Contractual / legal

1. If we have a contract with a validity of 24 months but it is negotiated for 12 months, does it mean that the negotiated / non-contracted period will not be respected?

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.

2. Where can you review the failures of this year's event?

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

3. What will be the process to follow in case of not having all the lots requested in the supply orders? Will they accept the extension letter??

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. "

4. How could we request any clarification regarding the clarifying notes?

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.

5. What actions are you going to take for the presentation of the guarantee / surety to sustain offers, since surety companies do not guarantee "on first demand"?

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”.

6. Regarding the clarification procedure, will there be a deadline for UNOPS to publish clarifications?

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

7. What are the filters or eligibility criteria you mentioned to designate the award?

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.

Formal and eligibility criteria:

• The presentation of the offer complies with the format provided, indicates the validity of the required offer, is signed by the representative and the bidder accepts the general and special conditions of the contract
• The Bid Sustainment Guarantee complies with what is required in Bid Details
• The Warranty Manifest complies with what is required in Tender Details
• The information has been presented in full
• The bidder meets the eligibility criteria established in Article 4 of the Instructions for Bidders
• The person who signs the offer has authorization

Qualification criteria (Prequalification):

• The bidder is legally constituted
• The bidder's business line is related to the purpose of this process
• The bidder has executed contracts for similar goods
• Liquidity ratio

Enabling administrative criteria:

• Compliance with quantities offered
• Compliance with required delivery times

Enabling technical criteria:

• The medicine has a Sanitary Registry / Marketing Authorization approved by COFEPRIS; or, Sanitary Registry / Marketing Authorization issued by any of the Regulatory Agencies with recognition of equivalence (listed by UNOPS); or, Certificate of prequalification of the current medicine and issued by the WHO
• Correspondence of the product with the National Compendium of Health Supplies and compliance with national regulations

Complementary technical criteria:

• Current Good Manufacturing Practices Certificate issued by the Regulatory Entity
• The drug complies with the labeling
• The drug meets the quality criteria offered
• The heat-labile medicine complies with the special conditions for its commercialization
• Proof of initiation of the Sanitary Registration application process before COFEPRIS (When applicable)

Price evaluation:

The offers with the lowest price per lot that have passed the evaluation of the complementary technical criteria will be subjected to an analysis of price reasonableness and negotiation in order to determine the recommendation.

8. Do you have an estimated date of when you will begin to prequalify non-participating suppliers on the previous tender?

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.

9. Will you allow suppliers to update their prices year to year?

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

Shopping 2022

10.Do you have an estimated start date for the procedure?

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

11.By 2022, will the presentation of offers for patents and prioritized drugs be through e-sourcing or through the negotiation tables as in 2021?

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.

12.Are you going to make public the information of awards by code for this year to have the reference prices for next year?

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

13.When will you launch the dates for the market study for the 2022-2024 supply tenders?

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

14. Will the tender to be published for the 2022-2024 supply have reference prices?

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

15.For the 2022 purchase, will bidders who are not holders of the sanitary registry or manufacturers of the products participate?

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.

16.For the pre bases for supply 2022, what time will you allow for comments and observations?

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

17.By 2022, will the presentation of offers for patents and prioritized drugs be through e-sourcing or through the negotiation tables as in 2021?

See answer to question number 12.

18. Can distributors represent labs in Consolidated Purchase 2022 or just record holders?

See answer to question number 16.

19.Will the next tender be only for 2022 or will it be multi-year 2022-2024?

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

Technical file / Technical specifications

20.To know the demand of each institution, will it be possible to know the disaggregated demand?

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

21. If my client already has prequalification, for new calls for bids, what documents are omitted with this prequalification?

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.

22.Once I have been prequalified, during the lifetime of the LTA the financial capacity changes, would that be a disqualifying reason in the evaluation?

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.

23. For consortia, we understand that even when they belong to a pharmaceutical Group, can they participate individually without falling into conflict of interest?

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.

24. Bidders who do not have an LTA but can bid on a product. How is the process to enter an offer?

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.

25. Will the LTA keys that are established by UNOPS be published so that the rest of the industry knows them?

See answer to question number 13.

Regulatory framework / Sanitary registry

26.Considering that the quantities required are very high, will two sources of supply be considered?

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.

27. In the 3 calls for bids referred to in subsection a), another requirement manifested in the Details of the Announcement, in the category of Partial Bids, was that the bidders should offer 100% of the quantities specified for each product of a lot; However, in the aforementioned Technical Session, UNOPS pointed out that for the 2022 purchase, partialities of medicines may already be offered in a single batch. In this regard, and in order to carry out an effective planning of the production of our goods, we attentively request the ratification of this new provision; as well as if they could share with us the methodology that they will implement in said requirement.

Please refer to answer number 26 of this document.

28. If it is attributable to the contracting party, will short expiration dates be accepted??

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.

29. A change in the sanitary registry, can the offer be presented with the current registry and later present the new one?

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.

30.In the 3 calls for bids that we participated for generic products, one of the Qualifying Technical Criteria to be able to present a proposal was that the drugs that did not have the Sanitary Registry issued by COFEPRIS, had to present the following 2 requirements:

• Current Health Registry issued by any of the Regulatory Agencies with recognition of equivalence; the bidder appearing as the holder of the registry or legal representative of the holder of the sanitary registry.
• Proof of initiation of the request for the Sanitary Registry before COFEPRIS (indicating that the successful bidder for the formalization of the respective contract should present the sanitary registry issued by COFEPRIS).

Can you please confirm if these two requirements will continue to apply for the 2022 purchase?

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.

31.In case of participating in a Call for Bids for generic drugs, with a biocomparable product that does not have the GMP issued by COFEPRIS, will it be enough to present Good Manufacturing Practices (GMP) issued by a recognized agency for the release in Mexico of the product?

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

32.Have you ever thought about considering EDI communication (Electronic Data Interchange) to speed up the sending and receiving of invoices and purchase orders?

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.

33.How will you improve the issue of receipt of supplies?

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.

34.There are cases in which the wineries do not want to receive the products and this affects the payment of the entire order.

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.

35.Regarding delivery schedules, is UNOPS adherence to them guaranteed?

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.

36.What about government warehouses that don't recognize purchase orders?

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.

37.Is there an opportunity for the institutions (IMSS) to request advance deliveries?

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.

38.In deliveries to logistics operators they do not want us to receive product. what can we do?

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.

39.When will they officially publish the documents required by logistics operators for deliveries?

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

40.Where can we find the new UNOPS procurement manual in Spanish?

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/business-opportunities/how-we-procure

41.Where can we find the presentation / material they gave today?

It can be found on the website https://www.proyectosaludmexico.org/eventos.htmlg in the Events section.

42.Apart from email, is there any other means of communication with you?

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