Licensing
What the exam tests
Licensing questions test jurisdiction: which licence, issued by whom, for what activity, and what invalidates it. The recurring error is confusing federal product and manufacturing licensing with provincial premises licensing for sale.
The licence families
- Manufacturing licence - DRAP, for each premises and dosage-form line; requires approved layout, qualified technical staff, GMP compliance and a named person responsible for batch release.
- Drug sale licences - issued by provincial health/quality-control authorities for wholesale, retail pharmacy and restricted categories, tied to the premises, the licence holder, and the presence of a registered pharmacist where required.
- Import authorisation - per consignment, on top of product registration.
- Controlled drugs - additional narcotics handling permission and register obligations.
- Medical devices and cosmetics - separate registration/licensing streams.
Core rules
A licence does not travel with the business: change of ownership, address, premises area or responsible pharmacist needs prior intimation, usually inspection and endorsement. Licences run for a fixed term and lapse if not renewed. Operating while suspended is an offence; suspension or cancellation follows contravention, repeated failed inspections, or a substandard product traced to the site.
Worked example
A wholesale distributor wants to open a retail counter in the same building. A wholesale licence covers sale to licensed buyers only. Retail sale to the public needs a separate retail licence for those premises, a registered pharmacist, compliant storage with a working refrigerator and a locked narcotics cupboard. Trading on the wholesale licence alone is unlicensed retail sale.
Traps
Assuming a manufacturing licence permits sale to consumers; keeping a licence in the name of a pharmacist who has left or died; relocating without endorsement; treating a device as a drug or vice versa.