A Drug Establishment licence (DEL) is required in Canada to manufacture, package, label, distribute, import, wholesale, or test a drug. A drug’s intended use includes claims for diseases, disorders, organic functions or the disinfection of food premises.
Operating a licensed drug establishment requires the drafting and implementation of Good Manufacturing Practices (GMP), which ensure that drugs are produced consistently and to high quality standards. Health Canada will conduct inspections of establishments to ensure such procedures are being followed. NHP Consulting can submit the DEL application on your behalf and ensure your facility, equipment, utilities and supporting GMP procedures and technical reports are sufficient based on your product portfolio prior to the Health Canada inspection.
Canadian importers of drugs may add a foreign site to their DEL. Foreign sites must demonstrate GMP compliance by submitting inspection reports. These reports are assessed to determine compliance. If the foreign site is an MRA (Mutual Recognition Agreement) country, the Inspectorate will contact the applicable regulatory authority to request supporting GMP compliance. If the importer is in a non-MRA country, the importer will have to provide a certificate from a Canadian inspector (such as NHP Consulting) certifying that the facilities, equipment, practices and procedures meet the applicable requirements of the Canadian GMP’s.
In addition to a DEL, narcotics and controlled drugs must hold a valid licence under the Narcotic Control Regulations. This licence is issued by the Office of Controlled Substances within Health Canada. (See Precursor Licence for further details.)
NHP Consulting will apply for a DEL on your behalf, providing the necessary documentation and act as your primary advocate with Health Canada.