Procurement of drugs for rare diseases

Ministry of Health of Republic of North Macedonia

Procurement of drugs for rare diseases

Рок

Рокот за прием на понудите беше 2022-10-05. Набавката беше објавена на 2022-09-06.

Кој? Што? Каде?
Историја на набавките
Датум Документ
2022-09-06 Оглас за договор
Оглас за договор (2022-09-06)
Предмет
Опсег на набавката
Наслов: Medical equipments, pharmaceuticals and personal care products
Краток опис: Procurement of drugs for rare diseases
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: suzana.manevska@zdravstvo.gov.mk 📧
URL за документи: https://www.e-nabavki.gov.mk/PublicAccess/Home.aspx#/home 🌏
URL за учество: https://www.e-nabavki.gov.mk/PublicAccess/Home.aspx#/home 🌏

Референца
Датуми
Датум на испраќање: 2022-09-06 📅
Рок за поднесување: 2022-10-05 📅
Датум на објавување: 2022-09-09 📅
Идентификатори
Број на огласот: 2022/S 174-494170
OJ-S издание: 174
Дополнителни информации
The bidder submits Certificate issued by the Drugs Bureau to the authorized person for procurementimplementation, certifying that the cold chamber and alarm system in case of temperature variations and theaggregate are functional. NOTE: In order to qualify, the bidder in addition to the bid, besides the standarddocuments (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; Registrationapproval for whole sale trade with drugs or temporary or final approval for parallel import, pursuant to the Lawon drugs and medical aids issued by Drugs Bureau or if the medicine has not been approved - Approval fortrading in EU members, Norway, Switzerland, USA, Canada and Japan; Declare a statement that at the momentof 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 asunacceptable and as such rejected by the Public Procurement Commission.
Прикажи повеќе

Предмет
Опсег на набавката
Наслов на делот: N07XX06 tetrabenazine 25mg
Број на дел: 1
Краток опис: N07XX06 tetrabenazine 25mg
Времетраење: 12 месеци
Наслов на делот: N03AG04 vigabatrin 500mg
Број на дел: 2
Краток опис: N03AG04 vigabatrin 500mg
Наслов на делот: C02DA01 diazoxide 25mg
Број на дел: 3
Краток опис: C02DA01 diazoxide 25mg

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 RM, approving whole sale trading with drugs.
Прикажи повеќе
Техничка и професионална способност:
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 signalization in
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 orerrorsin the drug’s series, submitting his/her data: name, surname, profession and contact phone
in orderto be availableat any time; Graduated pharmacist licensed to work in the procurement phases
(reception,keepingandissuing drugs);Declare a statement that the conditions for drugs safe keeping,
accommodation,transport andmanaging arefulfilled 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 tha tthe economic operator owns - cold chamber for accommodation
with automatic all integrated thermometer from (20-80C for the offered drugs which require this range) and
temperature reader forthe drugs chambe rand requires special temperature regimen;- Declare a statement that
the economic operator owns 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 signalization and alarm (SMS notification) from the chamber
to the person responsiblefor24 hours monitoring of 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 not older than12 months

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: 2022-10-05 📅
Време на отворање на понудите: 12:00
Место: Ministry of Health of Republic of North Macedonia

Договорен орган
Контакт
Интернет-адреса: www.moh.gov.mk 🌏
URL на документи: https://www.e-nabavki.gov.mk/PublicAccess/Home.aspx#/home 🌏

Референца
Дополнителни информации
The bidder submits Certificate issued by the Drugs Bureau to the authorized person for
procurementimplementation, certifying that the cold chamber and alarm system in case of temperature
variations and theaggregate are functional. NOTE: In order to qualify, the bidder in addition to the bid,
besides the standarddocuments (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;
Registrationapproval for whole sale trade with drugs or temporary or final approval for parallel import, pursuant
to the Lawon drugs and medical aids issued by Drugs Bureau or if the medicine has not been approved -
Approval fortrading in EU members, Norway, Switzerland, USA, Canada and Japan; Declare a statement
that at the momentof 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 asunacceptable 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 2022/S 174-494170 (2022-09-06)
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