Drug Establishment Licence Requirements

To apply, you send Health Canada a complete application on form FRM-0033 containing everything listed in section C.01A.005 of the Food and Drug Regulations. To check whether a company holds a drug establishment licence (DEL), you search Health Canada's Drug and Health Products Inspections Database (DHPID), which has replaced the old DEL listing. Health Canada's DHPID page currently says the database is "temporarily offline" for cybersecurity reasons, and I couldn't reach the database itself, so for now you have to ask Health Canada directly.

Approach: I read Division 1A (C.01A.005 to C.01A.014) of the Food and Drug Regulations (C.R.C., c. 870) as published by Justice Laws Canada. The datasets I can search don't hold Canada's DEL or inspection listings, so the filing details and the licence check come from Health Canada pages I opened.

Applying for a DEL

What the regulations require

• The applicant "shall submit an application to the Minister, in a form established by the Minister." Under C.01A.005(1), the application must contain ^[6]:
  • contact details, plus an emergency contact (a)-(b)
  • each activity from Table I to C.01A.008 (c)
  • each drug category from Table II (d)
  • dosage form classes and whether any are sterile (e)
  • whether active ingredients are involved (f)
  • each building in Canada used to fabricate, package/label, test or store, and each building where records are kept, and whether any of them is a dwelling-house (g)-(i)
  • DINs or drug names (j)
  • the date of the last inspection (k)
  • evidence that buildings, equipment and practices meet Divisions 2 to 4 (l)
• Importers must also list each foreign fabricator, packager/labeller and tester, with building addresses.
  • For sites in MRA countries, give the designated regulatory authority that recognised the building (m).
  • For other sites, give a Canadian inspector's certificate or other evidence of GMP compliance (m)(iii), (n)-(o) ^[7].
• Under C.01A.005(2), the application may include a statement that it relates to a drug for a condition on the List of Conditions that Threaten Public Health. The Minister then takes that public health need into account ^[7][8].

How Health Canada reviews it

• The Minister may ask for further details, an inspection of the listed buildings during normal business hours, or samples of materials (C.01A.007) ^[9].
• Once that information is received, the Minister "shall" issue the licence, subject to the refusal grounds in C.01A.010 ^[8].
• The licence states:
  • the authorised activities and drug categories, and whether sterile forms are authorised
  • the Canadian buildings
  • for importers, the foreign suppliers and their buildings
• The Minister may also impose terms and conditions (C.01A.008(2)-(4)).
• Refusal:
  • The Minister may refuse for a false or misleading statement or a prior suspension.
  • The Minister "shall" refuse if issuing would risk consumer health.
  • Either way, you get written reasons and an opportunity to be heard (C.01A.010) ^[10].

How to file in practice (Health Canada pages)

• Use FRM-0033, the DEL application form and instructions. The main guidance documents are GUI-0002 and GUI-0127. Cost-recovery fees apply; for fee details contact criu-ufrc@hc-sc.gc.ca. General DEL questions go to del.questions-leppp@hc-sc.gc.ca (Drug establishment licences).
• Submitting the application (GUI-0127):
  • Email is preferred, to el.applications-le@hc-sc.gc.ca. Split large attachments across emails marked "Part X of Y".
  • You can also mail it to the Drug Establishment Licensing Unit, 200 Eglantine Driveway, Address Locator #1913B, Ottawa ON K1A 0K9. CDs and DVDs are accepted; USB drives are not.
• What to include:
  • the current FRM-0033
  • Table A for foreign building amendments
  • a cover letter (strongly recommended)
  • foreign-building GMP evidence prepared under GUI-0080
• File each amendment as a separate application.
• Health Canada sends an acknowledgement or completion notice within 20 calendar days (GUI-0127: How to prepare and submit a DEL application).

Keeping the licence

• Amendments (C.01A.006): you need one to add an activity, a drug category, sterile forms or a building. Importers also need one to add or change a foreign fabricator, packager/labeller or tester ^[11].

• Annual review (C.01A.009): a holder whose licence is not suspended "shall" apply for review before April 1 each year, with the C.01A.005 information ^[12].

• 15-day notifications (C.01A.013):

  • changes to the information in C.01A.005(1)(a), (b) or (e)-(i)
  • any GMP contravention that may affect a drug's quality, safety or efficacy

  ^[13]

• Change notices (C.01A.014): this covers changes to building plans, equipment or practices that may affect GMP compliance. You must file a notice, receive Health Canada's letter, and then wait 90 days without an objection before continuing that activity ^[14].

Checking a company's licence

• The DHPID shows which establishments Health Canada has licensed or registered. It covers inspections since 2012, in Canada and abroad, and replaces the DEL live listing. Drugs and establishment licences have their own search portal (DHPID).
• The DEL page links to the drug portal at drug-inspections.canada.ca/gmp. It describes the portal as the place to see whether domestic or foreign facilities have compliant or non-compliant ratings.
• Current status: the DHPID page says the database "is temporarily offline while work is underway to restore service securely." It tells users to contact Health Canada for inspection information in the meantime. I also could not reach the drug portal itself. For now, ask del.questions-leppp@hc-sc.gc.ca or the company for its DEL and its current Annex (the attached list of authorised activities, categories and buildings).
• What to check on the licence: whether the activity, drug category, sterile authorisation and building you rely on are all on it. For an importer, also check that your foreign site is named as an authorised supplier. These are the items C.01A.008(2) says the licence must indicate ^[8].

Sources:

• Drug establishment licences, Health Canada
• The drug and health products inspections database (DHPID), Health Canada
• GUI-0127 overview
• GUI-0127: How to prepare and submit a DEL application

A medical device establishment licence (MDEL) is issued under section 44 of the Medical Devices Regulations (SOR/98-282), not the Food and Drug Regulations. It is narrower and lighter than a drug establishment licence (DEL). It covers only importing or selling devices. Most manufacturers are exempt from it, and you apply with senior-official attestations about your procedures, not with GMP evidence for each building. The annual review, refusal and suspension rules are very close to the DEL rules.

Approach: I read the establishment licence provisions (sections 44 to 51.1) and the related distribution-record, complaint-handling and incident-reporting sections of the consolidated Medical Devices Regulations, and compared them with the Division 1A drug provisions from your last question.

Who needs it

DEL: you need one to fabricate, package/label, import, test, distribute (C.01A.003) or wholesale drugs.

MDEL: section 44(1) says "No person shall import or sell a medical device unless the person holds an establishment licence." Section 44(2) lists who that does not apply to ^[15]:

• retailers
• health care facilities
• manufacturers of Class II, III or IV devices
• manufacturers of Class I devices, but only if they import or distribute "solely through a person who holds an establishment licence"

So in practice MDELs are held by importers and distributors, and by Class I manufacturers who sell directly. Manufacturing, packaging, labelling and testing are not licensed activities under an MDEL, unlike under a DEL.

Importer's duty to check its supplier: under s. 44(3), anyone who imports a device "shall ensure" that the person they import from holds an establishment licence. Section 44(4) lifts that duty in two cases ^[15]:

• you import a Class II, III or IV device from its manufacturer
• you import a Class I device from its manufacturer and you hold an MDEL yourself

Side-by-side

Point	DEL (Food and Drug Regulations, Div. 1A)	MDEL (Medical Devices Regulations)
Licensed activities	Fabricate, package/label, import, test, distribute, wholesale	Import and/or distribute (s. 45(c))
Application content	Activities, drug categories, dosage forms, sterile status, every Canadian building, DINs, last inspection, GMP evidence for buildings and foreign sites	Name and address, contact person, any previous names, whether you import or distribute, the manufacturers whose devices you handle, medical specialities and device classes for each manufacturer, and senior-official attestations (s. 45) [16]
Quality evidence	Proof that buildings, equipment and practices meet Divisions 2 to 4 (GMP)	Attestation of documented procedures for distribution records, complaint handling and recalls. Importers of Class I devices also attest to incident reporting under s. 59(1) and (1.1); importers of Class II to IV devices attest to s. 59(1) reporting and s. 61.2 information. Anyone handling Class II to IV devices attests to procedures for handling, storage, delivery, installation, corrective action and servicing. You also give each building address where these procedures are in place (s. 45(g)-(j))
Issuance	"shall" issue, subject to the refusal grounds	"shall" issue if the application meets s. 45, subject to s. 47 (s. 46) [17]
Annual review	Before April 1 (C.01A.009)	Same: before April 1 each year, with the s. 45 information (s. 46.1) [18]
Notifying changes	15 days for a wider set of changes, plus GMP contraventions; 90-day change notices for buildings, equipment and practices	15 days, and only for changes to the name and address (s. 45(a)) or the contact person (s. 45(b)) (s. 48) [19]
Refusal	May refuse for a false statement; shall refuse if there is a health risk	Same structure: "may" refuse for a false or misleading statement; "shall" refuse where issuing would risk the health or safety of patients, users or others; you get written reasons and an opportunity to be heard (s. 47) [20]

Suspension, reinstatement and cancellation

• Suspension:
  • The Minister "may" suspend for a contravention, a false statement or a health or safety risk.
  • Before suspending, the Minister considers your compliance history and the risk, sends written notice, allows time for corrective action and gives you an opportunity to be heard (s. 49) ^[21].
  • If it is necessary to prevent risk, the Minister can suspend immediately. You may then ask in writing for reconsideration, and you must be given a hearing within 45 days (s. 50) ^[22].
• Reinstatement: the Minister "shall" reinstate the licence once the problem is corrected or the reason turns out to be unfounded (s. 51) ^[23].
• Cancellation: the Minister "shall" cancel the licence after more than 12 months of suspension, or if you miss the annual review application (s. 51.1) ^[24]. I did not find an equivalent cancellation section in the DEL provisions covered last time.

Duties that come with handling devices

The attestations in your application commit you to these obligations:

• Distribution records:
  • Manufacturers, importers and distributors "shall" each keep a record for each device (s. 52) ^[25].
  • The record must contain enough to allow a "complete and rapid recall" (s. 53) ^[26].
  • Keep it for the longer of the device's projected useful life and two years after shipment (s. 55) ^[27].
  • Retailers are exempt. So are health care facilities, for devices they distribute for use within the facility (s. 52(2)).
• Complaints and recalls: keep complaint records and have documented procedures for investigation and recall (ss. 57-58) ^[28][29].
• Incident reporting (importers):
  • Importers, like manufacturers, report Canadian incidents under s. 59 ^[30].
  • The preliminary report is due within 10 days for death or serious deterioration, and within 30 days where it could happen if the incident recurred (s. 60) ^[31].
  • A manufacturer may let its importer file reports on its behalf (s. 61.1) ^[32].
• Foreign risk information: if your MDEL lets you import Class II, III or IV devices, you "shall" send the Minister information on serious risks communicated by listed foreign regulatory agencies within 72 hours (s. 61.2) ^[33].

What this means in practice:

• An MDEL is not a product authorisation. It doesn't list the devices you handle, and it doesn't certify a site's GMP the way a DEL's building and foreign-site annex does. It records which manufacturers' devices you import or distribute, their device classes and their medical specialities.
• A manufacturer of Class II, III or IV devices doesn't need an MDEL to sell its own devices (s. 44(2)(c)).

I did not look up MDEL fees, the application form or Health Canada's MDEL listing this time. I can do that next if useful.