Public procurement notice: Contract Notice
Published: 2016-07-22
Buyer: PHI University Clinic of Otrinolaringology
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Estimated value: 120000 EUR
Submission deadline: 2016-08-23
Award criteria: Lowest price

Technical requirements: Evidence 1. Document on registered activity as an evidence that it is registered as a natural person or as a legal entity for performance of the activity related to the subject matter of the agreement on public procurement or an evidence that it belongs to appropriate professional association in accordance with the regulations of the country where it is registered.
Evidence 2. Valid decision for performance of an activity — wholesale of medical devices issued by the Ministry of Health of the Republic of Macedonia, or an appropriate document issued by a competent authority in the country where the bidder is registered.
— Valid Decision for an approval to place a medical device on the market on the territory of the Republic of Macedonia, issued by the Agency of Medicines and Medical Devices or
— Valid temporary or permanent approval for parallel import of the medical device, issued by the Agency for Medicines and Medical Devices.
— For the materials that it offers, the bidder should provide valid Decisions for approval to place a medical device on the market on the territory of the Republic of Macedonia, issued by the Agency of Medicines and Medical Devices,
The Bidder should have temporary and permanent approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices.
In order to be able to participate in the procedure, you should register in the EPPS and to possess a digital certificate. The economic operator registers in the EPPS by completing a registration form which is an integral part of the EPPS, whereby the EPPS automatically processes the data from the registration form, it generates a code and delivers it to the registered e-mail of the economic operator. More information about the manner of registration and the use of the system are available in the User Manual for the EPPS intended for economic operators, which can be downloaded from the home page of the EPPS in the part ‘Economic operators’.

Eligibility requirements: Evidence 1. Document on registered activity as an evidence that it is registered as a natural person or as a legal entity for performance of the activity related to the subject matter of the agreement on public procurement or an evidence that it belongs to appropriate professional association in accordance with the regulations of the country where it is registered. Evidence 2. Valid decision for performance of an activity — wholesale of medical devices issued by the Ministry of Health of the Republic of Macedonia, or an appropriate document issued by a competent authority in the country where the bidder is registered. Not required. Required documents to prove the technical or professional ability of the economic operator: — Valid Decision for an approval to place a medical device on the market on the territory of the Republic of Macedonia, issued by the Agency of Medicines and Medical Devices or — Valid temporary or permanent approval for parallel import of the medical device, issued by the Agency for Medicines and Medical Devices. — For the materials that it offers, the bidder should provide valid Decisions for approval to place a medical device on the market on the territory of the Republic of Macedonia, issued by the Agency of Medicines and Medical Devices, or The Bidder should have temporary and permanent approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices.
Not required.
Required documents to prove the technical or professional ability of the economic operator: — Valid Decision for an approval to place a medical device on the market on the territory of the Republic of Macedonia, issued by the Agency of Medicines and Medical Devices or — Valid temporary or permanent approval for parallel import of the medical device, issued by the Agency for Medicines and Medical Devices. — For the materials that it offers, the bidder should provide valid Decisions for approval to place a medical device on the market on the territory of the Republic of Macedonia, issued by the Agency of Medicines and Medical Devices, or The Bidder should have temporary and permanent approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices.
Required documents to prove the technical or professional ability of the economic operator: — Valid Decision for an approval to place a medical device on the market on the territory of the Republic of Macedonia, issued by the Agency of Medicines and Medical Devices or — Valid temporary or permanent approval for parallel import of the medical device, issued by the Agency for Medicines and Medical Devices.
— For the materials that it offers, the bidder should provide valid Decisions for approval to place a medical device on the market on the territory of the Republic of Macedonia, issued by the Agency of Medicines and Medical Devices, or The Bidder should have temporary and permanent approval for parallel import of the medical device issued by the Agency for Medicines and Medical Devices.