Drugs for Treatment of Rare Diseases

Ministry of Health

Drugs for treatment of rare diseases.

Рок

Рокот за прием на понудите беше 2019-05-06. Набавката беше објавена на 2019-03-22.

Кој?

• Ministry of Health

Што?

• Медицинска опрема, фармацевтски производи и производи за лична нега

Каде?

• Северна Македонија

Историја на набавките

Датум	Документ
2019-03-22	Оглас за договор

Оглас за договор (2019-03-22)
Предмет
Опсег на набавката
Наслов: Medical equipments, pharmaceuticals and personal care products
Краток опис: Drugs for treatment of 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
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: http://www.bjn.gov.mk/ 🌏

Референца
Датуми
Датум на испраќање: 2019-03-22 📅
Рок за поднесување: 2019-05-06 📅
Датум на објавување: 2019-03-26 📅
Идентификатори
Број на огласот: 2019/S 060-140470
OJ-S издание: 60

Предмет
Опсег на набавката
Број на дел: 1
Времетраење: 12 месеци
Број на дел: 2
Краток опис: Drugs for treatment of rare diseases
Број на дел: 3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

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

Ability to perform professional activity of the economic operator:

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.

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 of 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 of 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).

Постапка
Правна основа: 32014L0024
Време за прием на понуди: 12:00
Јазици на кои може да се поднесат понуди или барања за учество: македонски 🗣️
Датум на отворање на понудите: 2019-05-06 📅
Време на отворање на понудите: 12:00

Договорен орган
Контакт
Контактна точка: Suzana Manevska
Интернет-адреса: www.moh.gov.mk 🌏
URL на документи: http://www.bjn.gov.mk/ 🌏

Дополнителни информации
Тело за преглед
Име: State Appeals Commission
Поштенско место: Skopje
Земја: Северна Македонија 🇲🇰
Орган од каде што може да се добијат информации за постапката за ревизија
Име: Ministry of Health of Republic of Macedonia
Извор: OJS 2019/S 060-140470 (2019-03-22)

Нови набавки во поврзани категории 🆕

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