Procurement of Drugs for Rare Diseases — IVACAFTОR and RISIDIPLAM

Ministry of Health of Republic of North Macedonia

Procurement of drugs for rare diseases — IVACAFTОR and RISIDIPLAM.

Рок

Рокот за прием на понудите беше 2021-07-26. Набавката беше објавена на 2021-06-28.

Кој?

• Ministry of Health of Republic of North Macedonia

Што?

• Медицинска опрема, фармацевтски производи и производи за лична нега

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2021-06-28	Оглас за договор

Оглас за договор (2021-06-28)
Предмет
Опсег на набавката
Наслов: Medical equipments, pharmaceuticals and personal care products
Краток опис: Procurement of drugs for rare diseases — IVACAFTОR and RISIDIPLAM.
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 📦
Дополнителен CPV: Медицинска опрема, фармацевтски производи и производи за лична нега 📦
Место на извршување
NUTS регион: Северна Македонија 🏙️

Постапка
Вид на постапка: Отворена постапка
Вид на понуда: Поднесување за сите 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 of Republic of North Macedonia
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 📧
URL за документи: https://www.bjn.gov.mk/ 🌏
URL за учество: https://www.bjn.gov.mk/ 🌏

Референца
Датуми
Датум на испраќање: 2021-06-28 📅
Рок за поднесување: 2021-07-26 📅
Датум на објавување: 2021-07-02 📅
Идентификатори
Број на огласот: 2021/S 126-335331
OJ-S издание: 126
Дополнителни информации

The bidder submits certificate issued by the drugs bureau to the authorised person for procurement implementation, certifying that the cold chamber and alarm system in case of temperature variations and the aggregate are functional. Note: in order to qualify, the bidder in addition to the bid, besides the standard documents (proof of personal status, capacity for professional activity; technical and professional status), submits: certificate for quality of drug product issued by the manufacturer no more than 3 years old or certificate for trading with drug product issued by the manufacturer no more than 3 years old; Registration approval for whole sale trade with drugs or temporary or final approval for parallel import, pursuant to the Law on drugs and medical aids issued by drugs bureau or if the medicine has not been approved — approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan; Declare a statement that at the moment of reception of the drugs, the expiry date shall be at least 12 months valid out of the total drugs expiry date. If the bid does not cover the requested certificates/registration approval/statement, shall be considered as unacceptable and as such rejected by the Public Procurement Commission.

Предмет
Опсег на набавката
Број на дел: 1
Времетраење: 12 месеци
Број на дел: 2

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

Confirmation issued from authorized body for compliance of special criteria for performing legal business activity related to the public procurement subject. A decision issued by the Agency for drugs and medical aids of RNM, approving whole sale trading with drugs.

Економска и финансиска состојба:

List of employees responsible for the procurement phase, enclosing M1/M2 formulary for:

— declare a statement for engaged 24 hours available person for monitoring of the cold chain functioning and signalisation case of variations in the temperature range;

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

— 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 the 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 equipment – reserve (spare) electricity aggregate for the cold chain;

— declare statement for available sound, visual signalisation and alarm (SMS notification) from the chamber to the person responsible for 24 hours monitoring of the cold chain;

— certificate issued by Malmed that the cold chain system is functional and signalises in case of variations in the temperature range and the aggregate is also functional not older than 12 months;

— declaration that the procurement subject does not require specific storage regimen.

Постапка
Правна основа: 32014L0024
Време за прием на понуди: 12:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Период на важност на понудата: 4 месеци
Датум на отворање на понудите: 2021-07-26 📅
Време на отворање на понудите: 12:00

Договорен орган
Контакт
Интернет-адреса: www.moh.gov.mk 🌏
URL на документи: https://www.bjn.gov.mk/ 🌏

Референца
Дополнителни информации

The bidder submits certificate issued by the drugs bureau to the authorised person for procurement implementation, certifying that the cold chamber and alarm system in case of temperature

variations and the aggregate are functional.

Note: in order to qualify, the bidder in addition to the bid, besides the standard documents (proof of personal status, capacity for professional activity; technical and professional status), submits: certificate for quality of drug product issued by the manufacturer no more than 3 years old or certificate for trading with drug product issued by the manufacturer no more than 3 years old;

Registration approval for whole sale trade with drugs or temporary or final approval for parallel import, pursuant to the Law on drugs and medical aids issued by drugs bureau or if the medicine has not been approved — approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan;

Declare a statement that at the moment of reception of the drugs, the expiry date shall be at least 12 months valid out of the total drugs expiry date. If the bid does not cover the requested certificates/registration approval/statement, shall be considered as unacceptable and as such rejected by the Public Procurement Commission.

Дополнителни информации
Тело за преглед
Име: State Appeals Commission
Поштенско место: Skopje
Земја: Северна Македонија 🇲🇰
Информации за роковите за приговор: 10 days.
Орган од каде што може да се добијат информации за постапката за ревизија
Име: Ministry of Health of Republic of North Macedonia
Извор: OJS 2021/S 126-335331 (2021-06-28)

Нови набавки во поврзани категории 🆕

Медицинска опрема, фармацевтски производи и производи за лична нега (19 нови набавки)