Drug Establishment License
Get complete end-to-end licensing solution by Pharma 4u Inc – our solution is a complete compliance package. We’ll ensure every part of your operations is compliant with Health Canada requirements:
- Facility Licensing
- Drafting of standard operating procedures
- GMP Training
- Temperature monitoring of your facility
- Product Testing
Pharma 4u offers complete licensing service. Whether it is a distribution of few health products from your home office or a complex manufacturing operation with multiple facilities across the globe, Pharma 4u works to build exactly what you need.
Enjoy the peace of mind that comes from knowing your business is protected. We identify your toughest compliance challenges and address them with custom solutions. We’ll provide you with compliance security that grows and adapts with your business or needs, so you’ll have the best possible quality system for years to come.
Who needs Drug Establishment License (DEL)?
Drug Establishment License is required by Health Canada for companies that:
- Fabricate drug products.
- Package drug products into cartons, containers, bottles, blister packs.
- Compliant labeling and marking of packaged products.
- Distribution of finished products to pharmacies, retailers, and consumers.
- Importation of Active Pharmaceutical Ingredients (API) and drug products from China, India, US, Europe, etc.
- Testing of manufactured goods in licensed GMP laboratory facilities.
What Activities do not require Drug Establishment License (DEL)?
- Wholesale of drug products.
- Distribution or wholesale of active pharmaceutical ingredients (API).
- Storage of medical products.
- Transportation of drug products.
- Importation or compounding by pharmacist or physicians of medical products that are not commercially available for sale in Canada.
Licensing Process
1. Submit License application and associated fees to Health Canada.
2. Health Canada will process and review the application. Health Canada will examine information about the company. This may include details about the company's:
- manufacturing processes
- quality control procedures
- testing methods
- material handling
3. Health Canada will schedule GMP (Good Manufacturing Practices) inspection of the facility.
4. If the application is approved, the company will be issued a Drug Establishment License that is valid for a specified period of time (usually two years). The license will specify the activities that the company is authorized and may include conditions that the company must comply with to maintain the license.
5. Companies that hold a Drug Establishment License are subject to ongoing monitoring and inspections by Health Canada, to ensure that they continue to comply with the regulatory requirements.
6. Companies are also required to report any adverse reactions or other safety issues associated with their products to Health Canada, and to maintain appropriate records of their activities related to drugs.
Health Canada Fees for Drug Establishment License Application
|
1 |
Fabrication - sterile dosage form |
$43,171 |
|
2 |
Importation |
$31,688 |
|
3 |
Fabrication - non-sterile dosage form |
$30,677 |
|
4 |
Distribution |
$15,691 |
|
5 |
Wholesaling |
$7,962 |
|
6 |
Packaging/labelling |
$6,255 |
|
7 |
Testing |
$4,129 |
|
8 |
Building outside Canada (each) |
$949 |
Get in Touch with Your Licensing Expert
Find out what licensing solution would work best for your business.
For more information on our services and to help you secure your business, contact us below.
