an internationally accepted equivalent; In this case Vendors will be required to additionally submit a Valid GMP Compliance Certificate or internationally accepted equivalent for the Manufacturers of all the products they offer to the UN. 2.3. Awarded vendor(s) shall be responsible for ensuring that all above mentioned certifications remain valid throughout the term of the contract(s) and any extensions thereof. Vendors shall provide the UN with notification of any changes to the status of their certifications, including renewals, as necessary. 2.4. Logistics and Sourcing Capability – Vendor shall provide evidence of capability to source and provide the requirements of the SOR, either through manufacture (if manufacturer) or utilizing established business relationships with other suppliers. Such evidence shall include a brief description of the vendor’s supply chain including but not limited to: management of various aspects of the supply chain from manufacturing to delivery; cold chain management; existing contractual arrangements with manufacturers, wholesalers and/or other 1st and 2nd tier suppliers(sub-contractors) where the vendor shall provide whichever is applicable from manufacturer"s licence, manufacturer"s authorization for distribution, a copy of contract (without prices) and/or a certificate of free sale; supplier performance management tools and procedures; established KPIs for the main suppliers; contingency plans and alternative sources of supply to ensure timely deliveries. 2.5. Customer Management Capability: Vendor shall demonstrate availability of experienced workforce dedicated to managing the activities of their supply chain and customer requirement with a brief about their organizational layout and structure indicating total number of personnel and key supply chain functions e.g. customer relationship management, warehouse location and inventory management, distribution hub, technical maintenance etc.., and shall provide an Account Management Plan indicating the proposed team dedicated to the fulfilment of this SOR and operational set up (proposed names of at least two (2) account managers). 2.6. The UN reserves the right to request vendors to provide additional documentation proving compliance with the requirements stipulated in Section 2 of this SOR.