Public procurement notice: Contract Notice
Published: 2017-02-15
Buyer: Ss. Cyril and Methodius University Faculty of Medicine Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33124131 | 33694000 | 33696500
Estimated value: 15476832 MKD
Submission deadline: 2017-03-27
Award criteria: Lowest price

Technical requirements: ELISA test to detect antigen of Cryptosporidium parvum and Cryptosporidium hominis from feces: microtiter plate with a maximum of 96 well (divisible into strips) coated with a specific antibody to the antigen of Cryptosporidium parvum and Cryptosporidium hominis, buffer for dilution of sample (buffered solution) min 100 ml, buffer washing (buffered solution, concentrated with thimerosal) min 100 ml, positive control (inactivated antigen of Cryptosporidium) min 2 ml, negative control (buffer) min 2 ml, conjugate 1 (antibody specific AG of Cryptosporidium conjugated with biotin in stabilized protein solution) min. 11 ml, 2 conjugate (Streptavidin poly-peroxidaza stabilized protein conjugate in solution) min. 11 ml, substrate (chromogen, tetramethyl-benzidine and peroxide) min. 13 ml, stop reagent min. 8 ml.
ELISA test for the detection of mannan antigen of Candida in human samples: microtiter plate 96-well coated with anti-mannan monoclonal antibodies EBCA-1 washing buffer (buffered solution, concentrated) min. 70 ml, calibrator 0 — Tris NaCl trehalose buffer, min. 2 ml, calibrator 62.5 — Tris NaCl trehalose buffer, min. 2 ml, 125 calibrator -Tris NaCl trehalose buffer, min. 2 ml, 250 calibrator — Tris NaCl trehalose buffer, min. 2 ml, calibrator 500 — Tris NaCl buffer trehalose min. 2 ml, anti-mannan conjugate monoclonal antibody labeled with peroxidase min. 17 ml, positive control (containing serum mannan antigen Candida) min. 1.5 mL, negative control (human serum which does not contain mannan antigen naCandida) min 1.5 mL, TMB substrate (chromogen 3,3 ‘, 5,5’-tetramethylbenzidine) min. 28 ml, stop reagent min. 28 ml.
ELISA test for detection of Aspergillus galactomannan antigen in human samples: microtiter plate 96-well coated with anti-galactomannan monoclonal antibody, washing buffer (buffered solution, concentrated) min. 70 ml, anti-galactomannan conjugate monoclonal antibody labeled with peroxidase min. 8 ml, positive control (serum containing galactomannan antigen of Aspergillus) min. 1.7 mL, negative control (human serum that contains galactomannan antigen of Aspergillus) min 1.7 mL, TMB substrate (chromogen-3,3 ‘, 5,5’-tetramethylbenzidine) min. 28 ml, stop reagent min. 28 ml.
Microimmunofluorescence test for the detection of specific IgM, IgA and IgG antibodies to Chlamydia trachomatis; microscopic glass caused by antigens (PPE) of the species or serotypes of the purified elementary bodies of Chlamydia trachomatis; semikvantitativen test to determine the titer of IgM, IgA and IgG antibodies; controls (positive and negative human serum specially for IgG, IgM and IgA) and antihuman immunoglobulin conjugated with flourescein (FITC reagent).
Microimmunofluorescence test for the detection of specific IgM, IgA and IgG antibodies to C.psittaci; Microscopic glass caused by antigens (PPE) of species or serotypes of the purified elementary bodies of chlamydia C.psittaci; semi-equivalent test to determine the titer of IgM, IgA and IgG antibodies; controls (positive and negative human serum specially for IgG, IgM and IgA) and anti-human immunoglobulin conjugated with flourescein (FITC reagent).
Statement by the economic operator that it has not been sentenced, in the last 5 years, with effective Court decision for participation in criminal organization, corruption, fraud or money laundering;
Certificate for paid taxes, contributions and other public dues by the competent authority in the country wherethat economic operator is established;
Certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — prohibition toparticipate in public competitions, public procurement contract award and public-private partnership contractaward procedures;
Certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — temporary or permanent prohibition to perform certain professional activity;
Certificate that it is not being sanctioned for misdemeanor with an effective Court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing certain activity.
— Certificate for wholesale of medical devices in accordance with the Law on medicines and medical devices.
Certificate for sale of the medical device or temporary or permanent Approval for parallel import in accordance with the Law on medicines and medical devices for Group: 132. (Code: 8117, 4488, 3482, 3483, 4493, 4917, 2572 and 8110); Group: 141. (Code: 7819, 7006, 7005 and 7824); Group: 142. (codes 2666 and 2667); Group: 346. Code: 6998, 7554, 6996, 6995, 2576, 6991, 6999, 6989 and 6994; Group: 347. Codes: 2677 and 2658;
License to Import (authorization for intervention import) in accordance with the Law on medicines and medical devices for Group: 132. code 6057; Group: 141. Code: 3484, 3485, 7823, 2656 и 6576; Group: 141 — G. Code: 2662 and 2661; Group: 272. Code: 6687, 8459, 8460, 8472, 8461, 8462, 8466, 8467, 8468, 8464, 8469, 8451, 8452, 8447, 8448, 8449, 8457, 8453, 8463, 8450, 8465, 8458, 8492, 8442, 8445, 8446, 8443, 8444, 8454, 8455, 8456, 8440, 8441, 8491, 8493, 8482, 8487, 8488, 8485, 8489, 8486, 8480, 8481, 8490, 8495, 8499, 8500, 8501, 8502, 8503, 8494, 8470, 8484, 8483, 8479, 8439, 8438, 8496, 8497, 8498, 8504, 8505, 8506, 8507, 8508, 8509, 8473, 8476, 8477, 6682, 6690, 8478, 8475, 8474, 6686 and 8471; Group: 343 — А. code: 8321, 8320 and 8322.
(please see tender documentation or the link provided in additional information for the correspondence of internal codes with Lot numbers).
For the Registered medical devices:The economic operator for the items of Group: 132. Code: 8117, 4488, 3482, 3483, 4493, 4917, 2572 and 8110; Group: 141. Codes 7819, 7006, 7005 and 7824; Group: 142. codes 2666 and 2667; Group: 346. Code: 6998, 7554, 6996, 6995, 2576, 6991, 6999, 6989 and 6994; Group: 347. Codes: 2677 and 2658, to have obtained approval for sale of the medical device or temporary or permanent Approval for parallel import in accordance with the Law on medicines and medical devices;

Eligibility requirements: Statement by the economic operator that it has not been sentenced, in the last 5 years, with effective Court decision for participation in criminal organization, corruption, fraud or money laundering; Certificate that it is not subject to bankruptcy procedure issued by competent authority; Certificate that it is not subject to liquidation procedure issued by competent authority; Certificate for paid taxes, contributions and other public dues by the competent authority in the country wherethat economic operator is established; Certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — prohibition toparticipate in public competitions, public procurement contract award and public-private partnership contractaward procedures; Certificate from the Legal Entities Penal Registry that it is not being imposed a side sanction — temporary or permanent prohibition to perform certain professional activity; Certificate that it is not being sanctioned for misdemeanor with an effective Court decision, resulting in prohibition for pursuing professional activity or duty, i.e. temporary prohibition for performing certain activity. Ability for performing professional activity of the economic operator: — Document for registered business activity; — Certificate for wholesale of medical devices in accordance with the Law on medicines and medical devices. For the Registered medical devices: Certificate for sale of the medical device or temporary or permanent Approval for parallel import in accordance with the Law on medicines and medical devices for Group: 132. (Code: 8117, 4488, 3482, 3483, 4493, 4917, 2572 and 8110); Group: 141. (Code: 7819, 7006, 7005 and 7824); Group: 142. (codes 2666 and 2667); Group: 346. Code: 6998, 7554, 6996, 6995, 2576, 6991, 6999, 6989 and 6994; Group: 347. Codes: 2677 and 2658; For the unregistered medical devices: License to Import (authorization for intervention import) in accordance with the Law on medicines and medical devices for Group: 132. code 6057; Group: 141. Code: 3484, 3485, 7823, 2656 и 6576; Group: 141 — G. Code: 2662 and 2661; Group: 272. Code: 6687, 8459, 8460, 8472, 8461, 8462, 8466, 8467, 8468, 8464, 8469, 8451, 8452, 8447, 8448, 8449, 8457, 8453, 8463, 8450, 8465, 8458, 8492, 8442, 8445, 8446, 8443, 8444, 8454, 8455, 8456, 8440, 8441, 8491, 8493, 8482, 8487, 8488, 8485, 8489, 8486, 8480, 8481, 8490, 8495, 8499, 8500, 8501, 8502, 8503, 8494, 8470, 8484, 8483, 8479, 8439, 8438, 8496, 8497, 8498, 8504, 8505, 8506, 8507, 8508, 8509, 8473, 8476, 8477, 6682, 6690, 8478, 8475, 8474, 6686 and 8471; Group: 343 — А. code: 8321, 8320 and 8322. (please see tender documentation or the link provided in additional information for the correspondence of internal codes with Lot numbers). For the Registered medical devices:The economic operator for the items of Group: 132. Code: 8117, 4488, 3482, 3483, 4493, 4917, 2572 and 8110; Group: 141. Codes 7819, 7006, 7005 and 7824; Group: 142. codes 2666 and 2667; Group: 346. Code: 6998, 7554, 6996, 6995, 2576, 6991, 6999, 6989 and 6994; Group: 347. Codes: 2677 and 2658, to have obtained approval for sale of the medical device or temporary or permanent Approval for parallel import in accordance with the Law on medicines and medical devices; For the Unregistered medical devices the economic operator for the offered items of Group: 132. code 6057; Group: 141. Code: 3484, 3485, 7823, 2656 и 6576; Group: 141 — G. Code: 2662 and 2661; Group: 272. Code: 6687, 8459, 8460, 8472, 8461, 8462, 8466, 8467, 8468, 8464, 8469, 8451, 8452, 8447, 8448, 8449, 8457, 8453, 8463, 8450, 8465, 8458, 8492, 8442, 8445, 8446, 8443, 8444, 8454, 8455, 8456, 8440, 8441, 8491, 8493, 8482, 8487, 8488, 8485, 8489, 8486, 8480, 8481, 8490, 8495, 8499, 8500, 8501, 8502, 8503, 8494, 8470, 8484, 8483, 8479, 8439, 8438, 8496, 8497, 8498, 8504, 8505, 8506, 8507, 8508, 8509, 8473, 8476, 8477, 6682, 6690, 8478, 8475, 8474, 6686 and 8471; Group: 343 — А. code: 8321, 8320 and 8322 to have obtained a permit to import (authorization for intervention import) in accordance with the Law on medicines and medical devices. (please see tender documentation or the link provided in additional information for the correspondence of internal codes with Lot numbers).
For the Registered medical devices: Certificate for sale of the medical device or temporary or permanent Approval for parallel import in accordance with the Law on medicines and medical devices for Group: 132. (Code: 8117, 4488, 3482, 3483, 4493, 4917, 2572 and 8110); Group: 141. (Code: 7819, 7006, 7005 and 7824); Group: 142. (codes 2666 and 2667); Group: 346. Code: 6998, 7554, 6996, 6995, 2576, 6991, 6999, 6989 and 6994; Group: 347. Codes: 2677 and 2658; For the unregistered medical devices: License to Import (authorization for intervention import) in accordance with the Law on medicines and medical devices for Group: 132. code 6057; Group: 141. Code: 3484, 3485, 7823, 2656 и 6576; Group: 141 — G. Code: 2662 and 2661; Group: 272. Code: 6687, 8459, 8460, 8472, 8461, 8462, 8466, 8467, 8468, 8464, 8469, 8451, 8452, 8447, 8448, 8449, 8457, 8453, 8463, 8450, 8465, 8458, 8492, 8442, 8445, 8446, 8443, 8444, 8454, 8455, 8456, 8440, 8441, 8491, 8493, 8482, 8487, 8488, 8485, 8489, 8486, 8480, 8481, 8490, 8495, 8499, 8500, 8501, 8502, 8503, 8494, 8470, 8484, 8483, 8479, 8439, 8438, 8496, 8497, 8498, 8504, 8505, 8506, 8507, 8508, 8509, 8473, 8476, 8477, 6682, 6690, 8478, 8475, 8474, 6686 and 8471; Group: 343 — А. code: 8321, 8320 and 8322. (please see tender documentation or the link provided in additional information for the correspondence of internal codes with Lot numbers). For the Registered medical devices:The economic operator for the items of Group: 132. Code: 8117, 4488, 3482, 3483, 4493, 4917, 2572 and 8110; Group: 141. Codes 7819, 7006, 7005 and 7824; Group: 142. codes 2666 and 2667; Group: 346. Code: 6998, 7554, 6996, 6995, 2576, 6991, 6999, 6989 and 6994; Group: 347. Codes: 2677 and 2658, to have obtained approval for sale of the medical device or temporary or permanent Approval for parallel import in accordance with the Law on medicines and medical devices; For the Unregistered medical devices the economic operator for the offered items of Group: 132. code 6057; Group: 141. Code: 3484, 3485, 7823, 2656 и 6576; Group: 141 — G. Code: 2662 and 2661; Group: 272. Code: 6687, 8459, 8460, 8472, 8461, 8462, 8466, 8467, 8468, 8464, 8469, 8451, 8452, 8447, 8448, 8449, 8457, 8453, 8463, 8450, 8465, 8458, 8492, 8442, 8445, 8446, 8443, 8444, 8454, 8455, 8456, 8440, 8441, 8491, 8493, 8482, 8487, 8488, 8485, 8489, 8486, 8480, 8481, 8490, 8495, 8499, 8500, 8501, 8502, 8503, 8494, 8470, 8484, 8483, 8479, 8439, 8438, 8496, 8497, 8498, 8504, 8505, 8506, 8507, 8508, 8509, 8473, 8476, 8477, 6682, 6690, 8478, 8475, 8474, 6686 and 8471; Group: 343 — А. code: 8321, 8320 and 8322 to have obtained a permit to import (authorization for intervention import) in accordance with the Law on medicines and medical devices. (please see tender documentation or the link provided in additional information for the correspondence of internal codes with Lot numbers).
For the Registered medical devices: Certificate for sale of the medical device or temporary or permanent Approval for parallel import in accordance with the Law on medicines and medical devices for Group: 132. (Code: 8117, 4488, 3482, 3483, 4493, 4917, 2572 and 8110); Group: 141. (Code: 7819, 7006, 7005 and 7824); Group: 142. (codes 2666 and 2667); Group: 346. Code: 6998, 7554, 6996, 6995, 2576, 6991, 6999, 6989 and 6994; Group: 347. Codes: 2677 and 2658; For the unregistered medical devices: License to Import (authorization for intervention import) in accordance with the Law on medicines and medical devices for Group: 132. code 6057; Group: 141. Code: 3484, 3485, 7823, 2656 и 6576; Group: 141 — G. Code: 2662 and 2661; Group: 272. Code: 6687, 8459, 8460, 8472, 8461, 8462, 8466, 8467, 8468, 8464, 8469, 8451, 8452, 8447, 8448, 8449, 8457, 8453, 8463, 8450, 8465, 8458, 8492, 8442, 8445, 8446, 8443, 8444, 8454, 8455, 8456, 8440, 8441, 8491, 8493, 8482, 8487, 8488, 8485, 8489, 8486, 8480, 8481, 8490, 8495, 8499, 8500, 8501, 8502, 8503, 8494, 8470, 8484, 8483, 8479, 8439, 8438, 8496, 8497, 8498, 8504, 8505, 8506, 8507, 8508, 8509, 8473, 8476, 8477, 6682, 6690, 8478, 8475, 8474, 6686 and 8471; Group: 343 — А. code: 8321, 8320 and 8322. (please see tender documentation or the link provided in additional information for the correspondence of internal codes with Lot numbers).
For the Registered medical devices:The economic operator for the items of Group: 132. Code: 8117, 4488, 3482, 3483, 4493, 4917, 2572 and 8110; Group: 141. Codes 7819, 7006, 7005 and 7824; Group: 142. codes 2666 and 2667; Group: 346. Code: 6998, 7554, 6996, 6995, 2576, 6991, 6999, 6989 and 6994; Group: 347. Codes: 2677 and 2658, to have obtained approval for sale of the medical device or temporary or permanent Approval for parallel import in accordance with the Law on medicines and medical devices; For the Unregistered medical devices the economic operator for the offered items of Group: 132. code 6057; Group: 141. Code: 3484, 3485, 7823, 2656 и 6576; Group: 141 — G. Code: 2662 and 2661; Group: 272. Code: 6687, 8459, 8460, 8472, 8461, 8462, 8466, 8467, 8468, 8464, 8469, 8451, 8452, 8447, 8448, 8449, 8457, 8453, 8463, 8450, 8465, 8458, 8492, 8442, 8445, 8446, 8443, 8444, 8454, 8455, 8456, 8440, 8441, 8491, 8493, 8482, 8487, 8488, 8485, 8489, 8486, 8480, 8481, 8490, 8495, 8499, 8500, 8501, 8502, 8503, 8494, 8470, 8484, 8483, 8479, 8439, 8438, 8496, 8497, 8498, 8504, 8505, 8506, 8507, 8508, 8509, 8473, 8476, 8477, 6682, 6690, 8478, 8475, 8474, 6686 and 8471; Group: 343 — А. code: 8321, 8320 and 8322 to have obtained a permit to import (authorization for intervention import) in accordance with the Law on medicines and medical devices. (please see tender documentation or the link provided in additional information for the correspondence of internal codes with Lot numbers).