Establishment Licensing and Good Manufacturing Practices for Drugs

AuthorT. Nessim Abu-Zahra/Simon Carvalho/David Edwards
Establishment Licensing and Good
Manufacturing Practices for Drugs
Establishments that manufacture, import, and conduct other activities with
respect to drugs that are subject to the Food and Drug Regulations (FDRs) are
governed by Divisions A, , , and  of Part C of those Regulations. Division
A requires an establishment that fabricates, packages/labels, tests, imports,
distributes, or wholesales a drug to be licensed. To obtain an establishment
licence (EL), an application must be led demonstrating that the activities can
be conducted in accordance with the rules for “good manufacturing practices”
(GMPs) that are set out in Divisions  to . ese EL and GMP rules are
administered by Health Canada’s Regulatory Operations and Enforcement
Branch (ROEB).
e processes to obtain an EL are for the most part distinct from the
process to obtain a drug identication number (DIN)/notice of compliance
(NOC). In addition, the person who holds an establishment licence is not
always the same person who holds a DIN and/or an NOC for a drug. For
example, an importer that holds an EL may import and distribute drugs for
which the DIN/NOC are held by someone else.
is chapter rst sets out the rules regarding establishment licensing and
then provides some examples of GMP rules.
CRC, c .
Ibid. e establishment licensing and related GMP requirements for natural health
products are distinct from the rules for drugs. ese requirements are set out in the
Natural Health Products Regulations, SOR/-, which are discussed in Chapter .

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