Vaccines and Antimalarials (Second Time)

PHO Center for Public Health — Skopje

Detailed description of the subject of the public procurement contract and the required amounts is given in the part of technical specifications, which is an integral part of the bidding documents.

Рок

Рокот за прием на понудите беше 2018-10-04. Набавката беше објавена на 2018-09-14.

Кој?

• PHO Center for Public Health — Skopje

Што?

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2018-09-14	Оглас за договор

Оглас за договор (2018-09-14)
Предмет
Опсег на набавката
Наслов: Vaccines
Количина или опсег: 4 721 171,70
Вкупна вредност на набавката: 4 721 171,70 💰
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Вакцини 📦

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за еден или повеќе делови
Критериуми за доделување
Најниска цена

Договорен орган
Идентитет
Земја: Северна Македонија 🇲🇰
Вид на органот кој доделува: Тело уредено со јавно право
Име на органот кој доделува: PHO Center for Public Health — Skopje
Поштенска адреса: Nr.18, Third Macedonian Brigade str.
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://www.cph.mk 🌏
Е-пошта: info@cph.mk 📧
Телефон: +389 71248572 📞
Факс: +389 23298251 📠

Референца
Датуми
Датум на испраќање: 2018-09-14 📅
Рок за поднесување: 2018-10-04 📅
Датум на објавување: 2018-09-18 📅
Идентификатори
Број на огласот: 2018/S 179-407171
OJ-S издание: 179
Дополнителни информации

The economic operators should meet the following conditions: Based on the previously received written request on behalf of the authorized person of each centre separately, the offered goods must be delivered to the following locations, based on the technical specifications: — PHI Center for Public Health: Skopje, located at nr.18 „3rd Macedonian brigade“ str., Skopje — PHI Center for Public Health: Veles located at nr.14 „Lazo Osmakov“ str. Veles, — PHI Center for Public Health: Kumanovo located at n.n.„11th October“ str, Kumanovo, — PHI Center for Public Health: Tetovo located at nr.73 „29th November“ str., Tetovo, — PHI Center for Public Health: Prilep located at n.n. „October“ str.. Prilep, — PHI Center for Public Health: Kochani located at nr.21 „Milan Zaechar“ str. Kochani, — PHI Center for Public Health: Bitola located at ул.n.n „Partizanska“ str. Bitola, — PHI Center for Public Health: Strumica located at n.n. „Panche Peshev“ str.. Strumica and — PHI Center for Public Health: Ohrid located at n.n. „Sirma Vojvoda’ str. Ohrid. After the delivery of the public procurement contract is done, the invoices should be submitted in the archives of each centre, in accordance with the contract for public procurement, with a deferred payment of at least 90 days. — Upon reception of the subject of procurement, the shelf life should not be shorter than 1 year from the overall duration of the subject of procurement, except for item 10 (code 8112 - Influenza vaccine) Vaccine against seasonal influenza, — to maintain/meet the shelf life of item 10 (code 8112 — Influenza vaccine), the deadline of which should be in accordance with the recommendations of the WHO, but not longer than 1 year, — the subject of procurement is to be on the WHO List of Pre-qualified Vaccines, with the exception of items 3 (Hepatitis A, inactivated, whole virus) and item 10 (code 8112 - Influenza vaccine) which should be approved for use and be located in the EU Member States, Norway, Switzerland, USA, Canada and Japan, — the procurement subject – vaccines should possess a certificate for releasing a batch of the drug on the market (OCABR – Official Control Authority Batch Release certificate), or equivalent, in accordance with the recommendations of the EU, not older than 3 years, except for item 7 (code 8108 - Pneumococcus, purified polysaccharides antigen conjugated) of the technical specifications. The contractor of the procurement has to submit the following documents for proving the fulfillment of the above mentioned conditions: — a declaration that the overall alloted time of the procurement subject on the date of delivery should not be shorter than 1 year from the overall duration of the subject of procurement except for item 10 (code 8112 — Influenza vaccine), — a statement signed and certified by the economic operator that the shelf life for item 10 (code 8112 — Influenza vaccine) will be in accordance with the recommendations of the WHO, but not longer than one year, — to submit the list of pre-qualified WHO vaccines with the exception of item 3 (Hepatitis A, inactivated, whole virus) and item 10 (code 8112 — Influenza vaccine), for which a certificate for a pharmaceutical product, issued by a competent administrative body, not older than 3 (three) years (CPR), should be submitted as an evidence that it is approved for use and is on the market in an EU Member State, Norway, Switzerland, USA, Canada and Japan, — to submit a certificate for releasing a batch of the drug on the market (OCABR – Official Control Authority Batch Release certificate), or equivalent, in accordance with the recommendations of the EU, not older than 3 years, except for item 7 (code 8108 — Pneumococcus, purified polysaccharides antigen conjugated) of the technical specifications.

Дополнителни информации

The economic operators should meet the following conditions:

Based on the previously received written request on behalf of the authorized person of each centre separately, the offered goods must be delivered to the following locations, based on the technical specifications:

— PHI Center for Public Health: Skopje, located at nr.18 „3rd Macedonian brigade“ str., Skopje

— PHI Center for Public Health: Veles located at nr.14 „Lazo Osmakov“ str. Veles,

— PHI Center for Public Health: Kumanovo located at n.n.„11th October“ str, Kumanovo,

— PHI Center for Public Health: Tetovo located at nr.73 „29th November“ str., Tetovo,

— PHI Center for Public Health: Prilep located at n.n. „October“ str.. Prilep,

— PHI Center for Public Health: Kochani located at nr.21 „Milan Zaechar“ str. Kochani,

— PHI Center for Public Health: Bitola located at ул.n.n „Partizanska“ str. Bitola,

— PHI Center for Public Health: Strumica located at n.n. „Panche Peshev“ str.. Strumica and

— PHI Center for Public Health: Ohrid located at n.n. „Sirma Vojvoda’ str. Ohrid.

After the delivery of the public procurement contract is done, the invoices should be submitted in the archives of each centre, in accordance with the contract for public procurement, with a deferred payment of at least 90 days.

— Upon reception of the subject of procurement, the shelf life should not be shorter than 1 year from the overall duration of the subject of procurement, except for item 10 (code 8112 - Influenza vaccine) Vaccine against seasonal influenza,

— to maintain/meet the shelf life of item 10 (code 8112 — Influenza vaccine), the deadline of which should be in accordance with the recommendations of the WHO, but not longer than 1 year,

— the subject of procurement is to be on the WHO List of Pre-qualified Vaccines, with the exception of items 3 (Hepatitis A, inactivated, whole virus) and item 10 (code 8112 - Influenza vaccine) which should be approved for use and be located in the EU Member States, Norway, Switzerland, USA, Canada and Japan,

— the procurement subject – vaccines should possess a certificate for releasing a batch of the drug on the market (OCABR – Official Control Authority Batch Release certificate), or equivalent, in accordance with the recommendations of the EU, not older than 3 years, except for item 7 (code 8108 - Pneumococcus, purified polysaccharides antigen conjugated) of the technical specifications.

The contractor of the procurement has to submit the following documents for proving the fulfillment of the above mentioned conditions:

— a declaration that the overall alloted time of the procurement subject on the date of delivery should not be shorter than 1 year from the overall duration of the subject of procurement except for item 10 (code 8112 — Influenza vaccine),

— a statement signed and certified by the economic operator that the shelf life for item 10 (code 8112 — Influenza vaccine) will be in accordance with the recommendations of the WHO, but not longer than one year,

— to submit the list of pre-qualified WHO vaccines with the exception of item 3 (Hepatitis A, inactivated, whole virus) and item 10 (code 8112 — Influenza vaccine), for which a certificate for a pharmaceutical product, issued by a competent administrative body, not older than 3 (three) years (CPR), should be submitted as an evidence that it is approved for use and is on the market in an EU Member State, Norway, Switzerland, USA, Canada and Japan,

— to submit a certificate for releasing a batch of the drug on the market (OCABR – Official Control Authority Batch Release certificate), or equivalent, in accordance with the recommendations of the EU, not older than 3 years, except for item 7 (code 8108 — Pneumococcus, purified polysaccharides antigen conjugated) of the technical specifications.

Предмет
Опсег на набавката
Краток опис:

Detailed description of the subject of the public procurement contract and the required amounts is given in the part of technical specifications, which is an integral part of the bidding documents.

Број на дел: 1
Наслов на делот: 8101-Hepatitis A + B vaccine (Twinrix), adult:
Краток опис:

— АTC Code: J07BC20,— pharmaceutial form: suspension for injection,— package form: ampoule / filled injection syringe.

— АTC Code: J07BC20,

— pharmaceutial form: suspension for injection,

— package form: ampoule / filled injection syringe.

Количина или опсег: 200 pieces
Број на дел: 2
Наслов на делот: 8103-Meningococcus A,C,Y,W-135 vaccine, tetravalent purified polysaccharides antigen:
Краток опис:

— АTC Code: J07AH08,— pharmaceutial form: suspension for injection,— drug dosage: 4 mcg / 0,5 ml + 4 mcg / 0,5 ml + 4 mcg / 0,5 ml + 4 mcg / 0,5 ml,— package form: vial / filled injection syringe.

— АTC Code: J07AH08,

— drug dosage: 4 mcg / 0,5 ml + 4 mcg / 0,5 ml + 4 mcg / 0,5 ml + 4 mcg / 0,5 ml,

— package form: vial / filled injection syringe.

Број на дел: 3
Наслов на делот: 8105 — Tetanus vaccine — Tetanus toxoid:
Краток опис:

— АTC Code: J07AM01,— pharmaceutial form: suspension for injection,— drug dosage: 40 IU / 0,5 ml,— package form: ampoule / filled injection needle syringe.

— АTC Code: J07AM01,

— drug dosage: 40 IU / 0,5 ml,

— package form: ampoule / filled injection needle syringe.

Количина или опсег: 240 pieces
Број на дел: 4
Наслов на делот: 8108 — Pneumococcus, purified polysaccharides antigen conjugated (adult):
Краток опис:

— ATC Code: J07AL02,— pharmaceutial form: suspension for injection,— drug dosage: 25 mcg of each polysaccharide of 23 serotypes,— package form: filled injection needle syringe.

— ATC Code: J07AL02,

— drug dosage: 25 mcg of each polysaccharide of 23 serotypes,

— package form: filled injection needle syringe.

Број на дел: 5
Наслов на делот: 8104 — Yellow fever vaccine, live attenuated:
Краток опис:

— АTC Code: J07BL01,— pharmaceutial form: powder and solvent for suspension for injection,— drug dosage: at least 1000 IU virus of yellow fewer, 17D-204 strain (live, attenuated),— package form: a vial with powder + vehiculum in a filled injection needle syringe.

— АTC Code: J07BL01,

— pharmaceutial form: powder and solvent for suspension for injection,

— drug dosage: at least 1000 IU virus of yellow fewer, 17D-204 strain (live, attenuated),

— package form: a vial with powder + vehiculum in a filled injection needle syringe.

Количина или опсег: 1 000 pieces
Број на дел: 6
Наслов на делот: 8110-Poliomyelitis vaccine – IPV (inactiv polio) monodoses:
Краток опис:

— ATC Code: J07BF,— pharmaceutial form: suspension for injection,— package form: ampoule / filled injection needle syringe.

— ATC Code: J07BF,

Количина или опсег: 100 pieces
Број на дел: 7
Наслов на делот: 8112-Influenza vaccine, inactivated, split virus or surface аntigen (seasonal – 4 types) for persons 6 months and older:
Краток опис:

— ATC Code: JO7BB02,— Pharmaceutial form: Suspension for injection,— Drug dosage: 15 mcg +15 mcg + 15 mcg+ 15 mcg,— Package form: 0,5 ml. Filled injection needle syringe.

— ATC Code: JO7BB02,

— Pharmaceutial form: Suspension for injection,

— Drug dosage: 15 mcg +15 mcg + 15 mcg+ 15 mcg,

— Package form: 0,5 ml. Filled injection needle syringe.

Количина или опсег: 5000 pieces
Број на дел: 8
Наслов на делот: 7996 — Тetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed:
Краток опис:

— ATC Code: J07AM01,— pharmaceutial form: suspension for injection;,— drug dosage: at least 30 IU tetanus toxoid, minimum 60 IU diphtheria toxoid, minimum 4 IU inactive BP,— package form: filled injection needle syringe.Vial.

— ATC Code: J07AM01,

— pharmaceutial form: suspension for injection;,

— drug dosage: at least 30 IU tetanus toxoid, minimum 60 IU diphtheria toxoid, minimum 4 IU inactive BP,

— package form: filled injection needle syringe.Vial.

Број на дел: 9
Наслов на делот: 7994 — Мeasles, combination with mumps and rubella, live attenuated:
Краток опис:

— ATC Code: J07BD52,— pharmaceutical form: powder and vehiculum for solution for injection and powder and vehiculum for suspension for injection,— drug dosage: minimum 103 CCID50/0.5 ml, alive, attenuated virus of measles, minimum 103,7 CCID50/0,5 ml alive,attenuated strain of mumps and minimum 103 CCDI50/0,5 ml of rubella virus,— package form: vial with powder + ampoule with a vesicle / filled injection syringe.

— ATC Code: J07BD52,

— pharmaceutical form: powder and vehiculum for solution for injection and powder and vehiculum for suspension for injection,

— drug dosage: minimum 103 CCID50/0.5 ml, alive, attenuated virus of measles, minimum 103,7 CCID50/0,5 ml alive,attenuated strain of mumps and minimum 103 CCDI50/0,5 ml of rubella virus,

— package form: vial with powder + ampoule with a vesicle / filled injection syringe.

Број на дел: 10
Наслов на делот: 3699 — Vaccine against contagious jaundice А, monodosis, for children, 0,5 ml.:
Краток опис:

— ATC Code: J07BC,— pharmaceutial form: suspension for injection,— package form: ampoule / filled injection needle syringe.Vial.

— ATC Code: J07BC,

— package form: ampoule / filled injection needle syringe.Vial.

Времетраење: 12 месеци
Референтен број: 0507-1049-2/2018
Место на извршување
Главна локација или место на извршување: PHO Centre for Public Health – Skopje, No. 18, 3-th Macedonian brigade street

Правни, економски, финансиски и технички информации
Услови за учество
Способност за вршење на стручната дејност:

— In order to prove that it is able to perform a professional activity, the economic operator should submit a document for registered activity, as an evidence that it is registered as a natural or legal entity for performing the activity related to the subject of the Public procurement contract, or an evidence that it belongs to an appropriate professional association in compliance with the regulations of the country it is registered in,

— decision / approval for performing wholesale trade with medicines on the territory of the Republic of Macedonia issued by the Ministry of Health in accordance with the Law on medicines and medical devices.

Економска и финансиска состојба:

No documents are required to prove the economic situation of the economic operator.

Минимално ниво(а) на стандарди:

No documents are required to prove the economic situation of the economic operator.

Техничка и професионална способност:

To qualify as capable of carrying out the relevant public procurement contract in terms of its technical or professional capability, the economic operator must meet the following minimum requirements:

— a document for the unregistered medicines should be provided, which allows interventional import, in accordance with the Law on Medicines and Medical Devices,

— the conditions for safe storage, accommodation, transportation and handling of vaccines should be in accordance with the content Rulebook of the application and the details regarding space, equipment and staff in order it obtains an approval for wholesale trade of medicines ("Official Gazette of RM "No. 151/08).

Should possess its own cold chamber for storage and maintenance with an automatic temperature reader, which should be continuously maintained from 2-8 C;

— for the registered medicines there should be provided an Approval for placing on the market a finished medicinal product or temporary or permanent approval for parallel import, in accordance with the Law on Medicines and Medical Devices.

Минимално ниво(а) на стандарди:

The economic operator shall prove the fulfillment of the minimum requirements of subsection 2.4.1 by submitting of the:

— import permit (Intervention Import Authorization) in accordance with the Law on Medicines and Medical Devices,

— a declaration that it meets the conditions for safe storage, accommodation, transportation and handling of vaccines should be in accordance with the content Rulebook of the application and the details regarding space, equipment and staff in order it obtains an approval for wholesale trade of medicines ("Official Gazette of RM "No. 151/08),

— a declaration that it possesses its own cold chamber for storage and maintenance with an automatic temperature reader, which should be continuously maintained from 2-8 C,

— decision / authorization that grants approval marketing a drug on the territory of the Republic of Macedonia or approval for parallel import or temporary parallel import clearance issued by the Ministry of Health / Agency for Medicinal Products and Medical Devices of the Republic of Macedonia.

Извршување на договорот
Потребни депозити и гаранции:

Warrantee for quality performance of the contract in the amount of 10 % of the Contract value

Главни услови за финансирање и аранжмани за плаќање и/или упатување на релевантните одредби што ги уредуваат:

The payment should be done in a period of at list 90 days from the day the invoice is received

Постапка
Период на важност на понудата: 90 дена
Датум на отворање на понудите: 2018-10-04 📅
Место на отворање: PHO Center for Public Health – Skopje (meeting room, first floor)
Место: PHO Center for Public Health – Skopje (meeting room, first floor)
Информации за овластени лица и постапка за отворање:

Authorized representatives of the economic operators of public opening must have an authorization signed by the authorized person of the economic operators at the public opening of tenders may attend any interested person. Only authorized representatives of the bidders may participate in the proceedings of a public bid opening by giving their comments in the minutes of the bid opening.

Јазици
Други јазици: Macedonian language

Договорен орган
Контакт
Контактна точка: Sector for public procurements
Snezana SAZDOVA
Е-пошта: dkzjn@gs.gov.mk 📧

Референца
Идентификатори
Референтен број доделен од договорниот орган: 0507-1049-2/2018
Дополнителни информации

The economic operators should meet the following conditions:

Based on the previously received written request on behalf of the authorized person of each centre separately, the offered goods must be delivered to the following locations, based on the technical specifications:

— PHI Center for Public Health: Skopje, located at nr.18 „3rd Macedonian brigade“ str., Skopje

— PHI Center for Public Health: Veles located at nr.14 „Lazo Osmakov“ str. Veles,

— PHI Center for Public Health: Kumanovo located at n.n.„11th October“ str, Kumanovo,

— PHI Center for Public Health: Tetovo located at nr.73 „29th November“ str., Tetovo,

— PHI Center for Public Health: Prilep located at n.n. „October“ str.. Prilep,

— PHI Center for Public Health: Kochani located at nr.21 „Milan Zaechar“ str. Kochani,

— PHI Center for Public Health: Bitola located at ул.n.n „Partizanska“ str. Bitola,

— PHI Center for Public Health: Strumica located at n.n. „Panche Peshev“ str.. Strumica and

— PHI Center for Public Health: Ohrid located at n.n. „Sirma Vojvoda’ str. Ohrid.

After the delivery of the public procurement contract is done, the invoices should be submitted in the archives of each centre, in accordance with the contract for public procurement, with a deferred payment of at least 90 days.

— Upon reception of the subject of procurement, the shelf life should not be shorter than 1 year from the overall duration of the subject of procurement, except for item 10 (code 8112 - Influenza vaccine) Vaccine against seasonal influenza,

— to maintain/meet the shelf life of item 10 (code 8112 — Influenza vaccine), the deadline of which should be in accordance with the recommendations of the WHO, but not longer than 1 year,

— the subject of procurement is to be on the WHO List of Pre-qualified Vaccines, with the exception of items 3 (Hepatitis A, inactivated, whole virus) and item 10 (code 8112 - Influenza vaccine) which should be approved for use and be located in the EU Member States, Norway, Switzerland, USA, Canada and Japan,

— the procurement subject – vaccines should possess a certificate for releasing a batch of the drug on the market (OCABR – Official Control Authority Batch Release certificate), or equivalent, in accordance with the recommendations of the EU, not older than 3 years, except for item 7 (code 8108 - Pneumococcus, purified polysaccharides antigen conjugated) of the technical specifications.

The contractor of the procurement has to submit the following documents for proving the fulfillment of the above mentioned conditions:

— a declaration that the overall alloted time of the procurement subject on the date of delivery should not be shorter than 1 year from the overall duration of the subject of procurement except for item 10 (code 8112 — Influenza vaccine),

— a statement signed and certified by the economic operator that the shelf life for item 10 (code 8112 — Influenza vaccine) will be in accordance with the recommendations of the WHO, but not longer than one year,

— to submit the list of pre-qualified WHO vaccines with the exception of item 3 (Hepatitis A, inactivated, whole virus) and item 10 (code 8112 — Influenza vaccine), for which a certificate for a pharmaceutical product, issued by a competent administrative body, not older than 3 (three) years (CPR), should be submitted as an evidence that it is approved for use and is on the market in an EU Member State, Norway, Switzerland, USA, Canada and Japan,

— to submit a certificate for releasing a batch of the drug on the market (OCABR – Official Control Authority Batch Release certificate), or equivalent, in accordance with the recommendations of the EU, not older than 3 years, except for item 7 (code 8108 — Pneumococcus, purified polysaccharides antigen conjugated) of the technical specifications.

Дополнителни информации
Тело за преглед
Име: State commission for appeals on public procurements
Поштенска адреса: No. 63a, bul.„Ilinden“
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Е-пошта: dkzjn@gs.gov.mk 📧
Телефон: +389 23251251 📞
Интернет-адреса: http://dkzjn.mk 🌏
Факс: +389 23251250 📠
Информации за роковите за приговор:

The appeals procedure shall be initiated by filing a complaint or a request for cancellation of the award of a Public Contract for failure documentation to the State Commission in accordance with Article 222. Appeal will be filed within eight days of:

— The announcement of the award of a public contract in terms of information, actions or failure to take action by the announcement.

Орган од каде што може да се добијат информации за постапката за ревизија
Исто како: Тело за преглед
Извор: OJS 2018/S 179-407171 (2018-09-14)

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