DRAFT GUIDANCE DOCUMENT

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
DRAFT GUIDANCE DOCUMENT
Administrative Processing of Submissions and
Applications Involving Human or Disinfectant Drugs
This guidance document is being distributed for comment purposes only.
20
21
Published by authority of the
Minister of Health
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
Draft Date 2017/02/17
Health Products and Food Branch
37

38
39
40
41
42
43
44
45
Our mission is to help the people of Canada
maintain and improve their health.
Health Canada
© Minister of Public Works and Government Services Canada 2017
The Health Products and Food Branch’s (HPFB) mandate
is to take an integrated approach to managing the healthrelated
risks and benefits of health products and food by:
$ minimizing health risk factors to Canadians while
maximizing the safety provided by the regulatory
system for health products and food; and,
$ promoting conditions that enable Canadians to make
healthy choices and providing information so that
they can make informed decisions about their health.
Health Products and Food Branch
Également disponible en français sous le titre : Ébauche de la Ligne directrice : Traitement
administratif des présentations et des demandes de drogues à usage humain ou pour produits
désinfectants

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
FOREWORD
Guidance documents are meant to provide assistance to industry and health care professionals on
how to comply with governing statutes and regulations. Guidance documents also provide
assistance to staff on how Health Canada’s mandates and objectives should be implemented in a
manner that is fair, consistent and effective.
Guidance documents are administrative instruments not having force of law and, as such, allow
for flexibility in approach. Alternate approaches to the principles and practices described in this
document may be acceptable provided they are supported by adequate justification. Alternate
approaches should be discussed in advance with the relevant programme area to avoid the
possible finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right
to request information or material, or define conditions not specifically described in this
document, in order to allow the Department to adequately assess the safety, efficacy or quality of
a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable
and that decisions are clearly documented.
This document should be read in conjunction with the accompanying notice and the relevant
sections of other applicable guidance documents.
Draft Date: 2017/02/17
i

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
Table of Contents
1. INTRODUCTION .................................................................................................................... 1
1.1 Policy Objective ............................................................................................................... 1
1.2 Policy Statements ............................................................................................................. 1
1.3 Scope and Application ..................................................................................................... 2
1.4 Definitions........................................................................................................................ 2
1.5 Background ...................................................................................................................... 4
2. GUIDANCE FOR IMPLEMENTATION ................................................................................ 4
2.1 When to File Drug Submissions and Applications for Administrative Processing ......... 4
2.2 Roles and Responsibilities of Manufacturers .................................................................. 5
2.2.1 Additional Responsibilities for Licensors and Licensees ...................................... 6
2.3 General Document Requirements .................................................................................... 7
2.4 Additional Document Requirements and Submission/Application Types ...................... 8
2.4.1 Manufacturer Name Changes ................................................................................ 8
2.4.2 Product Name Changes ......................................................................................... 8
2.4.3 Changes in Product Ownership ............................................................................. 8
2.4.4 Mergers and Buyouts ............................................................................................. 9
2.4.5 Licensing Agreements ......................................................................................... 10
2.4.5.1 Post-Authorization Labelling Changes, including Revised/Updated
Product Monographs or Prescribing Information ................................................ 11
2.4.5.2 Post-Authorization Deviations to Labelling and Chemistry and
Manufacturing ..................................................................................................... 11
2.4.5.3 Post-Authorization Chemistry and Manufacturing Updates (CMC) [Only
for Schedules C and D drug products] ................................................................ 12
2.5 Drug Identification Number (DIN) Issuance ................................................................. 12
2.5.1 Changes in Product Ownership including Mergers and Buyouts ........................ 12
2.5.2 Additional Product Names .................................................................................. 13
2.5.3 Licensing Agreements ......................................................................................... 13
2.5.4 Transfer of a Cancelled Drug Identification Number (DIN)............................... 14
2.5.4.1 Licensing Agreements ............................................................................. 14
2.6 Labelling ........................................................................................................................ 15
2.7 Fees ................................................................................................................................ 15
3. CONTACT INFORMATION ................................................................................................. 16
4. REFERENCES ....................................................................................................................... 16
5. APPENDICES ........................................................................................................................ 18
APPENDIX 1: ADMINISTRATIVE CHANGES - CERTIFICATION FORM .......................... 20
APPENDIX 2: SAMPLE - ATTESTATION - CHANGE IN PRODUCT OWNERSHIP
ii Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
106 (ACQUIRING MANUFACTURER) ..................................................................................... 22
107 APPENDIX 3: SAMPLE - LETTER OF AUTHORIZATION - CHANGE IN PRODUCT
108 OWNERSHIP (DIVESTING MANUFACTURER) .............................................................. 23
109 APPENDIX 4: SAMPLE - ATTESTATION - MERGER / BUYOUT (NEW manufacturer) .....24
110 APPENDIX 5: SAMPLE - LETTER OF AUTHORIZATION (LICENSING AGREEMENT) . 25
111 APPENDIX 6: SAMPLE - STATEMENT OF COMMITMENT (LICENSING
112 AGREEMENT)....................................................................................................................... 26
113
Draft Date: 2017/02/17
iii

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
1. INTRODUCTION
Pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations (hereafter the
Regulations), no manufacturer shall sell a drug in Canada unless a Drug Identification Number
(DIN) [C.01.014 (1)] or DIN and Notice of Compliance (NOC) [C.08.002 (1)] have been issued
by Health Canada, which grant market authorization for that product. Paragraph C.01.014.4 (b)
of the Regulations sets out obligations for manufacturers to notify Health Canada of information
changes pertaining to the manufacturer and drug product. These information changes must, in
some cases, be supported by a new DIN application or Post-Authorization Division 1 Change
(PDC) for Division 1 drugs. For Division 8 drugs [C.08.003 (1)], an Extraordinary Use New
Drug Submission (EUNDS), New Drug Submission (NDS), Abbreviated NDS (ANDS),
Abbreviated EUNDS (AEUNDS), Supplement or Notifiable Change (NC) may be required.
For the purpose of this guidance document, Health Canada has determined that certain
submissions and applications involving human or disinfectants drugs may be submitted for
administrative processing to the Office of Submissions and Intellectual Property (OSIP) of the
Therapeutic Products Directorate (TPD). These submissions and applications do not contain
scientific data, or require regulatory review.
1.1 Policy Objective
To clarify the requirements for eligible drug submissions and applications that will be processed
under the administrative pathway.
The only policy that explicitly governs the administrative processing of submissions and
applications is the Change in Manufacturer’s / Product Name Policy (CMPN), written in 1998
and updated in 2001. The Policy outlines the conditions and procedures by which Health Canada
processes administratively a change in manufacturer name or product name as a result of certain
business circumstances, when there are no deviations to the product.
Once finalized, the guidance document will supersede the above-noted Policy.
1.2 Policy Statements
To be eligible for administrative processing, all aspects of the submission and application
pertaining to the drug product, except for the manufacturer name and/or product name, must be
identical to those previously authorized for that product. These include, but are not limited to, the
submission type, all clinical data, chemistry and manufacturing data, product formulation,
strength, route of administration, dosage form, authorized indication(s) and condition(s) of use as
Draft Date: 2017/02/17 1

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
well as all product labels 1 . Any deviations from the previously authorized product will not be
acceptable under the administrative pathway.
Submissions and applications may be processed administratively only if the original
manufacturer’s drug product has undergone a full review and received authorization from Health
Canada [that is (i.e.), a DIN for Division 1 drugs and a DIN/NOC for Division 8 drugs]. This
policy does not apply to secondary licensing agreements between licensees and third-parties.
In addition, for licensing agreements, the licensor’s drug product must be marketed in Canada
and market notified with Health Canada [C.01.014.3] at the time of the licensee’s filing.
Health Canada has the regulatory authority to consider brand names when making a decision on
whether or not to grant a DIN or DIN/NOC to a manufacturer.
For application of the Patented Medicines (Notice of Compliance) Regulations, refer to the
Guidance Document: Patented Medicines (Notice of Compliance) Regulations.
1.3 Scope and Application
This guidance document applies to drug submissions and applications involving biologics,
radiopharmaceuticals, human pharmaceuticals (includes prescription and non-prescription drugs)
and disinfectants regulated under the Food and Drugs Act. More specifically, it captures a DIN
application [C.01.014.1 (1)] and PDC, EUNDS [C.08.002.01 (1)], NDS [C.08.002 (1)], ANDS or
AEUNDS [C.08.002.1 (1)], including supplements [C.08.003 (1)] and NCs.
1.4 Definitions
Brand Name 2 (or proprietary drug name) - C.01.001 (1) of the Food and Drug Regulations
states that a "brand name" means, with reference to a drug, the name, whether or not including
the name of any manufacturer, corporation, partnership or individual, in English and/or French:
a. that is assigned to the drug by its manufacturer,
b. under which the drug is sold or advertised, and
1
2
Due to the regulatory mock-up requirements under the Regulations Amending the Food and Drug
Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use), manufacturers of
prescription products and those administered or obtained through a health professional are
required to certify that the new labels and packaging are similar to those initially approved with
respect to location and size of the text and graphics (including logos). Refer to section 2.6 on
Labelling.
For the purpose of this guidance document, brand name and product name are interchangeable.
2 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
c. that is used to distinguish the drug.
Division 1 drug - a drug that was submitted to Health Canada as a Drug Identification Number
application and authorized pursuant to the requirements of Division 1 in Part C of the Food and
Drug Regulations.
Division 8 drug - a drug that was submitted to Health Canada as a New Drug Submission and
authorized pursuant to the requirements of Division 8 in Part C of the Food and Drug
Regulations.
Drug Identification Number (DIN) - a computer-generated eight digit number assigned by Health
Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug
products sold in a dosage form in Canada and is located on the label of prescription and over-thecounter
drug products that have been evaluated and authorized for sale in Canada. A DIN
uniquely identifies the following product characteristics: manufacturer; product name; active
ingredient(s); strength(s) of active ingredient(s); pharmaceutical form; route of administration.
Cross-licensed product - is a drug product (for which a licensee is seeking market authorization)
for which all aspects of the submission or application are identical to that of the licensor in terms
of all clinical data, chemistry and manufacturing data, product formulation, strength, route of
administration, dosage form, authorized indication(s) and condition(s) of use as well as all
product labels 1 . For a cross-licensed product to be eligible for administrative processing, the
licensor’s product must have undergone a full review and received authorization from Health
Canada; it must be marketed in Canada and market notified with Health Canada [C.01.014.3 of
the Regulations] at the time of the licensee’s filing.
Drug Product Market Notification - the manufacturer notifies Health Canada of the date of first
sale pursuant to section C.01.014.3 of the Food and Drug Regulations.
Label - as per the Food and Drugs Act, is interpreted to include labels affixed to the container or
packaging of the drug, any separate package inserts 3 , product monographs, prescribing
information, fact sheets, consumer information/patient medication information (i.e., patient
leaflets), patient diaries, or other material containing information specific to the drug product.
These separate package labels generated by the manufacturer/sponsor may be included in the
packaging or supplied to the consumer at the time of dispensing.
3
Note that package inserts could also include wallet cards, tear-off pads and hand-outs directed to
the consumer and whose content is Part III of the PM.
Draft Date: 2017/02/17 3

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
Licensing Agreement - an agreement between two manufacturers whereby one manufacturer
(licensor) supplies a drug product to another manufacturer (licensee) for sale under the second
manufacturer’s name.
Manufacturer or Distributor (as per section A.01.010 of the Regulations) - means a person,
including an association or partnership, who under their own name, or under a trade, design or
word mark, trade name or other name, word or mark controlled by them, sells a food or drug. For
the purpose of this document, a manufacturer is a DIN Holder.
Merger or Buyout - the combining of two or more manufacturers into one, through a purchase,
acquisition or a pooling of interests or purchase of controlling interest in one manufacturer by
another manufacturer, in order to take over assets and/or operations.
Change in Product Ownership - when a manufacturer transfers the possession and responsibility
for a product to another manufacturer.
1.5 Background
The 1998 Change in Manufacturer’s / Product Name Policy (CMPN) governs the administrative
processing of submissions and applications. Since the implementation of the CMPN policy, the
number of drug submissions and applications filed under the administrative pathway increased
significantly. The draft guidance document addresses certain policy gaps that were identified
throughout the years.
The CMPN policy replaced the 1996 policy entitled, Therapeutic Products Directorate Policy
Issues: Changes in Manufacturer's Name, January 18, 1996.
2. GUIDANCE FOR IMPLEMENTATION
2.1 When to File Drug Submissions and Applications for Administrative Processing
1. Manufacturer Name Change and/or Product Name Change 4 . These include:
• Changes in Product Ownership (i.e., Change in DIN Holder)
• Mergers and Buyouts
2. Additional Product Names 2 .
4
Certain product names cannot be processed administratively. Refer to section 2.6 on Labelling.
4 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
3. Licensing Agreements between two manufacturers. These include:
• Post-Authorization Labelling Changes, including Revised/Updated Product
Monographs or Prescribing Information
• Post-Authorization Chemistry and Manufacturing Updates (CMC) [Only for products
regulated under Schedules C and D of the Regulations]
Health Canada will not process administratively drug submissions and applications that
reference only certain aspects of the licensor’s submission or application for the drug product
(i.e., strengths, dosage forms or indications).
For Division 8 drugs, when a product is authorized for marketing, a NOC will be issued
indicating the reason for the submission. For example, if a manufacturer files a submission under
the administrative pathway as a result of a licensing agreement between two manufacturers, the
NOC will indicate, under the Reason for Submission section, "Administrative - Licensing
Agreement between two manufacturers". Although not exhaustive, a list of examples for
different types of administrative changes is included below:
• Administrative - Manufacturer Name Change
• Administrative - Product Name Change
• Administrative - Changes in Product Ownership (i.e. Change in DIN Holder)
• Administrative - Merger/Buyout
• Administrative - Additional Product Name
• Administrative - Licensing Agreement between two Manufacturers
• Administrative - Revised / Updated Product Monograph
2.2 Roles and Responsibilities of Manufacturers
All manufacturers (which comprises licensees) filing submissions and applications under the
administrative pathway must meet the same regulatory standards as the original manufacturers.
These include, but are not limited to:
• Adhering to filing requirements, if the information supporting the DIN application is no
longer correct [sections C.01.014.4 (b), C.01.014.5 and C.08.003 (1) of the Regulations].
This applies equally to DIN assigned drugs under Division 1 and drugs with an NOC
under Division 8.
• Complying with the labelling requirements governed by sections 3, 9, and 10 of the
Food and Drugs Act and by sections contained in Parts A, C, D, G, and J of the
Regulations.
• Keeping the product’s safety information up-to-date and filing the appropriate drug
submission or application where changes to product labels are required.
Draft Date: 2017/02/17 5

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
• Obtaining authorization from Health Canada for label updates and for chemistry and
manufacturing changes before implementing changes to marketed products, as required
by the Regulations (and explained in the Post-DIN and Post-NOC guidance documents).
• Applying for, and obtaining, a Drug Establishment License (DEL) [C.01A.001] 5 , as part
of the regulatory requirements associated with selling a drug.
• Assuming responsibility for the drug product such as complying with Good
Manufacturing Practices (GMP) requirements under Division 2 of Part C of the
Regulations 6 7 and post-authorization requirements.
• Complying with all other provisions of the Food and Drugs Act and the Regulations,
which include having systems in place to handle complaints, report and monitor the
safety and efficacy of drugs (i.e., pharmacovigilance activities), and manage recalls.
• Notifying Health Canada of any recalls of their drug product [C.01.051].
• Ensuring that Schedule D products meet the requirements of the Biologics and Genetic
Therapies Directorate (BGTD)’s lot release program prior to the sale of the lot in
Canada.
2.2.1 Additional Responsibilities for Licensors and Licensees
In addition to the regulatory responsibilities listed above, for licensing agreements:
• Licensors and licensees must have a direct relationship whereby the licensor grants
permission to a licensee(s) via a Letter of Authorisation (LoA) to reference their drug
submission or application in support of the cross-licensed product. This policy does
not apply to secondary licensing agreements between licensees and third-parties.
• Licensors are expected to provide their licensees with the most complete and up-todate
submission or application information to: support the development and
maintenance of product labels for the cross-licensed product(s); and, ensure
5
6
7
For the minimum requirements that must be in place prior to the filing of a DEL Application,
consult the document “Drug Establishment Good Manufacturing Practices - Pre-Application
Package (Importers, Distributors and Wholesalers)” at http://www.hc-sc.gc.ca/dhp-mps/compliconform/gmp-bpf/docs/gmp-package-bpf-eng.php.
Except for low-level disinfectants which are exempt from these Regulations.
For further information on GMPs, consult the GUI-0001 - Good Manufacturing Practices
Guidelines at http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/index-eng.php.
6 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
355
356
357
358
359
360
361
362
363
364
365
366
367
368
consistency with that of the Canadian Reference Product (CRP), if applicable. Failure
to update product labels may impact the approval of the licensee’s drug submission or
application.
• Licensees must have all required documents available on the premises as prescribed
by Division 2 of the GMP Regulations 8 .
• Licensees are expected to update their product labels consistently with those of the
licensor. Approvability of the licensee’s drug submission or application is contingent
on the licensor’s product labels being up-to-date. In cases where the licensor’s
product is a generic drug, it is expected that the licensor’s product labels be up-todate
with those of the CRP.
2.3 General Document Requirements
Manufacturers must satisfy the conditions for obtaining market authorization from Health
Canada and are responsible for the quality and completeness of their drug submission or
application by providing the following documentation to OSIP:
• a signed Administrative Changes - Certification Form For Human or Disinfectant Drugs
for each drug product, certifying that all aspects of the drug submission or application
pertaining to the drug product and product labels 9 are identical, except for manufacturer
name and/or product name 2 ;
• a completed Drug Submission Application (3011) Form;
• all proposed labels, including mock-ups as applicable 10 ;
• a Mock-Up Labels and Packages Certification Form stating that the label and packaging
material are similar to the original product with respect to size and placement of graphics,
logos and font, as applicable;
8
9
10
For further information on GMP, consult “Good Manufacturing Practices (GMP) Questions and
Answers” at http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/question/gmp-bpfeng.php
.
Refer to section 1.4 Definitions.
For non-prescription products, these requirements will come into effect in 2017. For prescription
products and products administered or obtained through a health professional for human use, refer
to the Guidance Document Questions and Answers: Plain Language Labelling Regulations.
Draft Date: 2017/02/17 7

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
369
370
371
372
373
374
375
376
377
378
379
380
381
382
383
384
385
386
387
388
389
390
391
392
393
394
395
396
397
398
399
400
401
402
403
404
405
406
407
408
409
410
• a completed Submission Fee Application Form and the relevant fee (not applicable to
PDCs and NCs);
• a Letter of Authorization (LoA); and,
• a Certified Product Information Document (CPID) for Schedules C and D products.
2.4 Additional Document Requirements and Submission/Application Types
2.4.1 Manufacturer Name Changes
When there is a change to the manufacturer’s name or a change to both the
manufacturer’s and product names 2 , manufacturers must file a DIN application for
Division 1 drugs and an EUNDS, NDS, ANDS or AEUNDS for Division 8 drugs.
Authorization from Health Canada must be obtained before any changes are made to
labels on the market.
2.4.2 Product Name Changes
When there is a change to an existing product name, manufacturers must file a DIN
application for Division 1 drugs or a supplement to an EUNDS, NDS, ANDS or
AEUNDS for Division 8 drugs. Authorization from Health Canada must be obtained
before any changes are made to labels on the market.
Certain product names cannot be processed administratively.
2.4.3 Changes in Product Ownership
For changes in product ownership 9 [i.e. Change in DIN Holder], it is understood that one
manufacturer is acquiring ownership of a product from another manufacturer. For
Division 1 drugs, the manufacturer must file a DIN application. For Division 8 drugs, the
manufacturer must file an EUNDS, NDS, ANDS or AEUNDS. Authorization from
Health Canada must be obtained before any changes are made to labels on the market.
In addition to the general document requirements, the following must be provided:
1. A written attestation (Refer to Appendix 2) from the acquiring manufacturer attesting
that:
• It assumes all responsibility for the drug product and no changes are taking place
within the drug submission or application including, but not limited to, all clinical,
chemistry and manufacturing data, product formulation, strength, route of
8 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
411
412
413
414
415
416
417
418
419
420
421
422
423
424
425
426
427
428
429
430
431
432
433
434
435
436
437
438
439
440
441
442
443
444
445
446
447
448
449
450
451
452
administration and dosage forms, authorized indication(s) and condition(s) of use as
well as all product labels 1 , except for the manufacturer name and/or product name.
• Once the drug product is marketed under the name of the acquiring manufacturer, it
will notify Health Canada within 30 days of the sale of its product [C.01.014.3] and
submit copies of labels, if applicable. Health Canada expects that there is a 6 month
phase-in period to replace the original product labels with the new product labelling.
2. A LoA (Refer to Appendix 3) from the divesting manufacturer stating that it is
transferring ownership of its product and associated DIN(s) to the acquiring
manufacturer.
2.4.4 Mergers and Buyouts
For mergers and buyouts 11 , it is understood that the new manufacturer (i.e., acquiring or
merged firm) is the DIN Holder.
Following a merger or buyout, the new manufacturer must file, for all affected products
regardless of market status, a DIN application for Division 1 drugs or an EUNDS, NDS,
ANDS or AEUNDS for Division 8 drugs. Authorization from Health Canada must be
obtained before any changes are made to labels on the market.
Manufacturers are encouraged to contact Health Canada to discuss filing strategies when
a large number of products are affected.
In addition to the general document requirements, the following must be provided:
1. A written confirmation from the original manufacturer stating that:
• There is a changed business circumstance from the original DIN Holder and
authorization is given to the new manufacturer (i.e., acquiring or merged firm) to
access the drug submission or application.
2. A written attestation (Refer to Appendix 4) from the new manufacturer stating that:
• It assumes all responsibility for the drug product and no changes are taking place
within this drug submission or application including, but not limited to, all clinical,
chemistry and manufacturing data, product formulation, strength, route of
administration and dosage forms, authorized indication(s) and condition(s) of use as
well as all product labels 1 , except for the manufacturer name and/or product name.
Draft Date: 2017/02/17 9

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
453
454
455
456
457
458
459
460
461
462
463
464
465
466
467
468
469
470
471
472
473
474
475
476
477
478
479
480
481
482
483
484
485
486
487
488
489
490
491
• Once the drug product is marketed under the name of the new manufacturer, it will
notify Health Canada within 30 days of the sale of its product [C.01.014.3] and
submit copies of labels, if applicable. Health Canada expects that there is a 6 month
phase-in period to replace the original product labels with the new product labels.
2.4.5 Licensing Agreements
For licensing agreements 11 , it is understood that the final dosage form is being supplied
by a licensor to the licensee (i.e., the drug is in a form which is ready for use by the
consumer without requiring any further manufacturing). For Division 1 drugs, the
manufacturer must file a DIN application. For Division 8 drugs, the manufacturer must
file an EUNDS, NDS, ANDS or AEUNDS.
In addition to the general document requirements, the following is required as part of the
submission:
1. A LoA (Refer to Appendix 5) from the licensor (i.e. original DIN Holder) confirming
that:
• Permission is granted to the licensee to reference its drug submission or application
for the cross-licensed product and to Health Canada to access the submission or
application in support of the licensee’s filing;
• Labelling information will be kept up-to-date and any label updates will be
communicated to licensees to allow them to file identical updates with Health
Canada; and,
• Any updates to the chemistry and manufacturing information and product formulation
will be communicated to licensees to allow them to remain in compliance. For
Schedules C and D products, refer to section 2.4.5.3 Post-Authorization Chemistry
and Manufacturing Updates (CMC).
2. A statement of commitment (Refer to Appendix 6) from the licensee confirming that
it will:
• Comply with the regulatory requirements associated with selling a drug and maintain
safety and efficacy information updates within 30 days of the licensor; and,
10 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
492
493
494
495
496
497
498
499
500
501
502
503
504
505
506
507
508
509
510
511
512
513
514
515
516
517
518
519
520
521
522
523
524
525
526
527
528
• Remain consistent with the licensor’s post-authorization chemistry and manufacturing
updates and product formulation updates 11 . For Schedules C and D products, refer to
section 2.4.5.3 Post-Authorization Chemistry and Manufacturing Updates (CMC).
2.4.5.1 Post-Authorization Labelling Changes, including Revised/Updated Product
Monographs or Prescribing Information
All manufacturers are required under the Regulations to ensure that drug product labels,
including the product monograph or prescribing information, are up-to-date and support
the products’ safe conditions of use.
For licensing agreements, where product labelling identicality is maintained throughout
the products’ life-cycle, licensees are expected to reflect the licensors’ label changes -
meaning they should provide identical safety and efficacy updates for their cross-licensed
products within 30 days of the licensors’ updates. For Division 1 drugs, the manufacturer
must file a DIN Application or a PDC. For Division 8 drugs, the manufacturer must file a
supplement to an EUNDS, NDS, ANDS, AEUNDS or an NC. Authorization from Health
Canada must be obtained before any changes are made to labels.
For additional information, refer to the Guidance Document on Post-Drug Identification
Number (DIN) Changes and the Post-Notice of Compliance (NOC): Safety and Efficacy
Document.
When filing these changes, a licensee must obtain permission from the licensor through a
LoA to make reference to its drug submission or application and to allow Health Canada
to access the submission or application in support of the licensee’s post-authorization
labelling change.
2.4.5.2 Post-Authorization Deviations to Labelling and Chemistry and Manufacturing
After obtaining market authorization for the cross-licensed product, all aspects of the
authorization for the licensee’s product must remain identical in every way to that of the
licensor’s throughout the product’s life-cycle, with the exception of the manufacturer
name and/or product name. Should a licensee wish to deviate from the licensor in terms
of strength, route of administration, dosage form, labels, chemistry and manufacturing
information or product formulation, these changes will not be eligible for processing
under the administrative pathway and will require a drug submission or application with
11
To exercise due diligence, Health Canada may request an attestation of product identicality from
the licensee at any time during the products' life-cycle.
Draft Date: 2017/02/17 11

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
529
530
531
532
533
534
535
536
537
538
539
540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556
557
558
559
560
561
562
563
564
565
566
567
568
569
supporting data. The cross-licensed product would no longer be eligible for any future
filings under the administrative pathway as the aspects of the authorization would no
longer be considered identical to the licensor.
2.4.5.3 Post-Authorization Chemistry and Manufacturing Updates (CMC) [Only for
Schedules C and D drug products]
For licensing agreements involving biologics and radiopharmaceuticals, licensees are
expected to file a drug submission or application following the reporting categories
outlined in the Post-Notice of Compliance (NOC) Changes: Quality Document. In the
absence of a guidance specific to Quality changes to drugs which were authorized
through a DIN Application - Biologics (DIN-B drugs), the Post-Notice of Compliance
(NOC) Changes: Quality Document applies to those products.
When filing these changes, a licensee must obtain permission from the licensor through a
LoA to make reference to its drug submission or application and to allow Health Canada
to access the submission or application in support of the licensee’s post-market chemistry
and manufacturing change.
Licensees must provide an updated CPID at time of filing, if applicable.
2.5 Drug Identification Number (DIN) Issuance
2.5.1 Changes in Product Ownership including Mergers and Buyouts
When the appropriate regulatory steps are taken, Health Canada will reissue the same
DINs, for all changes in product ownership including mergers or buyouts.
These business arrangements may involve:
• an approved product which is not marketed (DIN with an approved or dormant
status):
If the acquiring manufacturer or new manufacturer markets its drug product, it must
notify Health Canada within 30 days of the sale of the product [C.01.014.3].
If, at any time after the transfer is approved, the acquiring manufacturer or new
manufacturer discontinues the sale of its drug product [C.01.014.7], this will result
in DIN cancellation [C.01.014.6 (1)(a)].
12 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
570
571
572
• an approved product which is marketed:
If the acquiring manufacturer or new manufacturer continues to market its drug
573
product, they must notify Health Canada within 30 days of the sale of the product
574
575
576
[C.01.014.3].
Health Canada expects that there is a 6 month phase-in period to replace the
577
578
579
original product labels with the new product labels.
The acquiring manufacturer or new manufacturer must notify Health Canada within
580
30 days when a drug product has not been sold for a period of 12 months
581
[C.01.014.12 (2) of the Regulations Amending the Food and Drug Regulations
582
(Shortages of Drugs and Discontinuation of Sale of Drugs)]. This will result in a
583
change to the status of the product in the Drug Product Database (DPD) from
584
585
586
‘marketed’ to ‘dormant’.
If, at any time after the transfer is approved, the acquiring manufacturer or new
587
manufacturer discontinues the sale of its drug product [C.01.014.7], this will result
588
589
590 •
in DIN cancellation [C.01.014.6 (1)(a)].
a drug product with a cancelled DIN (Refer to section 2.5.4 Transfer of a
591
592
Cancelled DIN).
593 2.5.2 Additional Product Names
594
595
596
597
598
When manufacturers request an additional product name (same product and supplier)
through a DIN application or an EUNDS, NDS, ANDS or AEUNDS, Health Canada will
issue a new DIN to the product bearing the additional name to ensure that one DIN is
linked to one product name (Refer to section 2.6 on Labelling).
599
600 2.5.3 Licensing Agreements
601
602 Licensors are expected to keep their DINs active to allow licensees to maintain safety
603 updates.
604
605 If the drug submission or application is authorized, Health Canada will issue new DINs to
606 licensees entering first time licensing agreements.
607
608 For pharmaceuticals, when licensees make changes to their licensing agreements and
609 wish to change from one licensor to another, this is considered a new licensing agreement
610 and a new drug submission or application must be filed that meets the conditions of this
611 guidance. In this case, licensees will be required to retain the same DIN(s).
Draft Date: 2017/02/17 13

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
612
613
614
615
616
617
618
619
620
621
622
623
624
625
626
627
628
629
630
631
632
633
634
635
636
637
638
639
640
641
642
643
644
645
646
647
648
649
650
651
652
In cases where changes in licensing agreements involve cross-licensing products
authorized under different regulatory pathways and requirements (i.e. full safety, efficacy
and quality data package for an NDS versus comparative bioequivalence data to a CRP
for an ANDS), licensees will not be permitted to retain the same DINs as this would be
misleading to drug plan providers and patients.
2.5.4 Transfer of a Cancelled Drug Identification Number (DIN)
The transfer of a cancelled DIN will require a drug submission or application, which will
result in the reissuance of the DIN upon approval. For more information, contact the DIN
Division at the following address:
Office of Submissions and Intellectual Property
Finance Building #2
Tunney’s Pasture, Address Locator: #0201A1
Ottawa, Ontario
K1A 0K9
Fax: 613- 941-0825
Telephone: 613-941-7281
Email: SIPD-DINrequest@hc-sc.gc.ca
For additional information with respect to DIN cancellations, refer to Health Canada’s
Draft Guidance Document - Cancellation of a Drug Identification Number (DIN) and
Notification of the Discontinuation of Sales.
2.5.4.1 Licensing Agreements
When a licensor’s DIN is cancelled by Health Canada for safety reasons, Health Canada
will cancel the licensee’s DIN because the safety data for the cross-licensed product
relies on the safety data of the licensor.
When a licensor notifies Health Canada of the discontinuance of sale of its product
[C.01.014.7], Health Canada will cancel the licensor’s DIN and licensees will be required
to:
a) discontinue the sale of their cross-licensed product, which would result in Health
Canada cancelling the DIN following notification from the licensees;
b) enter in a new licensing agreement and file accordingly; or,
c) file their own drug submission or application with supporting data.
14 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
653
654
655
656
657
658
659
660
661
662
663
664
665
666
667
668
669
670
671
672
673
674
675
676
677
678
679
680
681
682
683
684
685
686
687
688
689
690
691
692
693
2.6 Labelling
For manufacturers who are transitioning products due to new business arrangements, Health
Canada expects that there is a 6 month phase-in period to replace the original product labels with
new product labels.
With the coming into force on June 13, 2015 of the Regulations Amending the Food and Drug
Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use), for prescription
products and products administered or obtained through a health professional for human use, all
manufacturers are required to file mock-ups of their inner and outer labels and packaging in both
English and French as part of their submission package at the time of filing.
Where a sponsor is requesting a product name change, unless the change fits the exemptions set
out in the Frequently Asked Questions - Guidance document for Industry - Review of Drug
Brand Names, the submission should be filed as a Labelling Only submission and should
include evidence supporting the product name(s) submitted along with the appropriate fee.
Manufacturers will still be required to certify that all aspects of the drug submission or
application pertaining to their product remain the same as was previously authorized. However,
they will also be required to certify that the new labels and packaging are similar to those
initially approved with respect to location and size of the text and graphics (including logos).
Manufacturers who wish to change the location and/or size of text and/graphics are required to
file a Labelling Only submission with the appropriate fees.
Manufacturers are also required to file the Mock-up Labels and Packages Certification Form
with their submission package which includes an attestation to the accuracy of translation.
For additional information about changes resulting from the Plain Language Labelling
amendments, consult the Guidance Document: Questions and Answers on Plain Language
Labelling.
2.7 Fees
For information on issues related to drug submission/application evaluation fees and annual
authority to sell fees, refer to current versions of the Guidance Document: Fees for the Review of
Drug Submissions and Applications, How to Pay Fees to the Health Products and Food Branch,
and the Guidance Document: Fees for the Right to Sell Drugs. For fee reduction information
refer to the Guidance Document: Fees for the Right to Sell Drugs and the Right to Sell Drug Fee
Remission Request and Attestation Form.
Draft Date: 2017/02/17 15

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
694
695
696
697
698
699
700
701
702
703
704
705
706
707
708
709
710
711
712
713
714
715
716
717
718
719
720
721
722
723
724
725
726
727
728
729
730
731
732
733
734
735
3. CONTACT INFORMATION
Questions or comments related to this guidance document should be directed to:
Health Canada
Office of Submissions and Intellectual Property
Health Products and Food Branch
Therapeutic Products Directorate
Address Locator: 0201D
101 promenade Tunney's Pasture Driveway
Ottawa Ontario
K1A 0K9
Canada
Email: OSIP-BPPI@hc-sc.gc.ca
Fax number: 613-946-5610 or 613- 941-0825
4. REFERENCES
Submission/Application Related Documents:
Blank Certified Product Information Document (Schedule D Drugs) (CPID (Schedule D
Drugs)) Template in the CTD Format (http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applicdemande/guides/qualit/prod/tech-doc-biologic/ctd_cpid-dcip_schd-ann-eng.php)
Drug Submission Application (3011) Form (http://www.hc-sc.gc.ca/dhpmps/alt_formats/pdf/prodpharma/applic-demande/form/hc3011_sc3011-eng.pdf)
Guidance Document: Fees for the Review of Drug Submissions and Applications
(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php)
Guidance Document: Fees for the Right to Sell Drugs (http://www.hc-sc.gc.ca/dhpmps/prodpharma/fees-frais/right_sell_guid_droit_vendre-eng.php)
Guidance Document: Post-Drug Identification Number (DIN) Changes (http://www.hcsc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/change_din-eng.php)
Guidance Document: Patented Medicines (Notice of Compliance) Regulations
(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guideld/patmedbrev/pmreg3_mbreg3-eng.php)
16 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
736
737
738
739
740
741
742
743
744
745
746
747
748
749
750
751
752
753
754
755
756
757
758
759
760
761
762
763
764
765
766
767
768
769
770
771
772
773
774
775
776
Guidance for Industry: Management of Drug Submissions (http://www.hc-sc.gc.ca/dhpmps/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd-eng.php)
Guidance for Sponsors: Lot Release Program for Schedule D (biologic) Drugs
(http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/lot/gui_sponsorsdir_promoteurs_lot_program-eng.php)
How to Pay Fees to the Health Products and Food Branch (http://www.hc-sc.gc.ca/dhpmps/prodpharma/applic-demande/guide-ld/costs-couts/crpay_rcfrais_for-eng.php)
Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy
Document (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guideld/postnoc_change_apresac/noc_pn_saf_ac_sa_inn-eng.php)
Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document
(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guideld/postnoc_change_apresac/noc_pn_quality_ac_sa_qualite-eng.php)
Right to Sell Drugs Fee Remission Request and Attestation Form (http://www.hcsc.gc.ca/dhp-mps/prodpharma/applic-demande/form/right_sell_form_droit_vendre-eng.php)
Drug Submission Application Fee Form (http://www.hc-sc.gc.ca/dhpmps/alt_formats/pdf/prodpharma/applic-demande/form/feef_fraisf-eng.pdf)
Labelling Related Guidances:
Guidance Document for Industry: Review of Drug Brand Names (http://www.hcsc.gc.ca/dhp-mps/pubs/medeff/_guide/2014-review-examen_drug-medicament_namesmarques/index-eng.php)
Guidance Document: Labelling of Pharmaceutical Drugs for Human Use (http://www.hcsc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label_guide_ld-eng.php)
Guidance Document: Product Monograph (http://www.hc-sc.gc.ca/dhpmps/prodpharma/applic-demande/guide-ld/monograph/pm_mp_2013-eng.php)
Guidance Document: Questions and Answers: Plain Language Labelling Regulations
(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/pll_qa_fin_qr_elceng.php)
Draft Date: 2017/02/17 17

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
777
778
779
780
781
782
783
784
785
786
787
788
789
790
791
792
793
794
795
796
797
798
799
800
801
802
803
804
805
806
807
808
Frequently Asked Questions - Guidance Document for Industry: Review of Drug Brand
Names (http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2014-review-examen_drugmedicament_names-marques/faq-eng.php)
Mock-Up Labels and Packages Certification Form (http://www.hc-sc.gc.ca/dhpmps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/form-formulaire-mock-labelspackages-maquettes-etiquettes-emballages-eng.pdf)
Legislation and Regulations:
Food and Drugs Act (http://laws-lois.justice.gc.ca/eng/acts/f-27/)
Food and Drug Regulations (http://lawslois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/index.html)
Patented Medicines (Notice of Compliance) Regulations (http://lawslois.justice.gc.ca/eng/regulations/SOR-93-133/FullText.html)
5. APPENDICES
Appendix 1: Administrative Changes - Certification Form
Appendix 2: Sample - Attestation - Change in Product Ownership (Acquiring Manufacturer)
Appendix 3: Sample - Letter of Authorization - Change in Product Ownership (Divesting
Manufacturer)
Appendix 4: Sample - Attestation - Merger / Buyout (New Manufacturer)
Appendix 5: Sample - Letter of Authorization (Licensing Agreement)
Appendix 6: Sample - Statement of Commitment (Licensing Agreement)
18 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
809
Draft Date: 2017/02/17 19

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
810
811
812
813 814
815
816
817
818
819
820
821
822
823
824
825
826
827
828
829
830
831
832 833
834
835
836
837
838
839
840
841
842
843
844
845
846
847
848
849
850
851
852
853
854
855
856
APPENDIX 1: ADMINISTRATIVE CHANGES - CERTIFICATION FORM
Administrative Changes - Certification Form for Human or Disinfectant Drugs
Reason for Submission:
Manufacturer Name Change Existing DIN(s) must be retained
Product Name Change Existing DIN(s) must be retained
Manufacturer and Product Name Changes Existing DIN(s) must be retained
Changes in Product Ownership Existing DIN(s) must be retained
Additional Product name New DIN(s) must be issued
Merger/Buyout Existing DIN(s) must be retained
Licensing Agreement between two Manufacturers 12 New DIN(s) issued or Existing DIN(s) retained
………………………
……………………....
………………………
Labelling Update (to match Licensor) Existing DIN(s) must be retained
CMC Update (to match Licensor) Existing DIN(s) must be retained
I, the undersigned, certify that all aspects of the drug submission or application pertaining to:
..................................................................................................................................................................
(Name of Product)
submitted by:
..................................................................................................................................................................
(Name of Manufacturer)
are identical to;
............................................................................................................................ ................................
(Name of product, Name of Manufacturer)
[Current DIN(s)]
except for name changes to the manufacturer and/or product, and that the product will be manufactured in the same
location(s) with identical specifications and procedures.
12
If existing DINs are retained, please clearly list the DINs under this check box.
20 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
857
For prescription and products obtained or administered through a health professional for human use
only:
Please certify below that the location and size of graphics, text and logos on the inner and outer labels
and packaging are similar to the product outlined above. Changes to labels or packaging that fall
outside of these elements will require the filing of a Labelling Only submission and a clear indication in
the cover letter as to the nature of the administrative change.
I further certify:
that the location and size of graphics, text and logos on the inner and outer labels and
packaging are similar to the product outlined above, or
that the location and size of graphics, text and logos on the inner and outer labels and
packaging are not similar to the product outlined above and this submission is being filed as a
Labelling Only submission.
858
859
860
861
862
863
864
865
866
867
868
869
870
871
872
............................................................................................................. ..................................
Name of Authorized Signing Official and Title
Authorized Signature
............................................................................................................. .........................................................................
Manufacturer Name
Telephone Number
........................................................................
Email
Draft Date: 2017/02/17 21

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
873
874
875
876
877
878
879
880
881
882
883
884
885
886
887
888
889
890
891
892
893
894
895
896
897
898
899
900
901
902
903
APPENDIX 2: SAMPLE - ATTESTATION - CHANGE IN PRODUCT OWNERSHIP
(ACQUIRING MANUFACTURER)
Office of Submissions and Intellectual Property
Therapeutic Products Directorate
Finance Building, Address Locator: 0201A
101 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Dear Sir or Madam:
RE: (Name of Product)
We confirm that the ownership of the product is being transferred from (Divesting Manufacturer)
and acknowledge that Health Canada will reissue the DINs to (Acquiring Manufacturer).
We assume all regulatory responsibilities for the product. We confirm that no changes are taking
place within this drug submission or application including, but not limited to, all clinical data,
chemistry and manufacturing data, product formulation, strength, route of administration and
dosage forms, authorized indication(s) and condition(s) of use as well as all product labels 1 ,
except for the manufacturer name and/or product name.
We will submit a market notification to Health Canada [C.01.014.3] within 30 days of the first
day of sale of the product with accompanying labels, if applicable.
Yours sincerely,
(Authorized signature - Acquiring Manufacturer)
(Signee’s Name and Title)
22 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
904
905
906
907
908
909
910
911
912
913
914
915
916
917
918
919
920
921
922
923
924
925
926
927
928
929
930
APPENDIX 3: SAMPLE - LETTER OF AUTHORIZATION - CHANGE IN PRODUCT
OWNERSHIP (DIVESTING MANUFACTURER)
Office of Submissions and Intellectual Property
Therapeutic Products Directorate
Finance Building, Address Locator 0201A
101 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Dear Sir or Madam:
RE: (Name of Product)
We confirm that the ownership of the product (state specific product name and DIN) is being
transferred to (Acquiring Manufacturer) and acknowledge that Health Canada will reissue the
DINs to (Acquiring Manufacturer).
We confirm that we have provided (Acquiring Manufacturer) with the most complete and up-todate
drug submission or application information to: support the maintenance of product labels;
and, ensure consistency with that of the Canadian Reference Product, if applicable.
Yours sincerely,
(Authorized signature - Divesting Manufacturer)
(Signee’s Name and Title)
Draft Date: 2017/02/17 23

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
931
932
933
934
935
936
937
938
939
940
941
942
943
944
945
946
947
948
949
950
951
952
953
954
955
956
957
958
959
960
961
APPENDIX 4: SAMPLE - ATTESTATION - MERGER / BUYOUT (NEW
MANUFACTURER)
Office of Submissions and Intellectual Property
Therapeutic Products Directorate
Finance Building, Address Locator 0201A
101 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Dear Sir or Madam:
RE: (Name of Product)
As a result of a (merger or buyout) between (Divesting Manufacturer) and (Acquiring
Manufacturer or New Manufacturer), we acknowledge that Health Canada will reissue the DINs
to (Acquiring Manufacturer or New Manufacturer).
We assume all regulatory responsibility for the product. We confirm that no changes are taking
place within this drug submission or application including, but not limited to, all clinical,
chemistry and manufacturing data, product formulation, strength, route of administration and
dosage forms, authorized conditions of use as well as all product labels 1 , except for the
manufacturer name and/or product name.
We will submit a market notification to Health Canada [C.01.014.3] within 30 days of the first
day of sale of our product with accompanying labels, if applicable.
Yours sincerely,
(Authorized signature - New Manufacturer)
(Signee’s Name and Title)
24 Draft Date: 2017/02/17

Health Canada
Draft Guidance Document - For comment purposes only
Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
962
963
964
965
966
967
968
969
970
971
972
973
974
975
976
977
978
979
980
981
982
983
984
985
986
987
988
989
990
991
992
993
994
995
996
997
998
999
1000
1001
1002
APPENDIX 5: SAMPLE - LETTER OF AUTHORIZATION (LICENSING
AGREEMENT)
Office of Submissions and Intellectual Property
Therapeutic Products Directorate
Finance Building, Address Locator 0201A
101 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Dear Sir or Madam:
RE: (Name of Cross-licensed Product)
(Licensor) hereby authorizes the licensee to reference, and Health Canada to access, (submission
type), (Product name), (Control#), and subsequent drug submission or application updates for the
product, in order to support the submission or application filed by (licensee) that will be
processed administratively for their (product name).
(Licensor) certifies that (Licensee) (product name) will be manufactured, controlled and
packaged as per (licensor) using the systems and procedures submitted and authorized by Health
Canada.
We confirm that we have provided (Licensee) with the most complete and up-to-date submission
or application information to: support the development and maintenance of product labels for the
cross-licensed product(s); and, to ensure consistency with that of the Canadian Reference
Product, if applicable. We understand that failure to update product labels may impact the
approval of the licensee’s drug submissions or applications.
As the licensor, we acknowledge our responsibility to ensure that:
Product labels are kept up-to-date and any safety and efficacy updates are communicated
to the licensee upon approval.
Any post-authorization updates to the chemistry and manufacturing data and product
formulation are communicated to the licensee.
Yours sincerely,
(Authorized signature - Licensor)
(Signee’s Name and Title)
Draft Date: 2017/02/17 25

Administrative Processing of Submissions and
Applications Involving Human or Disinfectants Drugs
Health Canada
Draft Guidance Document - For comment purposes only
1003
1004
1005
1006
1007
1008
1009
1010
1011
1012
1013
1014
1015
1016
1017
1018
1019
1020
1021
1022
1023
1024
1025
1026
1027
1028
1029
1030
1031
1032
1033
1034
1035
1036
1037
APPENDIX 6: SAMPLE - STATEMENT OF COMMITMENT (LICENSING
AGREEMENT)
Office of Submissions and Intellectual Property
Therapeutic Products Directorate
Finance Building, Address Locator 0201A
101 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Dear Sir or Madam:
RE: (Name of Product)
As a drug manufacturer under the Food and Drugs Act and its Regulations, we commit to:
• Comply with all regulatory requirements associated with selling a drug as listed in section
2.2 of the Guidance Document Administrative Processing of Drug Submissions and
Applications Involving Human or Disinfectants Drugs.
• Remain identical in every way [i.e., all aspects of the authorization] to the licensor’s
product throughout its life-cycle, with the exception of the manufacturer name and/or
product name, including filing safety and labelling updates within 30 days of the licensor.
• File the appropriate chemistry and manufacturing updates for our Schedules C and D
product(s) subsequent to the licensor's approved post authorization Chemistry and
Manufacturing updates such that all aspects of the authorization remain identical to the
licensor's product throughout its life-cycle, with the exception of the manufacture name
and/or product name.
Yours sincerely,
(Authorized signature - Licensee)
(Signee’s Name and Title)
26 Draft Date: 2017/02/17