INDEX [products.thomsonreuters.ca] · CTA see Clinical Trial Application CTA-As see Clinical Trial Application Amendments Canada-United States Free Trade Agreement Canadian obligationsprior

I-1 (Life Sciences Law) (Release 2006)

INDEX

[References are to chapter- and heading-numbers, with initial abbreviations and ac-ronyms appearing before full-text words.]

AHR – see Assisted Human Reproduction

AHRAC – see Assisted Human Reproduc-tion Agency of Canada

ANDS – see Abbreviated New Drug Sub-missions

APS – see Advertising/Promotion Systems

ASC – see Advertising Standards Canada

Abbreviated New Drug Submissionsdata protection and, 9.1, 9.4drug identification number and, 1.3(1)notice of compliance and, 1.3(2), 4.3supplemental, 1.6

Act to Amend the Patent Act and the Foodand Drugs Act

Bill C-56, 8.4

Adverse Drug Reactionpost-market surveillance and, 1.5

Advertising – see Marketing

Advertising/Promotion Systemsmarketing to health care professionals,

12.5(1)

Advertising Standards Canadaconsumer advertising, 12.4(2)regulatory control over marketing, 12.3

Agreement on Trade-Related Aspects of In-tellectual Property Rights

Canadian previous obligations• Berne Convention for the Protection of Liter-

ary and Artistic Works, 7.2(1)

• Canada-U.S. Free Trade Agreement, 7.2(3)• General Agreement on Tariffs and Trade,

7.2(2)• Paris Convention for the Protection of Indus-

trial Property, 7.2(1)cross-border pharmaceutical trade rules and,

10.2data protection and, 9.2Declaration on the TRIPS Agreement and Pub-

lic Health, 8.2dispute settlement mechanisms• pharmaceutical patents, 7.6(1)(b)• term of patent protection, 7.6(1)(a)Doha Declaration of 2001 and, 8.2implementation in Canada• Bill C-22, 7.4(1)• Bill C-91, 7.4(2)• generally, 7.4• legislation, 7.4(3)international obligations and, 7.1life sciences products, relevant provisions re• basic obligations, 7.5(1)• data protection, 7.5(7)• enforcement, 7.5(8)• exceptions, limited, 7.5(5)• licensing, compulsory, 7.5(6)• non-discrimination, 7.5(2)• patent protection, term of, 7.5(4)• patent rights, 7.5(3)• patentability, 7.5(2)negotiations, 7.3(1)

Assisted Human Reproduction Actgenerally, 16.2.1, 16.2.4framework of Act• Assisted Human Reproduction Agency of

Canada, 16.2.3(4)• generally, 16.2.3• goals, 16.2.3(1)• offences, 16.2.3(5)

� LIFE SCIENCES LAW IN CANADA

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• Parliamentary review, 16.2.3(7)• prohibitions, 16.2.3(2)• regulations, 16.2.3(6)• restrictions, 16.2.3(3)generally, 16.2policy concerns addressed, 16.2.2

Assisted Human Reproduction Agencyof Canada

legislative framework and, 16.2.3(4)

BGTD – see Biologic and Generic Thera-pies Directorate

Bankruptcy and Insolvency Acttechnology transfer and, 13.3(12)(c),

13.3(13)(d)

Berne Convention for the Protection of Liter-ary and Artistic Works

Canadian obligations prior to TRIPS andNAFTA, 7.2(1)

Biologic and Generic Therapies Direc-torate

generally, 1.4marketing, labelling and advertising, 12.3(1)submissions and review, 1.7(1)

Biologicsregulation of products and, 1.4

Budapest Treatypatentability of life forms, 2.5(3)

CADRIS – see Canadian Adverse ReactionInformation System

CAMP – see Canadian Association of Medi-cal Publishers

CDRP – see CIRA Dispute ResolutionPolicy (under Guidelines and Policies)

CIPO – see Canadian Intellectual PropertyOffice

CIRA – see Canadian Internet RegistrationAuthority

CMA – see Canadian Medical Association

CTA – see Clinical Trial Application

CTA-As – see Clinical Trial ApplicationAmendments

Canada-United States Free Trade AgreementCanadian obligations prior to TRIPS and

NAFTA, 7.2(3)international obligations and, 7.1

Canadian Adverse Reaction Informa-tion System

post-market surveillance and, 1.5

Canadian Association of Medical Pub-lishers

marketing to health care professionals,12.5(2)

Canadian Intellectual Property Office –see also Chapter 2 generally

patent listing and, 4.5trademarks and, 5.1(2)(a)

Canadian Internet Registration Author-ity

domain names and, 5.2(1)

Canadian Medical Associationmarketing to health care professionals,

12.5(3)

Clarifaxsubmissions and review, 1.7(2)(a)(iii)

Clarification Requestsubmissions and review, 1.7(2)(a)(iii)

Clinical Trialsgenerally, 1.8humans, on, 1.11(6)

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I-3 (Life Sciences Law) (Release 2007-2)

• authorization, 1.11(6)(a), 1.11(6)(b)• cancellation of authorization, 1.11(6)(b)• sponsor obligations and, 1.11(6)(c)• suspension of authorization, 1.11(6)(b)natural health products, 1.11(6)

Clinical Trial Applicationregulation of products and, 1.8

Clinical Trial Application Amendmentsregulation of products and, 1.8

Companies’ Creditors Arrangement Acttechnology transfer and, 13.3(12)(c)

Compendium of Monographsproduct licence applications and, 1.11(3)(a)

Competition Actadvertising and labelling, 12.1, 12.4(2)

Compliancenatural health products, 1.11(8)notice of, 1.3(2), 1.6notice of non-compliance, 1.7(2)(a)(v)notice with conditions, 1.7(1)

Controlled Drugs and Substances Actregulation of products, 1.1

Convention on Biological Diversitylife sciences products, 7.5(2)

Copyrightassignment, 6.2(2)(b)authorship, 6.2(2)Crown copyright, 6.2(2)(d)employment and, 6.2(2)(c)fair dealing, 6.4generally, 6.1infringement of, 6.3obtaining, 6.2originality, 6.2(1)ownership, 6.2(2)primary infringement, 6.3research purposes, 6.4

secondary infringement, 6.3

Copyright Act – see Copyright, or Chapter 6generally

implementation of TRIPS and NAFTA,7.4(3)

Cosmetic Regulationsadvertising, labelling and marketing, 12.2

Criminal Codeadvertising, labelling and marketing, 12.2(3)

Cross-Border Pharmaceutical TradeCanadian Internet pharmacy industry• generally, 10.1• mechanics of trade, 10.1(3)• rationale for, 10.1(4)• scope of trade, 10.1(2)international trade rules governing, 10.2regulatory laws, applicable• Canadian drug laws, 10.3(2)• generally, 10.3• proposed legislation, 10.3(4)• provincial regulatory standards, 10.3(3)• United States drug laws, 10.3(1)

DIN – see Drug Identification Number

DSU – see Dispute Settlement Understand-ing

DTC – see direct to customer advertising(under Marketing)

Data ProtectionCanada, in, 9.4Canadian international obligations, 9.2countries, in other, 9.3generally, 9.1proposed regulations for, 9.5Regulatory Impact Analysis Statement, 9.5

Declaration on the TRIPS Agreement andPublic Health

compulsory licensing of patents and, 8.2


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Dispute Settlement Understandingmechanisms under TRIPS and NAFTA, 7.6

DohaDecision of August 30, 2003• exporting obligations, 8.3(2)• General Council Chairperson’s Statement,

8.3(4)• generally, 8.3• importing obligations, 8.3(2)• WTO members, obligations on, 8.3(3)Declaration of 2001, 8.2Declaration on the TRIPS Agreement and Pub-

lic Health, 8.2

Domain NamesCanadian presence requirements, 5.2(1)dot-CA, 5.2(1)dispute resolution, 5.2(2)generally, 5.2presence requirements, Canadian, 5.2(1)

Drug Identification Numbermarketing approval and, 1.3(1)

Drug-Medical Device CombinationProducts

regulation of, 1.10

Drug Submissionsabbreviated new, 1.3(1), 1.3(2)new, 1.3(1), 1.3(2)

Drugsabbreviated new submissions, 1.3(1), 1.3(2)adverse reactions, 1.5advertising – see Marketingapproval, changes after, 1.6biologics, 1.4Canadian Adverse Reaction Information

System, 1.5changes to new, 1.6clinical trials, 1.8combination products, 1.10“drug” defined, 12.2(1)generic therapies, 1.4identification numbers, 1.3(1)

innovative drug, 9(4)labelling – see Marketingmarketing approval for, 1.3medical device combination product, 1.10new submissions, 1.3(1), 1.3(2), 1.6radiopharmaceuticals, 1.4regulation of, 1sale of, 1.2serious adverse reactions, 1.5supplemental abbreviated new submissions,

1.6supplemental new submissions, 1.6surveillance, post-market, 1.5

EC – see European Community

EPAM – see Environmental Protection Al-ternative Measure

EPC – see European Patent Convention

EPCO – see Environmental ProtectionCompliance Order

EU – see European Union

Environmental LawCanada’s Clean Air Act, 15.2(3)Canadian Environmental Assessment Act,

15.2(3)Canadian Environmental Protection Act, 1999

(CEPA, 1999), 15.2(1)• animate products of biotechnology,

15.2(1)(b)• enforcement, 15.2(1)(e)• environmental protection alternative meas-

ure, 15.2(1)(e)• environmental protection compliance or-

ders, 15.2(1)(e)• generally, 15.2(1)• hazardous waste, 15.2(1)(c)• National Pollutant Release Inventory,

15.2(1)(d)• regulations under, 15.2(1)(a) – see also reg-

ulations• toxic substances, 15.2(1)(a)federal legislation, 15.2

INDEX �


• CEPA, 15.2(1) – see also Canadian Envi-ronmental Protection Act, 1999

• other, 15.2(3)• Transportation of Dangerous Goods Act,

1992, and regulations, 15.2(2)Feeds Act, 15.2(3)Fertilizers Act, 15.2(1)(a), 15.2(3)Fisheries Act, 15.2(3)Food and Drugs Act, 15.2(1)(a), 15.2(2)generally, 15.1, 15.4Health Canada, 15.2(1)(a)Health of Animals Act, 15.2(1)(a)Kyoto Protocol, 15.2(3)Kyoto Protocol Implementation Act, 15.2(3)Pest Control Products Act, 15.2(1)(a), 15.2(3)provincial legislation• contaminated land, 15.3(2)• enforcement, 15.3(5)• environmental assessments, 15.3(4)• Environmental Protection Act (Ontario), 15.3• generally, 15.3• Ontario Water Resources Act, 15.3(5)• pollution control, 15.3(1)• Waste Diverson Act, 2002 (Ontario),

15.3(3)• waste management, 15.3(3)regulations• Export and Import of Hazardous Waste and

Hazardous Recyclable Materials Regulations,15.2(1)(e)

• New Substances Notification Regulations(Chemicals and Polymers), 15.2(1)(a)

• New Substances Notification Regulations (Or-ganisms), 15.2(1)(a)

• Prohibition of Certain Toxic Substances Reg-ulations, 2005, 15.2(1)(a)

Seeds Act, 15.2(1)(a), 15.2(3)Transportation of Dangerous Goods Act, 1992,

15.2(2)

Environmental Protection AlternativeMeasure

enforcement of environmental law,15.2(1)(e)

Environmental Protection ComplianceOrders

enforcement of environmental law,15.2(1)(e)

Establishmentsapplication of good manufacturing practices,

1.3(3)(b)good manufacturing practices, 1.3(3)licences• drugs, 1.3(3)(a)• medical devices, 1.9(2)manufacturing and, 1.3(3)natural health products, 1.3(3)(a)standards for, 1.3(3)

European CommunityTRIPS negotiations, 7.3(1)

European Patent Conventionpatentability of DNA, RNA and antibodies,

2.6(2)(b)

European Unionconsumer advertising and, 12.4(1)data protection, 9.3life sciences products and, 7.5(2)

Expertadvisory committees, use of, 1.7(2)(b)(iv)opinions, 1.7(2)(b)(iv)

FDA – see Food and Drug Administration(U.S.)

FD&C Act – see Food Drug and CosmeticAct (under United States’ Legislation)

Food and Drug Administration (U.S.)cross-border trade in pharmaceuticals,

10.1(3), 10.3(1)data protection, 9.3Internet pharmacy industry in Canada and,

10.1(3)regulatory laws re cross-border trade, 10.3(1)

Food and Drug Regulations – see also Chap-ter 1 generally


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advertising and, 12.2, 12.4consumer advertising, 12.4(1), (2)data protection and, 9.4, 9.5environmental law and, 15.2framework of, 4.3, 12.2labelling and, 12.2NOC Regulation proceedings and, 4.4patent infringement actions and, 4.4patented medicines policy concerns, 4.2policy concerns re patented medicines, 4.2regulation of products under statute, 1trademarks and, 5.1(7)

Food and Drugs Act – see also Chapters 1 and12 generally

advertising of drugs, medical devices andnatural health products, 12

Bill C-56 amendments to, 8.4Bill C-83 amendments to, 10.3(4)cross-border trade, 10.1(3), 10.3(2)dangerous goods, transportation of, 15.2(2)environmental law and, 15.2patented medicines policy concerns, 4.2pharmaceuticals, cross-border trade of,

10.1(3), 10.3(2)policy concerns re patented medicines, 4.2regulation of products under, 1regulations under, 1toxic substances, 15.2(1)(a)transportation of dangerous goods, 15.2(2)

GATT – see General Agreement on Tariffsand Trade

GMP – see Good Manufacturing Practices

General Agreement on Tariffs andTrade

Canadian obligations before TRIPS andNAFTA, 7.2(2)

Generic Therapiesregulation of products and, 1.4

Good Manufacturing Practicesapplication of, 1.3(a)generally, 1.3(3)

natural health products and, 1.11(5)

Guidelines – see Index to Guidelines, Poli-cies, Papers and Other Non-LegislativeMaterials

HHS – see Health and Human Services(U.S.)

HPFB – see Health Products and FoodBranch

Health and Human Services (U.S.)Canadian Internet pharmacy industry and,

10.1(2)

Health Canada – see also Chapter 1 gener-ally

advertising, 12.2(1), 12.3, 12.4consumer advertising and, 12.4(1)environmental law and, 15.2(1)(a)labelling, 12.2(1), 12.3Licensing Services Division, 1.7(1)notice of compliance and, 4.3patent listing and, 4.5patented medicines and, 4.3product liability and, 14.9recalls and, 14.9regulatory control, 12.3trademarks and, 5.1(7)

Health Products and Food Branchadvertising and, 12.3(1)generally, 1.1labelling and, 12.3(1)

International Trade ObligationsCanadian previous obligations• Berne Convention for the Protection of Liter-

ary and Artistic Works, 7.2(1)• Canada-U.S. Free Trade Agreement, 7.2(3)• General Agreement on Tariffs and Trade,

7.2(2)• Paris Convention for the Protection of Indus-

trial Property, 7.2(1)cross-border pharmaceutical trade rules, 10.2

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data protection and, 9.2dispute settlement mechanisms• generally, 7.6

[Next page is I-7.]

INDEX �


• NAFTA, 7.6(2)• pharmaceutical patents, 7.6(1)(b)• TRIPS, 7.6(1)• term of patent protection, 7.6(1)(a)generally, 7.1, 7.7implementation in Canada• Bill C-22, 7.4(1)• Bill C-91, 7.4(2)• generally, 7.4• legislation, 7.4(3)licensing, compulsory• Act to Amend the Patent Act and the Food

and Drugs Act, 8.4• anti-diversion measures, 8.4(2)• Bill C-9, 8.4• Bill C-56, 8.4• Doha Decision, 8.3• Doha Declaration, 8.2• duration, 8.4(4)• framework, 8.4(1)• Jean Chretien Pledge to Africa (JCPA), 8.4• royalty, 8.4(3)• termination, 8.4(5)life sciences products, relevant provisions re• basic obligations, 7.5(1)• data protection, 7.5(7)• enforcement, 7.5(8)• exceptions, limited, 7.5(5)• licensing, compulsory, 7.5(6)• non-discrimination, 7.5(2)• patent protection, term of, 7.5(4)• patent rights, 7.5(3)• patentability, 7.5(2)negotiations• NAFTA, 7.3(2)• TRIPS, 7.3(1)

JCPA – see Jean Chretien Pledge to Africa

Jean Chretien Pledge to AfricaBill C-9, 8.1, 8.4

LA/SA – see Look Alike Sound Alike

LOI – see Letter of Intent

Labelling – see Marketing

Letter of Intentoutsourcing and, 16.4.3(2)

Licencescompulsory – see also Chapter 8 generally• anti-diversion measures, 8.4(2)• Canadian legislation, 8.4• commercial nature, agreements of, 8.5• Doha Decision, 8.3• Doha Declaration of 2001, 8.2• duration, 8.4(4)• exporting obligations, 8.3(2)• framework, 8.4(1)• General Council Chairperson’s Statement,

8.3(4)• generally, 8.1• importing obligations, 8.3(2)• royalty, 8.4(3)• termination, 8.4(5)establishment• drugs, 1.3(3)(a)• medical devices, 1.9(2)product• amending, 1.11(3)(b)• application for, 1.11(3)(a)• cancellation of, 1.11(3)(c)• generally, 1.11(3)• reporting obligations, 1.11(3)(d)• suspension of, 1.11(3)(c)site, 1.11(4)technology transfer – see Technology Trans-

fer

Licensing Services Divisionsubmissions and review, 1.7(1)

Linkage Regulations – see Patented Medi-cines

Look Alike Sound Aliketrademarks, 5.1(7)

MOU – see Memorandum of Understanding

MTAs – see Material Transfer Agreements


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Manufacturingapplication of good practices, 1.3(3)(b)establishment licences, 1.3(3)(a)establishments and, 1.3(3)good practices, 1.3(3)natural health products, 1.3(3)(a)standards for, 1.3(3)

Marketed Health Products Directoratemarketing, advertising and labelling, 12.3(1)

Marketingadvertising – see labelling and advertisingapproval• abbreviated new drug submission, 1.3(1),

1.3(2)• compliance, notice of, 1.3(2)• drug identification number, 1.3(1)• drug submissions, 1.3(1), 1.3(2)• generally, 1.3• good manufacturing practices, 1.3(3)• new drug submission, 1.3(1), 1.3(2)• notice of compliance, 1.3(2)• standards – see standards for approvaldirect to customer advertising, 12.4(1)health care professionals• generally, 12.5• Pharmaceutical Advertising Advisory

Board, 12.5(1)• provincial medical associations, 12.5(3)• research-based pharmaceutical companies,

12.5(2)labelling and advertising• Advertising Standards Canada, 12.3(2)• consumer advertising, 12.4• deceptive advertising, 12.2(3)• definitions, 12.2(1)• false advertising, 12.2(3)• framework, 12.2• future directions, 12.6• generally, 12.1• health care professionals – see health care

professionals• Health Canada, 12.3(1)• legislative provisions, 12.2(2)• medical devices, 12.4(3)• misleading advertising, 12.2(3)

• natural health products, 12.4(2)• non-prescription drugs, 12.4(2)• Pharmaceutical Advertising Advisory

Board, 12.3(3), 12.5(1)• prescription drugs, 12.4(1)• regulatory control, 12.3• research-based pharmaceutical companies,

12.3(4), 12.5(2)natural health products, 1.11(7), 12.4(2)product licences, 12.4(2)standards for approval• application of good marketing practices,

1.3(3)(b)• establishment licences, 1.3(3)(a)• establishments, of, 1.3(3)• good marketing practices, application of,

1.3(3)(b)• manufacturing, of, 1.3(3)• natural health products, 1.3(3)(a)terms of market authorization, 12.4(2)

Master Services Agreement – see alsoOutsourcing

business terms• change orders, 16.4.3(3)(a)(vii)• delivery, 16.4.3(3)(a)(iii)• development, 16.4.3(3)(a)(i)• dispute resolution, 16.4.3(3)(a)(viii)• equipment, 16.4.3(3)(a)(vi)• generally, 16.4.3(3)(a)• manufacturing, 16.4.3(3)(a)(i)• materials, 16.4.3(3)(a)(vi)• payment, 16.4.3(3)(a)(v)• pricing, 16.4.3(3)(a)(iv)• process failure, 16.4.3(3)(a)(ii)• product failure, 16.4.3(3)(a)(ii)• shipping, 16.4.3(3)(a)(iii)generally, 16.4.3(3)legal terms• compliance with applicable law,

16.4.3(3)(b)(iii)• confidentiality, 16.4.3(3)(b)(v)• force majeure, 16.4.3(3)(b)(viii)• generally, 16.4.3(3)(b)• indemnification, 16.4.3(3)(b)(vi)• insurance, 16.4.3(3)(b)(vii)

INDEX �


• intellectual property, 16.4.3(3)(b)(i)• privacy, 16.4.3(3)(b)(v)• representations and, 16.4.3(3)(b)(ii)• term, 16.4.3(3)(b)(iv)• termination, 16.4.3(3)(b)(iv)• warranties, 16.4.3(3)(b)(ii)schedules• generally, 16.4.3(3)(c)• scope, 16.4.3(3)(c)(iii)• service level agreement, 16.4.3(3)(c)(ii)

Material Transfer Agreementstechnology transfer and, 13.2(2)

Medical Devicesadvertising – see Marketingapproval to sell in Canada, 1.9(1)combination products, 1.10drug combination products, 1.10establishment licences, 1.9(2)generally, 1.9labelling – see Marketingregulations• advertising, 12.2, 12.4(3)• combination products, 1.10• generally, 1.9• labelling, 12.2• marketing, 12.2reporting obligations, 1.9(4)sell in Canada, approval, 1.9(1)special access, 1.9(3)testing, investigational, 1.9(5)

Memorandum of Understandingoutsourcing and, 16.4.3(2)

Minister of Consumer and CorporateAffairs

pricing of medicines and, 11.1(1)

Minister of Healthapproval to sell medical devices, 1.9(1)clinical trials and, 1.8cross-border trade of pharmaceuticals,

10.3(4)establishment licences, 1.9(2)investigational testing, 1.9(5)

medical devices and, 1.9patented medicines and, 4.1, 4.3reporting obligations, 1.9(4)special access, 1.9(3)

Minister of Industrypricing of medicines and, 11.1(1)

NAFTA – see North American Free TradeAgreement

NDAs – see Non-Disclosure Agreements

NDS – see New Drug Submissions

NHP – see Natural Health Product

NHPD – see Natural Health Product Direc-torate

NOA – see Notice of Allegation

NOC – see Notice of Compliance

NOC/c – see Notice of Compliance withConditions

NOD – see Notice of Deficiency

NON – see Notice of Non-Compliance

NRPI – see National Pollutant Release In-ventory

National Pollutant Release InventoryCanadian Environmental Protection Act, 1999,

and, 15.2(1)(d)

Natural Health Productadvertising – see Marketingclinical trials on humans, 1.11(6)• authorization, 1.11(6)(a), 1.11(6)(b)• cancellation of authorization, 1.11(6)(b)• sponsor obligations and, 1.11(6)(c)• suspension of authorization, 1.11(6)(b)compliance, 1.11(8)


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defined, 12.2(1)directorate, 1.11(3)(a), 12.3(1)enforcement, 1.11(8)establishments, standards for, 1.3(3)generally, 1.11good manufacturing practices re, 1.11(5)labelling, 1.11(7) – see also Marketingmanufacturing, standards, for, 1.3(3)packaging, 1.11(7)product licences• amending, 1.11(3)(b)• application for, 1.11(3)(a)• cancellation of, 1.11(3)(c)• generally, 1.11(3)• reporting obligations, 1.11(3)(d)• suspension of, 1.11(3)(c)regulations re• advertising, 12.2, 12.4(2)• generally, 1.11• history, 1.11(1)• labelling, 12.2• marketing, 12.2• scope, 1.11(2)site licences, 1.11(4)transition, 1.11(8)

Natural Health Product Directorate – seealso Natural Health Product

generally, 1.11(3)(a)marketing, advertising and labelling, 12.3(1)

New Drug Submissionsabbreviated – see Abbreviated New Drug

Submissionsdrug identification number and, 1.3(1)notice of compliance and, 1.3(2), 4.3patent listing and, 4.5(4)supplemental, 1.6, 4.5(4)

Non-Disclosure Agreementstechnology transfer and, 13.2(1)

North American Free Trade AgreementCanadian previous obligations• Berne Convention for the Protection of Liter-

ary and Artistic Works, 7.2(1)• Canada-U.S. Free Trade Agreement, 7.2(3)

• General Agreement on Tariffs and Trade,7.2(2)

• Paris Convention for the Protection of Indus-trial Property, 7.2(1)

data protection and, 9.2dispute settlement, 7.6(2)implementation in Canada• Bill C-22, 7.4(1)• Bill C-91, 7.4(2)• generally, 7.4• legislation, 7.4(3)international obligations and, 7.1life sciences products, relevant provisions re• basic obligations, 7.5(1)• data protection, 7.5(7)• enforcement, 7.5(8)• exceptions, limited, 7.5(5)• licensing, compulsory, 7.5(6)• non-discrimination, 7.5(2)• patent protection, term of, 7.5(4)• patent rights, 7.5(3)• patentability, 7.5(2)negotiations, 7.3(2)

North American Free Trade Agreement Im-plementation Act

Canadian implementation of, 7.4

Notice of AllegationNOC Regulations and• challenges to, 4.6(3)• generally, 4.3, 4.6(1)• sufficiency of, 4.6(2)

Notice of Allowancepatent, of, 2.2(12)

Notice of Compliancechanges to new drugs and, 1.6conditions, with, 1.7(1)data protection, 9.4marketing approval and, 1.3(2)NOC-regulation – see Patented Medicinesregulation re – see Patented Medicinessubmissions and review, 1.7(1)

INDEX �


Notice of Compliance with Conditionssubmissions and review, 1.7(1)

Notice of Deficiencysubmissions and review, 1.7(2)(a)(iv)withdrawal letter, 1.7(2)(a)(iv)

Notice of Non-Compliancesubmissions and review, 1.7(2)(a)(v)withdrawal letter, 1.7(2)(a)(v)

Outsourcinggenerally, 16.4life cycle, 16.4.2• negotiation phase, 16.4.2(2)• operational phase, 16.4.2(4)• selection and negotiation phase, 16.4.2(2)• strategy phase, 16.4.2(1)• termination phase, 16.4.2(5)• transition phase, 16.4.2(3)preliminary/temporary agreements• confidentiality agreements, 16.4.3(1)• generally, 16.4.3• letters of intent (LOI), 16.4(3)(2)• master services agreement, 16.4.3(3) – see

also Master Services Agreement• memoranda of understanding (MOU),

16.4.3(2)

PAAB – see Pharmaceutical Advertising Ad-visory Board

PAB – see Patent Appeal Board

PCT – see Patent Cooperation Treaty

PIPEDA – see Personal Information Protec-tion and Electronic Documents Act

PLs – see Product Licences

PMPRB – see Patented Medicine PricesReview Board

Packagingnatural health products, 1.11(7)

Paris Convention for the Protection of Indus-trial Property

Canadian obligations prior to TRIPS andNAFTA, 7.2(1)

priority of, 2.2(1)trademark registration and, 5.1(2)(a)

Patent Act – see also Patents, or Chapters 2,3 and 4 generally

Bill C-9, 8.4Bill C-22, 11.1(1)Bill C-56, 8.4Bill C-91, 11.1(1)compulsory licensing and, 8.4, 8.5dispute settlement cases under TRIPS, 7.6(1)implementation of TRIPS and NAFTA, 7.4international obligations and, 7.1pricing and, 11.1(1)regulations, 8.4(2), 8.4(3) – see also Patented

Medicines

Patent Act Amendment Act, 1992 – see alsoPatented Medicines

Bill C-91 and, 7.4(2)patented medicines and, 4.1

Patent Appeal Boardprosecution of application, 2.2(11)

Patent Cooperation Treatypatentability of DNA, RNA and antibodies,

2.6(3)(a)patentability of life forms, 2.5(3)prosecution of application and, 2.2(4)

Patent Registerpatent listing and, 4.5

Patent Rules – see Patents

Patented Medicinesappeal from Federal Court (Trial Level), 4.8Bill C-22 and, 7.4(1)Bill C-91 and, 7.4(2)damages, legislative, 4.9generally, 4.1, 4.10


I-12

international obligations and, 7.4, 7.7Notice of Allegation• challenges to, 4.6(3)• generally, 4.6(1)• sufficiency of, 4.6(2)patent listing• eligibility for, 4.5(2)• entitlement to list, who has, 4.5(1)• generally, 4.5• invalidity, allegations re, 4.6(4)• non-infringement, allegations re, 4.6(5)• Notice of Allegation – see Notice of Alle-

gation• prior to June 17, 2006, 4-Appendix A• submission, nature of associated, 4.5(4)• timing requirements, 4.5(3)Prices Review Board – see Patented Medi-

cines Prices Review Board, or Chapter 11generally

proceedings re• burden of proof, 4.7(2)• generally, 4.4• indirect infringement, 4.7(3)• infringement action distinguished, 4.4• initiating, 4.7• time period for, 4.7(1)regulations• appeal from Federal Court (Trial Level),

4.8• damages, 4.9• framework of, 4.3• generally, 4.1• policy concerns, 4.2• proceedings, 4.4 – see also proceedings re

Patented Medicines (Notice of Compliance)Regulations – see Patented Medicines orChapter 4 generally

Patented Medicines Regulations, 1994pricing and, 11.1(2)

Patented Medicine Prices Review BoardBill C-22, 7.4(1)Canadian Internet pharmacy industry,

10.1(4)channels signalled

• generally, 11.1(6)• non-patented drug prices, 11.1(6)(e)• personnel, changes of, 11.1(6)(a)• price increases, 11.1(6)(d)• proposed amendments to regulations,

11.1(6)(b)• two-tiered pricing, possibility of,

11.1(6)(c)compendium• compliance policy, 11.1(3)(b)• excessive price guidelines, 11.1(3)(a)• • Dovobet� case, 11.1(6)(d)• • review of excessive price guidelines,

11.1(6)(c)• enforcement policy, 11.1(3)(b)• scientific review procedures, 11.1(3)(c)constitutionality of, 11.1(5)drug benefit plans, provincial, 11.1(7)generally, 11.1guidelines – see compendiumjurisdiction• dedicated patents, over, 11.1(4)(c)(i)• patent applications, over, 11.1(4)(c)(ii)• view of, 11.1(4)(b)mandate, 11.1(4)(a)medicine, meaning of, 11.1(4)(d)patentee, meaning of, 11.1(4)(c)pertains, meaning of, 11.1(4)(e)policies – see compendiumprocedures – see compendiumprocess, 11.1(4)(f)provincial drug benefit plans, 11.1(7)regulatory function, 11.1(4)(a)reporting function, 11.1(4)(a)statutory framework• agreements with provinces, 11.1(2)(d)(iv)• annual report, 11.1(2)(d)(ii)• board members, 11.1(2)(c)(ii)• certificates, 11.1(2)(c)(v)• confidentiality of pricing information,

11.1(2)(b)(iv)• confidentiality of sales and research infor-

mation, 11.1(2)(b)(vi)• definitions, 11.1(2)(d)(i)• excessive pricing, 11.1(2)(a)• generally, 11.1(2)

INDEX �

I-13 (Life Sciences Law) (Release 2010 – 1)

• hearings, 11.1(2)(c)(i)• identity of medicine, 11.1(2)(b)(i)• intention to sell, 11.1(2)(b)(iii)• meetings, 11.1(2)(d)(iii)• orders, 11.1(2)(c)(v)• powers of court, 11.1(2)(c)(iii)• price of medicine, 11.1(2)(b)(ii)• proceedings informal, 11.1(2)(c)(iv)• process, 11.1(2)(c)• regulation-making powers, 11.1(2)(c)(vi)• reporting requirements, 11.1(2)(b)• research and development expense infor-

mation, 11.1(2)(b)(v)• sales revenues, 11.1(2)(b)(v)technology transfer and, 13.2(6)view, 11.1(4)

Patents – see also Patented Medicinesapplication, prosecution of• action, final, 2.2(11)• allowance, 2.2(12), 2.2(13)• amendment after allowance, 2.2(13)• appeals, 2.2(11)• Convention priority, 2.2(1)• disclaimer, 2.2(15)• entity status, 2.2(5)• examination for application, 2.2(10)• examination, request for, 2.2(9)• filing date, official, 2.2(2)• generally, 2.2• issuance, 2.2(12)• maintenance fees, 2.2(16)• national entry, 2.2(4)• Notice of Allowance, 2.2(12)• office action, 2.2(10)• ownership, 2.2(6)• Patent Appeal Board, 2.2(11)• Patent Office action, 2.2(10)• public disclosure, restrictions re, 2.2(3)• publication, 2.2(7)• prior art, filing, 2.2(8)• re-examination of patents, 2.2(14)• reissue, 2.2(15)• request for examination, 2.2(9)• special order, 2.2(9)Bill C-22 and, 7.4(1)

Bill C-91 and, 7.4(2)Canadian Intellectual Property Office – see

Chapter 2 generallychemical and pharmaceutical claims• allowable, 2.4(1), 2.4(3)• amendments to, 2.4(4)• medical treatment claims, method of,

2.4(2)• sample, 2.4(1)• use, allowable, 2.4(3)defences – see infringement, defences toenforcement• accounting of profits, 3.2(3)(d)• actual rights, 3.2(1)• compensation, reasonable, 3.2(3)(e)• damages, 3.2(3)(c)• delivery up, 3.2(3)(b)• duration of rights, 3.2(2)• generally, 3• injunctions, 3.2(3)(a)• monopoly rights, 3.2• proceedings, 3.3 – see also infringement

proceedings• profits, accounting of, 3.2(3)(d)• reasonable compensation, 3.2(3)(e)• remedies generally, 3.2(3)expert witness• consultants, retainer of, 3.7(6)• damages, to, 3.7(3)(d)• definition, 3.7(1)• examples, 3.7(4)• fact, 3.7(3)(a)• generally, 3.7• infringement, to, 3.7(3)(b)• invalidity, to, 3.7(3)(c)• procedural issues, 3.7(5)• qualifications, 3.7(2)• role of, 3.7(3)generally, 2genetics• antibodies, 2.6(4)• claim format, 2.6(3)(c)• disclosure, 2.6(3)• discovery, 2.6(2)(b)• information, 2.6(2)(d)• invention, 2.6(2)(b)


I-14

• Lilly rule, the, 2.6(3)(b)• patentability generally, 2.6(1)• patentability debate, 2.6(2)• product of nature, 2.6(2)(a)• sequence listing, 2.6(3)(a)• support, 2.6(3)(b)• uniqueness, 2.6(2)(c)infringement• claim construction, 3.4(3)(a)• defences, 3.6 – see also infringement, de-

fences to• definition of, 3.4(1)• expert witnesses, 3.7 – see also expert wit-

ness• generally, 3.4• indirect, 4.7(3)• presumptions, 3.4(3)(b)• proceedings, 3.3 – see also infringement

proceedings• proof of, 3.4(3)• types of, 3.4(2)infringement, defences to• exceptions, limited, 3.6(1)(b)• exhaustion, doctrine of, 3.6(1)(a)(ii)• expert witnesses, 3.7 – see also expert wit-

ness• generally, 3.6• invalidity, 3.6(2), 4.6(4)• licence, 3.6(1)(a)• non-inducement, 3.6(1)• non-infringement, 3.6(1), 4.6(5)infringement proceedings• action, procedural steps in an, 3.3(2)(b)• alternative dispute resolution, 3.3(1)(b)• appeal, 3.3(2)(b)(vi)• assessment, 3.5(2)• cease and desist letter, 3.3(1)(a)• checklist, 3.5• choice of forum, 3.3(2)(a)• circumstances, other, 3.5(4)• defences, 3.6 – see also infringement, de-

fences to• discovery, 3.3(2)(b)(iii)• documents, discovery of, 3.3(2)(b)(iii)• documents to file, 3.3(2)(b)(i)• examination for discovery, 3.3(2)(b)(iii)

• expert reports, 3.3(2)(b)(iv)• expert witnesses, 3.7 – see also expert wit-

ness• Federal Court, 3.3(2)(a)(i)• information, basic, 3.5(1)• litigation, 3.3(2)• NOC Regulation proceedings distin-

guished, 4.4• preliminary motions, 3.3(2)(b)(ii)• pre-litigation, 3.3(1)• Provincial Superior Court, 3.3(2)(a)(ii)• procedural steps, 3.3(2)(b)• relief to be sought, 3.5(3)• Reply and Defence to Counterclaim,

3.3(2)(b)(i)• Reply to Defence to Counterclaim,

3.3(2)(b)(i)• Statement of Claim, 3.3(2)(b)(i)• Statement of Defence and Counterclaim,

3.3(2)(b)(i)• trial, 3.3(2)(b)(v)law re – see Chapters 2, 3, 4 generallylegislation – see Chapters 2, 3, 4 generallylife forms, patentability of• Abitibi case, 2.5(1)• biological matters, deposit of, 2.5(3)• Harvard Mouse case, 2.5(4)• Monsanto case, 2.5(5)• Pioneer Hi-Bred case, 2.5(2)listing, 4.5 – see also Patented Medicinesmedical treatment claims, 2.4(2) – see also

chemical and pharmaceutical claimsmedicines – see Patented MedicinesParis Convention for the Protection of Industrial

Property, 2.2(1)Patent Cooperation Treaty, 2.2(4)patentability• antibodies – see genetics• anticipation, 2.3(1)• DNA – see genetics• double-patenting, 2.3(2)• eggs fertilized, 2.6(5)(2)• inventiveness, 2.3(1)• life forms, 2.5 – see also life forms, patenta-

bility of• novelty, 2.3(1)

INDEX �

I-14.1 (Life Sciences Law) (Release 2010 – 1)

• obviousness, test for, 2.3(1)• Organs, 2.6(5)(3)• overlapping subject matter, 2.3(2)• RNA – see genetics• requirements, 2.3• specification, sufficiency of, 2.3(3)• stem cells, 2.6(5)(1)• subject application, 2.3(1)• tissues, 2.6(5)(3)

[Next page is I-15.]

INDEX �


• utility, 2.3(4)pharmaceutical claims, 2.4 – see also chemi-

cal and pharmaceutical claimproceedings, 3.3 – see also infringement pro-

ceedingsprosecution – see application, prosecution of

Personal Information Protection and Elec-tronic Documents Act

legislative overview and, 16.1.2personal health information and, 16.1.4

Pharmaceutical Advertising AdvisoryBoard

marketing, advertising and labelling, 12.3(1),12.5(1)

Plant Breeders’ Rights Actpatentability of life forms, 2.5(5)

Policies – see Index to Guidelines, Policies,Papers and Other Non-Legislative Materi-als

Post-Market Surveillanceregulation of products and, 1.5

Pricing – see Patented Medicine Prices Re-view Board

Privacy Lawcompliance, implementing, 16.1.6federal Privacy Act, 16.1.2generally, 16.1genetic information, 16.1.5health information, 16.1.4legislative overview, 16.1.2Model Code for the Protection of Personal Infor-

mation, 16.1.3Ontario’s Personal Health Information Protec-

tion Act, 16.1.2, 16.1.4, 16.1.5personal genetic information, 16.1.5personal health information, 16.1.4Personal Information Protection and Electronic

Documents Act, 16.1.2, 16.1.4rules, 16.1.3

what is, 16.1.1

Product Liabilitybreach, statutory, 14.8causation, 14.7class actions, 14.16compensation programs, 14.15costs, 14.14defences, 14.10design flaws, 14.3duty to warn, 14.4generally, 14.1intermediaries, learned, 14.5limitation periods, 14.12manufacturing defects, 14.2procedures, 14.13recalls, 14.9remedies, 14.11standard of care, 14.6statutory breach, 14.8

Product Licencesamending, 1.11(3)(b)application for, 1.11(3)(a)cancellation of, 1.11(3)(c)consumer advertising and, 12.4(2)generally, 1.11(3)reporting obligations, 1.11(3)(d)suspension of, 1.11(3)(c)

Product Specific Facility Informationgenerally, 1.4

RFI – see Request for Information

RFP – see Request for Proposals

RFQ – see Request for Quotes

Radiopharmaceuticalsregulation of products and, 1.4

Regulation of Productschanges to drugs after approval, 1.6clinical trials, 1.8combination products, 1.10


I-16

Controlled Drugs and Substances Act, 1.1drugs – see DrugsFood and Drugs Act, 1generally, 1Health Products and Food Branch, 1.1marketing approval, 1.3 – see also Marketing

Approvalmedical devices, 1.9 – see also Medical De-

vicesMinister of Health, 1.1natural health products – see also Natural

Health Product• generally, 1.11• standards re, 1.3(3)(a)post-market surveillance, 1.5review process – see also Submissionssale of products, 1.2, 1.9submissions, 1.7 – see also Submissionssurveillance, post-market, 1.5

Request for Informationoutsourcing and, 16.4.2

Request for Proposalsoutsourcing and, 16.4.2

Request for Quotesoutsourcing and, 16.4.2

Research-Based Pharmaceutical Com-panies

health care professionals, marketing to,12.5(2)

regulatory control over marketing, 12.3(4)

Review Process – see also Submissionsgenerally, 1.7priority, 1.7(1)

SANDS – see Supplemental AbbreviatedNew Drug Submissions

SNDS – see Supplemental New Drug Sub-missions

Sale of ProductsCanada, in, 1.2, 1.9regulation of products and, 1.2, 1.9

Screening Deficiency Noticesubmissions and review, 1.7(2)(a)(i)

Serious Adverse Drug Reactionpost-market surveillance and, 1.5

Site Licencesnatural health products and, 1.11(4)

Special Accessmedical devices and, 1.9(3)

Standardsestablishment licences, 1.3(3)(a)establishments, for, 1.3(3)good manufacturing practices• application of, 1.3(3)(b)• generally, 1.3(3)licences, establishment, 1.3(3)(a)manufacturing, for, 1.3(3)natural health products, 1.3(3)(a)

Submissions – see also Abbreviated NewDrug Submissions; New Drug Submis-sions

generally, 1.7information permitted, 1.7(2) – see also solic-

ited information; unsolicited informationmeetings prior to, 1.7(1)priority review, 1.7(1)solicited information• Clarifax, 1.7(2)(a)(iii)• Clarification Request, 1.7(2)(a)(iii)• generally, 1.7(2)(a)• Notice of Deficiency, 1.7(2)(a)(iv)• Notice of Non-Compliance, 1.7(2)(a)(v)• Screening Deficiency Notice, 1.7(2)(a)(i)• Update Notice, 1.7(2)(a)(ii)• withdrawal letters, 1.7(2)(a)(iv),

1.7(2)(a)(v)unsolicited information• administrative changes, 1.7(2)(b)(v)• data, final, 1.7(2)(b)(i)

INDEX �


• expert advisory committee, 1.7(2)(b)(iv)• expert opinions, 1.7(2)(b)(iv)• foreign regulatory, 1.7(2)(b)(iii)• generally, 1.7(2)(b)• other, 1.7(2)(b)(vi)• safety, re, 1.7(2)(b)(ii)

Supplemental Abbreviated New DrugSubmissions

changes to new drugs once approved, 1.6

Supplemental New Drug Submissionschanges to new drugs once approved, 1.6patent listing and, 4.5(4)

Surveillancepost-market, 1.5

TMA – see terms of market authorization(under Marketing)

TPCC – see Therapeutic Products Classifi-cation Committee

TPD – see Therapeutic Products Director-ate

TRIPS – see Agreement on Trade-Related As-pects of Intellectual Property Rights

Tax Issuesgenerally, 16.3goods and services tax, 16.3.5scientific research and experimental develop-

ment, 16.3.2tax credits, 16.3.2transfer pricing rules, 16.3.3withholding tax, 16.3.4

Technology Transferagreements, common types of• co-promotion agreements, 13.2(6)• development agreements, 13.2(3)• distribution agreements, 13.2(5)• generally, 13.2• licensing agreements, 13.2(4)

• material transfer agreements, 13.2(2)• non-disclosure agreements, 13.2(1)confidential information defined, 13.2(1)contractual terms, common• alternative dispute resolution, 13.3(13)(b)• assignment of control, 13.3(13)(h)• boilerplate, 13.3(13)• change of control, 13.3(13)(h)• choice of law, 13.3(13)(a)• compliance with laws, 13.3(13)(e)• confidentiality, 13.3(8)• definitions, 13.3(1)• definitions, improvements re, 13.3(7)(a)• disclaimers, 13.3(10)• entirety of contract, 13.3(13)(c)• force majeure, 13.3(13)(f)• form of payment, 13.3(6)(d)• further assurance, 13.3(13)(g)• generally, 13.3• grant clause, 13.3(3)• grant, improvements re, 13.3(7)(c)• implied terms, 13.3(5)• improvements, 13.3(7)• indemnities, 13.3(11)• independence of parties, 13.3(13)(k)• infringement, indemnities from,

13.3(11)(a)• licence estoppel, 13.3(4)• licence, nature of, 13.3(2)• lump sum payments, 13.3(6)(a)• minimum payments, 13.3(6)(c)• non-waiver, 13.3(13)(j)• notices, 13.3(13)(l)• payment terms, 13.3(6)• records and audits, 13.3(6)(e)• remedies on termination, 13.3(12)(e)• renewal rights, 13.3(12)(b)• reporting, improvements re, 13.3(7)(b)• representations, 13.3(9)• royalties, 13.3(6)(b)• severability, 13.3(13)(d)• surviving provisions, 13.3(13)(i)• term, 13.3(1)• termination, 13.3(12)• termination, consequences of, 13.3(12)(d)• termination, grounds for, 13.3(12)(c)


I-18

• warranties, 13.3(9)generally, 13.1

Therapeutic Products ClassificationCommittee

drug-medical device combination products,1.10

Therapeutic Products Directoratedrug-medical device combination products,

1.10marketing, labelling and advertising, 12.3(1),

12.3(2), 12.3(3)submissions and review, 1.7(1)

Trade Dress – see Trademarks

Trademarksdistinctiveness• opposition process and, 5.1(3)• pharmaceutical trade dress marks, 5.1(6)(a)generally, 5.1law re, 5.1legislation re, 5.1licences, 5.1(5)look-alike sound-alike names, 5.1(7)opposition process, 5.1(3)pharmaceutical trade dress• application requirements, 5.1(6)(c)• distinctiveness of marks, 5.1(6)(a)• functionality of marks, 5.1(6)(b)• generally, 5.1(6)• three-dimensional marks, 5.1(6)(c)registration process• application, 5.1(2)(a)• examination for registrability, 5.1(2)(b)• generally, 5.1(2)• registrability, examination for, 5.1(2)(b)• renewal and, 5.1(4)regulatory intersection and, 5.1(7)renewal, 5.1(4)trade dress – see pharmaceutical trade dress

Trade-Marks Act – see also Trademarks, orChapter 5 generally

consumer advertising and, 12.4(2)

implementation of TRIPS and NAFTA,7.4(3)

Trade-Marks Regulations – see Trademarks

UDRP – see Uniform Dispute ResolutionPolicy (under Guidelines and Policies)

USPTO – see United States Patent andTrademark Office

United States’ LegislationFood, Drug and Cosmetic Act, 10.3(1)Pharmaceutical Market Access and Drug Safety

Act, 10.3(1)Prescription Drug Marketing Act, 10.3(1)

United States Patent and TrademarkOffice

patentability of DNA, RNA and antibodies,2.6(3)(a)

Update Noticesubmissions and review, 1.7(2)(a)(ii)

Use of Patented Products for InternationalHumanitarian Purposes Regulations

anti-diversion measures, 8.4(2)compulsory licensing and, 8.4(2), 8.4(3)royalty, 8.4(3)

VCU – see Voluntary Compliance Under-taking

Voluntary Compliance Undertakingpricing and, 11.1(3)(b)

WIPO – see World Intellectual PropertyOffice

WTO – see World Trade Organization

World Intellectual Property Officepatentability of DNA, RNA and antibodies,

2.6(3)(a)

INDEX �


World Trade Organization – see alsoChapter 8 generally

compulsory licensing obligations, 8.3(3)cross-border pharmaceutical trade rules and,

10.2data protection, obligations re, 9.2dispute settlement mechanisms and, 7.6Doha Decision, obligations under, 8.3(3)

international obligations and, 7.1life sciences products and, 7.5(2)TRIPS negotiations, 7.3(1)trademark registration and, 5.1(2)(a)

World Trade Organization Agreement Im-plementation Act

TRIPS, Canadian implementation of, 7.4


I-20

Index to Guidelines, Policies, Papers and Other Non-LegislativeMaterials

CIRA Policies, Rules and Procedures – General Regulation Rules, 5.2(1)CIRA’s Dispute Resolution Policy, 5.2(2)Changes in Manufacturer’s Name and/or Product Name, 1.7(2)(b)(v)Changes to Marketed New Drugs, 1.6Code of Advertising Acceptance, 12.3(3), 12.3(4)Compendium of Guidelines, Policies and Procedures, 11.1(3)(c)Compliance with Paragraph 30(a) of the Trade-marks Act – Pharmaceuticals, 5.1(2)(a)Compliance Policy, 11.1(3)(b)Compliance Policy for Natural Health Products, 1.11(8)Consumer Advertising Guidelines for Marketed Health Products (draft), 12.3(2)Consumer Drug Advertising Guideline, 12.3(2), 12.4(2)Drug Name Review: Look-Alike Sound-Alike (LA/SA) Health Product Names, 5.1(7)Good Clinical Practice Consolidated Guideline, 1.8Guidelines for General Advertising, Supplied Advertising Inserts & Journal Supplements, 12.3(4),

12.5(2)Management of Drug Submission Policy, 1.10Manual of Patent Office Practice, 2.5(5)Marketed Health Product Name Assessment: Look-alike Sound-alike (LA/SA) Health Product Names,

5.1(7)Natural Health Products: A New Vision, 1.11(1)Principles for Claims Relating to Comparison of Non-Therapeutic Aspects of Non-Prescription Drug

Products, 12.4(2)Regulatory Framework for Natural Health Products, 1.11(1)Report on Prescription Drug Importation, 10.1(2)Therapeutic Comparative Advertising: Directive and Guidance Document, 12.4(2)Trade-marks Journal, 5.1(2)(b)Trade-marks Wares and Services Manual, 5.1(2)(a)Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans, 1.8Uniform Dispute Resolution Policy, 5.2(2)Working Group recommendations, 12.2(2)