In Vietnam: What shall be done in case an offered drug is changed during the contractor selection process?

Pursuant to Clause 6 Article 37 of the Circular 15/2019/TT-BYT (takes effect from 01/10/2019) stipulating as follows:

If an offered drug is changed during the contractor selection process, or the drug is supplied but the substitute drug is not offered in the bid, the investor may consider allowing the contractor to supply the substitute drug, to be specific:

- The name of the drug or the factory or package content is changed during its sale but the number of marketing authorization certificate or number of import license remains unchanged;

- The number of marketing authorization certificate is changed or new import license is issued but other information remains unchanged (name of drug, manufacturer, quality standards, shelf life, category); quality standards can be changed but the standard level and quality criteria shall not be lower than that of the selected drug (or offered in the bid or updated on Pharmacopoeia);

When using the substitute drug, the contractor must provide every information necessary for the procuring entity to evaluate the replacement, including: copies (certified by the contractor) of the marketing authorization or certificate of pharmaceutical product, written permissions from regulatory authorities (if any) and explanation for the unchanged quality standards of the offered drug and substitute drug.

- The selected proprietary drug or reference bioequivalence (or offered in the bid) whose the number of marketing authorization certificate or other information and the alternative drug on the list of orginal branded drugs or the list of reference bioequivalence published by Ministry of Health;

- Changes in name specification of herbal ingredients do not change components of the drug and allowed by the competent authority.

Best regards!