DRAFT GUIDANCE DOCUMENT
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<strong>DRAFT</strong> <strong>GUIDANCE</strong> <strong>DOCUMENT</strong><br />
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectant Drugs<br />
This guidance document is being distributed for comment purposes only.<br />
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Published by authority of the<br />
Minister of Health<br />
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Draft Date 2017/02/17<br />
Health Products and Food Branch<br />
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Our mission is to help the people of Canada<br />
maintain and improve their health.<br />
Health Canada<br />
© Minister of Public Works and Government Services Canada 2017<br />
The Health Products and Food Branch’s (HPFB) mandate<br />
is to take an integrated approach to managing the healthrelated<br />
risks and benefits of health products and food by:<br />
$ minimizing health risk factors to Canadians while<br />
maximizing the safety provided by the regulatory<br />
system for health products and food; and,<br />
$ promoting conditions that enable Canadians to make<br />
healthy choices and providing information so that<br />
they can make informed decisions about their health.<br />
Health Products and Food Branch<br />
Également disponible en français sous le titre : Ébauche de la Ligne directrice : Traitement<br />
administratif des présentations et des demandes de drogues à usage humain ou pour produits<br />
désinfectants
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
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FOREWORD<br />
Guidance documents are meant to provide assistance to industry and health care professionals on<br />
how to comply with governing statutes and regulations. Guidance documents also provide<br />
assistance to staff on how Health Canada’s mandates and objectives should be implemented in a<br />
manner that is fair, consistent and effective.<br />
Guidance documents are administrative instruments not having force of law and, as such, allow<br />
for flexibility in approach. Alternate approaches to the principles and practices described in this<br />
document may be acceptable provided they are supported by adequate justification. Alternate<br />
approaches should be discussed in advance with the relevant programme area to avoid the<br />
possible finding that applicable statutory or regulatory requirements have not been met.<br />
As a corollary to the above, it is equally important to note that Health Canada reserves the right<br />
to request information or material, or define conditions not specifically described in this<br />
document, in order to allow the Department to adequately assess the safety, efficacy or quality of<br />
a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable<br />
and that decisions are clearly documented.<br />
This document should be read in conjunction with the accompanying notice and the relevant<br />
sections of other applicable guidance documents.<br />
Draft Date: 2017/02/17<br />
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Table of Contents<br />
1. INTRODUCTION .................................................................................................................... 1<br />
1.1 Policy Objective ............................................................................................................... 1<br />
1.2 Policy Statements ............................................................................................................. 1<br />
1.3 Scope and Application ..................................................................................................... 2<br />
1.4 Definitions........................................................................................................................ 2<br />
1.5 Background ...................................................................................................................... 4<br />
2. <strong>GUIDANCE</strong> FOR IMPLEMENTATION ................................................................................ 4<br />
2.1 When to File Drug Submissions and Applications for Administrative Processing ......... 4<br />
2.2 Roles and Responsibilities of Manufacturers .................................................................. 5<br />
2.2.1 Additional Responsibilities for Licensors and Licensees ...................................... 6<br />
2.3 General Document Requirements .................................................................................... 7<br />
2.4 Additional Document Requirements and Submission/Application Types ...................... 8<br />
2.4.1 Manufacturer Name Changes ................................................................................ 8<br />
2.4.2 Product Name Changes ......................................................................................... 8<br />
2.4.3 Changes in Product Ownership ............................................................................. 8<br />
2.4.4 Mergers and Buyouts ............................................................................................. 9<br />
2.4.5 Licensing Agreements ......................................................................................... 10<br />
2.4.5.1 Post-Authorization Labelling Changes, including Revised/Updated<br />
Product Monographs or Prescribing Information ................................................ 11<br />
2.4.5.2 Post-Authorization Deviations to Labelling and Chemistry and<br />
Manufacturing ..................................................................................................... 11<br />
2.4.5.3 Post-Authorization Chemistry and Manufacturing Updates (CMC) [Only<br />
for Schedules C and D drug products] ................................................................ 12<br />
2.5 Drug Identification Number (DIN) Issuance ................................................................. 12<br />
2.5.1 Changes in Product Ownership including Mergers and Buyouts ........................ 12<br />
2.5.2 Additional Product Names .................................................................................. 13<br />
2.5.3 Licensing Agreements ......................................................................................... 13<br />
2.5.4 Transfer of a Cancelled Drug Identification Number (DIN)............................... 14<br />
2.5.4.1 Licensing Agreements ............................................................................. 14<br />
2.6 Labelling ........................................................................................................................ 15<br />
2.7 Fees ................................................................................................................................ 15<br />
3. CONTACT INFORMATION ................................................................................................. 16<br />
4. REFERENCES ....................................................................................................................... 16<br />
5. APPENDICES ........................................................................................................................ 18<br />
APPENDIX 1: ADMINISTRATIVE CHANGES - CERTIFICATION FORM .......................... 20<br />
APPENDIX 2: SAMPLE - ATTESTATION - CHANGE IN PRODUCT OWNERSHIP<br />
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106 (ACQUIRING MANUFACTURER) ..................................................................................... 22<br />
107 APPENDIX 3: SAMPLE - LETTER OF AUTHORIZATION - CHANGE IN PRODUCT<br />
108 OWNERSHIP (DIVESTING MANUFACTURER) .............................................................. 23<br />
109 APPENDIX 4: SAMPLE - ATTESTATION - MERGER / BUYOUT (NEW manufacturer) .....24<br />
110 APPENDIX 5: SAMPLE - LETTER OF AUTHORIZATION (LICENSING AGREEMENT) . 25<br />
111 APPENDIX 6: SAMPLE - STATEMENT OF COMMITMENT (LICENSING<br />
112 AGREEMENT)....................................................................................................................... 26<br />
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1. INTRODUCTION<br />
Pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations (hereafter the<br />
Regulations), no manufacturer shall sell a drug in Canada unless a Drug Identification Number<br />
(DIN) [C.01.014 (1)] or DIN and Notice of Compliance (NOC) [C.08.002 (1)] have been issued<br />
by Health Canada, which grant market authorization for that product. Paragraph C.01.014.4 (b)<br />
of the Regulations sets out obligations for manufacturers to notify Health Canada of information<br />
changes pertaining to the manufacturer and drug product. These information changes must, in<br />
some cases, be supported by a new DIN application or Post-Authorization Division 1 Change<br />
(PDC) for Division 1 drugs. For Division 8 drugs [C.08.003 (1)], an Extraordinary Use New<br />
Drug Submission (EUNDS), New Drug Submission (NDS), Abbreviated NDS (ANDS),<br />
Abbreviated EUNDS (AEUNDS), Supplement or Notifiable Change (NC) may be required.<br />
For the purpose of this guidance document, Health Canada has determined that certain<br />
submissions and applications involving human or disinfectants drugs may be submitted for<br />
administrative processing to the Office of Submissions and Intellectual Property (OSIP) of the<br />
Therapeutic Products Directorate (TPD). These submissions and applications do not contain<br />
scientific data, or require regulatory review.<br />
1.1 Policy Objective<br />
To clarify the requirements for eligible drug submissions and applications that will be processed<br />
under the administrative pathway.<br />
The only policy that explicitly governs the administrative processing of submissions and<br />
applications is the Change in Manufacturer’s / Product Name Policy (CMPN), written in 1998<br />
and updated in 2001. The Policy outlines the conditions and procedures by which Health Canada<br />
processes administratively a change in manufacturer name or product name as a result of certain<br />
business circumstances, when there are no deviations to the product.<br />
Once finalized, the guidance document will supersede the above-noted Policy.<br />
1.2 Policy Statements<br />
To be eligible for administrative processing, all aspects of the submission and application<br />
pertaining to the drug product, except for the manufacturer name and/or product name, must be<br />
identical to those previously authorized for that product. These include, but are not limited to, the<br />
submission type, all clinical data, chemistry and manufacturing data, product formulation,<br />
strength, route of administration, dosage form, authorized indication(s) and condition(s) of use as<br />
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well as all product labels 1 . Any deviations from the previously authorized product will not be<br />
acceptable under the administrative pathway.<br />
Submissions and applications may be processed administratively only if the original<br />
manufacturer’s drug product has undergone a full review and received authorization from Health<br />
Canada [that is (i.e.), a DIN for Division 1 drugs and a DIN/NOC for Division 8 drugs]. This<br />
policy does not apply to secondary licensing agreements between licensees and third-parties.<br />
In addition, for licensing agreements, the licensor’s drug product must be marketed in Canada<br />
and market notified with Health Canada [C.01.014.3] at the time of the licensee’s filing.<br />
Health Canada has the regulatory authority to consider brand names when making a decision on<br />
whether or not to grant a DIN or DIN/NOC to a manufacturer.<br />
For application of the Patented Medicines (Notice of Compliance) Regulations, refer to the<br />
Guidance Document: Patented Medicines (Notice of Compliance) Regulations.<br />
1.3 Scope and Application<br />
This guidance document applies to drug submissions and applications involving biologics,<br />
radiopharmaceuticals, human pharmaceuticals (includes prescription and non-prescription drugs)<br />
and disinfectants regulated under the Food and Drugs Act. More specifically, it captures a DIN<br />
application [C.01.014.1 (1)] and PDC, EUNDS [C.08.002.01 (1)], NDS [C.08.002 (1)], ANDS or<br />
AEUNDS [C.08.002.1 (1)], including supplements [C.08.003 (1)] and NCs.<br />
1.4 Definitions<br />
Brand Name 2 (or proprietary drug name) - C.01.001 (1) of the Food and Drug Regulations<br />
states that a "brand name" means, with reference to a drug, the name, whether or not including<br />
the name of any manufacturer, corporation, partnership or individual, in English and/or French:<br />
a. that is assigned to the drug by its manufacturer,<br />
b. under which the drug is sold or advertised, and<br />
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2<br />
Due to the regulatory mock-up requirements under the Regulations Amending the Food and Drug<br />
Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use), manufacturers of<br />
prescription products and those administered or obtained through a health professional are<br />
required to certify that the new labels and packaging are similar to those initially approved with<br />
respect to location and size of the text and graphics (including logos). Refer to section 2.6 on<br />
Labelling.<br />
For the purpose of this guidance document, brand name and product name are interchangeable.<br />
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c. that is used to distinguish the drug.<br />
Division 1 drug - a drug that was submitted to Health Canada as a Drug Identification Number<br />
application and authorized pursuant to the requirements of Division 1 in Part C of the Food and<br />
Drug Regulations.<br />
Division 8 drug - a drug that was submitted to Health Canada as a New Drug Submission and<br />
authorized pursuant to the requirements of Division 8 in Part C of the Food and Drug<br />
Regulations.<br />
Drug Identification Number (DIN) - a computer-generated eight digit number assigned by Health<br />
Canada to a drug product prior to being marketed in Canada. It uniquely identifies all drug<br />
products sold in a dosage form in Canada and is located on the label of prescription and over-thecounter<br />
drug products that have been evaluated and authorized for sale in Canada. A DIN<br />
uniquely identifies the following product characteristics: manufacturer; product name; active<br />
ingredient(s); strength(s) of active ingredient(s); pharmaceutical form; route of administration.<br />
Cross-licensed product - is a drug product (for which a licensee is seeking market authorization)<br />
for which all aspects of the submission or application are identical to that of the licensor in terms<br />
of all clinical data, chemistry and manufacturing data, product formulation, strength, route of<br />
administration, dosage form, authorized indication(s) and condition(s) of use as well as all<br />
product labels 1 . For a cross-licensed product to be eligible for administrative processing, the<br />
licensor’s product must have undergone a full review and received authorization from Health<br />
Canada; it must be marketed in Canada and market notified with Health Canada [C.01.014.3 of<br />
the Regulations] at the time of the licensee’s filing.<br />
Drug Product Market Notification - the manufacturer notifies Health Canada of the date of first<br />
sale pursuant to section C.01.014.3 of the Food and Drug Regulations.<br />
Label - as per the Food and Drugs Act, is interpreted to include labels affixed to the container or<br />
packaging of the drug, any separate package inserts 3 , product monographs, prescribing<br />
information, fact sheets, consumer information/patient medication information (i.e., patient<br />
leaflets), patient diaries, or other material containing information specific to the drug product.<br />
These separate package labels generated by the manufacturer/sponsor may be included in the<br />
packaging or supplied to the consumer at the time of dispensing.<br />
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Note that package inserts could also include wallet cards, tear-off pads and hand-outs directed to<br />
the consumer and whose content is Part III of the PM.<br />
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Licensing Agreement - an agreement between two manufacturers whereby one manufacturer<br />
(licensor) supplies a drug product to another manufacturer (licensee) for sale under the second<br />
manufacturer’s name.<br />
Manufacturer or Distributor (as per section A.01.010 of the Regulations) - means a person,<br />
including an association or partnership, who under their own name, or under a trade, design or<br />
word mark, trade name or other name, word or mark controlled by them, sells a food or drug. For<br />
the purpose of this document, a manufacturer is a DIN Holder.<br />
Merger or Buyout - the combining of two or more manufacturers into one, through a purchase,<br />
acquisition or a pooling of interests or purchase of controlling interest in one manufacturer by<br />
another manufacturer, in order to take over assets and/or operations.<br />
Change in Product Ownership - when a manufacturer transfers the possession and responsibility<br />
for a product to another manufacturer.<br />
1.5 Background<br />
The 1998 Change in Manufacturer’s / Product Name Policy (CMPN) governs the administrative<br />
processing of submissions and applications. Since the implementation of the CMPN policy, the<br />
number of drug submissions and applications filed under the administrative pathway increased<br />
significantly. The draft guidance document addresses certain policy gaps that were identified<br />
throughout the years.<br />
The CMPN policy replaced the 1996 policy entitled, Therapeutic Products Directorate Policy<br />
Issues: Changes in Manufacturer's Name, January 18, 1996.<br />
2. <strong>GUIDANCE</strong> FOR IMPLEMENTATION<br />
2.1 When to File Drug Submissions and Applications for Administrative Processing<br />
1. Manufacturer Name Change and/or Product Name Change 4 . These include:<br />
• Changes in Product Ownership (i.e., Change in DIN Holder)<br />
• Mergers and Buyouts<br />
2. Additional Product Names 2 .<br />
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Certain product names cannot be processed administratively. Refer to section 2.6 on Labelling.<br />
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3. Licensing Agreements between two manufacturers. These include:<br />
• Post-Authorization Labelling Changes, including Revised/Updated Product<br />
Monographs or Prescribing Information<br />
• Post-Authorization Chemistry and Manufacturing Updates (CMC) [Only for products<br />
regulated under Schedules C and D of the Regulations]<br />
Health Canada will not process administratively drug submissions and applications that<br />
reference only certain aspects of the licensor’s submission or application for the drug product<br />
(i.e., strengths, dosage forms or indications).<br />
For Division 8 drugs, when a product is authorized for marketing, a NOC will be issued<br />
indicating the reason for the submission. For example, if a manufacturer files a submission under<br />
the administrative pathway as a result of a licensing agreement between two manufacturers, the<br />
NOC will indicate, under the Reason for Submission section, "Administrative - Licensing<br />
Agreement between two manufacturers". Although not exhaustive, a list of examples for<br />
different types of administrative changes is included below:<br />
• Administrative - Manufacturer Name Change<br />
• Administrative - Product Name Change<br />
• Administrative - Changes in Product Ownership (i.e. Change in DIN Holder)<br />
• Administrative - Merger/Buyout<br />
• Administrative - Additional Product Name<br />
• Administrative - Licensing Agreement between two Manufacturers<br />
• Administrative - Revised / Updated Product Monograph<br />
2.2 Roles and Responsibilities of Manufacturers<br />
All manufacturers (which comprises licensees) filing submissions and applications under the<br />
administrative pathway must meet the same regulatory standards as the original manufacturers.<br />
These include, but are not limited to:<br />
• Adhering to filing requirements, if the information supporting the DIN application is no<br />
longer correct [sections C.01.014.4 (b), C.01.014.5 and C.08.003 (1) of the Regulations].<br />
This applies equally to DIN assigned drugs under Division 1 and drugs with an NOC<br />
under Division 8.<br />
• Complying with the labelling requirements governed by sections 3, 9, and 10 of the<br />
Food and Drugs Act and by sections contained in Parts A, C, D, G, and J of the<br />
Regulations.<br />
• Keeping the product’s safety information up-to-date and filing the appropriate drug<br />
submission or application where changes to product labels are required.<br />
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• Obtaining authorization from Health Canada for label updates and for chemistry and<br />
manufacturing changes before implementing changes to marketed products, as required<br />
by the Regulations (and explained in the Post-DIN and Post-NOC guidance documents).<br />
• Applying for, and obtaining, a Drug Establishment License (DEL) [C.01A.001] 5 , as part<br />
of the regulatory requirements associated with selling a drug.<br />
• Assuming responsibility for the drug product such as complying with Good<br />
Manufacturing Practices (GMP) requirements under Division 2 of Part C of the<br />
Regulations 6 7 and post-authorization requirements.<br />
• Complying with all other provisions of the Food and Drugs Act and the Regulations,<br />
which include having systems in place to handle complaints, report and monitor the<br />
safety and efficacy of drugs (i.e., pharmacovigilance activities), and manage recalls.<br />
• Notifying Health Canada of any recalls of their drug product [C.01.051].<br />
• Ensuring that Schedule D products meet the requirements of the Biologics and Genetic<br />
Therapies Directorate (BGTD)’s lot release program prior to the sale of the lot in<br />
Canada.<br />
2.2.1 Additional Responsibilities for Licensors and Licensees<br />
In addition to the regulatory responsibilities listed above, for licensing agreements:<br />
• Licensors and licensees must have a direct relationship whereby the licensor grants<br />
permission to a licensee(s) via a Letter of Authorisation (LoA) to reference their drug<br />
submission or application in support of the cross-licensed product. This policy does<br />
not apply to secondary licensing agreements between licensees and third-parties.<br />
• Licensors are expected to provide their licensees with the most complete and up-todate<br />
submission or application information to: support the development and<br />
maintenance of product labels for the cross-licensed product(s); and, ensure<br />
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7<br />
For the minimum requirements that must be in place prior to the filing of a DEL Application,<br />
consult the document “Drug Establishment Good Manufacturing Practices - Pre-Application<br />
Package (Importers, Distributors and Wholesalers)” at http://www.hc-sc.gc.ca/dhp-mps/compliconform/gmp-bpf/docs/gmp-package-bpf-eng.php.<br />
Except for low-level disinfectants which are exempt from these Regulations.<br />
For further information on GMPs, consult the GUI-0001 - Good Manufacturing Practices<br />
Guidelines at http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/index-eng.php.<br />
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consistency with that of the Canadian Reference Product (CRP), if applicable. Failure<br />
to update product labels may impact the approval of the licensee’s drug submission or<br />
application.<br />
• Licensees must have all required documents available on the premises as prescribed<br />
by Division 2 of the GMP Regulations 8 .<br />
• Licensees are expected to update their product labels consistently with those of the<br />
licensor. Approvability of the licensee’s drug submission or application is contingent<br />
on the licensor’s product labels being up-to-date. In cases where the licensor’s<br />
product is a generic drug, it is expected that the licensor’s product labels be up-todate<br />
with those of the CRP.<br />
2.3 General Document Requirements<br />
Manufacturers must satisfy the conditions for obtaining market authorization from Health<br />
Canada and are responsible for the quality and completeness of their drug submission or<br />
application by providing the following documentation to OSIP:<br />
• a signed Administrative Changes - Certification Form For Human or Disinfectant Drugs<br />
for each drug product, certifying that all aspects of the drug submission or application<br />
pertaining to the drug product and product labels 9 are identical, except for manufacturer<br />
name and/or product name 2 ;<br />
• a completed Drug Submission Application (3011) Form;<br />
• all proposed labels, including mock-ups as applicable 10 ;<br />
• a Mock-Up Labels and Packages Certification Form stating that the label and packaging<br />
material are similar to the original product with respect to size and placement of graphics,<br />
logos and font, as applicable;<br />
8<br />
9<br />
10<br />
For further information on GMP, consult “Good Manufacturing Practices (GMP) Questions and<br />
Answers” at http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/question/gmp-bpfeng.php<br />
.<br />
Refer to section 1.4 Definitions.<br />
For non-prescription products, these requirements will come into effect in 2017. For prescription<br />
products and products administered or obtained through a health professional for human use, refer<br />
to the Guidance Document Questions and Answers: Plain Language Labelling Regulations.<br />
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• a completed Submission Fee Application Form and the relevant fee (not applicable to<br />
PDCs and NCs);<br />
• a Letter of Authorization (LoA); and,<br />
• a Certified Product Information Document (CPID) for Schedules C and D products.<br />
2.4 Additional Document Requirements and Submission/Application Types<br />
2.4.1 Manufacturer Name Changes<br />
When there is a change to the manufacturer’s name or a change to both the<br />
manufacturer’s and product names 2 , manufacturers must file a DIN application for<br />
Division 1 drugs and an EUNDS, NDS, ANDS or AEUNDS for Division 8 drugs.<br />
Authorization from Health Canada must be obtained before any changes are made to<br />
labels on the market.<br />
2.4.2 Product Name Changes<br />
When there is a change to an existing product name, manufacturers must file a DIN<br />
application for Division 1 drugs or a supplement to an EUNDS, NDS, ANDS or<br />
AEUNDS for Division 8 drugs. Authorization from Health Canada must be obtained<br />
before any changes are made to labels on the market.<br />
Certain product names cannot be processed administratively.<br />
2.4.3 Changes in Product Ownership<br />
For changes in product ownership 9 [i.e. Change in DIN Holder], it is understood that one<br />
manufacturer is acquiring ownership of a product from another manufacturer. For<br />
Division 1 drugs, the manufacturer must file a DIN application. For Division 8 drugs, the<br />
manufacturer must file an EUNDS, NDS, ANDS or AEUNDS. Authorization from<br />
Health Canada must be obtained before any changes are made to labels on the market.<br />
In addition to the general document requirements, the following must be provided:<br />
1. A written attestation (Refer to Appendix 2) from the acquiring manufacturer attesting<br />
that:<br />
• It assumes all responsibility for the drug product and no changes are taking place<br />
within the drug submission or application including, but not limited to, all clinical,<br />
chemistry and manufacturing data, product formulation, strength, route of<br />
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administration and dosage forms, authorized indication(s) and condition(s) of use as<br />
well as all product labels 1 , except for the manufacturer name and/or product name.<br />
• Once the drug product is marketed under the name of the acquiring manufacturer, it<br />
will notify Health Canada within 30 days of the sale of its product [C.01.014.3] and<br />
submit copies of labels, if applicable. Health Canada expects that there is a 6 month<br />
phase-in period to replace the original product labels with the new product labelling.<br />
2. A LoA (Refer to Appendix 3) from the divesting manufacturer stating that it is<br />
transferring ownership of its product and associated DIN(s) to the acquiring<br />
manufacturer.<br />
2.4.4 Mergers and Buyouts<br />
For mergers and buyouts 11 , it is understood that the new manufacturer (i.e., acquiring or<br />
merged firm) is the DIN Holder.<br />
Following a merger or buyout, the new manufacturer must file, for all affected products<br />
regardless of market status, a DIN application for Division 1 drugs or an EUNDS, NDS,<br />
ANDS or AEUNDS for Division 8 drugs. Authorization from Health Canada must be<br />
obtained before any changes are made to labels on the market.<br />
Manufacturers are encouraged to contact Health Canada to discuss filing strategies when<br />
a large number of products are affected.<br />
In addition to the general document requirements, the following must be provided:<br />
1. A written confirmation from the original manufacturer stating that:<br />
• There is a changed business circumstance from the original DIN Holder and<br />
authorization is given to the new manufacturer (i.e., acquiring or merged firm) to<br />
access the drug submission or application.<br />
2. A written attestation (Refer to Appendix 4) from the new manufacturer stating that:<br />
• It assumes all responsibility for the drug product and no changes are taking place<br />
within this drug submission or application including, but not limited to, all clinical,<br />
chemistry and manufacturing data, product formulation, strength, route of<br />
administration and dosage forms, authorized indication(s) and condition(s) of use as<br />
well as all product labels 1 , except for the manufacturer name and/or product name.<br />
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• Once the drug product is marketed under the name of the new manufacturer, it will<br />
notify Health Canada within 30 days of the sale of its product [C.01.014.3] and<br />
submit copies of labels, if applicable. Health Canada expects that there is a 6 month<br />
phase-in period to replace the original product labels with the new product labels.<br />
2.4.5 Licensing Agreements<br />
For licensing agreements 11 , it is understood that the final dosage form is being supplied<br />
by a licensor to the licensee (i.e., the drug is in a form which is ready for use by the<br />
consumer without requiring any further manufacturing). For Division 1 drugs, the<br />
manufacturer must file a DIN application. For Division 8 drugs, the manufacturer must<br />
file an EUNDS, NDS, ANDS or AEUNDS.<br />
In addition to the general document requirements, the following is required as part of the<br />
submission:<br />
1. A LoA (Refer to Appendix 5) from the licensor (i.e. original DIN Holder) confirming<br />
that:<br />
• Permission is granted to the licensee to reference its drug submission or application<br />
for the cross-licensed product and to Health Canada to access the submission or<br />
application in support of the licensee’s filing;<br />
• Labelling information will be kept up-to-date and any label updates will be<br />
communicated to licensees to allow them to file identical updates with Health<br />
Canada; and,<br />
• Any updates to the chemistry and manufacturing information and product formulation<br />
will be communicated to licensees to allow them to remain in compliance. For<br />
Schedules C and D products, refer to section 2.4.5.3 Post-Authorization Chemistry<br />
and Manufacturing Updates (CMC).<br />
2. A statement of commitment (Refer to Appendix 6) from the licensee confirming that<br />
it will:<br />
• Comply with the regulatory requirements associated with selling a drug and maintain<br />
safety and efficacy information updates within 30 days of the licensor; and,<br />
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• Remain consistent with the licensor’s post-authorization chemistry and manufacturing<br />
updates and product formulation updates 11 . For Schedules C and D products, refer to<br />
section 2.4.5.3 Post-Authorization Chemistry and Manufacturing Updates (CMC).<br />
2.4.5.1 Post-Authorization Labelling Changes, including Revised/Updated Product<br />
Monographs or Prescribing Information<br />
All manufacturers are required under the Regulations to ensure that drug product labels,<br />
including the product monograph or prescribing information, are up-to-date and support<br />
the products’ safe conditions of use.<br />
For licensing agreements, where product labelling identicality is maintained throughout<br />
the products’ life-cycle, licensees are expected to reflect the licensors’ label changes -<br />
meaning they should provide identical safety and efficacy updates for their cross-licensed<br />
products within 30 days of the licensors’ updates. For Division 1 drugs, the manufacturer<br />
must file a DIN Application or a PDC. For Division 8 drugs, the manufacturer must file a<br />
supplement to an EUNDS, NDS, ANDS, AEUNDS or an NC. Authorization from Health<br />
Canada must be obtained before any changes are made to labels.<br />
For additional information, refer to the Guidance Document on Post-Drug Identification<br />
Number (DIN) Changes and the Post-Notice of Compliance (NOC): Safety and Efficacy<br />
Document.<br />
When filing these changes, a licensee must obtain permission from the licensor through a<br />
LoA to make reference to its drug submission or application and to allow Health Canada<br />
to access the submission or application in support of the licensee’s post-authorization<br />
labelling change.<br />
2.4.5.2 Post-Authorization Deviations to Labelling and Chemistry and Manufacturing<br />
After obtaining market authorization for the cross-licensed product, all aspects of the<br />
authorization for the licensee’s product must remain identical in every way to that of the<br />
licensor’s throughout the product’s life-cycle, with the exception of the manufacturer<br />
name and/or product name. Should a licensee wish to deviate from the licensor in terms<br />
of strength, route of administration, dosage form, labels, chemistry and manufacturing<br />
information or product formulation, these changes will not be eligible for processing<br />
under the administrative pathway and will require a drug submission or application with<br />
11<br />
To exercise due diligence, Health Canada may request an attestation of product identicality from<br />
the licensee at any time during the products' life-cycle.<br />
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supporting data. The cross-licensed product would no longer be eligible for any future<br />
filings under the administrative pathway as the aspects of the authorization would no<br />
longer be considered identical to the licensor.<br />
2.4.5.3 Post-Authorization Chemistry and Manufacturing Updates (CMC) [Only for<br />
Schedules C and D drug products]<br />
For licensing agreements involving biologics and radiopharmaceuticals, licensees are<br />
expected to file a drug submission or application following the reporting categories<br />
outlined in the Post-Notice of Compliance (NOC) Changes: Quality Document. In the<br />
absence of a guidance specific to Quality changes to drugs which were authorized<br />
through a DIN Application - Biologics (DIN-B drugs), the Post-Notice of Compliance<br />
(NOC) Changes: Quality Document applies to those products.<br />
When filing these changes, a licensee must obtain permission from the licensor through a<br />
LoA to make reference to its drug submission or application and to allow Health Canada<br />
to access the submission or application in support of the licensee’s post-market chemistry<br />
and manufacturing change.<br />
Licensees must provide an updated CPID at time of filing, if applicable.<br />
2.5 Drug Identification Number (DIN) Issuance<br />
2.5.1 Changes in Product Ownership including Mergers and Buyouts<br />
When the appropriate regulatory steps are taken, Health Canada will reissue the same<br />
DINs, for all changes in product ownership including mergers or buyouts.<br />
These business arrangements may involve:<br />
• an approved product which is not marketed (DIN with an approved or dormant<br />
status):<br />
If the acquiring manufacturer or new manufacturer markets its drug product, it must<br />
notify Health Canada within 30 days of the sale of the product [C.01.014.3].<br />
If, at any time after the transfer is approved, the acquiring manufacturer or new<br />
manufacturer discontinues the sale of its drug product [C.01.014.7], this will result<br />
in DIN cancellation [C.01.014.6 (1)(a)].<br />
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• an approved product which is marketed:<br />
If the acquiring manufacturer or new manufacturer continues to market its drug<br />
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product, they must notify Health Canada within 30 days of the sale of the product<br />
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576<br />
[C.01.014.3].<br />
Health Canada expects that there is a 6 month phase-in period to replace the<br />
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original product labels with the new product labels.<br />
The acquiring manufacturer or new manufacturer must notify Health Canada within<br />
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30 days when a drug product has not been sold for a period of 12 months<br />
581<br />
[C.01.014.12 (2) of the Regulations Amending the Food and Drug Regulations<br />
582<br />
(Shortages of Drugs and Discontinuation of Sale of Drugs)]. This will result in a<br />
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change to the status of the product in the Drug Product Database (DPD) from<br />
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585<br />
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‘marketed’ to ‘dormant’.<br />
If, at any time after the transfer is approved, the acquiring manufacturer or new<br />
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manufacturer discontinues the sale of its drug product [C.01.014.7], this will result<br />
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in DIN cancellation [C.01.014.6 (1)(a)].<br />
a drug product with a cancelled DIN (Refer to section 2.5.4 Transfer of a<br />
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592<br />
Cancelled DIN).<br />
593 2.5.2 Additional Product Names<br />
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595<br />
596<br />
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When manufacturers request an additional product name (same product and supplier)<br />
through a DIN application or an EUNDS, NDS, ANDS or AEUNDS, Health Canada will<br />
issue a new DIN to the product bearing the additional name to ensure that one DIN is<br />
linked to one product name (Refer to section 2.6 on Labelling).<br />
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600 2.5.3 Licensing Agreements<br />
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602 Licensors are expected to keep their DINs active to allow licensees to maintain safety<br />
603 updates.<br />
604<br />
605 If the drug submission or application is authorized, Health Canada will issue new DINs to<br />
606 licensees entering first time licensing agreements.<br />
607<br />
608 For pharmaceuticals, when licensees make changes to their licensing agreements and<br />
609 wish to change from one licensor to another, this is considered a new licensing agreement<br />
610 and a new drug submission or application must be filed that meets the conditions of this<br />
611 guidance. In this case, licensees will be required to retain the same DIN(s).<br />
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In cases where changes in licensing agreements involve cross-licensing products<br />
authorized under different regulatory pathways and requirements (i.e. full safety, efficacy<br />
and quality data package for an NDS versus comparative bioequivalence data to a CRP<br />
for an ANDS), licensees will not be permitted to retain the same DINs as this would be<br />
misleading to drug plan providers and patients.<br />
2.5.4 Transfer of a Cancelled Drug Identification Number (DIN)<br />
The transfer of a cancelled DIN will require a drug submission or application, which will<br />
result in the reissuance of the DIN upon approval. For more information, contact the DIN<br />
Division at the following address:<br />
Office of Submissions and Intellectual Property<br />
Finance Building #2<br />
Tunney’s Pasture, Address Locator: #0201A1<br />
Ottawa, Ontario<br />
K1A 0K9<br />
Fax: 613- 941-0825<br />
Telephone: 613-941-7281<br />
Email: SIPD-DINrequest@hc-sc.gc.ca<br />
For additional information with respect to DIN cancellations, refer to Health Canada’s<br />
Draft Guidance Document - Cancellation of a Drug Identification Number (DIN) and<br />
Notification of the Discontinuation of Sales.<br />
2.5.4.1 Licensing Agreements<br />
When a licensor’s DIN is cancelled by Health Canada for safety reasons, Health Canada<br />
will cancel the licensee’s DIN because the safety data for the cross-licensed product<br />
relies on the safety data of the licensor.<br />
When a licensor notifies Health Canada of the discontinuance of sale of its product<br />
[C.01.014.7], Health Canada will cancel the licensor’s DIN and licensees will be required<br />
to:<br />
a) discontinue the sale of their cross-licensed product, which would result in Health<br />
Canada cancelling the DIN following notification from the licensees;<br />
b) enter in a new licensing agreement and file accordingly; or,<br />
c) file their own drug submission or application with supporting data.<br />
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2.6 Labelling<br />
For manufacturers who are transitioning products due to new business arrangements, Health<br />
Canada expects that there is a 6 month phase-in period to replace the original product labels with<br />
new product labels.<br />
With the coming into force on June 13, 2015 of the Regulations Amending the Food and Drug<br />
Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use), for prescription<br />
products and products administered or obtained through a health professional for human use, all<br />
manufacturers are required to file mock-ups of their inner and outer labels and packaging in both<br />
English and French as part of their submission package at the time of filing.<br />
Where a sponsor is requesting a product name change, unless the change fits the exemptions set<br />
out in the Frequently Asked Questions - Guidance document for Industry - Review of Drug<br />
Brand Names, the submission should be filed as a Labelling Only submission and should<br />
include evidence supporting the product name(s) submitted along with the appropriate fee.<br />
Manufacturers will still be required to certify that all aspects of the drug submission or<br />
application pertaining to their product remain the same as was previously authorized. However,<br />
they will also be required to certify that the new labels and packaging are similar to those<br />
initially approved with respect to location and size of the text and graphics (including logos).<br />
Manufacturers who wish to change the location and/or size of text and/graphics are required to<br />
file a Labelling Only submission with the appropriate fees.<br />
Manufacturers are also required to file the Mock-up Labels and Packages Certification Form<br />
with their submission package which includes an attestation to the accuracy of translation.<br />
For additional information about changes resulting from the Plain Language Labelling<br />
amendments, consult the Guidance Document: Questions and Answers on Plain Language<br />
Labelling.<br />
2.7 Fees<br />
For information on issues related to drug submission/application evaluation fees and annual<br />
authority to sell fees, refer to current versions of the Guidance Document: Fees for the Review of<br />
Drug Submissions and Applications, How to Pay Fees to the Health Products and Food Branch,<br />
and the Guidance Document: Fees for the Right to Sell Drugs. For fee reduction information<br />
refer to the Guidance Document: Fees for the Right to Sell Drugs and the Right to Sell Drug Fee<br />
Remission Request and Attestation Form.<br />
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732<br />
733<br />
734<br />
735<br />
3. CONTACT INFORMATION<br />
Questions or comments related to this guidance document should be directed to:<br />
Health Canada<br />
Office of Submissions and Intellectual Property<br />
Health Products and Food Branch<br />
Therapeutic Products Directorate<br />
Address Locator: 0201D<br />
101 promenade Tunney's Pasture Driveway<br />
Ottawa Ontario<br />
K1A 0K9<br />
Canada<br />
Email: OSIP-BPPI@hc-sc.gc.ca<br />
Fax number: 613-946-5610 or 613- 941-0825<br />
4. REFERENCES<br />
Submission/Application Related Documents:<br />
<br />
<br />
<br />
<br />
<br />
<br />
Blank Certified Product Information Document (Schedule D Drugs) (CPID (Schedule D<br />
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)<br />
Drug Submission Application (3011) Form (http://www.hc-sc.gc.ca/dhpmps/alt_formats/pdf/prodpharma/applic-demande/form/hc3011_sc3011-eng.pdf)<br />
Guidance Document: Fees for the Review of Drug Submissions and Applications<br />
(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/fee_frais_guide-eng.php)<br />
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)<br />
Guidance Document: Post-Drug Identification Number (DIN) Changes (http://www.hcsc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/change_din-eng.php)<br />
Guidance Document: Patented Medicines (Notice of Compliance) Regulations<br />
(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guideld/patmedbrev/pmreg3_mbreg3-eng.php)<br />
16 Draft Date: 2017/02/17
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
736<br />
737<br />
738<br />
739<br />
740<br />
741<br />
742<br />
743<br />
744<br />
745<br />
746<br />
747<br />
748<br />
749<br />
750<br />
751<br />
752<br />
753<br />
754<br />
755<br />
756<br />
757<br />
758<br />
759<br />
760<br />
761<br />
762<br />
763<br />
764<br />
765<br />
766<br />
767<br />
768<br />
769<br />
770<br />
771<br />
772<br />
773<br />
774<br />
775<br />
776<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
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)<br />
Guidance for Sponsors: Lot Release Program for Schedule D (biologic) Drugs<br />
(http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/lot/gui_sponsorsdir_promoteurs_lot_program-eng.php)<br />
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)<br />
Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy<br />
Document (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guideld/postnoc_change_apresac/noc_pn_saf_ac_sa_inn-eng.php)<br />
Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document<br />
(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guideld/postnoc_change_apresac/noc_pn_quality_ac_sa_qualite-eng.php)<br />
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)<br />
Drug Submission Application Fee Form (http://www.hc-sc.gc.ca/dhpmps/alt_formats/pdf/prodpharma/applic-demande/form/feef_fraisf-eng.pdf)<br />
Labelling Related Guidances:<br />
<br />
<br />
<br />
<br />
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)<br />
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)<br />
Guidance Document: Product Monograph (http://www.hc-sc.gc.ca/dhpmps/prodpharma/applic-demande/guide-ld/monograph/pm_mp_2013-eng.php)<br />
Guidance Document: Questions and Answers: Plain Language Labelling Regulations<br />
(http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/pll_qa_fin_qr_elceng.php)<br />
Draft Date: 2017/02/17 17
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
777<br />
778<br />
779<br />
780<br />
781<br />
782<br />
783<br />
784<br />
785<br />
786<br />
787<br />
788<br />
789<br />
790<br />
791<br />
792<br />
793<br />
794<br />
795<br />
796<br />
797<br />
798<br />
799<br />
800<br />
801<br />
802<br />
803<br />
804<br />
805<br />
806<br />
807<br />
808<br />
Frequently Asked Questions - Guidance Document for Industry: Review of Drug Brand<br />
Names (http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2014-review-examen_drugmedicament_names-marques/faq-eng.php)<br />
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)<br />
Legislation and Regulations:<br />
Food and Drugs Act (http://laws-lois.justice.gc.ca/eng/acts/f-27/)<br />
Food and Drug Regulations (http://lawslois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/index.html)<br />
Patented Medicines (Notice of Compliance) Regulations (http://lawslois.justice.gc.ca/eng/regulations/SOR-93-133/FullText.html)<br />
5. APPENDICES<br />
Appendix 1: Administrative Changes - Certification Form<br />
Appendix 2: Sample - Attestation - Change in Product Ownership (Acquiring Manufacturer)<br />
Appendix 3: Sample - Letter of Authorization - Change in Product Ownership (Divesting<br />
Manufacturer)<br />
Appendix 4: Sample - Attestation - Merger / Buyout (New Manufacturer)<br />
Appendix 5: Sample - Letter of Authorization (Licensing Agreement)<br />
Appendix 6: Sample - Statement of Commitment (Licensing Agreement)<br />
18 Draft Date: 2017/02/17
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
809<br />
Draft Date: 2017/02/17 19
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
810<br />
811<br />
812<br />
813 814<br />
815<br />
816<br />
817<br />
818<br />
819<br />
820<br />
821<br />
822<br />
823<br />
824<br />
825<br />
826<br />
827<br />
828<br />
829<br />
830<br />
831<br />
832 833<br />
834<br />
835<br />
836<br />
837<br />
838<br />
839<br />
840<br />
841<br />
842<br />
843<br />
844<br />
845<br />
846<br />
847<br />
848<br />
849<br />
850<br />
851<br />
852<br />
853<br />
854<br />
855<br />
856<br />
APPENDIX 1: ADMINISTRATIVE CHANGES - CERTIFICATION FORM<br />
Administrative Changes - Certification Form for Human or Disinfectant Drugs<br />
Reason for Submission:<br />
Manufacturer Name Change Existing DIN(s) must be retained<br />
Product Name Change Existing DIN(s) must be retained<br />
Manufacturer and Product Name Changes Existing DIN(s) must be retained<br />
Changes in Product Ownership Existing DIN(s) must be retained<br />
Additional Product name New DIN(s) must be issued<br />
Merger/Buyout Existing DIN(s) must be retained<br />
Licensing Agreement between two Manufacturers 12 New DIN(s) issued or Existing DIN(s) retained<br />
………………………<br />
……………………....<br />
………………………<br />
Labelling Update (to match Licensor) Existing DIN(s) must be retained<br />
CMC Update (to match Licensor) Existing DIN(s) must be retained<br />
I, the undersigned, certify that all aspects of the drug submission or application pertaining to:<br />
..................................................................................................................................................................<br />
(Name of Product)<br />
submitted by:<br />
..................................................................................................................................................................<br />
(Name of Manufacturer)<br />
are identical to;<br />
............................................................................................................................ ................................<br />
(Name of product, Name of Manufacturer)<br />
[Current DIN(s)]<br />
except for name changes to the manufacturer and/or product, and that the product will be manufactured in the same<br />
location(s) with identical specifications and procedures.<br />
12<br />
If existing DINs are retained, please clearly list the DINs under this check box.<br />
20 Draft Date: 2017/02/17
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
857<br />
For prescription and products obtained or administered through a health professional for human use<br />
only:<br />
Please certify below that the location and size of graphics, text and logos on the inner and outer labels<br />
and packaging are similar to the product outlined above. Changes to labels or packaging that fall<br />
outside of these elements will require the filing of a Labelling Only submission and a clear indication in<br />
the cover letter as to the nature of the administrative change.<br />
I further certify:<br />
<br />
<br />
that the location and size of graphics, text and logos on the inner and outer labels and<br />
packaging are similar to the product outlined above, or<br />
that the location and size of graphics, text and logos on the inner and outer labels and<br />
packaging are not similar to the product outlined above and this submission is being filed as a<br />
Labelling Only submission.<br />
858<br />
859<br />
860<br />
861<br />
862<br />
863<br />
864<br />
865<br />
866<br />
867<br />
868<br />
869<br />
870<br />
871<br />
872<br />
............................................................................................................. ..................................<br />
Name of Authorized Signing Official and Title<br />
Authorized Signature<br />
............................................................................................................. .........................................................................<br />
Manufacturer Name<br />
Telephone Number<br />
........................................................................<br />
Email<br />
Draft Date: 2017/02/17 21
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
873<br />
874<br />
875<br />
876<br />
877<br />
878<br />
879<br />
880<br />
881<br />
882<br />
883<br />
884<br />
885<br />
886<br />
887<br />
888<br />
889<br />
890<br />
891<br />
892<br />
893<br />
894<br />
895<br />
896<br />
897<br />
898<br />
899<br />
900<br />
901<br />
902<br />
903<br />
APPENDIX 2: SAMPLE - ATTESTATION - CHANGE IN PRODUCT OWNERSHIP<br />
(ACQUIRING MANUFACTURER)<br />
Office of Submissions and Intellectual Property<br />
Therapeutic Products Directorate<br />
Finance Building, Address Locator: 0201A<br />
101 Tunney’s Pasture Driveway<br />
Ottawa, Ontario<br />
K1A 0K9<br />
Dear Sir or Madam:<br />
RE: (Name of Product)<br />
We confirm that the ownership of the product is being transferred from (Divesting Manufacturer)<br />
and acknowledge that Health Canada will reissue the DINs to (Acquiring Manufacturer).<br />
We assume all regulatory responsibilities for the product. We confirm that no changes are taking<br />
place within this drug submission or application including, but not limited to, all clinical data,<br />
chemistry and manufacturing data, product formulation, strength, route of administration and<br />
dosage forms, authorized indication(s) and condition(s) of use as well as all product labels 1 ,<br />
except for the manufacturer name and/or product name.<br />
We will submit a market notification to Health Canada [C.01.014.3] within 30 days of the first<br />
day of sale of the product with accompanying labels, if applicable.<br />
Yours sincerely,<br />
(Authorized signature - Acquiring Manufacturer)<br />
(Signee’s Name and Title)<br />
22 Draft Date: 2017/02/17
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
904<br />
905<br />
906<br />
907<br />
908<br />
909<br />
910<br />
911<br />
912<br />
913<br />
914<br />
915<br />
916<br />
917<br />
918<br />
919<br />
920<br />
921<br />
922<br />
923<br />
924<br />
925<br />
926<br />
927<br />
928<br />
929<br />
930<br />
APPENDIX 3: SAMPLE - LETTER OF AUTHORIZATION - CHANGE IN PRODUCT<br />
OWNERSHIP (DIVESTING MANUFACTURER)<br />
Office of Submissions and Intellectual Property<br />
Therapeutic Products Directorate<br />
Finance Building, Address Locator 0201A<br />
101 Tunney’s Pasture Driveway<br />
Ottawa, Ontario<br />
K1A 0K9<br />
Dear Sir or Madam:<br />
RE: (Name of Product)<br />
We confirm that the ownership of the product (state specific product name and DIN) is being<br />
transferred to (Acquiring Manufacturer) and acknowledge that Health Canada will reissue the<br />
DINs to (Acquiring Manufacturer).<br />
We confirm that we have provided (Acquiring Manufacturer) with the most complete and up-todate<br />
drug submission or application information to: support the maintenance of product labels;<br />
and, ensure consistency with that of the Canadian Reference Product, if applicable.<br />
Yours sincerely,<br />
(Authorized signature - Divesting Manufacturer)<br />
(Signee’s Name and Title)<br />
Draft Date: 2017/02/17 23
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
931<br />
932<br />
933<br />
934<br />
935<br />
936<br />
937<br />
938<br />
939<br />
940<br />
941<br />
942<br />
943<br />
944<br />
945<br />
946<br />
947<br />
948<br />
949<br />
950<br />
951<br />
952<br />
953<br />
954<br />
955<br />
956<br />
957<br />
958<br />
959<br />
960<br />
961<br />
APPENDIX 4: SAMPLE - ATTESTATION - MERGER / BUYOUT (NEW<br />
MANUFACTURER)<br />
Office of Submissions and Intellectual Property<br />
Therapeutic Products Directorate<br />
Finance Building, Address Locator 0201A<br />
101 Tunney’s Pasture Driveway<br />
Ottawa, Ontario<br />
K1A 0K9<br />
Dear Sir or Madam:<br />
RE: (Name of Product)<br />
As a result of a (merger or buyout) between (Divesting Manufacturer) and (Acquiring<br />
Manufacturer or New Manufacturer), we acknowledge that Health Canada will reissue the DINs<br />
to (Acquiring Manufacturer or New Manufacturer).<br />
We assume all regulatory responsibility for the product. We confirm that no changes are taking<br />
place within this drug submission or application including, but not limited to, all clinical,<br />
chemistry and manufacturing data, product formulation, strength, route of administration and<br />
dosage forms, authorized conditions of use as well as all product labels 1 , except for the<br />
manufacturer name and/or product name.<br />
We will submit a market notification to Health Canada [C.01.014.3] within 30 days of the first<br />
day of sale of our product with accompanying labels, if applicable.<br />
Yours sincerely,<br />
(Authorized signature - New Manufacturer)<br />
(Signee’s Name and Title)<br />
24 Draft Date: 2017/02/17
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
962<br />
963<br />
964<br />
965<br />
966<br />
967<br />
968<br />
969<br />
970<br />
971<br />
972<br />
973<br />
974<br />
975<br />
976<br />
977<br />
978<br />
979<br />
980<br />
981<br />
982<br />
983<br />
984<br />
985<br />
986<br />
987<br />
988<br />
989<br />
990<br />
991<br />
992<br />
993<br />
994<br />
995<br />
996<br />
997<br />
998<br />
999<br />
1000<br />
1001<br />
1002<br />
APPENDIX 5: SAMPLE - LETTER OF AUTHORIZATION (LICENSING<br />
AGREEMENT)<br />
Office of Submissions and Intellectual Property<br />
Therapeutic Products Directorate<br />
Finance Building, Address Locator 0201A<br />
101 Tunney’s Pasture Driveway<br />
Ottawa, Ontario<br />
K1A 0K9<br />
Dear Sir or Madam:<br />
RE: (Name of Cross-licensed Product)<br />
(Licensor) hereby authorizes the licensee to reference, and Health Canada to access, (submission<br />
type), (Product name), (Control#), and subsequent drug submission or application updates for the<br />
product, in order to support the submission or application filed by (licensee) that will be<br />
processed administratively for their (product name).<br />
(Licensor) certifies that (Licensee) (product name) will be manufactured, controlled and<br />
packaged as per (licensor) using the systems and procedures submitted and authorized by Health<br />
Canada.<br />
We confirm that we have provided (Licensee) with the most complete and up-to-date submission<br />
or application information to: support the development and maintenance of product labels for the<br />
cross-licensed product(s); and, to ensure consistency with that of the Canadian Reference<br />
Product, if applicable. We understand that failure to update product labels may impact the<br />
approval of the licensee’s drug submissions or applications.<br />
As the licensor, we acknowledge our responsibility to ensure that:<br />
Product labels are kept up-to-date and any safety and efficacy updates are communicated<br />
to the licensee upon approval.<br />
Any post-authorization updates to the chemistry and manufacturing data and product<br />
formulation are communicated to the licensee.<br />
Yours sincerely,<br />
(Authorized signature - Licensor)<br />
(Signee’s Name and Title)<br />
Draft Date: 2017/02/17 25
Administrative Processing of Submissions and<br />
Applications Involving Human or Disinfectants Drugs<br />
Health Canada<br />
Draft Guidance Document - For comment purposes only<br />
1003<br />
1004<br />
1005<br />
1006<br />
1007<br />
1008<br />
1009<br />
1010<br />
1011<br />
1012<br />
1013<br />
1014<br />
1015<br />
1016<br />
1017<br />
1018<br />
1019<br />
1020<br />
1021<br />
1022<br />
1023<br />
1024<br />
1025<br />
1026<br />
1027<br />
1028<br />
1029<br />
1030<br />
1031<br />
1032<br />
1033<br />
1034<br />
1035<br />
1036<br />
1037<br />
APPENDIX 6: SAMPLE - STATEMENT OF COMMITMENT (LICENSING<br />
AGREEMENT)<br />
Office of Submissions and Intellectual Property<br />
Therapeutic Products Directorate<br />
Finance Building, Address Locator 0201A<br />
101 Tunney’s Pasture Driveway<br />
Ottawa, Ontario<br />
K1A 0K9<br />
Dear Sir or Madam:<br />
RE: (Name of Product)<br />
As a drug manufacturer under the Food and Drugs Act and its Regulations, we commit to:<br />
• Comply with all regulatory requirements associated with selling a drug as listed in section<br />
2.2 of the Guidance Document Administrative Processing of Drug Submissions and<br />
Applications Involving Human or Disinfectants Drugs.<br />
• Remain identical in every way [i.e., all aspects of the authorization] to the licensor’s<br />
product throughout its life-cycle, with the exception of the manufacturer name and/or<br />
product name, including filing safety and labelling updates within 30 days of the licensor.<br />
• File the appropriate chemistry and manufacturing updates for our Schedules C and D<br />
product(s) subsequent to the licensor's approved post authorization Chemistry and<br />
Manufacturing updates such that all aspects of the authorization remain identical to the<br />
licensor's product throughout its life-cycle, with the exception of the manufacture name<br />
and/or product name.<br />
Yours sincerely,<br />
(Authorized signature - Licensee)<br />
(Signee’s Name and Title)<br />
26 Draft Date: 2017/02/17