Faq

FAQs

Term in Spanish (Mx): Acuerdo a largo plazo

An LTA is a written agreement between an organization of the United Nations system and a vendor that is established for a defined period of time for specific goods or services at prescribed prices or pricing provisions and with no legal obligation to order any minimum or maximum quantity.

Term in Spanish (Mx): Acciones correctivas y preventivas

A system for implementing corrective actions and preventive actions resulting from an investigation of complaints, product rejections, non-conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring.

Term in Spanish (Mx): Adquisición sostenible

Procurement that integrates requirements, specifications and criteria that are compatible and in favour of the protection of the environment, of social progress and in support of economic development, namely by seeking resource efficiency, improving the quality of products and services and ultimately optimizing costs.

Term in Spanish (Mx): Clave

It refers to the unique code with which each of the medicines and medical supplies and devices is identified.

Term in Spanish (Mx): Clave desierta

Code which is not supplied by suppliers.

Term in Spanish (Mx): Clave no adjudicada

Code that did not pass any stage of the evaluation process.

Term in Spanish (Mx): Demanda consolidada

Aggregate integration of the necessary quantity of products required to meet the needs of a population group in a specific period of time.

Term in Spanish (Mx): Garantía de Sostenimiento de oferta/propuesta


UNOPS may request this bid/proposal security to mitigate certain risks related to the bidder.

More information in the Procurement Manual, page 69.

Term in Spanish (Mx): Garantía de Cumplimiento

Performance securities can be requested by UNOPS from the selected vendor in order to mitigate the risk of supplier non-performance and breach of contractual obligations (such as delivery of all equipment, services rendered, and works completed as per the contract). More information in the Procurement Manual, page 71.

Term in Spanish (Mx): Llamado a Licitación/ Licitación Pública Internacional (LPI)

A formal method of solicitation where prospective suppliers are requested to submit a bid for the provision of goods, services or works. At UNOPS, and in the framework of this project, international open competition is the default method of competition. That is why the call for bids is also known as International Public Bidding (IPB).

Term in Spanish (Mx): Mejor valor por dinero

Lowest price is not necessarily the most important criterion in the procurement of goods and services; the concept of best value takes quality and price into account to select the optimal solution to a specific need.

Term in Spanish (Mx): Orden de compra

A type of contract that documents the purchase of goods and/or services.

Term in Spanish (Mx): Orden de reposición

It is included in the purchase order and is issued on a monthly basis. It details the requirements by code based on the institution, specifying the logistics operator, deadline and final destination.

Term in Spanish (Mx): Precio de referencia

Value set by the leader or by free competition that must be taken into account when setting prices. Also called market prices.

Term in Spanish (Mx): Portal mundial para los proveedores de las Naciones Unidas (UNGM)

Web portal used by over 25 UN agencies, including UNOPS. It includes, among other types of information, bidding announcements and lists of inter-institutional suppliers. To learn more information, visit the UNGM website: http://www.ungm.org

Term in Spanish (Mx): Solicitud de información

It is an instrument to conduct a market survey in order to obtain information that can be used to identify available or potential solutions to fulfill identified needs. RFIs may include information on cost and delivery time.

Term in Spanish (Mx): Solicitud de cotización

An informal method of bidding whereby suppliers are required to submit a quotation for the supply of goods or services. It is normally used for standard items for which the procurement value is less than the threshold established for formal methods of bidding.

Open competition and equal conditions for the Mexican and International markets

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

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

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.

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.

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

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.

These and other conditions will be established in detail in the bidding documents.

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.

These and other conditions will be established in detail in the bidding documents.

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

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.

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

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/busin...

UNOPS invites you to review the information available on our website: https://www.unops.org/es/busin...

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

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

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

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

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)

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

These and other conditions will be detailed in the tendering documents.

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

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

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.

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

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.

For procurement processes launched this year, delivery is expected in 2021. For the 2022-2024 supply, new processes will be launched during 2021.

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/#/...

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.

UNOPS recovery costs

UNOPS, as a United Nations entity, is a public international intergovernmental organization that does not have profit aims in the development of its activities, and operates on the basis of recovery of direct and indirect costs associated with its interventions. By statute and decision of the General Assembly, UNOPS is a fully self-financed entity, which emphasizes its efficiency and financial discipline

UNOPS indirect cost recovery amounts to $ 109,745,736 over a four-year period. Within the framework of Fair and Equitable Public Management, UNOPS seeks efficiency in public spending, for which it has achieved initial savings of 2,389 million pesos (USD 117 million) based on the reference prices paid by the public buyer last year. With the savings generated to date, the indirect costs of recovery of UNOPS services have already been covered for the entire 4 years of project execution; it is estimated to have greater savings in the following weeks.

Open competition and equal conditions for the Mexican and foreign markets

Equal opportunities is ensured through UNOPS procurement principles carried out, namely:
a) Optimal cost-quality
b) Fairness, integrity and transparency
c) Effective competition
d) Consideration of the interests of UNOPS and its partners

Quality, efficacy and safety of products, contractual

The amounts established in the UNOPS requirements are those required, this allows suppliers to have certainty in the conditions of the requirements to be able to make competitive offers.

Legal, evaluation criteria

These and other conditions are set out in detail within the bidding documents.

The contract is signed, the contractual relationship with UNOPS is established.

Selection, eligibility of providers

These and other conditions are set out in detail within the bidding documents.

For UNOPS and for all agencies involved in the procurement, quality requirements are fundamental and are established in the bidding rules. The prices are part of the competition that is generated between the offering suppliers.

These and other conditions are set out in detail within the bidding documents.

The participation of companies is not limited by not having participated in the RFI process.

COFEPRIS will apply the established rules of pharmacovigilance and not only the registry holders will participate, but also the medical units and patients who have rights and guarantees regarding the medicines that are supplied to them. Additionally, the tools available at the international level will be used, as well as technovigilance for healing materials. UNOPS guarantees open competition, under equal conditions and allows the participation of the Mexican and international markets, ensuring equal conditions and promoting effective and transparent competition.

Technical file, specifications

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 healing materials in Mexico, including special conditions, requirements and specifications on the goods to be purchased.

The keys are adjusted to the description of the National Compendium of Health Supplies.

The first process for the acquisition of patented drugs - patent on active principle - was adjusted according to the INSABI requirement, for the assurance of the supply of 2021. If new codes with these characteristics are required and other typifications are being considered for the new processes that are generated.

In the case of drugs with a Patent on Active Principle, a direct negotiation methodology was designed with its holders. For the other cases, differentiated processes will be carried out.

Logistics (delivery sites, Incoterms, etc.)

The periodicity of deliveries will conform to the delivery plan drawn up by INSABI and are established in the bidding conditions.

The scheme proposed by INSABI is maintained, Birmex will intervene in the distribution of medicines with the collaboration of logistics operators and with the warehouse infrastructure.

According to INSABI instructions, deliveries will be made in Mexico City and the State of Mexico.

Regulatory framework / Sanitary Registry

The requirements for submitting bids are established in the bidding conditions.

Payments

UNOPS is involved in the conduct of the bidding process and is the sole administrator of the contracts with the awarded suppliers, so it will be the sole payer. Payment will be made through a specific procedure, which is agreed with INSABI and in accordance with UNOPS standards, policies and procedures.

These and other conditions are set out in detail within the bidding documents.

UNOPS does not issue advance payments to suppliers.

Sustainability

UNOPS seeks to add value in the tenders it conducts, making sustainable purchases through the DRiVE program and the sustainability form. We offer suppliers the possibility of committing to carry out corrective action plans in Labor Standards, Equal Opportunities, Contractors, Human Rights, Environmental Management, Quality Management, Policies, Health and Safety, in order to maximize the economic impact, social and environmental, which is complemented by national initiatives and policies aligned with this same objective.

Others (Strategic)

The awarded contracts can be found on the UNGM website, the United Nations global market.

The award of the contracts is planned for the end of December 2020.

In May 2021 UNOPS will launch a market survey (RFI), define the multi-year purchasing strategy and begin negotiations on patents and curative materials. The awards are estimated for October 2021 and the supply as of January 2022.

The figure of direct award applies to Single Source and Patented Medicines.

1. Process of payment to suppliers after acceptance of goods

a. In accordance with the provisions of section VI: Payment Management of the bidding conditions of the consolidated purchase 2021, "UNOPS will make the payment for each delivery of goods as follows: one hundred percent (100%) within a period 45 days after receiving the goods and following the procedure described below:

i. Accreditation of documentation to conformity;

ii. Commercial invoice;

iii. Acceptance of the good by the competent authority. "

b. UNOPS is executing payments according to the procedure defined in the bidding conditions and it is working together with INSABI to speed up the acceptance times of goods by the competent authority.

c. Regarding the UNOPS 2022 consolidated purchase, the payment process is stipulated in section VII: Payment Management of the bidding conditions for the 2022 consolidated purchase: "UNOPS undertakes to make the payment of one hundred percent (100%) of the price of the goods accepted by the Institute of Health for Well-being (INSABI), within forty-five (45) calendar days following the moment in which UNOPS receives (i) from INSABI, the acceptance of the goods from compliance with the Specific Agreement and its amendments; (ii) on behalf of the supplier, the documentation listed in the following paragraph:

i. Commercial invoice, and;

ii. Additional documentation that is requested according to the case.

2. Consolidated purchase UNOPS 2022

a. Considering that the UNOPS 2021 consolidated purchase covers a supply until the first half of 2022, the purchase that UNOPS will make corresponds to the second half of the year.
b. Regarding the tender launched by INSABI, in the information session it was reported that there are no duplications between the INSABI and UNOPS processes for 2022.

3. Long-term purchase agreements consolidated UNOPS 2021

a. The long-term agreements resulting from consolidated purchasing UNOPS 2021, they may be used to meet additional requirements to those covered by purchase orders in force, for which UNOPS would be requesting confirmation of the ability of the contractor to supply the required quantities.

4. 2022 consolidated purchase tender

a. How to access bidding information?

i. Tenders were issued on December 1st in the [Mercado Global de las Naciones Unidas](https://www.ungm.org/). To access all the information of the tender, request clarification and make a bid through the eSourcing system, providers must be registered (basic) in UNGM as providers of UNOPS. Support guidelines for enrollment in UNGM and how to respond to ads UNOPS in the eSourcing system found in the tender documents tab. other resources are additionally available as videos, FAQ and contact support the eSourcing system: [eSourcing](https://esourcing.unops.org/#/...)

b. Previous meetings or clarification

i. The preliminary or clarification meetings will be virtual. To participate, bidders must register in the links provided for each of the meetings (see tab "AD DETAILS", section "Details of the previous meeting or clarification") available in the tender published in [UNGM](https://www.ungm.org/). After registration they will receive a confirmation email with information to join the webinar.

ii. Verbal responses provided by UNOPS during pre-clearance or clarification meetings will not be binding. However, the minutes of the meetings will be shared with all participants via eSourcing and as such will form part of the bidding documents.

c. Tender clarifications

i. Requests for clarification can be sent from the date of publication of the call and until the deadline for clarification indicated in the "Information about the announcement / General information" tab. Requests for clarification can be submitted via the "Ad Information / Request Clarification" tab.

d. Presentation of offers

i. Offers must be submitted through the eSourcing platform according to what is indicated in the "Information about the announcement / General information" tab in UNGM.

e. Prequalification letter i. The prequalification letter was sent through the eSourcing system to each of the bidders who passed the "Evaluation of the qualification criteria", corresponding to the drug and / or healing material purchase processes of December 2020 (ITB / 2020 / 17938, ITB / 2020/17978, ITB / 2020/17979, ITB / 2020/18035 and / or ITB / 2020/18036).

f. Due diligence process

i. The due diligence and background verification process is carried out in accordance with the provisions of Section 8.10.2 of the Procurement Manual, Revision 7, which is available at: [https://www.unops.org/es/busin...](https://www.unops.org/es/busin...). That verification is carried out for each of the bidders who have reached the final evaluation stage and have an award recommendation, whether these are Mexican or foreign companies. With this process, UNOPS verifies the eligibility of suppliers under equal conditions, ensuring that contracts are only awarded to duly incorporated companies and without conflicts of interest.

g. Evaluation

i. The bid evaluation process is carried out entirely by UNOPS. This invitation to tender is carried out in accordance with the provisions described in Section I: Instructions to Bidders (available on the Documents tab) and the applicable provisions of the UNOPS Procurement Manual in effect at the time of publication (the latest version can be consulted at [https://www.unops.org/es/busin...](https://www.unops.org/es/busin...) and the Organizational Directives and Administrative Instructions mentioned in the Procurement Manual.

5. Distribution and delivery of goods

a. The suppliers contracted by UNOPS deliver the goods to the central warehouses designated by INSABI. The distribution towards the end points corresponds to a process of internal coordination between INSABI and the institutions of the health sector.

b. Incidents in the distribution of goods:

i. Suppliers have the communication channels and tools implemented by UNOPS for reporting incidents during deliveries. These are managed with INSABI and the actions implemented are continuously monitored so that the goods are delivered in a timely manner.

6. UNOPS official communication channels

a. It is important to highlight that there are defined communication channels within each of the project processes.

b. The general public is reminded that UNOPS has the email [mexico@unops.org](mailto:mexico@unops.org) davailable for any queries.

c. For specific inquiries to the project processes, the following communication channels can be used:

i. Bidding - Clarifications with bidders are managed directly through the esourcing system.

ii. For inquiries about deliveries, contracts and payments, the awarded suppliers have the communication channels in place to manage their inquiries. Questions that do not correspond to each area will not be answered by these channels.

d. Value added through the consolidated purchase UNOPS 2021 - market opening questions, value added questions UNOPS.

e. The objective through the consolidated purchase of UNOPS is to support the Mexican Government in the transformation of the public procurement system of the Health sector. This through:

i. Manage the timely supply of medicines and healing materials with quality products.

ii. Promote transparency and prevent corruption through the adoption of practices in accordance with Fair and Equitable Public Management, with a view to expanding the market and achieving the best quality at the best price.

iii. Generate savings and increase the performance of public funds through efficiencies in the procurement process.

f. Regarding the above, it has been achieved:

i. The contracting of 878 million pieces for 1,050 keys for medicines and healing materials, for a value of $ 2,226 million USD.

ii. Estimated savings of more than $ 500 million USD ($ 10,000 million) considering the maximum official reference price of the Government in previous purchases.

iii. Efficiency of public spending through the 33% improvement in generic prices and 10% in patents, in relation to previous purchases.

iv. Market deconcentration - in the joint purchase of INSABI and UNOPS 2021, 97 suppliers account for 80% of drug spending, compared to 18 suppliers in 2018.

v. Market opening - suppliers from 7 different countries are part of the UNOPS purchase.

7. Health registrations and patents

a. Will the sanitary registrations submitted in the 2021 process be accepted by 2022, or will new registration processes have to be carried out?

i. The health records issued by COFEPRIS and authorized under any modality, are valid for the presentation of offers, as long as they meet the evaluation criteria of the purchase process for the 2022 supply.

ii. The new sanitary registration application procedures that are covered by the recognition agreements related to the Mexican regulation and presented for the 2021 process, or prior to this and that have not yet received a definitive response from COFEPRIS, may be submitted during the period for submitting offers in the 2022 purchase process, as long as they meet the process evaluation criteria.

iii. According to what is established in the bidding documents, for the offers presented under the modality "Medicines WITHOUT Health Registration or Marketing Authorization issued by COFEPRIS that have a Health Registration or Marketing Authorization issued by Regulatory Agencies or Prequalification with recognition of equivalence", The Sanitary Registry issued by COFEPRIS will not be required for the presentation of the offer, however, it is necessary for the conclusion of the contract.

b. How does UNOPS ensure non-infringement of patents?

i. UNOPS is fully committed to respecting industrial property rights, both those included in local laws and those established by international trade treaties. Consequently, UNOPS in its bidding rules asked the bidders to fill out form G "Declaration of technical compliance of the drug" in which the bidder declares under protest of being truthful that "My client has carried out the corresponding verifications and certifies that the drug offered does not cause an infringement of intellectual property rights in accordance with the provisions of the Federal Law for the Protection of Industrial Property ". Additionally, UNOPS will only sign a contract with bidders who achieve approval of the sanitary registry by COFEPRIS, as a result, and in accordance with the responsibilities of Mexican institutions established in the Mexican regulatory framework, COFEPRIS in its review, may consult to the IMPI on the product to authorize and confirm that there is no infringement of patents in accordance with the Federal Law for the Protection of Industrial Property.

Contractual / legal

The multi-year contracts will be exclusively Long Term Agreements (LTAs) that are for indefinite amounts. All other contracts will be for amounts defined within the year of validity and will be honored.

They can be consulted on the website: www.proyectosaludmexico.org in the Transparency section.

According to the policies, what is expected is that the bases indicate that "Except in situations of force majeure established in the UNOPS General Conditions of Contract, if a supplier does not deliver one or all of the required goods within the delivery period or does not perform the services related to the delivery of the goods within the contractual term, UNOPS may, without prejudice to the other resources available under the contract and if so indicated by the Details tab of the advertisement in the eSourcing system, deduct from the price of the contract, by way of liquidation of damages, an amount for each day of delay until the delivery actually takes place or the agreement in the contract is fulfilled. "

Any request for clarification must be made through the e-Sourcing system using the option Information on the Announcement> Request Clarification during the period indicated in the bidding rules.

It is specified that, in general terms, surety companies do guarantee "upon first request" the fulfillment of any type of obligation through the granting of guarantees for each branch provided for in article 36 of the Law of Insurance and Surety Institutions (LISF) and any risk foreseen in the Unique Insurance and Surety Circular in force, issued by the National Insurance and Surety Commission in Mexico. The form and the moment in which they are executed will be the one agreed between the Guarantor and the Beneficiary. In this sense, given that the surety policy states that “the payment will be made without conditions and without UNOPS having the need to prove anything or present any motive or reasoning to support its request or the amount claimed”, the elements are established Sufficient for the guarantee to be paid “on first demand”.

There is no set deadline for the release of clarifications by UNOPS. The publication of clarifications is done in such a way that the bidders have sufficient time to make the necessary corrections to their bids and thus ensure the success of the process.

Providers

For information, among the general criteria that are considered in the evaluation of offers are listed below. The criteria to be used in each process may vary and are detailed in the bidding conditions corresponding to each process.

The prequalification of suppliers is contemplated within the bidding process, for this the qualifications of the bidders who have satisfactorily passed the preliminary examination of their offers will be evaluated.

The result of the processes to be launched during 2021, for the 2022 purchase, will be valid for one year.

Shopping 2022

INSABI is already consolidating demand for 2022. It will be reported on this shortly.

In the case of patented drugs, it is expected that the offers will be presented in the same way as in 2021. Those prioritized will be contracted competitively.

The 2021 contracts can be consulted on the website: www.proyectosaludmexico.org in the Transparency section. But these cannot be considered as reference prices.

A market study is not expected to be launched before the tenders.

No, UNOPS does not publish reference prices in any tender.

The bidder must appear as manufacturer, importer, owner or legal representative of the owner, and must be registered and indicated in the Health Registry / Marketing Authorization of the drug to be offered.

UNOPS will not publish pre-rules for tenders to be launched for supply 2022.

See answer to question number 12.

See answer to question number 16.

Supply is expected for 2022 only, but this will depend on the request received from INSABI.

Technical file / Technical specifications

UNOPS receives a consolidated requirement from INSABI. The demand of each institution must be requested to INSABI to know it.

Bidders that have UNOPS prequalification must provide a copy of the Prequalification Notification and those requirements that have had changes in relation to the document (s) presented at the time to obtain their prequalification.

Regarding prequalification, see answer to question 22. In the case of having an LTA, the bidder will not be subject to a new evaluation during the execution of the agreement.

According to the policy, each company can present only one offer, either individually or in association with others. If companies from the same pharmaceutical group submit bids individually for the same lots, both bids will be disqualified from these lots.

The process will be described in the bidding conditions in due course. The offer may be submitted at the time UNOPS publishes a new procurement process that includes said product.

See answer to question number 13.

Regulatory framework / Sanitary registry

It is envisaged that if a bidder does not have the quantities required in the bidding base necessary for the supply of goods / services, said bidder may submit a bid together with other entities through the consortium figure to comply with the requirements. In the event that no offer covers all of the required quantities, UNOPS may then make partial awards to 2 or more companies - respecting the order of prices resulting from the evaluation - until all or a substantial percentage of the quantities are covered. required. UNOPS is not required to purchase all of the required quantities in any of the lots.

Please refer to answer number 26 of this document.

It is anticipated that, exceptionally and previously validated by INSABI, UNOPS may authorize the delivery of products with an expiration period of less than 12 months, but not less than 9 months counted from their entry to the delivery points indicated in the Purchase Order. On this occasion, the Supplier must present a replacement commitment letter, in which it indicates the lots to be delivered, the useful life at the time of delivery, the places of delivery and the corresponding quantities. In these exceptional cases, the Supplier must replace the products that expire or are close to expiring at INSABI's discretion, replacing them with products that meet all the requirements established for the awarded key and that comply with the minimum useful life stipulated in the sheet.

The sanitary registration offered must comply with the provisions of the bidding documents. At the time of signing the contract, the sanitary registration will be requested again for final review. The bidder must take into account that modifications to the sanitary registry must not go against what is requested in the bidding documents. It is highlighted that by submitting the offer, the bidder undertakes to maintain the validity of the Sanitary Registry during the contractual execution and that any change in the Sanitary Registry must be notified immediately to UNOPS. Likewise, any change or inconsistency in the information provided to UNOPS could lead to the rejection of the offer. The information may be confirmed by UNOPS in the Sanitary Registry or before COFEPRIS before the contract is signed and during the contractual performance.

The presentation of the Sanitary Registry / Marketing Authorization in force and issued by any of the Regulatory Agencies with recognition of equivalence is maintained as an enabling technical criterion; or, Certificate of prequalification of the current medicine and issued by the WHO. The Sanitary Registration / Sanitary Authorization application process before COFEPRIS will be required as a complementary technical criterion and must be submitted within a term of no more than five (5) calendar days, once requested by UNOPS. In all cases, the bidder must correspond to the manufacturer, importer, Holder or Legal Representative of the Holder who will be registered and indicated in the Sanitary Registry / Marketing Authorization issued by COFEPRIS.

Good Manufacturing Practices (GMP) issued by Regulatory Agencies with recognition by COFEPRIS will be acceptable for submitting bids. However, the bidder must take into account that, for the delivery of the product in the designated warehouses, the medicines have a health registration issued by COFEPRIS, therefore, for the release in Mexico of the product, it must adhere to the required local regulations. . Additional information on the release in Mexico should be consulted with COFEPRIS.

Logistics, delivery sites, Incoterms

Tools are being developed to improve the interface between UNOPS and suppliers in order to facilitate the communication and exchange of Supply Order documents, delivery evidence, among others.

UNOPS maintains spaces for dialogue and monitoring of deliveries both with logistics operators and technical work tables with the Chamber and Pharmaceutical Associations, which allows timely monitoring of deliveries.

If these cases arise, the casuistry will be analyzed for resolution together with the relevant institutions and logistics operators through the established channels for contacting suppliers.

UNOPS will always be in the best position to meet delivery schedules. As mentioned in the specifications, changes in calendars may be requested by acceptance by the supplier.

UNOPS tiene su alcance de actuación en los almacenes centrales de los Operadores Logísticos asignados y no así la gestión de las entregas en puntos finales.

According to the terms of the specifications, the institutions may require a change in the delivery schedule, which will be conditional on the acceptance by the suppliers.

In the delivery guidelines shared by UNOPS at the time of sending the first Replenishment Orders, the forms of contact and reporting of these cases are indicated. Apart from this, we are always on the lookout for opportunities to create the necessary collaboration spaces.

The list of documents required for deliveries are available from Logistics Operators and it is recommended, as part of the UNOPS delivery management guidelines, that they be required prior to the first deliveries.

Others

It is currently only available in the English version. In the coming weeks, the Spanish version will be available at https://www.unops.org/es/busin...

It can be found on the website https://www.proyectosaludmexic... in the Events section.

No, communication must always be done through the official channel enabled, which is the project email.