When a medicine stops reaching the shelf, the consequence is not commercial — it is a pharmacist telephoning a prescriber, a hospital substituting a therapy, and a patient waiting. Most shortages are not caused by demand. They are caused by something breaking in the supply chain that produces the medicine.
Raised Pharma works on the supply side of that problem: qualifying an alternate source of active ingredient, standing up a second manufacturing site, transferring a validated process, and preparing the regulatory work that has to accompany any of it. We also support Market Authorization Holders with the reporting obligations a shortage triggers in Canada.
Health Canada’s own figures for fiscal year 2024–2025. They explain why the second-source argument is a supply-chain argument rather than a sales one.
Exceptional importation into Canada can only be proposed by the holder of an active Drug Establishment Licence. Raised Pharma holds one. That means when a shortage cannot be met from domestic supply, we are able to act as the importing licensee ourselves — not simply advise a client to find one. It removes the step that most often stalls a shortage response.
Health Canada decides whether to permit any given importation. What the licence changes is who can put the proposal in front of them, and how quickly.
Two of these depend on decisions only Health Canada can make. We say so plainly below, because no consultancy can promise the outcome of a discretionary approval.
In Canada, reporting a shortage or a discontinuation is a legal obligation and it sits with the Market Authorization Holder. The regulations allow a designated third party to file on the holder’s behalf — the obligation itself stays with the holder. We can act as that designated representative, prepare and file the reports on the national registry, keep them current as the situation changes, and assemble responses when Health Canada asks for further information.
Identifying a second source of API or key excipient, reviewing the supplier’s documentation, auditing where the risk profile calls for it, and running the comparability and qualification work needed before the material can be used in a registered product.
Sixty-five per cent of Canadian shortages last year began with a manufacturing disruption. A single manufacturing site is a single point of failure for the whole supply. We develop and validate a second source so that one site going down does not take the product off the market.
Moving a validated process to another site without losing it: the documentation package, analytical method transfer and validation, equipment and facility fit, material alignment, trial and validation batches, and the stability commitment at the receiving site.
Where a critical shortage cannot be resolved from domestic supply, Health Canada may allow a foreign-authorised drug to be imported and sold in Canada. Only the holder of an active Drug Establishment Licence can propose one. Raised Pharma holds an active Drug Establishment Licence, so we can act as the importing licensee rather than only advising from the sidelines — adding the relevant foreign sites to our licence annexes, building the substitutability rationale, assembling the evidence of foreign authorisation and comparable quality, and preparing the labelling and risk-communication materials. The decision to permit importation remains Health Canada’s alone, and no party can guarantee it.
Canadian regulations now provide for specific lots to be listed with an extended expiration date where a shortage exists or is anticipated and the lot will continue to meet its specifications. We prepare the stability evidence that a request of this kind has to rest on. As with exceptional importation, the listing is Health Canada’s decision.
A new API supplier, a new manufacturing site or a new packaging site is a change to the registered product, and it has to be filed. We prepare and manage those post-approval submissions. The filing category is product-specific and is confirmed case by case rather than assumed.
The cheapest time to qualify a second supplier is while the first one is still working. Qualification during a shortage is the same work done under pressure, with the market already empty.
A supplier audit that looks past the immediate vendor to where the material genuinely originates is the difference between a mapped risk and a surprise.
Extension requests, shelf-life defences and site changes all rest on stability evidence. A programme that has been maintained is an asset when supply goes wrong.
Which reporting obligations bite, and which mechanisms are even available, follows from how the product is classified. That question is far easier answered in advance.
Canada’s shortage framework was amended with effect from 17 June 2026. Two changes matter commercially. The scope of mandatory reporting was widened through a ministerial list of drugs that can be added where a shortage could present a risk of injury to human health — and that list expressly reaches over-the-counter products, which were largely outside the regime before. Separately, a mechanism was introduced allowing specific lots to be listed with an extended expiration date where a shortage exists or is anticipated.
The amendments also renumbered the underlying regulatory provisions, which means a good deal of published guidance and third-party commentary now cites sections that have moved. If you are working from a shortage procedure written before June 2026, it is worth having it reviewed.
Important: this page is general information about the services Raised Pharma provides, not regulatory or legal advice. Exceptional importation and expiry-date extension are discretionary decisions of Health Canada — neither Raised Pharma nor any other party can guarantee an outcome. The legal obligation to report a shortage or discontinuation rests with the Market Authorization Holder and is not transferred by engaging a representative. Regulatory requirements in every market change; the position summarised here reflects our understanding at the time of writing and must be confirmed with the relevant authority and with a qualified regulatory professional before it is relied on.