New clarification added: Query 6; In Form D: Technical Bid Form - Under A. Technical specifications for goods Page (9/17) --> 1. Standard requirements :"The required Finished Pharmaceutical Products (FPPs) should meet the requirements of the pharmaceutical legislation and regulation of the country of origin for manufacturers. Country of origin means here the country where the finished product is manufactured and in Quality Assurance Requirements : "A GMP certificate issued by the NDRA of the country of Manufacturer based on the WHO Guidelines"In India, the licensing agency issues GMP certificates as per revised schedule M. In this schedule all terms and conditions for Good Manufacturing Practice are prescribed. The licensing authority after thorough inspection of the manufacturing plant and facilities under the manufacturing liscenses approves the plant and facilities and issues GMP certificate as per revised schedule M. Also, the products under schedule M GMP certificate are marketed locally in India. As UNOPS requirement says "Products (FPPs) should meet the requirements of the pharmaceutical legislation and regulation of the country of origin", products if offered by us with "GMP certificates as per revised schedule M" will meet UNOPS requirements. Please confirm if this is acceptable to UNOPS.Answer 6; Our standard requirements clearly mentioned that "The required Finished Pharmaceutical Products (FPPs) should meet the requirements of the pharmaceutical legislation and regulation of the country of origin for manufacturers. Country of origin means here the country where the finished product is manufactured" Hence it is acceptable for the offered products if they comply with Good Manufacturing Practices (GMP) standards as prescribed by the regulatory requirement of the country of the manufacturer.Query 7; As per the tender notification: B. Technical specifications, 1. Standard requirements --> You have stated "FPPs should also be compliant with monographs set by WHOInternational Pharmacopeia (Int Ph), United States Pharmacopoeia (USP), British Pharmacopeia (BP) and European Pharmacopeia. Where monographs are not available in house specifications will be acceptable" The licensing authority in India issues license to manufacture and market if the product complies with Indian Pharmacopeia(I.P.)These Indian Pharmacopiea products are also marketed locally in India. Will it be enough if the product complies with (I.P. specification)? In both questions above, we have looked at the quantities of product required in the ITB. As the quantities are small compared to batch size getting it manufactured in such small quantities with WHO GMP & BP/ USP/ Int Ph will not be possible as the minimum batch sizes are huge.Answer 7; Our standard requirements clearly mentioned that "FPPs should also be compliant with monographs set by WHO International Pharmacopoeia (Int Ph), United States Pharmacopoeia (USP), British Pharmacopeia (BP) and European Pharmacopoeia. Where monographs are not available in house specifications will be acceptable". Hence, please submit the offer as requested in ITB.
Edited on:
10-Dec-2022 09:30
Edited by:
webservice@unops.org
New clarification added: Query 5; Bidders to include the name of third party - What is meant by this statement?Because for this tender we are the bidders and we may quote for some products for which are are the third party manufacturers. Please clarify.Answer 5; This is for a 3rd party payment process. Detailed information was provided in Section IV under document section.
Edited on:
05-Dec-2022 13:05
Edited by:
webservice@unops.org
New clarification added: Query 4; We are willing to participate for this tender. Please suggest where and how can I find the required quantity of the products we want to quote for?Hoping to hear from you soon.Answer 4; Detail requirement was provided in Section II and Section III which were uploaded in the document section.
Edited on:
05-Dec-2022 13:02
Edited by:
webservice@unops.org
New clarification added: Query 3; Can we submit docs in our mother language or must be in English?Answer 3; The language of bids shall be in English as mentioned in the Bid Particular.
Edited on:
05-Dec-2022 05:45
Edited by:
webservice@unops.org
New amendment added #1: The following amendments were carried under ITB/2022/44461-There were quantity changes in Lot 5 and Lot 7 and revised quantities were updated in revised Section II and Section III under document section.There is one more lot by adding Flucytosine 500mg Tablet and there are a total 8 lots in this tender.Deadline for submission in general tab was extended up to 14-December-2022 (5:30 UTC)Deadline for clarification in general tab was extended up to 09-December-2022 (5:30 UTC)
Edited on:
24-Nov-2022 05:44
Edited by:
webservice@unops.org
New clarification added: Query 2; In the Quality Assurance Requirements part, there are mentioned we should submit: A GMP certificate issued by the NDRA of the country of Manufacturer based on the WHO Guidelines.We are a pharmaceutical factory in China. We have the GMP certificate issued by Chinese National Medical Products Administration. Does this GMP certificate complied with your requirement? Answer 2; If Chinese National Medical Products Administration is the NDRA of China, then it is ok.
Edited on:
24-Nov-2022 04:52
Edited by:
webservice@unops.org
New clarification added: Query 1; Whether trader can participate in the tender.Answer 1; No nationalities are excluded from submitting a bid. Other eligibilty requirements are provided in the criteria section.
Edited on:
23-Nov-2022 11:17
Edited by:
webservice@unops.org