Contract notice: Various medicinal products Tender, Bulgaria - 24560920

Procurement Summary

Country : Bulgaria

Summary : Contract notice: Various medicinal products

Deadline : 02 Aug 2018

Other Information

Notice Type : Tender

TOT Ref.No.: 24560920

Document Ref. No. : 276664-2018

Competition : ICB

Financier : Self Financed

Purchaser Ownership : -

Tender Value : Refer Document

Purchaser's Detail

Purchaser : ???????????? ?? ????????????????
Office Name: ???????????? ?? ????????????????
Address: ??. „????? ??????“ ? 5
Town: Sofia
Postal Code: 1000
Contact Point: ???? ???????

Phone: +359 29301-314
Fax: +359 29301-451
Bulgaria
Email :vmitkova@mh.government.bg
URL :https://www.mh.government.bg/

Tender Details

Object of the contract
Various medicinal products

Description: Contract notice: Various medicinal products

Authority Type: Ministry or any other national or federal authority
Contact Nature: Supplies
Procedure: Open procedure
Document: Contract notice
Regulation: European Union
Award criteria: Lowest price
CPV code: 33690000, 33690000, 09344000, 33690000, 09344000
CPV Description: Radioactive isotopes - "Supply of radioactive medicinal products, radiopharmaceuticals, radionuclide generators, whales and radionuclide precursors for 2018" on terminated lots - "Supply of radioactive medicinal products, radiopharmaceuticals, radionuclide generators, whales and radionuclide precursors for 2018. " on terminated lots, including 10lots:

Main Site: Gr. Sofia, Pleven, Plovdiv, Varna, Stara Zagora, Bourgas, Vratsa, Veliko Tarnovo, Rousse, Shumen, Gabrovo

Supply of Sodium Iodide [ 131 I] 740 MBq solution for injection - up to 106 op.x1, depending on the needs of the Assignor. The participants in the procedure for all lots have a valid license fortransport of radioactive substances, according to Art. 15, para. 3, item 5 of the Act on the Safe Use of Nuclear Energy (ASUNE) issued by the Nuclear Regulatory Agency - Documents for the set criterion to be submitted upon request in the course of the procedure in the cases of Art. 67, para. 5 and para. 6 of the Public Procurement Act or by the contractor designated as contractor prior to the conclusion of the contract are: a copy of a valid licensefor the transport of radioactive substances pursuant to Art. 15, para. 3, item 5 of the Safe Use of Nuclear Energy Act (ASUNE) issued by the Nuclear Regulatory Agency - The compliance with the stated criterion shall be declared by filling in Part IV, Section "A" of the EUEDOP. Sections 1 to 3, including a manufacturing authorization issued under the terms of nand the Law on Medicinal Products in Human Medicine (LMPHM) (in the cases under Article 196 (1) of LMPHM) or for wholesale trade in medicinal products or a certificate for the wholesale registration of medicinal products (the cases under Article 195, paragraph 1 and paragraph 2 of LMPHM), or an import permit (the cases under Article 196 (2) of LMPHM) - issued under the LMPHM - The documents for the criterion set, which are presented on request in the course of the procedure, in the cases of Art. 67, para. 5 and para. 6 of the Public Procurement Act or by the participant designated as contractor prior to the conclusion of the contract are: a copy of a valid manufacturing authorization issued under the Law on Medicinal Products for Human Medicine (LMPHM) (in the cases under Article 196, paragraph 1 of LMPHM) or for wholesale of medicinal products or certificates(the cases referred to in Article 195 (1) and (2) of the LMPHM) or an import permit (the cases under Article 196 (2) of LMPHM), issued in accordance with Compliance with the criterion set out shall be declared by filling in Part IV, Section "A" of the EDEPOP

3. Participants in the procedure under Lot No 4 No 5 No 6 No 7 No 8 No 9 No 10 to match andthe requirements of Art. 77, para. 1 or para. (2) of the Medical Devices Act (MIR).

Documents for the criterion submitted, submitted on request in the course of the procedure, in the cases of Art. 67, para. 5 and para. 6 of the Public Procurement Act or by the participant designated as contractor prior to the conclusion of the contract are: a copy of a valid wholesale license for medical devices from the Bulgarian Drug Agency-(BDA) or other document attesting to their right to trade in medical devices issued by a competent authority of another Member State or of another State Party to the Agreement on the European Economic Area or the Swiss Confederation or to be established in the territory of the Republic of Bulgaria.

Compliance with the set criterion is declared by filling in the itemThe contractor has no requirements to the participants for economic and financial condition

1 The guarantee for performance of the contract amounts to 3% (three percent) of the value of the contract for performance of the public procurement contract, excluding the VAT.

The guarantee for the performance of the contract may be deposited by bank transfer or may be presented in the form of a bank guaranteeor insurance that ensures performance by covering the contractor's liability. The participant chooses the form of the guarantee itself. Payment is made by bank transfer from the client to the contractor's bank account. The payment of the goods under the contract shall be postponed within 30 days after the submission of the following documents: - Delivery invoice, (3) (3), - Written applications - Allotments, copies of the documents, - Documents of the Ministry of Health, according to the Ministry of Health, prepared by the Ministry of Health and endorsed by the final recipients.

Medicinal products should be presented: - Certificate of release of each batch, issued by a qualified person under LMPHM - certified copy by the contractor, translated into Bulgarian by a company that has signed a contract with the Ministry of Foreign Affairs for official translations. to be submitted: - Declaration of conformity by the manufacturer or his authorized representative - for separateitems 4 to 10 that are designated as medical devices, - Valid certificate for a quality management system implemented according to BDS EN ISO 13485 or an equivalent certificate (certified copy of the original and translation) issued in the name of the manufacturer - for lots 4 to 10, - Declaration of conformity by the manufacturer or his authorized representative with substantialthe requirements of Directive 98/79 / EC for headings 4 to 10. - 3. Schedule for execution of supplies and duration of the contract (s): The MH distributes the necessary quantities in up to 2 valid written applications - allocations according to the available budget funds. Initial delivery is executed within 20 calendar days of the date of serviceand delivery under the contract is done weekly according to the individual needs of the healthcare establishments within the approved written application - distribution by the Ministry of Health - If the approved second written application - distribution by MH will not be executed at 100% due to lack of reported needs of the medical establishments, the provider shall notify the Directorate - h until 28.2.2019Applicant

4. Content of the participant's proposal according to the documentation for participation. When the selection criteria for the individual lots are the same, they are allowed to submit a single application form.


Internet address (URL): https://www.mh.government.bg/
Directive: Classical Directive (2014/24/EU)

Documents

 Tender Notice