Trade Agreement: Canadian Free Trade Agreement (CFTA)
Tendering Procedures: Generally only one firm has been invited to bid
Non-Competitive Procurement Strategy: Exclusive Rights
Comprehensive Land Claim Agreement: No
Vendor Name and Address:
HEYL CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH & CO. KG
Kurfürstendamm 178-179
Germany
10707
Nature of Requirements:
Dimercaptopropane (DMPS) 100 mg (DPMS (RS)-2,3- Bis(sulfanyl) propane-1-sulfonic acid, sodium-salt 1 H2O) capsules.
W6369-22A015/A
Summers(ph885), Julia
Telephone No. - (613) 859-0832
j••••••••@••••••••.••.ca
Line 1, Dimercaptopropane (DMPS) 100 mg (DPMS (RS)-2,3- Bis(sulfanyl) propane-1-sulfonic acid, sodium-salt 1 H2O) capsules
=====================
Purpose of ACAN:
Public Services and Procurement Canada proposes to negotiate a contract on behalf of the Dept. of National Defence with Heyl Chemisch-Pharmazeutische Fabrik GMBH & CO. KG for the purchase of Dimercaptopropane (DMPS) 100 mg (DPMS (RS)-2,3- Bis(sulfanyl)propane-1-sulfonic acid, sodium-salt 1 H2O) capsules.
1. Definition of the requirement
Public Services and Procurement Canada intends to establish a Contract for the annual supply of Dimercaptopropane (DPMS) 100mg capsules, active ingredient: 108.56mg (RS)-2,3-Bis(sulfanyl)propane-1-sulfonic acid, sodium salt H2O corresponding to 100mg DPMS sodium salt, to be distributed to the Dept. of National Defence, CMED, Petawawa, ON to help protect the Canadian armed forces suspected of being exposed to a chemical warfare threat agent.
2. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements)
Any interested supplier must demonstrate by way of a statement of capabilities that it meets the following requirements:
a) Product is a capsule, 108.56 mg (RS)-2,3-Bis(sulfanyl)propane-1-sulfonic acid, sodium salt 1 H2O corresponding to 100 mg DMPS sodium salt.
b) At the time of delivery, the product must hold a Health Canada issued Notice of Compliance in accordance with Division 8 of the Canadian Food and Drug Regulations, or be able to receive authorization for sale through the Health Canada Special Access Program (SAP).
c) Supplier must be able to provide evidence that the product will be manufactured in compliance with current Good Manufacturing Practices (cGMP) as set out in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7, website - https://database.ich.org/sites/default/files/Q7%20Gui… The evidence provided should
include, but is not limited to:
a) The Certificate of Analysis for the batch or lot to be delivered. Certificates should be signed by the manufacturer’s Quality Assurance department;
d) The product must have a minimum of 20 months of its labelled shelf-life remaining at time of delivery.
3. Applicability of the trade agreement(s) to the procurement
This procurement is subject to the Canadian Free Trade Agreement (CFTA).
4. Justification for the Pre-Identified Supplier
This requirement is being negotiated with Heyl Chemisch-Pharmazeutische Fabrik GMBH & Co. KG. as they are the only known supplier capable of providing Dimercaptopropane (DPMS) 100mg (20 capsules/box).
The following exception(s) to the Government Contracts Regulations is invoked for this procurement under subsection 6(d) only one person is capable of performing the work.
5. Period of the Contract
From date of Contract award to March 31st, 2024.
6. Name and address of the pre-identified supplier
HEYL CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH & CO. KG.
Kurfurstendamm 178-179
10707 Berlin
Germany
7. Closing date for submitting statements of capabilities
The closing date and time for accepting statements of capabilities is September 12th, 2021 at 2:00pm EDT.
8. Inquiries and statements of capabilities are to be directed to:
Julia Summers
Supply Officer
613-859-0832
j••••••••@••••••••.••.ca
Delivery Date: Above-mentioned
You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified above.
An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.
Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, may submit a statement of capabilities in writing to the contact person identified in this Notice on or before the closing date of this Notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.
The PWGSC file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page.
The Crown retains the right to negotiate with suppliers on any procurement.
Documents may be submitted in either official language of Canada.
