FAQs for Pharmaceutical Regulatory Consultants

1Do API drug facilities require Drug Establishment License?
Yes, all Canadian facilities involved in importation, packaging, labeling, manufacturing, and testing of active pharmaceutical ingredients (APIs) are required to hold Drug Establishment Licenses.
2What activities do not require holders to have a drug establishment license?
Drug Establishment licenses are not required to wholesale finished dosage form drugs that are over-the-counter drugs (OTCs) or active pharmaceutical ingredients.
3Are activities involving veterinary drugs also required to have a drug establishment license?
Yes, facilities that are involved in packaging, labeling, testing, and manufacturing of veterinary drugs are subject to Drug Establishment License requirements.
4What are Canadian export requirements for drug products?
For the purpose of the Food and Drug Regulation, exporting a drug product to another country is considered a sale in Canada. The regulatory requirements are the same for domestic sale and for a sale for the purpose of export. As such, to export a drug, a Drug Establishment License that authorizes the sale of the drug in Canada is required (e.g., distribute or wholesale).
5What are GMP inspections and do I need them?
GMP (Good Manufacturing Practices) audits help ensure products are made and controlled in accordance with appropriate quality standards and current industry best practices. They also ensure compliance with applicable health authority regulatory requirements and guidance documents. Passing a GMP inspection and obtaining a compliance rating is one of the requirements of obtaining a Drug Establishment License.
6What is NPN and what do I need to sell Natural Health Products?
To legally sell a Natural Health Product (NHP) in Canada, the product must undergo pre-market review with Health Canada's Non-prescription Drug and Natural Health Products Directorate (NNHPD). Approved products are assigned a valid Natural Product Number (NPN).

In order to sell an NHP in Canada, all manufacturers, packagers, labellers, and importers must have a valid site licence. To obtain a site licence, sites must maintain proper distribution records and procedures for product recalls. They also require proper procedures for safe handling, storage, and delivery of their products.