Drugs for treatment of rare diseases

Ministry of Health

Рок

Рокот за прием на понудите беше 2018-09-25. Набавката беше објавена на 2018-08-10.

Кој?

• Ministry of Health

Што?

• Медицинска опрема, фармацевтски производи и производи за лична нега

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2018-08-10	Оглас за договор

Оглас за договор (2018-08-10)
Предмет
Опсег на набавката
Наслов: Medical equipments, pharmaceuticals and personal care products
Метаподатоци на огласот
Оригинален јазик: англиски 🗣️
Вид на документ: Оглас за договор
Природа на договорот: Стоки
Регулатива: Друго
Заеднички речник на набавки (CPV)
Шифра: Медицинска опрема, фармацевтски производи и производи за лична нега 📦

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: Министерство или кој било друг национален или федерален орган
Име на органот кој доделува: Ministry of Health
Поштенска адреса: 50 divizija No 6
Поштенски број: 1000
Поштенско место: Skopje
Контакт
Интернет-адреса: http://www.moh.gov.mk 🌏
Е-пошта: ljupco.ilovski@zdravstvo.gov.mk 📧
Телефон: +389 76484471 📞
Факс: +389 76484471 📠

Референца
Датуми
Датум на испраќање: 2018-08-10 📅
Рок за поднесување: 2018-09-25 📅
Датум на објавување: 2018-08-14 📅
Идентификатори
Број на огласот: 2018/S 155-357484
OJ-S издание: 155

Предмет
Опсег на набавката
Краток опис: Drugs for treatment of rare diseases
Број на дел: 1
2
Времетраење: 12 месеци
Референтен број: 04-1-2018

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

A statement that no verdict in force has been passed to the economic operator in the last 5 years for participation in a criminal organization, corruption, fraud or money laundry;

— certificate that no bankruptcy proceedings have been instituted by a competent body,

— certificate that no liquidation proceedings have been instituted by a competent body,

— certificate for paid taxes, contributions and other public expenses from a competent body from the country where the economic operator is registered,

— certificate that no sanction for prohibition for participating in public procurement procedures, awarding public procurement contracts and contract for public-private partnerships is issued by the Sanction register for committed criminal acts of legal entities,

— certificate that no sanction for permanent or temporary prohibition for performing of separate activity is issued by the Sanction register for committed criminal acts of legal entities,

— certificate that no offence sanction has been passed by verdict in force — prohibition from practicing a profession, activity or duty that is temporary prohibition from exercising a certain duty.

Економска и финансиска состојба: n/a
Минимално ниво(а) на стандарди: n/a
Техничка и професионална способност:

— Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import pursuant to the Law on drugs and medical aids in RM,

— If the drug does not have trade approval in RM, then approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan,

— Declare a statement that the conditions for drugs safe keeping, accommodation, transport and managing are fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No. 151/08),

— Declare a statement that the economic operator owns…

… — cold chamber for accommodation with automatically integrated thermometer from (20-80C for the offered drugs which require this range) and temperature reader for the drugs chamber and requires special temperature regimen,

… vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 20-80C),

— Declare a statement for engaged 24 hours available person for monitoring of the cold chain functioning and signalization in case of variations in the temperature range,

— M1/M2 forms for at least 1 full time employed pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs),

— Declare a statement for equipment – Reserve (spare) electricity aggregate for the cold chain,

— Certificate issued by MALMED that the cold chain system is functional and signalizes in case of variations in the temperature range and the aggregate is also functional,

— Declare a statement that at the moment of reception of the drugs, the expiry date shall be at least 2/3 valid out of the total drugs expiry date,

— Declare a statement for full time employee with university degree in medicine or pharmacy in charge for pharmacovigilance and detection of problems in the drugs quality or errors in the drug’s series, submitting his/her data: name, surname, profession and contact phone in order to be available at any time,

— Submit notice for the parts of the procurement contract which the economic operator intends to transfer to subcontractor.

Минимално ниво(а) на стандарди:

— Procurement subject must be approved for trading with drugs in Macedonia by obtained Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import pursuant to the Law on drugs and medical aids in RM,

— If the drug does not have trade approval in RM, then approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan,

— The conditions for drugs safe keeping, accommodation, transport and managing must be fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No. 151/08),

— The economic operator owns — cold chamber for accommodation with automatically integrated thermometer from (20-80C for the offered drugs which require this range) and temperature reader for the drugs chamber and requires special temperature regimen,

— The economic operator owns vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 20-80C),

— The economic operator provides sound and visual signalization from the cold chain to the person engaged for 24 hours monitoring of the cold chain,

— The economic operator owns reserve (spare) electricity aggregate for the cold chain which shall be functional and activated in case of power failure or lack of electricity,

— Guarantee that at the moment of reception of the drugs, the expiry date shall be at least 2/3 valid out of the total drugs expiry date,

— Full time employee with university degree in medicine or pharmacy in charge for pharmacovigilance and detection of problems in the drugs quality or errors in the drug’s series, submitting his/her data: name, surname, profession and contact phone in order to be available at any time,

— Engaged available person 24 hours a day for monitoring of the cold chain functioning and signalization in case of variations in the temperature range,

— Employed pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs).

Извршување на договорот
Потребни депозити и гаранции:

IV.1.2) Tender guarantee: Yes, 3 %

IV.1.3) Solemnity Statement: No

IV.1.4) Guarantee for quality performance of the contract: Yes, 10 %

Правна форма што треба да ја преземе групата економски оператори на која ќе се додели договорот: no

Постапка
Период на важност на понудата: 120 дена
Датум на отворање на понудите: 2018-09-25 📅

Договорен орган
Контакт
Контактна точка: Ljupco Ilovski
Интернет-адреса: www.moh.gov.mk 🌏

Референца
Идентификатори
Референтен број доделен од договорниот орган: 04-1-2018

Дополнителни информации
Тело за преглед
Име: State Appeals Commission
Земја: Северна Македонија 🇲🇰
Име: n/a
Информации за роковите за приговор: 8 days
Орган од каде што може да се добијат информации за постапката за ревизија
Име: Ministry of Health of Republic of Macedonia
Извор: OJS 2018/S 155-357484 (2018-08-10)

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