FAQS - I OPEN INFORMATION SESSION. OCTOBER 5TH, 2020
Open competition and equal conditions for the Mexican and International markets
1. Will UNOPS guarantee fair and open competition for the Mexican and international markets in the international public tenders?
The international public bidding process will be implemented according to the regulations, rules, policies and procedures that apply to UNOPS. This is an open international process that guarantees open competition in equal conditions and allows the participation of the Mexican and international market, ensuring equal opportunities to all bidders and promoting effective and transparent competition
Quality, efficiency and safety of products
2. What will be the regulatory requirements for medicines and medical aid supplies?
The mandatory regulatory requirements are those established by the Federal Commission for Protection against Health Risks (COFEPRIS). The United Nations Office for Project Services (UNOPS) will provide all the necessary details related to each procurement process for the purchase of medicines and other medical supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured when the processes are launched. More information about COFEPRIS: https://www.gob.mx/cofepris
3. For products with expired patents but still branded as innovative, should we check the "brand/innovator" box?
This question refers to the Request for Information (RFI), which closed last September 16th. The answer is yes, the medicines considered as patented should have been marked as brand/innovator.
4. What will be the criteria for rejection due to latent defects? Who will cover the return cost? How will it be guaranteed?
UNOPS will provide all necessary details for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured with each procurement process.
5.How will the technologies to be procured be evaluated to ensure their safety and effectiveness? What types of analyses will be developed to ensure the efficiency of the technology?
The quality control of medicines is carried out based on the NOM. The mandatory regulatory requirements are those established by the Federal Commission for Protection against Health Risks (COFEPRIS). UNOPS will provide all the necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
Legal
6. How will the tri-annual contracts be? Will variations in price, exchange rate, supply conditions, plant closure, changes in the supply chain be considered?
The first processes to be launched for the procurement of medicines and medical aid supplies will only cover the need for the year 2021. The conditions for the procurement for 2022-2024 have not been defined yet.
7. In the multi-year process of procurement of medicines and medical aid supplies, what will be the sanctions for late deliveries?
These and other conditions will be established in detail in the bidding documents.
8. Will the contracts be signed directly with UNOPS or will they be formalized through all participating institutions?
Contracts will be signed directly by UNOPS. In due time, all necessary details will be provided related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured.
9. Will there be a process for the resolution of non-conformities? Will the Mexican authorities monitor compliance and adherence to regulations?
These and other conditions will be established in detail in the bidding documents.
10. After a company is awarded, will there be an additional negotiation process to improve the offer?
UNOPS will provide all the necessary details for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured with each procurement process
11. What will be the model contract for the procurement of medicines and medical aid supplies?
UNOPS will provide, in due time and in a transparent manner, all the necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured.
12. What will be the procedure for complaints and sanctions?
UNOPS will provide, in due time and in a transparent manner, all the necessary details related to each procurement process for the procurement of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured.
Evaluation/selection criteria
13. Will there be a pre-bidding meeting?
The international public bidding process will be implemented in accordance with the regulations, rules, policies and procedures that apply to UNOPS, which include a period of consultation and response, as well as the possibility of prior conferences. For more information, we invite you to review the UNOPS Procurement Process: https://www.unops.org/es/business-opportunities/how-we-procure
14. Will there be a general induction into UNOPS procurement and contracting procedures?
UNOPS invites you to review the information available on our website: https://www.unops.org/es/business-opportunities/how-we-procure In addition, UNOPS invites you to participate in the How to become a UNOPS Supplier course. This course is specially designed for interested vendors, and it is accessible online, official and free. The course can be taken in English, Spanish and French. To register for this online course, please fill out this form, and you will receive a confirmation email with the credentials to access the free course. For more information on how to become a UNOPS supplier, follow this link. For more information on UNOPS procurement policies and procedures, access these links in English, French and Spanish.
Supplier Eligibility
15. Will the bid opening be public? Will you make public the criteria for the approval or rejection of proposals?
The international public bidding process will be implemented in accordance with UNOPS internal policies, available at www.unops.org. The selection and evaluation criteria will be established in detail within the bidding documents.
Technical file/ Technical specifications
16. Will the labeling of medicines and medical aid supplies be required in Spanish? Will it include the text "propiedad del sector salud"?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS will provide all the necessary details for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured with each procurement process More information about COFEPRIS: https://www.gob.mx/cofepris
17. Will participants be required to deliver medicines and medical aid supplies packaged in spanish? If it is a foreign product, will it be necessary to modify the labels translating them to spanish?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS will provide all necessary details for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured with each procurement process. More information about COFEPRIS: https://www.gob.mx/cofepris
18. Will compliance with the regulations currently in force in the country be guaranteed?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS will provide all necessary details, for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured with each procurement process. More information about COFEPRIS: https://www.gob.mx/cofepris
Logistics (delivery sites, Incoterms)
19. What will be the delivery point for the first orders? Will the supplies be delivered directly to the distributor,to hospitals and institutions, or to a centralized or regionalized INSABI warehouse?
UNOPS will provide all necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured.
20. Is the price to be placed in the RFI the price before or after customs?
The RFI process was closed on September 16th. UNOPS will provide all necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured.
Regulatory framework / Health registration
21. Which Mexican authority will be in charge of overseeing the compliance with corresponding norms regulations?
The mandatory regulatory requirements are those established by COFEPRIS, and UNOPS will provide all the necessary details, related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
22. Will there be a sanitary compliance officer in Mexico?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS, in due time,will provide all necessary details for each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
23. What will be the applicable regulatory framework for the procurement of medicines and medical aid supplies?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS will provide all necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
24. What will be COFEPRIS’s role in the procurement processes?
COFEPRIS' decisions are autonomous and based on the NOM and its procedures. UNOPS respects the independence of the Commission. More information about COFEPRIS: https://www.gob.mx/cofepris
25. Will bidders need to present certificates of registration with COFEPRIS for consumables?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS will provide all necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
26. Regarding the concept of simplified health registration mentioned in the UNOPS-INSABI agreement, is it meant to reduce the registration time below the indicated by Mexican health regulations?
The mandatory regulatory requirements are those established by COFEPRIS.UNOPS will provide all necessary details, related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
27. Will national pharmaceutical laboratories have the possibility of registering their products under the same conditions as foreign companies?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS will provide all the necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
28. Will a list of recognized regulatory agencies be published to question the validity of the local health registration submitted?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS will provide all necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
29. Who will be the holder of the simplified health record? Will there be a sanitary compliance officer? Will it apply to companies in Mexico who have been waiting for years for the procedures in COFEPRIS?
The mandatory regulatory requirements are those established by COFEPRIS .UNOPS will provide all the necessary details, related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
30. What documentation will be required for foreign bidders who do not have a valid Health Registration in Mexico?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS will provide all necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
31. Will companies without health registration be able to participate? Will a support letter be required if they do not have one?
The mandatory regulatory requirements are those established by COFEPRIS.UNOPS will provide all the necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications for the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
32. In the event of a simplified registration, will priority be given to registrations in process that are already with COFEPRIS?
The mandatory regulatory requirements are those established by COFEPRIS. UNOPS will provide all necessary details related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured. More information about COFEPRIS: https://www.gob.mx/cofepris
Payments
33. What exchange rate will UNOPS use to conduct the evaluation of the offers to the RFI made in Dollars? The procurement process will be conducted in Dollars or Mexican Pesos?
These and other conditions will be detailed in the tendering documents.
34. When will the exchange rate be fixed?
UNOPS will provide all necessary details, related to each procurement process for the purchase of medicines and medical aid supplies in Mexico, including special conditions, requirements and specifications on the goods to be procured.
National Preference
35. The Request for Information (RFI) included patented products. In this process, will you respect products that have a valid patent in Mexico?
For the 2021 supply, a negotiation process will be carried out with suppliers that have medicines that are in the demand informed by INSABI and that have valid patents in Mexico.
Sustainability
36. What other direct costs associated with the technologies, in addition to the cost of procurement, are being considered in order to obtain savings for the health system?
This analysis is the responsibility of the respective health authority and its advisory bodies. UNOPS receives the requirements on the consolidated demand from the INSABI, to be incorporated into the procurement process.
37. When choosing the technology to be offered to patients, are the costs associated with potential interventions for the health system and their impact on patients' quality of life being considered?
This analysis is the responsibility of the respective health authority and its advisory bodies. UNOPS receives the requirements on the consolidated demand from the INSABI, to be incorporated into the procurement process.
Other
38. Will the Regional Observatory for Medicine Prices announced by UNOPS be maintained with open access?
The Regional Observatory for Medicine Prices (ORPM) is a tool developed by UNOPS for internal use, with the aim of facilitating the analysis of medicine prices in its public procurement processes. Currently, through the ORPM, UNOPS has made available to the general public the reference prices of the list of medicines recommended by PAHO/WHO for the treatment of patients infected by COVID-19, so that countries can benefit from this information to make decisions based on data or evidence. The ORPM draws from public sources of medicine awards in more than 21 countries. The sources of prices are of public access and can be consulted individually through the portals of public procurement agencies, public health entities, etc.
39. In the multi-year procurement process, if the award is made until December 2021, would supply begin in January 2022?
For procurement processes launched this year, delivery is expected in 2021. For the 2022-2024 supply, new processes will be launched during 2021.
40. Is it necessary to be registered and/or express interest in UNGM and eSourcing to respond to the RFI?
It was not required to be registered in UNGM to respond to the RFI. However, suppliers interested in participating in UNOPS bidding processes through the eSourcing system must be registered and express interest through the UNGM portal. Guides, videos, FAQ and support contact for UNGM registration and how to respond to UNOPS announcements in the eSourcing system are available in several languages. PFor more information go to: https://esourcing.unops.org/#/Help/Guides
41. When will the requirements for vaccines, other medicines and medical devices not included in the current RFI be published?
The codes that were not included in the RFI or that are not included in the tenders that UNOPS will carry out for the supply for 2021, will be procured under other procedures if non-consolidated demand exists.