Atropine 2mg/Obidoxime 220mg AutoInjectors

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: 
ChemProtect SK sro
Cukrovarnicka 1071/62
Czech Republic
16200
Nature of Requirements: 

Atropine Obidoxime

W6369-21A022/A
Duplin-Vu(ph870), Kim André
Telephone No. - (819) 956-7335 (    )
Fax No. - (   )    -     (    )


ATROPINE 2mg/OBIDOXIME 220MG IN AUTOINJECTOR FORM
Purpose of ACAN:

Public Services and Procurement Canada proposes to negotiate a contract with ChemProtect SK sro, on behalf of the Department of National Defence for the purchase of Atropine 2mg/Obidoxime 220mg in AutoInjector (AI) form.

Definition of Requirement:
Atropine/Obidoxime auto injectors are required as part of the Medical Counter Measure (MCM) stockpile.
Atropine 2mg/Obidoxime 220mg is an antidote used against nerve agent intoxication and is administered rapidly during an emergency situation.

Quantities:

The estimated quantity for the firm delivery is 28,000 Auto Injectors, with 32,000 Auto Injectors in optional quantities. 

Term of Contract:

The period of the contract will be from contract award to March 31, 2023.

Evaluation Criteria:

1) The Vendor must demonstrate that their proposed Atropine/Obidoxime 2mg/220mg Autoinjectors has the following Certification and Compliance:

-  Must be manufactured in accordance with Good Manufacturing Practices (GMP) as set out in the Food and Drugs Act - Food and Drug Regulations (FDR) - Division 2 - Good Manufacturing Practices, website http://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-108.html#h-186 and Health Canada’s Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001), website https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/good-manufacturing-practices-guidelines-2009-edition-version-2-0001.html

Proof of GMP must be included in the statement of capabilities.

2)  The Vendor must demonstrate that their proposed Atropine/Obidoxime autoinjector contains the following drug type and potency:

Drug Product (Obidoxime)   
 Active ingredient: Obidoxime dichloride in water for injection   
 Dose: 220 mg   
 Volume: 2.0 mL (+/- 0.2 mL)   
 pH: 2.0 - 6.0   
 Primary packaging: Pharmaceutical grade glass, rubber, stainless steel   Physical characteristics:Free from undissolved materials or particulates   
 Sterility: Sterile  
 
 Drug Product (Atropine)   
 Active ingredient: Atropine sulfate monohydrate in water for injection   Dose: 2 mg   
 Volume: 2.0 mL (+/- 0.2 mL)   
 pH: 2.0 - 6.0   
 Primary packaging: Pharmaceutical grade glass, rubber, stainless steel   Physical characteristics:Free from undissolved materials or particulates   
 Sterility: Sterile   

The Vendor must include an executed Certificate of Analysis in the statement of capabilities.

3)  The Vendor must demonstrate that their proposed Atropine/Obidoxime 2mg/220mg has the following configuration and drug administration method:
Requirement/Specification   
 Device: (Autoinjector)   
 Maximum dimensions(Length x Width):Length 150 mm +/- 15 mm; Width 25 mm +/- 5 mm   
 Materials: Approved for medical device use   
 Robustness: Operational after stability and environmental tests conducted in accordance with applicable International Conference on Harmonization (ICH) standards and MIL-STD-810, respectively.   
 Needle Gauge:   20 - 23   
 Needle Length:  19 - 22 mm   
 Weight: 75 g +/- 25g    
 Ease of Use: Less than 3 steps and be operated while wearing gloves   
 Maximum delivery time: 10 seconds   
 Safety Mechanisms: Mechanism to prevent accidental firing   
 Injection of air: < 0.5 mL   

Drug insert and packaging information must be in English

A copy of the package insert, product labelling and a picture of the product must be provided.

4)The Vendor must demonstrate that their proposed Atropine/Obidoxime 2mg/220mg AI has the following minimum shelf life:
Shelf-life must be 2.5 years at 15 - 25°C (Minimum acceptable shelf-life for delivery is 30 months or better upon arrival at DND Central Medical Depot).

5) The Vendor must demonstrate that their proposed Atropine/Obidoxime 2mg/220mg AI has the following information included on its label:
Labelling - Each autoinjector must be labelled with the lot or batch number and the expiry date.

6) The Vendor must demonstrate that their proposed Atropine/Obidoxime 2mg/220mg AI has secondary packaging to protect the product from water and particles (e.g. dust).  The secondary packaging must be easily opened while wearing gloves.
A picture of the product within its secondary packaging must be provided.

Delivery:

On or before March 1, 2021 for the firm quantity. As and when required for the optional quantities.

Limited Tendering Reason:

In accordance with Government Contract Regulations (GCRs Part 1 - Conditions of Contract Entry - Bids - 6.(d)) ChemProtect SK sro, is the only known supplier capable of providing Atropine 2mg/Obidoxime 220mg in AutoInjector form.




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.