Alternative drugs for bridging inhibitory activity

Institute of Transfusion Medicine

ALTERNATIVE DRUGS FOR BRIDGING INHIBITORY ACTIVITY, Coagulation factor VIIa eptacog alfa ( activated) 1 mg, Coagulation factor VIIa eptacog alfa ( activated) 2 mg and Factor VIII inhibitor bypassing activity 500 IE.

Рок

Рокот за прием на понудите беше 2014-05-26. Набавката беше објавена на 2014-04-16.

Кој?

• Institute of Transfusion Medicine

Што?

• Лекови за кардиоваскуларниот систем › Антихипертензиви

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2014-04-16	Оглас за договор

Оглас за договор (2014-04-16)
Предмет
Опсег на набавката
Наслов: Antihypertensives
Вкупна вредност на набавката: 6 512 400 💰
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Антихипертензиви 📦

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: Друго
Име на органот кој доделува: Institute of Transfusion Medicine
Поштенска адреса: Vodnjanska 17
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Е-пошта: transfuziologija@gmail.com 📧
Телефон: +38 923226923 📞
Факс: +38 923119227 📠

Референца
Датуми
Датум на испраќање: 2014-04-16 📅
Рок за поднесување: 2014-05-26 📅
Датум на објавување: 2014-04-19 📅
Идентификатори
Број на огласот: 2014/S 078-137909
OJ-S издание: 78

Предмет
Опсег на набавката
Краток опис:

Број на дел: 1
Наслов на делот: Coagulation Factor VIIa ( recombinant) -Coagulation factor VIIa eptacog alfa ( activated) 1 mg
Краток опис:

Coagulation Factor VIIa ( recombinant) -Coagulation factor VIIa eptacog alfa ( activated) 1 mg.

Количина или опсег: 200 packages.
Времетраење: 365 дена
Број на дел: 2
Наслов на делот: Coagulation Factor VIIa ( recombinant) -Coagulation factor VIIa eptacog alfa ( activated) 2 mg
Краток опис:

Coagulation Factor VIIa ( recombinant) -Coagulation factor VIIa eptacog alfa ( activated) 2 mg.

Количина или опсег: 900 packages.
Број на дел: 3
Наслов на делот: Activated Prothrombin Complex ( plasmatic) - Factor VIII inhibitor bypassing activity 500 IE
Краток опис:

Activated Prothrombin Complex ( plasmatic) - Factor VIII inhibitor bypassing activity 500 IE.

Количина или опсег: 810 packages.
Референтен број: 08/2014

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

- Within the last five years has had a legally effective judgement pronounced against him/her for participation in a criminal organization, corruption, fraud or money laundering;

- Has been pronounced a secondary sentence for prohibition of participation in public bidding procedures or awarding public procurement or public private partnership contracts;

- Has been sentenced with provisional or permanent prohibition to execute a specific business activity;

- Is subject to a bankruptcy procedure or a liquidation procedure;

- Has unpaid taxes, contributions or other public dues;

- That has a misdemeanour sanction - prohibition to perform a profession, activity or duty, or prohibition to perform a specific activity and

- Gives false information or fails to submit the data requested by the Contracting Authority.

- Document for registered activity - DRD form issued by the Central Registry or an appropriate document issued by an authorized body in the country where the bidder is registered

- Valid Decision for performing activities with drugs trade and medical devices issued by the Ministry of Health of Republic of Macedonia or an appropriate document issued by an authorized body in the country where the bidder is registered

Економска и финансиска состојба:

- a document for registration of the company issued by an authorized body

- minimum average turnover up to 20 000 000 MKD for the last year for economic operators that have worked less than three years.

- statement for the entire profit of the company (data given from the income statement issued by an authorized body, i.e. revised income statement) and when appropriate , statement for the profit in the area covering the subject of the contract regarding this public procurement, mostly for the last three financial years for which such information is available depending on the date when the company is founded or started working, and also depending on the availability of such information.

Минимално ниво(а) на стандарди:

- to have positive financial results in the recent years,

- to have performed its activities not less than three years or to have a minimal average turnover for the active years up to 20 000 000 MKD.

Техничка и професионална способност:

- list of major drug deliveries in the last three years, with values, dates, name of buyers, providing also a confirmation of made deliveries issued by the recipients or if such confirmations cannot be provided from reasons out economic operator's control, only with a statement given by the operator for made deliveries;

- description of the technical equipment and ability of the economic operator, taken measures to ensure quality level as well as its capability for performing testing and research work;

- statement for the technical staff and technical bodies irrelevantly if they have employment contracts directly with the economic operator;

- statement with the list of the individuals responsible for ensuring quality control;

- authorization by the manufacturer, i.e. by the drug authorized representative for the drugs offered for participation in the Open procedure

- Statement for Provision of all the required quantity which will declare that the required quantity from the tender documentation can be entirely provided for the part for which the bidder applies

- Statement that in case of price reduction, with Decision for a maximum price given by the Ministry of Health and new reference price stated by the Health Insurance Fund of Macedonia or by an Institution that regulates prices of drugs in Republic of Macedonia, valid price will always be the lower price and the bidder will accept it and provide drugs upon the new price.

- A document (Decisions) with all additional attachments, that drugs are approved for marketing authorization on the territory of Republic of Macedonia in accordance with the Law on drugs and Medical Devices or a confirmation issued by the Drugs Bureau that the procedure for drug registration is open and will be finished within the period of 30 days maximum, calculated from the day of confirmation issuance

- Statement by the economic operator that the drugs to be delivered will be with expiry date at least 12 months from the day of drug delivery.

Минимално ниво(а) на стандарди:

- Bidder needs to perform drugs delivery in the last three years;

- Economic operator needs to be technically equipped and capable to take measures for ensuring quality and to be equipped and able to perform testing and research;

- Bidder needs to have technical staff and technical bodies irrelevant if the staff has employment contracts with the economic operator or not;

- Bidder needs to provide individuals for quality control;

- Drugs bidder needs to provide an authorization by the manufacturer of pharmaceuticals, i.e. by the authorized representative for the participation in the Open Procedure

- Drugs bidder needs to submit a Statement for Provision of all the required quantity which will declare that the required quantity from the tender documentation can be entirely provided for the part for which the bidder applies

- Drug bidder should provide valid approvals for marketing authorizations of finished drug, issued by the Ministry of Health of Republic of Macedonia- Bureau of Drug in accordance with the Law on Drug and Medical Devices or confirmation that the registration is in process.

- Drugs on delivery to be with expiry date from at least 12 months from the day of drug delivery.

Извршување на договорот
Потребни депозити и гаранции: Performance guarantee of 5%.

Постапка
Период на важност на понудата: 90 дена
Датум на отворање на понудите: 2014-05-26 📅
Место на отворање: Institute of blood transfusion Skopje, Vodnjanska 17.
Место: Institute of blood transfusion Skopje, Vodnjanska 17.
Информации за овластени лица и постапка за отворање: Each person with authorization letter from economic operator.
Јазици
Други јазици: Macedonian.

Договорен орган
Идентитет
Друг вид договорен орган: Other
Контакт
Контактна точка: Institute of Transfusion Medicine

Референца
Идентификатори
Референтен број доделен од договорниот орган: 08/2014

Дополнителни информации
Тело за преглед
Име: Appeal comitee
Поштенско место: Skopje
Поштенски број: 1000
Земја: Северна Македонија 🇲🇰
Извор: OJS 2014/S 078-137909 (2014-04-16)

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