Launch Your Montreal Drugs and Druggists' Sundries Wholesalers Business
This page gives you a practical, action-focused roadmap for starting a Drugs and Druggists' Sundries Merchant Wholesalers business in Montreal (NAICS 424210). It lays out the 13 regulatory requirements, the permits you’ll need, and the typical costs and timelines to get up and running. Use the clear checklist to plan, register, and responsibly store and distribute pharmaceutical products.
From licensing to launch, you’ll learn exactly what to expect: federal Drug Establishment Licence considerations, Quebec business registration, municipal permits, and tax registrations. We’ll outline facility and security needs, inventory control, record-keeping, labeling, and recalls, plus estimates of setup costs and a realistic project timeline so you can budget and schedule with confidence.
Why Montreal works for this niche: a robust healthcare and logistics ecosystem, a bilingual market, and competitive warehousing options make it easier to serve Quebec and nearby markets. If you’re ready to tackle the 13 requirements, this city offers a strong foundation for a scalable drug wholesaler business.
Requirements Overview
The most critical requirement for operating a drugs and druggists' sundries merchant wholesaler in Montreal is the Drug Establishment License (DEL). This license from Health Canada is legally required to handle, store, and distribute drug products, and you cannot operate without it. It’s non-negotiable and subject to ongoing compliance checks and renewals, so plan to obtain the DEL early and maintain it with strict record-keeping and proper facilities.
On the operational side, you must meet health and safety obligations and obtain the key permits. Include Product Safety and Recall Obligations—have a system to verify product safety, document handling procedures, and act quickly if a recall is needed. If you ship risky materials, you’ll need Transportation of Dangerous Goods (TDG) compliance. Ensure you hold the city’s Business Licence as the minimum local permit to operate.
Business Registration & Tax: In parallel, get your business numbers in order. Register for a Business Number (BN) with the federal government, obtain a Quebec Enterprise Number (NEQ) and complete the Quebec Business Registration (REQ - Registraire des entreprises). Depending on your structure you may need Partnership Registration, an Import/Export Business Number, or Quebec Corporation Registration. You’ll likely also need GST/HST Registration, Payroll Deductions Registration, and Quebec CNESST Employer Registration for workers’ compensation.
Next steps: map out which registrations you’ll need, gather the required documents, and start applications early. Consider consulting a regulatory advisor or a Montreal business services office to confirm local permits and any industry-specific rules. With the DEL secured and registrations underway, you’ll have a clear path to compliant, practical operation and can focus on building supplier partnerships and serving customers.
Detailed Requirements
Here are the specific requirements for starting a drugs and druggists' sundries merchant wholesalers in Montreal:
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Product Safety and Recall Obligations RequiredWholesalers must ensure products meet Canadian safety standards and report serious incidents. Must participate in product recalls and maintain records for traceability. No registration - compliance law. Manufacturers/importers/sellers must ensure products are safe. MANDATORY REPORTING to Health Canada if: death/serious injury occurred or could occur, defects found, inadequate labeling, or recall in other jurisdiction. Keep records 6 years. Penalties: fines, seizure, criminal charges. Report incidents online or call 1-866-662-0666.
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Drug Establishment License (DEL) RequiredWholesalers of drugs, pharmaceuticals, and medical devices must be licensed as a Drug Establishment by Health Canada. Includes requirements for quality assurance, record keeping, and reporting. Health Canada Drug Establishment License (DEL). Required for manufacturing, packaging, labeling, importing, distributing, wholesaling drugs. Good Manufacturing Practices (GMP). Annual renewal. Site license. Inspection program. Drug Identification Number (DIN) separate. Contact Health Canada: 1-866-225-0709.
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Business Licence RequiredGeneral business licence required to operate a business in Ville de Montreal. Apply to Ville de Montréal for Business Licence: 1. Determine business category 2. Complete business licence application 3. Submit required documents (ID, lease, zoning confirmation) 4. Pay application and annual fees 5. Await approval and receive licence Contact Ville de Montréal Business Licensing for specific requirements. Home-based businesses may have different requirements. Annual renewal required.
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Business Number (BN) Registration RequiredA 9-digit Business Number is required for most businesses operating in Canada. It is used to interact with the Canada Revenue Agency and other federal programs. Required for GST/HST, payroll, corporation income tax, and import/export accounts. Register FREE online through Business Registration Online (BRO) at canada.ca. Takes 15-30 minutes. As of November 3, 2025, online registration is MANDATORY for new BNs - phone registration no longer available. You'll need: business name, address, owner SIN, business type, and start date. BN (9-digit number) issued INSTANTLY online. Available 21 hours/day, 7 days/week (closed 3-6am ET for maintenance).
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Quebec Enterprise Number (NEQ) Registration RequiredRegistration of business with the Quebec Enterprise Registrar. Register with Registraire des entreprises du Québec: 1. Access quebec.ca/entreprises services 2. Complete declaration of registration online 3. Pay registration fee ($38 sole proprietorship, $367 corporation) 4. Receive NEQ (Numéro d'entreprise du Québec) Annual registration fee: $35 (exempt first 2 years). Annual update declaration required. 30-day deadline for changes.
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Quebec Business Registration (REQ - Registraire des entreprises) RequiredAll businesses operating in Quebec must register with the Registraire des entreprises du Québec (Quebec Enterprise Registrar). This includes sole proprietorships, partnerships, and corporations. Registration provides a Quebec Enterprise Number (NEQ) which is required for all business activities including banking, licensing, and tax purposes. Unlike other provinces, registration is mandatory for ALL businesses in Quebec, not just those with a business name different from the owner. Registration can be completed online. Annual declarations must be filed to keep the registration current. Register with Registraire des entreprises within 60 days of starting business. Required for sole proprietors operating under trade name, partnerships, and corporations. $39 for sole proprietorship, $60 for partnership. Receive NEQ (Quebec Enterprise Number).
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Partnership Registration ConditionalRequired if operating as partnership. Registration of general or limited partnerships in Quebec. Register partnership with Registraire des entreprises: 1. Complete declaration of registration 2. Provide partner information 3. Submit registration 4. Pay registration fee General and limited partnerships. NEQ assigned upon registration. Annual update declaration required.
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Import/Export Business Number ConditionalRequired for specific regulated activities. Wholesalers engaged in importing or exporting goods must register for an import/export account with Canada Border Services Agency (CBSA) in addition to their CRA Business Number. As of Oct 21, 2024, register RM account through CBSA's CARM Client Portal (not CRA). Need BN9 first - get via CARM or CRA's BRO. FREE registration. Required for importing/exporting commercial goods. Ensure all business names match exactly to avoid border delays. CBSA manages RM accounts; CRA issues BN9. Contact CBSA Border Information Service: 1-800-461-9999.
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Transportation of Dangerous Goods (TDG) Compliance ConditionalRequired for dangerous goods transport. Wholesalers handling or shipping dangerous goods must comply with TDG regulations, including proper classification, packaging, labeling, documentation, and emergency response information. Training required before handling dangerous goods - no federal license. Employer must provide/approve training. Certificate valid 3 years. Two components: general education + site-specific training. Employer issues formal TDG Certificate of Training after both components. Online courses available ($50-$150). Contact Transport Canada: 1-855-824-2020.
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Quebec Corporation Registration ConditionalRequired if incorporating in Quebec. Incorporation of a company under Quebec law. Incorporate through Registraire des entreprises: 1. Conduct name search (NUANS) 2. Prepare articles of incorporation 3. Submit through quebec.ca or registry office 4. Pay incorporation fee ($367) Annual reporting required. Must file annual update declaration. Federal incorporation alternative available ($200).
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GST/HST Registration ConditionalRequired if annual taxable revenue exceeds $30,000 (small supplier threshold). Taxi/ride-share drivers must register regardless of revenue. Businesses with gross revenues over $30,000 in any single quarter or over four consecutive quarters must register for, collect, and remit GST/HST. Small suppliers (under $30,000) may register voluntarily. Register FREE online through Business Registration Online (BRO) when your revenue exceeds $30,000 in any 4 consecutive quarters (small supplier threshold). Takes 15-30 minutes. You MUST register within 29 days of exceeding threshold and start charging GST/HST immediately on the sale that made you exceed it. Need your BN (or get one simultaneously). As of Nov 3, 2025, online registration is mandatory. Voluntary registration available anytime for input tax credits.
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Payroll Deductions Registration ConditionalRequired if you pay salaries, wages, or other remuneration to employees. Must register before first pay period. Required if you have employees. You must withhold Canada Pension Plan (CPP), Employment Insurance (EI), and income tax from employee wages and remit to CRA. Register FREE online through Business Registration Online (BRO) when you hire your first employee. Takes 15-20 minutes. You'll need your Business Number (BN) or can get one simultaneously. Payroll account (RP) added to your BN instantly. Register BEFORE your first pay date. Required to deduct CPP, EI, and income tax from employee wages. For 2025: CPP rate 5.95%, EI employee rate $1.66/$100 insurable earnings.
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Quebec CNESST Employer Registration (Workers Compensation) ConditionalRequired if you have employees in Quebec. Employers in Quebec must register with the CNESST (Commission des normes, de l'équité, de la santé et de la sécurité du travail) and maintain coverage for workers. CNESST provides insurance coverage for workplace injuries and occupational diseases under Quebec's workers' compensation system. Most employers are required to register within 60 days of hiring their first worker. Employers pay contributions (premiums) based on their business activity classification and assessable payroll. Register with CNESST within 60 days of hiring first employee. CNESST provides workplace health and safety coverage. Premium rates based on industry classification. Annual declaration of wages required by March 14.
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