자료캐나다규정 1 법령체계 법령체계개요 - 캐나다의법령체계를살펴보면다음과같음 FOOD AND DRUGS ACT( 식품의약품법 ) https://laws-lois.justice.gc.ca/eng/acts/f-27/ 가장상위단의법임 식품의약품법 은의약품, 식품, 화장품등의생산, 수입, 수출, 수송, 판매를 규제하는법임 FOOD AND DRUG REGULATIONS https://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._870/rpdc.html NATURAL HEALTH PRODUCT REGULATIONS https://laws.justice.gc.ca/eng/regulations/sor-2003-196/page-1.html NHP 규정은식품의약품법하에있지만식품의약품법에는 NHP 에대한정의가 없기때문에, 기본적으로식품의약품법과독립적임. 그러나, 식품의약품법에의 한의약품과여러조항의규제를받는독특한규제체계를가지고있음 < 주의사항 > 식품의약품법을읽어보면, NHP 는 Drug 용어하에있음 COSMETIC REGULATIONS https://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._869/index.html 식품의약품법하에있는규정임 OTHERS 용어정의 : Cosmetics, NHP, Drug 화장품 (cosmetics), 자연건강제품 (natural health product), 의약품 (Drug) 각각의정의및사례는다음과같음 1 화장품 - 식품의약품법 (FOOD AND DRUGS ACT) 제2조에서화장품을 피부, 머리카락, 치아의청결, 개선또는변화를위해사용되는물질또는혼합물로데오트란트와향수가이에포함된다 고정의하고있음 < 참고 > - Cosmetics Includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes 출처 : 식품의약품법 (FOOD AND DRUGS ACT) 제2조 2 자연건강제품 (Natural Health Product, NHP) - 캐나다의 Natural Health Product는미국에서 OTC로분류되는식이보조제 (Dietary supplement) 와비슷하다고생각할수도있는데, 미국의경우에는 OTC 제품의경우시판후사후모니터링 ( 사전승인제도가아님 ) 되지만, 캐나다의 NHP(Natural Health Product) 는시판전에제품별로허가를받아야함 - 또한 NHP는 식품의약품법 (FOOD & DRUG ACT) 의 NHP 규정 (Natural Health Product Regulations) 에따라미국과달리의약품 (drug) 의범주로분류되어관리됨 - 자연건강제품 (Natural Health Product, NHP) 은기능요소및성분요소로구성됨 기능요소는아래와같은용도로제조, 판매또는표시된성분을담기위한목적과관련이있음 인체질병, 질환또는신체적이상상태나증상진단, 치료, 경감또는예방 인체기관의기능회복또는조정 인체기관의기능완화 ( 예. 건강유지또는증진위해기능완화 ) 성분요소는자연건강제품의약물성분유래와관련이있다. - NHP 규정에서는 Natural Health Product 에사용가능한품목과사용불가 ( 금지 ) 품목리스트를제시하고있음 ( 다음페이지표참조 ) 비타민, 무기질, 허브요법 (Herbal remedies), 프로바이오틱스, 아미노산과필수지방산등 - 1 - - 2 -
을단독으로또는조합하여제조한제품과동종요법 (Homeopathic medicines) 및전통의약품이 NHP에해당됨 https://laws.justice.gc.ca/eng/regulations/sor-2003-196/page-13.html - 의약품으로분류됨에따라, 최종제품은 의약품법 에서정한규격에따라야하며, 판매전허가신청서 ( 제품, 원료, 효과, 사용목적, 안전성과효능을입증하는근거 ) 및제품규격을제출하여허가받아야함캐나다에서판매되는모든자연건강제품은제품라이센스 (PRODUCT LICENSE) 를, 캐나다에서제품을제조, 포장, 표지혹은수입하는모든장소는장소라이센스 (SITE LICENSE) 를받아야함 - 캐나다에서판매되는모든자연건강제품은제품라이센스 (PRODUCT LICENSE) 를, 캐나다에서제품을제조, 포장, 표지혹은수입하는모든장소는장소라이센스 (SITE LICENSE) 를받아야함 - 자외선차단제의경우, 유럽에서는화장품으로분류되지만미국에서는 OTC Drug이고, 캐나다에서는 Natural Health Product 또는 Drug로분류됨 무기자외선차단제라면캐나다에서는 Natural Health Product로분류됨 무기자외선차단제 : Titanium dioxide, Zinc oxide, PABA 유기자외선차단제라면캐나다에서는 Drug로분류됨 유기자외선차단제 : Avobenzone, Bemotrizinol, oxybenzone, Benzophenone-4, Benzophenone-8, Bisoctrizole, Cinoxate 등 자외선차단성분을함유하고있더라도자외선차단을표시광고하지않는다면화장품으로캐나다에수입될수있음 3 의약품 (Drug) - 의약품에는의사의처방이필요한전문의약품과처방전이필요하지않은비처방의약품이있음 prescription pharmaceuticals non-prescription pharmaceuticals < 참고 > - Drug drug includes any substance or mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying organic functions in human beings or animals, or (c) disinfection in premises in which food is manufactured, prepared or kept 출처 : 식품의약품법 (FOOD AND DRUGS ACT) 제 2 조 - The Category IV Monograph 는아래항목을포함하고있음 https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/gu idance-documents/non-prescription-drugs-category-iv-monographs.html - 3 - - 4 -
Acne Therapy (2016) http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atreq.do?atid=acne&lang=eng Sunscreen Monograph - Version 2.0 (2013) http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atreq.do?atid=sunscreen-ecransolaire&lang=eng Medicated Skin Care Products (2007) http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atreq.do?atid=skin_peau&lang=eng Diaper Rash Products (2007) http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atreq.do?atid=diaprash_erytfess&lang=eng Anti-Dandruff Products (2006) http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atreq.do?atid=antidandruff_anitpelliculaire&lang=eng Antiseptic Skin Cleansers (2006) http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atreq.do?atid=antiseptic_antiseptique&lang=eng Athletes Foot Treatments (1995) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/g uidance-documents/non-prescription-drugs-category-iv-monographs/athletes-foot-treatments.html Throat lozenges (1995) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/gu idance-documents/non-prescription-drugs-category-iv-monographs/throat-lozenges.html 2 화장품 캐나다의화장품제품보고 (Notification) - 캐나다에서는화장품을시판하고나서 10일내에제품보고를해야함. 이것은의무사항이지만사전승인 (pre-approval) 은아님. 즉. 제품보고를하면시스템상으로자동으로제품보고가접수되는것이지, 캐나다보건부 (Health Canada) 가이를검토하여승인해준다는개념은아님 https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notifi cation-cosmetics.html 제품보고데드라인을놓쳐도큰상관은없음. 화장품의경우위해도가낮은물품이기때문에캐나다보건부가관리하는정도는 Drug 및 NHP(Natural Health Product) 보다덜엄격함 그러나경쟁사가이를 Health Canada에고발하는상황이발생할수는있음 - 수입제품의경우에는현실적으로는수입이전에화장품보고가되어있어야함 - 화장품보고양식은아래링크에서확인할수있음 Cosmetic Notification Form http://healthycanadians.gc.ca/apps/radar/cps-spc-0007.08.html - 화장품보고방법에대한가이드라인은아래링크에서확인할수있음 How to complete a Cosmetic Notification form https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notific ation-cosmetics/guidance-document-complete-cosmetic-notification-form.html - 화장품제품보고대상의예는아래와같음 soaps artificial nail builders adhesives such as for artificial nails, hair extensions, etc. moisturizers tinted moisturizers (concealer) tattoo inks makeup products tooth whiteners cleansing wipes - 5 - - 6 -
feminine douches - 캐나다에서화장품으로간주되지않는제품의예는다음과같음 ( 화장품보고대상이아님 ) sunscreens (including makeup products with SPF) 자외선차단제 ( 자외선차단지수를표기한메이크업제품포함 ) 는캐나다에서화장품으로분류되지않기때문에화장품제품보고대상이아님. 자외선차단성분이무기 (Natural) 성분인지유기 (Chemicals) 성분인지여부에따라 NHP 또는 Drug로분류됨 acne treatment skin whiteners or lighteners denture cleaners hand sanitizers artificial nails and hair extensions brushes laser treatment hair removers collagen or "Botox" injections insect repellents oral supplements room or fabric sprays non-prescription contact lenses < 화장품보고양식 > - 7 - - 8 -
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캐나다의화장품라벨링 - 캐나다에서라벨링은 2개국어 ( 영어, 프랑스어 ) 로표기되어야함 전성분표기는 INCI 명칭으로표시하면됨 - 공간이협소할경우, 스티커를부착하는방법을사용하기도함 - 캐나다보건부에서발간한화장품라벨링가이드라인이있음 Guidelines for Cosmetic Advertising and Labelling Claims https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publica tions/industry-professionals/labelling-cosmetics.html - 비처방의약품및화장품의광고및라벨링클레임수준에대해서는 2016년에캐나다광고표준협회 (Advertising Standards) 에서발간한가이드라인을참조하면됨 Guidances for the Non-prescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims(2016) https://adstandards.ca/wp-content/uploads/2018/09/guidelines-for-the-nonprescription-and -Cosmetic-Industry.pdf 캐나다의화장품성분관련규정 : Hotlist - Hotlist 는캐나다의화장품원료관련규정으로, 배합금지성분목록과배합한도제한성분목록으로구성되어있음 https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/cosm etic-ingredient-hotlist-prohibited-restricted-ingredients.html Cosmetic Ingredient Hotlist https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/cosm etic-ingredient-hotlist-prohibited-restricted-ingredients/hotlist.html - Hotlist 는정기적으로검토및개정되고있음 - 13 - - 14 -
cription/regulation.html#a2 캐나다보건부 (Health Canada) 에서자료검토후해당제품의안전성, 품질, 효능에문제가없다고판단하면 8자리숫자로구성된 NPN(Natural Product Number) 을부여해줌. NPN은제품라벨에표기해야하며, NPN을부여받았다는것은해당제품이캐나다보건부의검토를거쳐승인된제품이라는것을의미함 Licensed Natural Health Products Database (LNHPD) https://health-products.canada.ca/lnhpd-bdpsnh/index-eng.jsp 3 NHP (Natural Health Product) NHP 제품허가 - 캐나다에는식품의약품법이있으며, NHP의경우식품의약품법하에있지만 NHP 법이별도로있음 - 캐나다에서 NHP를판매하기위해서는라이센스를보유해야함. 즉, NHP 제품을판매하기위해서는제품허가신청을하여 NPN(Natural Product Number) 을부여받아야함 - 미국의 Dietary Supplement Notification은사전승인개념이아님. 그러나캐나다의 NHP 신고 (Product licensing) 사전승인개념이라고보면됨 제품허가신청시에는캐나다보건부 (Health Canada) 에제품에대한상세정보 ( 의약성분 (medicinal ingredients), 기원, 용량, 효능, 비의약성분 (non-medicinal ingredients), 권고된사용법등의정보를제출해야함 Licensing Requirements https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-pres - NHP 라벨링은화장품라벨링과는완전히다른별개의규정이있으며, Natural product number(npn) 및아래사항이표기되어야함 brand name of health product non-proprietary name (proper or common name) of health product strength dosage form route of administration (other than for oral solids, such as tablets) warnings, as relevant population, as relevant (e.g., pediatric) storage instructions, as relevant Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffe ct-canada/good-label-package-practices-guide-non-prescription-drugs-natural-health-products.html - 승인받은 NHP 인지여부는 Health Canada 사이트에서검색할수있으며, 아래항목의정보를볼수있음 product name product licence holder Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) product's medicinal ingredients product's non-medicinal ingredients product's dosage form product's recommended use or purpose (i.e. its health claim or indication) - 15 - - 16 -
risk information associated with the product's use (i.e. cautions, warnings, contra-indications and known adverse reaction) Licensed Natural Health Products Database (LNHPD) https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescr iption/applications-submissions/product-licensing/licensed-natural-health-products-database.html Site Licences (SL) 가이드라인 https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescr iption/legislation-guidelines/guidance-documents/site-licensing-guidance-document.html List of site licence holders https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescr iption/applications-submissions/site-licensing/list-site-licence-holders.html NHP 업소허가 (Site Licences : SL) - 수입화장품의경우에는라벨링규정을준수하고, 제품신고 (notification) 를한다면, 캐나다에판매할수있음. 또한화장품의경우에는 site license를받을필요가없음 - 그러나, natural health products인경우에는 site license를받아야함 - natural health products의경우에는수입자가캐나다에소재한 ( 물리적으로소재하고있는 ) 회사여야하며, site license를가지고있어야함. 또한 NPN(Natural Product Number) 을부여받아야하며, 해당규정에따라라벨링을해야함 - NHP(Natural Health Product) 를제조, 포장, 표시, 수입하는기업은해당활동에대한업소허가 (Site licence) 를받아야함 https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescr iption/applications-submissions/site-licensing/guidance-documents.html 캐나다의 NHP 성분데이터베이스 : Natural Health Products Ingredients Database - Natural Health Product 의성분명은아래사이트에서검색가능함 http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-recherchereq.do - 업소허가를받기위해서는정부의 GMP 기준에따른품질관리근거를제출해야함 Good Manufacturing Practices Guidance Document https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-presc ription/legislation-guidelines/guidance-documents/good-manufacturing-practices.html - NHP 수입시 Canadian Quality Assurance Person은서류를검토하여모든것이정확하며, 완료되어있음을확인한후, 반출허가서에서명함 (sign the release form) - 반출허가서는한국의제조업자또는한국회사에송부되며, 물류창고 (warehouse) 에도송부됨 - 모든것은이메일로진행되는데, 물류창고에서반출허가서를받으면캐나다전지역으로반출될준비가되는것임. 배송되어야하는곳의정확한주소를주면해당배송지로배송이됨. 이러한과정은 natural health products일경우에적용되며, 화장품에는해당하지않음 - 17 - - 18 -
4 Drug - 수입업자가제조소허가 (EL) 보유 - 수입업자의제조소허가에해외제조소명시 - 수입업자의정보에주원료공급업자정보변경 의약품식별번호 (Drug Identification Number, DIN) - 의약품식별번호 (Drug Identification Number, DIN) 는 식품의약품법 및 식품의약품규정 에따라판매하는각의약품에부여되는 8자리숫자코드임 - 헬스캐나다에서는의약품이허가되면캐나다에서제조업자의의약품판매를허가하는의약품식별번호를발행함 Drug Facts Panel 의약품제조소허가 (Drug Establishment Licences : DEL) - 의약품제조소허가 (Drug Establishment Licence, DEL) 는제조, 포장 / 라벨, 시험, 수입, 유통, 도매의 6개허가활동에종사하는자에게요구됨. 또한주원료의제조, 포장 / 라벨, 시험, 수입에도필요함 - 캐나다의모든의약품제조소 (Drug Establishment) 는제조소허가 (Drug Establishment Licences) 를받아야함 - 캐나다에소재한시설만제조소허가를보유할수있음 - 수입업자는해외제조업자가캐나다 GMP 기준에따라제조하게할책임이있음 - 제조소허가를받은모든시설에대한실사는실사관이수행함 - 실사주기는제조업자, 포장업자 / 라벨업자및실험실의경우 24개월, 수입업자, 유통업자및도매업자의경우 36개월임 Drug Establishment Licences https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforc ement/establishment-licences/drug-establishment-licences.html Drug Establishment Licences (DEL) 가이드라인 https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforc ement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establis hment-licences-drug-establishment-licensing-fees-0002.html 일반의약품수입시준수사항 - 제품별의약품식별번호 (DIN) - 19 - - 20 -
- Drug에대해서는국내제조소뿐아니라해외제조소도실사를함 - 해외제조소의경우에는대부분의경우 Health Canada에서직접실사를나가는것이아니라, 제3자 (third party) 가실사를하고캐나다보건부에서는이에대한서류검토를하는방식으로진행됨 https://www.canada.ca/en/health-canada/services/inspecting-monitoring-drug-health-produc ts/drug-health-product-inspections/about-drug-inspections.html 제3자리스트는 Health Canada에서제공하지않음 https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescr iption/applications-submissions/guidance-industry-third-party-issuance-international-trade-c ertificates.html - 캐나다보건부에서해외제조소실사를나가는경우도있긴한데, 정말매우심각한부작용이발생해야해외제조소실사를나감. 그외일반적인경우에는제3자로부터실사를받으면됨 - 제조소실사결과는캐나다보건부홈페이지에게재됨 http://www.healthycanadians.gc.ca/apps/gmp-bpf/index-en.html - Drug의경우실사주기는제조업자, 포장업자 / 라벨업자및실험실의경우 2년, 수입업자, 유통업자및도매업자의경우 3년임 https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforc ement/establishment-licences.html Health Canada Good Manufacturing Practices (GMP) Inspection List https://www.canada.ca/en/health-canada/services/inspecting-monitoring-drug-health-produ cts/drug-health-product-inspections.html 해외제조소실사관련 - 화장품에대해서는캐나다보건부에서국내제조소, 해외제조소모두거의실사를하지않는다고함 - 공무원인력이화장품에까지신경쓸정도로충분하지않기때문에화장품은제조소실사를거의하지않는것으로알고있으며, 제조소실사는 Natural Health Care products와 Drug에집중하고있음 - 21 - - 22 -
5 규정개정방향 < 캐나다의현행규제체계 : 퍼스널케어제품구분 > Self Care Products 규제개정 - Self-Care Products 는대략적으로아래와같은 3가지카테고리로구분됨 cosmetics natural health products (NHP) non-prescription drugs - 각각의카테고리는다른요건을준수해야함. non-prescription drugs의경우에는규제가생긴지약 50년정도되었으나, natural health products에대한새로운규제는 2004년에생김 - 자외선차단제같은 NHP의경우의약품 GMP 기준을따라야함 - 어떤내용을표시광고 (claim) 하느냐에따라화장품으로분류되기도하고, NHP로분류되기도하고, Drug로분류되기도함 샴푸를예로들자면 Cleans hair 라고표시광고한다면 화장품으로분류됨 Prevent flaking 라고표시광고한다면 NHP(Natural Health Product) 로분류됨 Controls dandruff 라고표시광고한다면 Drug로분류됨 치약, 구강청결제의경우에도마찬가지임 - 사실이로인해소비자는상당히혼란스러워함. ( 왜비슷해보이는제품이어떤것은화장품이고, 어떤것은 NHP이고, 어떤경우에는 Drug인가?) - 이러한이유로 Self Care Products 규제전면개정이있을예정임 Next steps on the self-care products initiative https://www.canada.ca/en/health-canada/services/self-care-framework.html - 규정개정을위해캐나다에서는수년간여러차례의공청회가진행되었으며, 2020년도에는 Self-Care Products 규정전면개정이있을것으로예상됨 - 23 - - 24 -
< 캐나다의현행규제체계 : 문제점 > <Self Care 제품규정개정방향 > - 25 - - 26 -
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