Evaluation of bids/proposals, consideration for contract award and use of drugs in Vietnam

Evaluation of bids/proposals, consideration for contract award and use of drugs in Vietnam (Internet image)

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Evaluation of bids/proposals, consideration for contract award and use of drugs in Vietnam

According to Article 15 of Circular 07/2024/TT-BYT, the evaluation of bids/proposals, consideration for contract award and use of drugs in Vietnam is as follows:

(1) Bids/proposals shall be evaluated in accordance with regulations of law on bidding. During evaluation of the drug-related information, in addition to the documents provided by the bidder, the procuring entity may use the drug-related information (certificate of marketing authorization or import license), information on fulfillment of GMP requirements of the manufacturer and other information in official dispatches and/or decisions giving approval of Drug Administration of Vietnam, or Traditional Medicine Administration of Vietnam, or published on the websites of these authorities.

(2) The award of contract shall be subject to a bidder’s satisfaction of the prerequisites set out in Article 61 of the Law on Bidding 2023 and the issued bidding documents or RFP, and the following provisions:

- The procuring entity shall propose the successful bidder for each part specified in the approved drug supplier selection plan (except the contract package specified in Point b Clause 2 of this Article). Only a drug, herbal material or traditional medicinal material in a category (which is a part of the contract package) which satisfies technical and quality requirements specified in the bidding documents or RFP and for which the bid after error correction and deviation adjustment minus (-) discount (if any) is the lowest bid (if the least-cost method is applied), or the evaluated bid is the lowest bid (if the lowest evaluated bid method is applied), shall be proposed;

- Regarding a contract package of various drugs procured and packaged according to the requested quantity to serve disaster preparedness and control, search and rescue, or epidemic prevention and control: the procuring entity shall propose the successful bidder for the requested quantity (comprising multiple parts, called contract package) if the bidder meets technical and quality requirements specified in the bidding documents or RFP and its submitted bid for each part of the contract package and total value of the contract package after error correction and deviation adjustment minus (-) discount (if any) is the lowest bid (if the least-cost method is applied), or its evaluated bid is the lowest bid (if the lowest evaluated bid method is applied). In this case, the price of the contract package includes costs of packaging for the requested quantity of drugs.

(3) If there are changes in a drug bidded for during the drug supplier selection or the drug supply but the substitute drug is not offered in the bid or proposal, the purchaser may consider allowing the drug supplier to supply the substitute drug to meet its medical examination and treatment requirements in the following cases:

- There are changes in information on an original brand-name drug or reference biological in comparison with the information in the decision to grant marketing authorization:

= If the changes do not involve any contents of the decision to announce the list of original brand-name drugs and reference biologicals, a drug authority's approval for such changes is required or such changes must be disclosed following procedures for registration of changes in the marketing authorization;

= If there are changes in the contents of the decision to announce the list of original brand-name drugs and reference biologicals, such changes must be updated and included in the list of original brand-name drugs and reference biologicals;

- There are any of the following changes in information on a generic drug but its marketing authorization number remains unchanged: change in name of the drug; change in name of the manufacturer or the method for specifying address of the manufacturer (but the manufacturing factory is unchanged); changes in the manufacturing factory which do not influence on the manufacturer’s fulfillment of GMP requirements; increase in shelf life of the drug; changes in packaging specifications but the content, concentration or volume of the drug specified in the bidding documents or RFP remains unchanged; changes in quality specifications of the drug as a result of application of new version of Pharmacopoeia as prescribed; changes in quality specifications but new qualification specifications shall not be lower than those of the selected drug or offered in the bid or proposal;

- There are changes in the marketing authorization number of a generic drug or a new import license is issued but other information remains unchanged;

- There are changes in the marketing authorization number of a generic drug or a new import license is issued and there is one or some of the following changes: change in name of the drug; change in name of the manufacturer or the method for specifying address of the manufacturer (but the manufacturing factory is unchanged); changes in the manufacturing factory which do not influence on the manufacturer’s fulfillment of GMP requirements; increase in shelf life of the drug; changes in packaging specifications but the content, concentration or volume of the drug specified in the bidding documents or RFP remains unchanged; changes in quality specifications of the drug as a result of application of new version of Pharmacopoeia as prescribed; changes in quality specifications but new qualification specifications shall not be lower than those of the selected drug or offered in the bid or proposal.

(4) When supplying a substitute drug in the cases prescribed in Clause (3), the supplier shall provide all necessary information for the procuring entity for its evaluation of the substitute drug, including: decisions and official dispatches on approval of the changes issued by competent authorities, and explanations and/or commitments on unchanged quality specifications of the substitute drug.

(5) The head of the health facility and the successful drug supplier shall execute the drug supply contract in accordance with relevant laws on business contracts, and ensure that at least 80% of the value of each part in the signed contract shall be executed. For specially controlled drugs, intravenous fluids and other cases, after reporting to a competent authority, the health facility ensures that at least 50% of the value of each part in the signed contract shall be executed. For emergency treatment drugs, antidotes and rare drugs, public health facilities shall take actions appropriate for its actual conditions.

If a health facility fails to complete at least 80% or 50%, for specially controlled drugs and intravenous fluids, of the value of each part in the signed contract, its head shall be required to provide explanations to a competent person.

Nguyen Ngoc Que Anh

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