W6369-21A022/A - Atropine 2mg/Obidoxime 220mg AutoInjectors (W6369-21A022/A)

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 (

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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:

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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: