Public procurement notice: Contract Notice
Published: 2019-03-12
Buyer: PHI University Clinic of Otrinolaringology
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Estimated value: 150000 EUR
Submission deadline: 2019-04-17
Award criteria: The most economic tender

Technical requirements: Lääketieteelliset laitteet, farmaseuttiset valmisteet ja henkilökohtaiseen hygieniaan liittyvät tuotteet
A document for registered activity — a form of a DRD as proof that it is registered as a physical or legal entity for performing the activity related to the subject of the public procurement contract or evidence that it belongs to an appropriate professional association in accordance with the regulations of the country where it is registered.
— Decision for wholesale of medicinal products in accordance with the Law on medicinal products and medical devices
Statement for hired trained personnel, who will provide support for intraoperative measurements of surgery and who will be present during postoperative inclusion and speech adjustment processor that manages the operation of the cochlear implant, in the client's premises — Statement for engaged doctor-surgeon who will attend the surgical intervention and support performing cochlear implantation, in the client's premises. For the registered medical devices:
— a solution for placing a medical device on the market either temporarily or permanent approval for parallel import, in accordance with the Law on medicines and medical devices.
Condition 1 The bidders should ensure the presence of trained personnel on surgical intervention (min. 1 person), trained by the manufacturer or other entity authorised by the manufacturer, who will provide support for intraoperative measurements during surgery as well as for postoperative surgery. Inclusion and tuning of the speech processor that manages the work of the cochlear implant, in premises of the conditioner.
Condition 2: The bidder should provide the presence of a surgeon-doctor on surgical intervention, which will provide support when performing cochlear implantation, in the premises of the client Condition 3: For the registered medical means:
— The economic operator for the goods offered to have been granted marketing authorisation for medicinal products or temporary or permanent approval for parallel import, in accordance with the Medicines and Medical Law funds.
— The economic operator for the offered goods has provided a document permitting import (approval for interim import) in accordance with the Law on medicines and medical devices.
In order for you to participate in the procedure, you need to register in the EPPS and have a digital certificate. The economic operator is registered in the ESPP by filling in the registration form which is an integral part of the ESPP, after which the EPPS automatically processes the data from the registration form, generates a code and the same one submitted to the registered e-mail of the econ

Eligibility requirements: A document for registered activity — a form of a DRD as proof that it is registered as a physical or legal entity for performing the activity related to the subject of the public procurement contract or evidence that it belongs to an appropriate professional association in accordance with the regulations of the country where it is registered. — Decision for wholesale of medicinal products in accordance with the Law on medicinal products and medical devices

Award value: 150000