Active pharmaceutical ingredients: Related activities now subject to drug establishment licensing requirements

4 minute read
17 December 2013

If you import, fabricate, package/label or test drugs in Canada, then it is likely that recent regulatory changes will affect your regulatory responsibilities. These changes expand the application of licensing and Good Manufacturing Practices (GMP) responsibilities to those in the drug supply chain who were not previously subject to these requirements.

On November 8, 2013, amendments to the Food and Drug Regulations came into force applying establishment licensing and GMP provisions to active pharmaceutical ingredients (APIs) used in drugs for human use. The amendments include a new definition for APIs as active ingredients used to manufacture pharmaceuticals. The term “active ingredient” is also defined and includes raw material used in the fabrication of drugs that provides its intended effect. These new requirements are aimed at ensuring the overall quality and consistency of marketed drug products, and will also allow for enhanced traceability of APIs from the original manufacturer to the drug dosage form manufacturer.

Practically speaking, the amendments will affect a significant portion of the industry. First, all establishments in Canada that are fabricating, packaging/labelling, testing and importing APIs will, before February 8, 2014, be required to hold a Drug Establishment Licence (DEL) for that ingredient or to amend their existing DEL to cover APIs. Secondly, importers of finished dosage forms (who are not conducting any API activities in Canada) will be required to submit an amendment to their existing EL by signing the attestation to the GMP compliance status of the foreign buildings where fabrication, packaging/labelling and/or testing of APIs occur and submitting the Foreign Building Information Table to Health Canada before February 8, 2014. Lastly, distributors and wholesalers of APIs in Canada that import APIs from abroad will be required to submit a  DEL application to Health Canada before February 8, 2014 to cover API importation activity and will be subject to the applicable GMP requirements for API importers.

While Health Canada indicated that active ingredients used solely in NHPs were not subject to the new requirements, the fate of substances that may be used in pharmaceutical drugs as well as NHPs, such as titanium dioxide, is unclear. For these products and other OTC raw material ingredients, Health Canada is running a pilot project which puts establishment licensing requirements on hold, and instead requires  the submission of  information supporting the GMPs for those ingredients as well as traceability information.

As the average service standard for the review of DEL applications by Health Canada is 250 calendar days, it may be difficult to have on hand new or amended DELs by the February 8, 2014 deadline. However, as long as a complete application is submitted prior to that date, Health Canada has indicated that establishments will be able to continue to conduct API activities until otherwise advised by Health Canada. We should note that this lenience will not apply to new establishments proposing to start licensable activities related to APIs on or after November 8, 2013 – new activities cannot commence until the establishment has been inspected and deemed compliant by Health Canada, and a licence issued.

In addition to its Frequently Asked Questions page, Health Canada is preparing new guidance documents on GMPs for APIs, and on the Inspection Policy for Canadian API Drug Establishments. Information regarding the pilot project for manufacturers of selected consumer health products and their associated APIs can be found here.

Prepared with assistance from Jean-Francois Graillon.

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