The Drug Establishment Licensing Bulletin

The Health Product Compliance Directorate (HPCD) within the Regulatory Operations and Enforcement Branch oversees the national compliance and enforcement program for health products. HPCD manages the risk that health products pose to public health and safety in a number of ways. We provide:

Through compliance promotion activities, we strive to prevent problems from occurring in the first place by:

To help with these efforts we send Drug Establishment Licensing (DEL) Bulletins regularly to our stakeholders. These DEL Bulletins give information on our regulatory activities, process changes and hot issues.

The table below lists all of the DEL Bulletins that have been sent out to date. If a specific bulletin is not available for viewing, you can ask for a copy by emailing us at Be sure to give us the bulletin number, date and title of the ones you would like to receive.

Stakeholders will continue to receive notifications by email when a new bulletin is available for viewing.

List of Bulletins
Bulletin number Title Date
84 Guidance on business impact mitigation and additional measures for operational relief amid COVID-19 2020-04-16
124 Announcement of webinars for GUI-0028 and GUI-0029 2022-01-27
133 New guidance for evaluating and managing the risks of N-nitrosamine impurities in products 2022-04-07
132 Changes to policy on drug good manufacturing practices and DEL enforcement (POL-0004) 2022-04-01
131 Drug quality and supply chain requirements in light of Russia's invasion of Ukraine 2022-03-28
130 Guidance on veterinary antimicrobial sales reporting 2022-03-14
129 Guidance on new regulations for exceptional importation and sale of foreign-authorized drugs in Canada to mitigate drug shortages 2022-02-21
128 Webinar for Good manufacturing practices guidelines for active pharmaceutical ingredients (GUI-0104) 2022-02-15
125 Notice of publication: Good manufacturing practices guidelines for active pharmaceutical ingredients 2022-02-11
123 Update to the drug establishment licence application form and process 2022-07-12
122 Modernizing the Medical Device & Drug Establishment Licensing Framework (Phase I) 2021-12-14
121 ICMRA Reflections on the regulatory experience of remote approaches to GMP and GCP regulatory oversight during the COVID-19 Pandemic 2021-12-13
120 New regulatory provisions for distributing Canadian drugs outside Canada and providing information related to drug shortages 2021-11-23
119 Introducing the new DEL Bulletin Webpage 2021-08-12
118 Notice of Publication - GUI-0050 2021-08-10
117 Health Canada transitions interim order to the FDR for importing, selling, and advertising drugs in relation to COVID-19 2021-08-05
116 Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes before April 1, 2021 2021-07-07
115 Notice of Publication (GUI-0028 and GUI-0029) 2021-07-02
114 Notice of consultation for regulatory amendments supporting export-only drugs and transshipments 2021-06-18
113 Requirements to notify or report to Health Canada 2021-04-11
112 Consultation GUI-0074, process validation: Terminal sterilization processes for drugs 2021-05-03
111 Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes after March 31, 2021 2021-04-22
110 Veterinary antimicrobial sales reporting 2021-03-04
109 Changes to the drug establishment licence exemptions for hand sanitizers 2021-03-02
108 Reminder: Cost-benefit analysis survey on proposed regulations due March 1, 2021 2021-02-18
107 CETA Regulatory Cooperation Forum – Stakeholder debrief meeting, February 10, 2021 2021-02-01
106 Health Canada nitrosamines webinar, February 10, 2021 2021-01-15
105 Transition measures for exceptional importation interim order 2021-01-25
104 Invitation stakeholder information session on the allocation of drugs accessed via exceptional importation 2021-01-19
103 Nitrosamine update to market authorisation holders of human pharmaceutical, biological and radiopharmaceutical products 2020-12-16
102 Consultation on the recommendations for interoperability of track and trace systems for medicines 2020-12-15
101 Brexit: Summary information for Canadian companies 2020-12-03
100 New interim order - Safeguarding the drug supply 2020-12-03
99 New COVID hold for certain DEL applications 2020-11-13
98 Health Canada is adding tools to help prevent and alleviate drug shortages related to the COVID-19 pandemic 2020-10-28
97 Notice of consultation (GUI-0026) 2020-10-07
96 Electronic issuance of pharmaceutical product and good manufacturing practices certificates 2020-10-01
95 New pathway to expedite the authorization for importing, selling and advertising of COVID-19 drugs 2020-09-21
94 Notice of publication (GUI-0066 and GUI-0069) 2020-08-25
93 Notice of webinar (GUI-0069) 2020-08-13
92 Guidance: Importing and exporting health products for commercial use (GUI-0117) 2020-08-13
91 Extension revised to complete risk assessments for nitrosamine impurities 2020-08-10
90 Notice of publication (GUI-0005) 2020-08-20
89 Coming into force of regulatory amendments (CUSMA) (June 30, 2020) 2020-06-30
88 Enhanced guidance to support submission of proposals for inclusion on List of Drugs for Exceptional Import and Sale 2020-06-25
87 Updated question and answer document regarding nitrosamine impurities 2020-06-12
86 Guidance on transportation and storage considerations 2020-05-15
85 Requests for Information on additional supply of certain drugs used in the treatment of COVID-19 2020-04-22
83 Health Canada COVID-19 update for health product licence holders 2020-04-09
82 Health Canada is taking action to quickly respond to potential drug shortages during the COVID-19 pandemic 2020-04-06
81 Electronic issuance of drug establishment licences 2020-04-02
80 Revised drug establishment licences (DEL) guides and form 2020-04-01
79 Information to market authorization holders (MAHs) of human pharmaceutical products regarding nitrosamine impurities 2020-03-27
78 Health product inspections and licensing blog 2020-03-27
77 Health Canada alleviates confirmatory and identity testing requirements for certain low-risk non-prescription drugs 2020-03-26
76 Canada announces interim drug product testing measures for licensed importers 2020-03-23
75 Approach to management of COVID-19 2020-03-17
74 COVID-19 disinfectants and hand sanitizers 2020-03-17
73 Cost associated with foreign on-site assessments 2020-03-06
72 Notice of consultation (Annex 1) 2020-02-20
71 Important reminders (environmental crisis coronavirus) 2020-02-19
70 Notice of consultation - Annex 4 to the good manufacturing practices guide – Veterinary drugs (GUI-0012) 2020-02-19
69 Small business training session 2020-02-19
68 ALR webex links 2020-02-05
67 Health Canada stakeholder information webinar - Nitrosamines in pharmaceuticals, January 31, 2020 2020-01-24
66 Introduction of telecommunication tools during GMP inspections 2020-01-17
65 CETA Regulatory Cooperation Forum - Stakeholder debrief meeting, February 4, 2020 2020-01-16
64 Follow-up to letter to drug establishment licence (DEL) holders to inform them about steps to take to avoid nitrosamine impurities 2019-12-05
63 Notice of consultation PIC/S GMP guide 2019-12-02
62 Management of applications and performance for drug establishment licences (GUI-0127) 2019-11-29
61 Training sessions on revised guidance documents related to the Fees in Respect of Drugs and Medical Devices Order 2019-12-29
60 Canada-EU CETA Civil Society Forum call for participation 2019-11-06
59 Migration of drug establishment licence (DEL) API foreign building data to the DEL database 2019-11-06
58 Terms and conditions relating to angiotensin II receptor blockers (ARBs), known as "sartans" 2019-11-06
57 Letter to market authorization holders of human pharmaceutical products to inform on steps to take to avoid nitrosamine impurities 2019-11-06
56 Transition period for new DEL requirements for active pharmaceutical ingredients (API) for veterinary use 2019-11-05
55 Revised fees for drugs and medical devices 2019-05-17
54 Survey on Canadian drug exportation 2019-05-02
53 Certificate of pharmaceutical product & good manufacturing practice certificate annual fee increase 2019-04-10
52 Health Canada's fees for drugs and medical devices 2019-04-01
51 Best practices for submitting drug establishment licence (DEL) applications 2019-03-22
50 Stakeholder webinar presentation on the expanded sunscreen pilot 2019-02-18
49 Annual licence review webinar presentation and recording 2019-01-30
48 Pause-the-clock proposal webinar presentation and recording 2019-01-26
47 Additional Information regarding the expanded sunscreen pilot 2019-01-22
46 Presentation and recording on GUI-0031 webinar 2019-01-11
45 Notice to stakeholders – Release of good manufacturing practices for active pharmaceutical ingredients (GUI-0104) for consultation 2018-12-31
44 DEL annual licence review webinar 2018-12-21
43 Notice of consultation GUI-0069 2018-12-20
42 Notifying Health Canada of foreign actions - Guidance document for industry 2018-12-19
41 Launch of the expanded sunscreen pilot 2018-11-29
40 Webinar stop-the-clock 2018-11-28
39 Notice of consultation GUI-0028 & GUI-0029 2018-11-21
38 Call of expression of interest 2018-11-14
37 Technical issue with the Drug & Health Product Inspection Database 2018-11-07
36 Inclusion of API in Australia-Canada Mutual Recognition Agreement 2018-11-01
35 Pause-the-clock proposal for drug and medical device establishment licence applications 2018-10-18
34 Introducing new blog 2018-10-15
33 Important reminders – Hurricane Florence 2018-09-27
32 Health Minister announces access to a U.S.-approved epinephrine auto-injector 2018-09-04
31 Stakeholder engagement seminars (GUI-0001) 2018-09-04
30 Notice of publication – GUI-0071 2018-07-10
29 Notice of consultation – GUI-0071 2018-07-05
28 Licensing requirements for reclassified high-level disinfectants and sterilants as medical devices 2018-07-23
27 Webinar GUI-0001 2018-06-01
26 Revised fee proposal for drugs and medical devices 2018-05-25
25 Important notice to stakeholders regarding revisions of drug establishment licensing guidance documents and forms as a result of amendments to the Food and Drug Regulations 2018-05-22
24 Antimicrobial regulatory amendment webinars affecting veterinary drugs – Drug establishment licensing and good manufacturing practices requirements 2018-03-29
23 GUI-0031 webinar 2018-03-15
22 Notice of publication 2018-02-18
21 Antimicrobial regulator amendment webinars affecting veterinary drugs – Health Canada 2018-02-07
20 GUI-0080 2018-01-09
19 Notice of consultation 2017-12-22
18 Pilot for sunscreen products 2017-12-21
17 Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients 2017-11-29
16 Important reminders – Puerto Rico 2017-10-04
15 Importation of drugs for an urgent public health need 2017-07-05
14 Change to the Health Canada website 2017-06-08
13 Publication of Proposed Regulations Amending the Food and Drug Regulations (Vanessa's Law) in Canada Gazette, Part I [2017-05-05] 2017-05-05
12 Publication of proposed regulations amending the Food and Drug Regulations (importation of drugs for an urgent public health need) in Canada Gazette, Part I 2017-05-02
11 Certificate of pharmaceutical product and good manufacturing practice certificate annual fee increase 2017-03-31
10 Annual licence review product list 2017-02-03
9 Launch of the new pilot for sunscreen products 2017-01-27
8 Notice of consultation 2017-01-18
7 Implementation of a new pilot for sunscreens 2016-12-22
6 Reminder: Active pharmaceutical ingredient (API) application screening as of November 8, 2016 2016-11-08
5 Reminder: Table B for active pharmaceutical ingredients (APIs) 2016-11-08
4 Implementation of establishment licensing requirements for atypical active pharmaceutical ingredients 2016-11-04
3 Important notice to stakeholders regarding drug establishment licence applications submitted on portable storage devices 2016-09-20
2 Good manufacturing practices requirements for foreign buildings conducting activities in relation to active pharmaceutical ingredients destined for Canada or used to fabricate finished dosage forms destined for Canada 2016-08-04
1 Changes to the application process related to foreign buildings listed on drug establishment licences 2016-07-21
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