Establishment Licensing and Good Manufacturing Practices for Drugs

• Author: T. Nessim Abu-Zahra/Simon Carvalho/David Edwards
• Pages: 69-79

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FIVE

Establishment Licensing and Good

Manufacturing Practices for Drugs

A. OVERVIEW

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 .