Public procurement notice: Prior Information Notice Without Call For Competition
Published: 2021-03-26
Buyer: Centrul pentru Achiziţii Publice Centralizate în Sănătate
Country: MD
Contract type: Supplies
CPV classification: 33600000: Pharmaceutical products
Estimated value: 70000000 MDL

Technical requirements: The vaccine that obtained conditional marketing authorization in the Republic of Moldova (at the time of opening of tenders), or authorized by the European Medicines Agency (hereinafter EMA) (at the time of opening of tenders) or authorized by the United States Food and Drug Administration (FDA USA) (at the time of opening of tenders) or included in the World Health Organization list for emergency use (Emergency Use Listing) or in the list of COVID-19 vaccines in the WHO EUL / PQ evaluation process at the time of opening of tenders is eligible.
* If the vaccine hasn’t obtained conditional marketing authorization in the Republic of Moldova the tenderer will present the proof of conditional authorization for the vaccine obtained in the country of origin (Regulatory approval) (at the time of opening of tenders).
* The vaccine must have a high safety and efficacy profile. The efficacy of the vaccine needs to be higher than 60 %.
* Statement from the tenderer guaranteeing the delivery of the vaccine with a remaining shelf life not less than 80 % of the initial term (at the time of delivery).
* GMP certificate - copy in state or Russian or English languages additionally supplemented with the electronic signature of the participant valid at the time of opening the tender.
* At the time of opening the tenders, the tenderer will submit a Statement from the vaccine manufacturer, guaranteeing the delivery of the vaccine in the quantity and terms of delivery required in the award documentation.
* Summary of product characteristics: - complete, with full specification of the age for which it can be administered. (to be translated into the state or Russian or English languages).
* Statement from the tenderer guaranteeing the delivery of the vaccine in accordance with uninterrupted cold chain conditions of - according to the manufacturer's instructions throughout the route from the manufacturer to the consignee, certified by special temperature recording devices.
* Within 5 days from the date of notification of the results of the public procurement procedure, the winner tenderer will submit to the contracting authority and the Public Procurement Agency:
Statement on the confirmation of the identity of the beneficial owners and their non-involvement in conviction for participation in the activities of a criminal organization or groups, for corruption, fraud and/or money laundering, in accordance with the model approved by the Order of the Ministry of Finance no. 145 of 24 November 2020.
* At the time of delivery of the vaccine, the winner tenderer shall ensure that each batch of vaccine is accompanied by the batch release certificate issued by the national control authority of the country of origin and the certificate of conformity issued by the manufacturer and the protocol of tests and trials performed by manufacturer certifying the quality of the product, Certificate of origin of the product.
* The winner tenderer will ensure that the vaccine obtains conditional marketing authorisation in the Republic of Moldova until the time of delivery.


Award value: 70000000