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:
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:
