HSA | Regulatory overview of cosmetic products

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data-guid="ef526abe-209f-4f29-bb86-785b2df26818"> Listing of approvals and post-registration actions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/guidance-documents" data-guid="62872c1e-38a5-42f9-a2c8-a8a83702109b"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/fees" data-guid="1579b0f9-3040-487c-b455-9d1225222d98"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="246268ec-0756-45b3-bb95-b3c4a6da2846" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Health supplements</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/overview" data-guid="84b7033f-f384-49c1-9fad-6fce15c92285"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/vns" data-guid="7ec10a91-7ddf-4814-8b8f-1a0e8b12767f"> Voluntary Notification of HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/list-of-notified-health-supplements-and-traditional-medicines" data-guid="3cd877f0-bcc4-43b5-9908-9a514e8c844e"> List of Notified HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/claims" data-guid="a689b476-c59b-42ee-8be8-5935bafc7a00"> Health supplement claims </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/advertisements-and-promotions-of-medicinal-products" data-guid="7b38c6d6-debf-4912-a85b-7effbd0542d1"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/adverse-events-reporting-of-health-supplements" data-guid="d1d02256-9c76-4627-8061-7f0f2e96945c"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/international-collaboration-for-complementary-health-products" data-guid="44cb8d61-8291-4751-8aa5-4a5e4140e007"> International collaboration </a> </li> </ul> </div> <div data-label="9895f1ad-a865-4b50-89e5-98b27e3af020" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Traditional medicines</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/overview" data-guid="0271bb00-51f7-429b-9c70-6b0184385233"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/vns" data-guid="478b3953-40f7-43d2-84f0-f90f43d7b780"> Voluntary Notification of HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/list-of-notified-health-supplements-and-traditional-medicines" data-guid="de01dba9-e076-4233-81ed-3f3cb07476c4"> List of Notified HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/advertisements-and-promotions-of-medicinal-products" data-guid="6ab913a0-34c6-4c0e-98c4-575dfc1f56cf"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/report-adverse-events" data-guid="8f86ce68-926e-491f-ad7b-b1867f32353e"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/traditional-medicinal-materials" data-guid="d18617f7-d012-49c3-93b0-f297a10a4c78"> Traditional medicinal materials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/international-collaboration" data-guid="24d76262-844a-413d-a536-e3129d9e5122"> International collaboration </a> </li> </ul> </div> <div data-label="7680548f-411c-4b43-8fe7-4da5f27833c8" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Chinese proprietary medicines</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/overview" data-guid="cd89cf57-15f3-4d97-b828-84e95aff4990"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="dae1b05b-8161-4833-95a5-14b6eda06caf"> Product listing </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="17eb371c-7d1b-4ff8-8586-9190c021a006"> Dealer's licensing and certification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/export" data-guid="2bbcbc75-0270-469e-a292-a0036fc4d414"> Free Sale Certificate </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/advertisements-medicinal-products-tmm" data-guid="0a97d25a-e690-4971-92f6-32e0da1303cc"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/adverse-events" data-guid="96939874-b945-4831-92e2-d2134f573983"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/traditional-medicinal-materials" data-guid="257986ec-60d1-48bc-a72a-36362f874a4b"> Traditional medicinal materials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/international-collaboration-for-complementary-health-products" data-guid="f17d68c4-d044-43c9-915a-486f8f6c7c32"> International collaboration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/fees" data-guid="334e5c37-3e3f-400d-acfe-f7dbdf9df385"> Fees and Turnaround time of Chinese Proprietary Medicines </a> </li> </ul> </div> <div data-label="6fb37491-3203-4b13-a276-7bbef8b824a9" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Cosmetic products</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/overview" data-guid="bd161848-e281-4eb4-88eb-d50718fab34f"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="b6ca1f1f-75c5-4537-be36-0505ef1d1b42"> Cosmetic product notification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/asean-cosmetic-directive" data-guid="75199b88-06c7-4911-ade6-c0fae6b5beb1"> ASEAN Cosmetic Directive </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/good-manufacturing-practice" data-guid="41295286-4d99-4719-90a6-80e36db75b62"> Good Manufacturing Practice certification for cosmetic products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/report-adverse-events-of-cosmetic-products" data-guid="08ab8f6c-5867-4cde-8a64-29c2b44ee781"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/fees" data-guid="fe44fb88-0d08-4e8c-84cd-7dd749b82b1b"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="4617683f-c959-4829-b97a-b3cdb93ccb68" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco regulation</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/overview" data-guid="e9dbbf4f-2d76-4024-a8e8-31f55492d7b4"> Overview of tobacco control </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="25429b7c-80af-4fa8-bf40-70f62681eb5f"> Tobacco licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/suspended-revoked-licences" data-guid="dac2e9d7-81e1-4a0b-8322-bb68908885de"> List of suspended and revoked licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/report" data-guid="81d704aa-5059-46a4-97ac-1e2ed7577345"> Report tobacco-related offences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/fees" data-guid="cfd6e504-5352-4c4f-a428-21530c94e642"> Fees and turnaround time </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/tobacco-retailer-educational-video-and-quiz" data-guid="a910f388-93e3-4ba7-962b-3fee461fbc95"> Tobacco retailer educational video and quiz </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/vaping-enforcement" data-guid="6ac998c5-a57a-4820-b755-97d5a1a12702"> Vaping enforcement </a> </li> </ul> </div> <div data-label="979de975-13ac-4941-8c9c-1527e7dde9d3" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">CTGTP</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/regulatory-overview" data-guid="37e4cfd4-8234-40a4-9c7d-e81b349126b3"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/class1-notification" data-guid="b3c9c340-ad73-4183-a44a-d649ab1b5785"> Class 1 CTGTP notification </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="8bf23c04-8c49-4780-b303-542f375a2b39"> Register a Class 2 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/variation" data-guid="9a0f3708-b4df-4965-a393-603cb816fbe3"> Variation applications </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-notice" data-guid="584b3b0a-e144-49e2-975b-079e228e6c8d"> Dealer's notice </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f1513b1d-d5e5-4eb6-aa96-ff39b5c36981"> Dealer's licensing and certification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/rmp" data-guid="751614d8-2439-42e2-af1e-cf1c4317b485"> Risk management plan requirements </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/adverse-events" data-guid="be485ef9-c825-45dc-83d6-ba0d7b0824f8"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/defect-and-recalls" data-guid="49abb8dc-d30b-4a8b-9413-5cb6abd35447"> Report or recall defective products </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="0baf57d7-e63c-4c85-b702-a326bda7a2c4"> Clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/product-consultation" data-guid="f583337c-a42b-4305-a0a1-0a4a925ecfcb"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/advertisements" data-guid="d191cdf2-3199-4595-938d-cc13590e89c0"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/cpp" data-guid="adaa0f41-df0b-4b7f-9eb2-6f7fc35c513e"> Certificate of a Pharmaceutical Product </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/duties-and-obligations" data-guid="bc235ae3-678e-4ae8-a40b-74d2e9bb8fc7"> Duties And Obligations </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/guidance-documents" data-guid="c6ee0f87-ea10-46ce-b7e4-c624336c1a70"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/fees-and-TAT" data-guid="b62d4bbb-97e6-403a-bd29-9ab4b83a94b1"> Fees and turnaround time </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/notified-ctgtp" data-guid="92827969-ea7a-4e98-8c47-7ebe73ff323f"> Notified Class 1 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/ctgtp-register" data-guid="0146ad7a-a482-4a40-9e06-ac39f3ab4e62"> Register of Class 2 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/register-of-cell-tissue-or-gene-therapy-products-licensees" data-guid="face7927-ccdd-4a6a-85a0-212dba24d693"> Register of Licensed CTGTP Importers, Wholesalers and Manufacturers </a> </li> </ul> </div> <div data-label="09c13846-b094-41b6-94ef-724cbfda293a" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Bringing personal medications into Singapore</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/personal-medication/overview" data-guid="ef3465c3-1f30-4ff7-8cf0-1783ac3266b0"> Regulations for bringing in personal medications </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/personal-medication/check-requirements" data-guid="5ae34c46-f9c8-475f-871d-fcd85e3e8460"> Check medication requirements </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/personal-medication/submit-application-for-approval-to-bring-in-personal-medications-(new)" data-guid="65a1f011-4fc7-4b84-8e1f-7863289bf53b"> Submit application for approval to bring in personal medication </a> </li> </ul> </div> <div data-label="0b00adf2-a40d-4ea3-bc12-b0aaf14c0ab5" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Active ingredients</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/regulatory-overview" data-guid="dcb8d11f-bba3-4ff4-bfb3-981179948c72"> Regulatory Overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f9b17351-9e31-4cbe-9368-89990285d3ab"> Licensing and certification of importers and wholesalers </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="3115698c-9584-4b2a-980e-61f2f1ddce20"> Licensing and certification of manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/certificate-of-a-pharmaceutical-product" data-guid="f04be9be-c430-420a-ac52-f0305b04671c"> Certificate of a Pharmaceutical Product </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/requirements-for-active-ingredients-notification" data-guid="a48c2a91-e94f-461e-b488-154280aa1155"> Active ingredients used in Clinical Research/Clinical Trial </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/guidance-documents" data-guid="9822345f-a5dc-463f-ad36-02059ab63caa"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/fees-and-turnaround-time" data-guid="98f5142a-bfed-475e-9e1e-eeacae915249"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="3864b786-c4b7-4761-93f5-8f0738454fc0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Clinical trials</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/overview" data-guid="e06cd0df-ef61-43ec-9d14-4d516cfbc560"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="8c5c2c4d-0e40-4323-a87e-b4a3f03a4c2b"> CTA, CTN or CTC submissions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/crm-notification" data-guid="4cd0dc10-3e32-4dd6-8566-eebb43a02b40"> Submit a CRM notification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/good-clinical-practice" data-guid="6eda14e6-f44e-4eb5-9a9f-7946ec0df452"> Good Clinical Practice Inspections </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/adverse-events" data-guid="9d1d8955-7769-4a88-ae31-f21375fc837d"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/innovation-office" data-guid="a970778f-fe31-451c-8bb4-11be032be3d1"> Innovation Office </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="525bb14a-8f6c-4ea3-920d-8126125f5443"> Conducting clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/participating" data-guid="d8ddf9e6-4343-49ed-8bb7-322d59f9df25"> Participating in clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/regulatory-guidances" data-guid="43b28bbc-936f-4bab-8b59-cab37069b687"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/clinical-trials-register" data-guid="b5fb8906-c682-4bda-839a-9043ec9e3a72"> Clinical Trials Register </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/statistics" data-guid="47ae6c12-8e21-4b6c-9632-2a9ec584dea7"> Clinical trials statistics </a> </li> </ul> </div> <div data-label="bddf8db1-ce0e-497d-ae77-857efec4566e" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Controlled drugs and psychotropic substances</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="2dfb1261-9d74-487f-b59a-8f0c75330def"> Controlled drugs </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/psychotropic-substances" data-guid="9368ffd0-861d-42af-a664-3128948d061c"> Psychotropic substances </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/restricted-substances" data-guid="3b4abff4-06ed-4895-8031-b263d2d1f16a"> Restricted substances </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/fees" data-guid="8f70fe0f-d8f7-4565-9dcc-acec2ff00efd"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="e5c77d76-09c8-40ba-ae32-8960fd5212a7" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Poisons</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/overview" data-guid="0a0b16ae-b87a-464e-afbc-6318a4d0078e"> Overview of Form A Poisons Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/apply" data-guid="eb91b4aa-a3f3-4535-a294-1006eb31b074"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/amend" data-guid="0e4a341a-ee1c-4dfa-9079-0d8fb2835567"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/renew" data-guid="bc36d7bb-a0fe-4558-969f-a56a849c1d30"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/fees" data-guid="fe3dc090-03e8-4b05-88ee-47aa717da9b9"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="de6b77c3-03f4-4b75-8f1a-fe28c36f7fd0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Topical antiseptics</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/topical-antiseptics/overview" data-guid="b0bda773-e4cd-43d6-801c-5910a6addc0d"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/topical-antiseptics/classification" data-guid="c957249f-9b1c-4e2a-b196-d791b90fc6a0"> Topical antiseptics classification guide </a> </li> </ul> </div> <div data-label="1b050871-6f13-424b-9169-c5f607c45b70" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">COVID-19 regulatory information and consumer advisories</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/covid-19-information-and-advisories/hsa_review_swiss_study" data-guid="fb1a705c-f655-472e-8732-eba57bedd7c6"> HSA's review of Swiss study </a> </li> </ul> </div> <div data-label="5dab3d87-61e1-4634-8e84-6de88ede8ef0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">E-services</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/e-services/eGIRO" data-guid="720bfe3e-013c-4a09-9e08-75de89fb0f39"> eGIRO </a> </li> </ul> </div> <div data-label="bd4d47da-3264-48f7-b788-f7ec3192566a" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Consumer safety</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="a42d2730-7835-4ae5-bf0e-f23171a903e5"> Articles </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/consumer-safety/make-a-report" data-guid="37e114c1-1313-478a-9456-ddf438abf2a3"> Make a report </a> </li> </ul> </div> <div data-label="47b22a70-25fc-4858-a0c6-5808f105461d" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Why join HSA</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/apply" data-guid="826776c8-7652-4790-8a89-486de533b723"> Apply for a job </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/sponsorship-for-diploma-in-nursing" data-guid="b43bd040-0e61-498c-b9a9-7f4200475fcb"> Sponsorship for Diploma in Nursing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/benefits" data-guid="98fda3e9-d25c-4052-b385-b35110b6f3a3"> Employment benefits </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="adfe758d-5941-4ea6-baf1-69fa38b2a74e"> Articles </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/forensic-odontology-scholarship" data-guid="a3e7ab3f-c4cd-46a2-b1ab-89188e470964"> Forensic Odontology Scholarship </a> </li> </ul> </div> </div> <div class="hsa-header__sidebar__extender__column-2"> <div data-label="7ede8f61-ff1c-4c69-a6a4-df1fd414c539" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Register your device</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/overview" data-guid="4a0a9bfd-e83f-4cac-ab82-30f548c7dfa0"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/is-it-a-medical-device" data-guid="0ddfe170-9c1e-44fc-8827-7c8a73854b0a"> Is it a medical device <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/risk-classification-rule" data-guid="f4fac194-4032-4e22-9ddc-5a0e214e4619"> Risk classification rules and factors </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/risk-classification" data-guid="2e0cc6ab-f76d-4b71-a4a9-3ab6b1fd473a"> Risk classification tool <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/requirements" data-guid="b9c4171b-7fb0-4b77-a8c8-d2479ec34896"> Registration and licensing requirements <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/identifying-md-grouping" data-guid="9dc2b5a8-f5fe-4cd2-80b1-a0af4a75a057"> Medical device grouping tool <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="4ab762eb-155b-466b-8a25-82bd36c8a446"> Grouping medical devices </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f2dbc2a3-5dd0-48e9-8050-6eefb4934da4"> Registration guides </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/priority-review-scheme" data-guid="aefddcf5-7ca3-43fc-b6c7-e7783239225d"> Priority Review Scheme </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="04b8be8f-e147-47dd-89b7-56c00dd52cdc"> Special Access Routes </a> </li> </ul> </div> <div data-label="30939644-bd18-43b4-b6d1-de9a663ccdb4" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licence</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/apply" data-guid="471507f9-e42c-4931-a6e0-40b8fc7e39a6"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/amend-licence" data-guid="60791d45-21e2-4661-b9bd-a9c144e51de3"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/renew" data-guid="cafdc875-fc28-4b2d-bec3-eefb3cae23e4"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/good-distribution-practice" data-guid="570127a0-ec1a-4c01-8691-5c70cea0234e"> Good Distribution Practice for Medical Devices </a> </li> </ul> </div> <div data-label="668d06f0-a4bb-4de1-8caf-df59aed1ed04" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Field Safety Corrective Action reporting</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/field-safety-corrective-action/when-to-report" data-guid="d24d93f8-8fb7-4b96-a2ca-7b5b777fe053"> When to report </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/field-safety-corrective-action/how-to-report" data-guid="0db2317b-2b8e-47dd-8930-dbbd185b03ab"> How to report </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/field-safety-corrective-action/corrective-actions" data-guid="f5468317-a7b2-4680-9177-0a6e01b7aa7d"> Risk management </a> </li> </ul> </div> <div data-label="27da00ef-00ec-4790-9d18-6916d678ecfd" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">International collaboration</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/international-collaboration-medical-devices/imdrf" data-guid="b0404985-fb75-4ba2-9984-890a03321340"> International Medical Device Regulators Forum (IMDRF) </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/international-collaboration-medical-devices/amdc" data-guid="d61db71a-7a93-46ad-a667-9fcfe7566a68"> ASEAN Medical Device Committee (AMDC) </a> </li> </ul> </div> <div data-label="1bb793b7-6ebc-4614-ab26-f3486e8d47b8" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Register your product</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="87e8659d-45a2-40d7-9189-993d38a0633c"> Registration overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="e10dc8cc-ed64-45f7-b36b-4a3cde564f61"> Registration guides for therapeutic products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/rmp" data-guid="7dd5cd91-7696-4034-9093-a95c3107c759"> RMP submission for product registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/ectd-submissions" data-guid="7b957570-e4b0-4284-8943-8d8071370815"> eCTD submissions for Therapeutic Products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/summary-reports-of-benefit-risk-assessment" data-guid="187939d4-5a68-4657-a077-e9d00bc5f99c"> Summary Reports of Benefit-Risk Assessment </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="6e925ab4-a2e4-4933-8edc-d51e50dafe86"> Special Access Routes (SAR) </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/gmp-conformity-assessment" data-guid="171464e4-b6af-4d89-a1b6-c091f73f04a6"> GMP conformity assessment of overseas manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/vaccine-lot-release" data-guid="a7da8b5f-b675-48ea-ae81-fe833f29c17a"> Lot release for imported vaccines </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/pre-submission-consultation-mechanisms" data-guid="d566e8c5-3a97-48bd-8d98-03674add1d28"> Pre-submission Consultation Mechanisms </a> </li> </ul> </div> <div data-label="382c3665-f125-4dbd-aa45-33855a4edecc" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Apply for post-approval variation</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/overview" data-guid="7740ca55-114c-40cc-b6b3-e0c70fe2a1fd"> Overview of variation application types </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="81f2aeb5-71fc-4437-bcbe-363566451aa3"> Major variation (MAV-1) application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/major-variation-(mav-2)-application" data-guid="6125cd60-e055-4946-a956-da4ee2b4002c"> Major variation (MAV-2) application </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="2309de76-0cee-4377-bc01-65f576892d9d"> Minor variation (MIV) application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/miv-tool" data-guid="4e9c7bc2-7929-421d-a639-ac4254fdc3b2"> Minor variation (MIV) self-guided tool </a> </li> </ul> </div> <div data-label="c7d36f32-24f2-4341-852f-879820bd2f95" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Reclassify your product</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/reclassification/apply" data-guid="e17c9ffe-34d9-4e3d-9b76-f8928b998559"> Apply for reclassification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/reclassification/gsl-preparations" data-guid="d0881b89-7e49-44cc-abbd-9c82ff224ce0"> Preparations allowed as General Sale List </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/reclassification/list-of-reclassified-medicines" data-guid="3f4cdc7d-b9d6-44c4-baae-30ef723ff6c7"> List of reclassified medicines </a> </li> </ul> </div> <div data-label="610292f3-004d-4e6e-8995-c25be4a1273b" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licensing and certification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/overview" data-guid="ff94a8de-0f52-4326-a3d0-904f94453385"> Overview of dealer's licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/apply" data-guid="acb36be4-f93e-43f3-9319-70da968ad961"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/amend" data-guid="899be1f3-552e-4269-99fe-a7615d0e9716"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/renew-cancel" data-guid="b093e7ef-4fe0-46e5-bcff-0f8c85b4e22a"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/gmp-gdp" data-guid="1a2c9571-60d0-4865-8bf1-46344bccb039"> Good Manufacturing Practice and Good Distribution Practice Standards </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="32be46d4-2acb-4aef-8f28-ebb7fb04cd48"> Certification of local dealers </a> </li> </ul> </div> <div data-label="25fc1ebe-32a2-4170-ae07-309d697d35e5" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Retail pharmacy licensing</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/overview" data-guid="846633be-094f-4199-b920-c6531091efc8"> Overview of pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/apply" data-guid="f245d777-06aa-4348-a351-b85487c9ce55"> Apply for a pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/amend" data-guid="1584bcc1-9336-4aa3-961a-d1c3f0032337"> Amend a pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/renew" data-guid="0353546c-97e6-4d66-85c5-fe1e53963535"> Renew or cancel a pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/compounding" data-guid="60098304-7263-4df6-a7c5-174b08dd82c0"> Compounding of therapeutic products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/medicines-vending-machine" data-guid="7f972414-5cef-49a6-a1fd-f7ed0e4af21c"> Supply of medicines via vending machine </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/supply-of-registered-therapeutic-products-through-e-pharmacy" data-guid="828f1524-09e6-4ff9-ac6e-b088ec682eb6"> Supply of registered therapeutic products through e-pharmacy </a> </li> </ul> </div> <div data-label="efa56797-fabe-4d38-810f-4cd825fa6486" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Clinical trials </span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/regulatory-overview" data-guid="e001496c-1ac0-48b7-ac9a-0a31e6d8b278"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/new-cta-or-ctn-submission" data-guid="11ae3c13-c8d9-4466-9994-18c749d46398"> New CTA or CTN submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/subsequent-submissions" data-guid="4d2246bc-01b6-4141-91e0-33d1223c966c"> Subsequent submissions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/good-clinical-practice-inspections" data-guid="553ade66-b060-42dc-baa9-56144a172d44"> Good Clinical Practice Inspections </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/report-adverse-events" data-guid="af55b5df-88f7-4678-809f-23f4c2929fa2"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/product-development-consultation-tp" data-guid="27d291f9-ebf1-4608-8fa6-713085708fa4"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/conducting-clinical-trials" data-guid="fc3b622a-e44c-46d3-a383-a1018014ee3f"> Conducting clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/clinical-trials-register" data-guid="15ea591f-c5e0-4227-9b65-60994fc1f227"> Clinical Trials Register </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/clinical-trials-statistics" data-guid="23cf3a53-6367-4294-b3b8-a0421d0c845f"> Clinical trials statistics </a> </li> </ul> </div> <div data-label="c28d32cb-4d78-48ec-bb2a-e42249225222" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">CPP and SLS</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/cpp-sls/certificate-pharmaceutical-product" data-guid="4c2bb65e-ba3d-494c-9146-a1af2bf5a198"> Certificate of a Pharmaceutical Product </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/cpp-sls/statement-of-licensing-status" data-guid="38b573be-688f-4201-bae1-05c3242f820f"> Statement of Licensing Status </a> </li> </ul> </div> <div data-label="669e5508-668c-45fb-b768-d34e6d5fef95" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">International collaboration</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/access" data-guid="cd88ddb0-067d-40e3-a481-170f88c6562d"> Access Consortium </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/project-orbis" data-guid="13772e92-b28e-436c-839f-f09eb40b5550"> Project Orbis </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/ich" data-guid="6fcd302f-db44-4cd2-97d7-6bd73026c319"> ICH </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/icmra" data-guid="7f94f1c1-c820-47d8-859f-4167caf86943"> ICMRA </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/ASEAN-JA" data-guid="599f42c0-3f96-4fd7-8573-2c4c888d90b1"> ASEAN Joint Assessment Procedure </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/npra" data-guid="42edfb18-8f08-4681-8c21-0883fdae9267"> NPRA </a> </li> </ul> </div> <div data-label="9abfc5d0-f746-49d7-8c7e-f71d93c182a9" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Medicines quality and compliance monitoring</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="05c2a122-d4f6-4009-9b51-f2586b1974b7"> Nitrosamine impurities in medicines </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/product-quality-surveillance-for-therapeutic-products" data-guid="5a600c68-25b2-4b36-884b-ac611a8fb77d"> Product Quality Surveillance for therapeutic products </a> </li> </ul> </div> <div data-label="dae1b05b-8161-4833-95a5-14b6eda06caf" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Product listing</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/apply" data-guid="d3dc33cb-72b6-455b-a4cc-bafecf04b9b4"> Apply for new product listing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/amend-or-cancel-product-listing" data-guid="8bf219a3-a0c3-4fa6-8e60-ac51232d435c"> Amend or cancel product listing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/transfer" data-guid="39b0a3ca-c3a5-4024-abd2-36f934846e6e"> Transfer product listing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/responsibilities" data-guid="b72ec571-5f19-455c-b014-d2328677ebb7"> Responsibilities of a CPM dealer </a> </li> </ul> </div> <div data-label="17eb371c-7d1b-4ff8-8586-9190c021a006" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licensing and certification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/overview" data-guid="704fcd23-901e-42a2-86ab-b176e7424c86"> Overview of dealer's licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/apply" data-guid="8aa5c9d5-196a-40ee-8690-59b98a73ec58"> Apply for a Chinese Proprietary Medicine dealer's licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/amend" data-guid="eda2ba95-18d7-4d9e-94ea-44c92daadadf"> Amend a Chinese Proprietary Medicine dealer's licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/renew" data-guid="0f88825d-0b84-474c-8644-15b3717b89e2"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/gmp-gdp-standards" data-guid="44f1fe10-f257-442c-bf08-95ad59209e4d"> Good Manufacturing Practice and Good Distribution Practice Standards </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="ebc90580-c276-42ef-981f-bddebc7d94ba"> Certification of local dealers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/import-reexport" data-guid="7a0c8192-a52e-4086-80d3-e38c482c5e3b"> Import for re-export of Chinese Proprietary Medicines </a> </li> </ul> </div> <div data-label="b6ca1f1f-75c5-4537-be36-0505ef1d1b42" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Cosmetic product notification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/notification/submit" data-guid="9ad25a41-d9b6-4fc5-8810-f64f01981dd6"> Submit notification and re-notification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/notification/amend" data-guid="2294cf3e-6181-44f9-a240-0f16af284bba"> Update or cancel notification </a> </li> </ul> </div> <div data-label="25429b7c-80af-4fa8-bf40-70f62681eb5f" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco licences</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="87ce5044-4900-4e2f-9bd0-9cd5157bbbc0"> Tobacco retail licence </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="62df10a0-59ba-444c-b39d-95df004b8e57"> Tobacco import and wholesale licence </a> </li> </ul> </div> <div data-label="8bf23c04-8c49-4780-b303-542f375a2b39" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Register a Class 2 CTGTP</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="e920cf5a-92be-4b4a-8511-94e6d69e67e6"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/gmp-comformity-assessment" data-guid="2781f73d-34ef-415d-b7df-4b427e017ace"> GMP conformity assessment of overseas manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/rmp" data-guid="4a3724cf-da51-4f02-8c3e-0c66e3880d1e"> RMP submission for product registration </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="68687f1e-54ec-4c56-97ca-8a69652bc5ca"> Special Access Routes (SAR) </a> </li> </ul> </div> <div data-label="f1513b1d-d5e5-4eb6-aa96-ff39b5c36981" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licensing and certification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/overview" data-guid="18185124-e2e4-4893-bc2d-24833390b73e"> Overview of dealer's licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/apply-licence" data-guid="467e86a7-6b65-4533-afe7-7bb2b6b6acf0"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/amend-licence" data-guid="bdc29b3b-28f0-4091-a3c7-e63b64d73625"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/renew-cancel-licence" data-guid="822e134d-17ba-4951-bb33-0420ca35d99b"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/gmp-gdp-standards" data-guid="04c2d289-a719-4cad-bffb-5eaac0928778"> Good Manufacturing Practice and Good Distribution Practice Standards </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f3731991-e630-4cde-85f6-a2b5a92caffd"> Certification of local dealers </a> </li> </ul> </div> <div data-label="0baf57d7-e63c-4c85-b702-a326bda7a2c4" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Clinical trials </span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/overview" data-guid="0531ad74-2289-4cea-a184-7a689f6d8671"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/apply-cta-ctn" data-guid="2d3c83f8-19ec-4568-9724-287712bced88"> New CTA or CTN submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/subsequent-submissions" data-guid="31160422-8263-4e27-bf3d-1defbd279d5d"> Subsequent submissions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/good-clinical-practice" data-guid="e3acb007-da0a-4179-be0b-34ef4e45a0db"> Good Clinical Practice Inspections </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/adverse-events" data-guid="f58f6596-9749-417f-8bce-58b3cecf0c27"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/innovation-office" data-guid="9fb4cc8b-4401-4cf5-99a9-72dec47ed6c1"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/conducting" data-guid="cbc80f0e-71aa-4edb-8b75-8dbe089eccdd"> Conducting clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/clinical-trials-register" data-guid="223ce50c-7b0e-4b00-a1d2-69ec9fb45bad"> Clinical Trials Register </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/statistics" data-guid="abe53f4d-bee9-45c6-aaaf-a596773a5bd1"> Clinical trials statistics </a> </li> </ul> </div> <div data-label="f9b17351-9e31-4cbe-9368-89990285d3ab" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Licensing and certification of importers and wholesalers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/overview" data-guid="af581c62-35ff-4a88-aa2d-410310050739"> Overview of Importer's and Wholesaler's Licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/apply-licence" data-guid="f9204d51-b719-4cfa-b572-091a60a75d78"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/amend-licence" data-guid="c4fdf9a4-20de-40bf-9e9a-1359f42092c5"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/renew-or-cancel-licence" data-guid="17fb6e80-e86c-428a-8109-4dcb153d751e"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/gdp-standards" data-guid="e2576b18-4901-4a7a-825d-932ec7a782b8"> Good Distribution Practice Standards </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/gdp-certification" data-guid="01c2a80e-143d-450e-a8e0-c14c4c20c76b"> Good Distribution Practice certification </a> </li> </ul> </div> <div data-label="3115698c-9584-4b2a-980e-61f2f1ddce20" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Licensing and certification of manufacturers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/overview" data-guid="d145ce20-5d5c-4bad-8a8e-b9257abbcb24"> Overview of Manufacturer's Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/apply-licence" data-guid="706e3708-bef4-4e46-87e6-360c7e1e79b4"> Apply for a Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/amend-licence" data-guid="3cb8cda8-4999-4003-9679-3875e8f8faeb"> Amend a Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/renew-or-cancel-licence" data-guid="9d235845-a7a7-4e8e-a7f8-1d7e5819b4b4"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/gmp-certificate" data-guid="411905ea-c379-472b-b78d-5135499a0340"> Good Manufacturing Practice Certificate </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/inspection-of-manufacturers" data-guid="e98d79ba-d283-4e7e-8d0e-5a74e2150e6f"> Inspection of Manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/responsibilities" data-guid="719a6af7-8c3c-4024-9dde-565b1774865d"> Responsibilities of Manufacturers </a> </li> </ul> </div> <div data-label="8c5c2c4d-0e40-4323-a87e-b4a3f03a4c2b" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">CTA, CTN or CTC submissions</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/application/apply-cta-ctn" data-guid="fd5a5cb0-e976-4737-8156-e4d7d89625c0"> New CTA or CTN submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/application/apply-ctc" data-guid="d881faa6-50b3-4e9a-b49f-c7e836f31927"> New CTC submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/application/subsequent-submissions" data-guid="8606a110-ffa7-48fd-b396-cee1a8c927f3"> Subsequent submissions </a> </li> </ul> </div> <div data-label="525bb14a-8f6c-4ea3-920d-8126125f5443" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Conducting clinical trials</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/principal-investigator" data-guid="09039b0a-e3c4-42c6-a479-256852c976f8"> Principal investigator </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/sponsor" data-guid="96af64b8-f78f-41a7-af9f-ebbeb3745c36"> Sponsor </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/informed-consent" data-guid="c32e93ea-aee8-4d3b-a7fb-7ddd1a03777d"> Informed consent </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/investigational-auxiliary-products" data-guid="d685bdff-7ee3-4fe3-9c5f-5e3da68cab65"> Investigational and auxiliary products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/investigator-site-file" data-guid="7d157444-ca14-4c71-9e7c-a70d6cfb25f6"> Investigator Site File </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/template-forms" data-guid="b86a54e6-d735-4935-9fd8-b5ec9c396afc"> Template forms </a> </li> </ul> </div> <div data-label="2dfb1261-9d74-487f-b59a-8f0c75330def" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Controlled drugs</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/controlled-drugs/apply" data-guid="09b0b42f-bb0e-4b88-87da-6217c20c9d79"> Apply for a controlled drugs licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/controlled-drugs/amend" data-guid="80363e35-b7c8-4fdd-89e5-1083b6cf44db"> Amend licence to wholesale or manufacture controlled drugs </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/controlled-drugs/renew" data-guid="b24dea71-b089-4f92-9965-b7267a6aeaa9"> Renew or cancel a licence </a> </li> </ul> </div> <div data-label="a42d2730-7835-4ae5-bf0e-f23171a903e5" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Articles</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/consumer-safety/articles/details" data-guid="af2478a5-7fc1-470a-b80f-e1d62b156a71"> Details </a> </li> </ul> </div> <div data-label="adfe758d-5941-4ea6-baf1-69fa38b2a74e" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Articles</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/articles/details" data-guid="48176b72-3c3b-4b1d-9889-363953f7e2da"> Details </a> </li> </ul> </div> </div> <div class="hsa-header__sidebar__extender__column-3"> <div data-label="4ab762eb-155b-466b-8a25-82bd36c8a446" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Grouping medical devices</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/dental-grouping-terms"> Dental Grouping Terms (DGT) </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/hearing-aids"> Hearing aids </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ihc-ivd"> Immunohistochemistry (IHC) IVD reagents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/fish-probes-ivd"> Fluorescence in situ hybridisation (FISH) probes IVD </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivd-analysers"> IVD analysers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivf-media"> In vitro fertilisation (IVF) media </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/family"> Family </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/system"> System </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/group"> Group </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/single"> Single </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivd-test-kit"> IVD Test Kit </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivd-cluster"> IVD cluster </a> </li> </ul> </div> <div data-label="f2dbc2a3-5dd0-48e9-8050-6eefb4934da4" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration guides</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-b-full-registration"> Class B full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-b-abridged-registration"> Class B abridged registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-b-immediate-registration"> Class B immediate registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-full-registration"> Class C full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-abridged-registration"> Class C abridged registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-expedited-registration"> Class C expedited registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-immediate-registration"> Class C immediate registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-full-registration"> Class D full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-abridged-registration"> Class D abridged registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-expedited-registration"> Class D expedited registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-medicinal-products-full-registration"> Class D with a registrable drug in a secondary role full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-medicinal-products-abridged-registration"> Class D with registrable drug in secondary role abridged registration </a> </li> </ul> </div> <div data-label="04b8be8f-e147-47dd-89b7-56c00dd52cdc" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Special Access Routes</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/export"> Import for re-export of unregistered devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/non-clinical-purpose"> Unregistered devices for non-clinical purposes </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/consignment-registered"> Registered medical devices on consignment basis </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/qualified-practitioner-request"> Unregistered devices requested by qualified practitioners </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/phmc-request"> Unregistered devices requested by licensed healthcare facility </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/custom-made-devices"> Custom-made medical devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/import-unregistered-devices-exhibition"> Import of unregistered medical devices for exhibition </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/import-of-unregistered-pre-owned-devices-returned-from-maintenance-repair"> Import of unregistered pre-owned devices from maintenance/repair </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/PSAR-MD"> PSAR for Supply of Emergency Medical Devices </a> </li> </ul> </div> <div data-label="87e8659d-45a2-40d7-9189-993d38a0633c" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration overview</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/overview"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/application-types"> Application types </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/evaluation-routes"> Evaluation Routes </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/application-dossier"> Application dossier </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/screening-evaluation"> Screening and evaluation stages </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/retain-cancel-transfer"> Retain, cancel or transfer registrations </a> </li> </ul> </div> <div data-label="e10dc8cc-ed64-45f7-b36b-4a3cde564f61" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration guides for therapeutic products</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/new-drug"> New drug application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/generic-drug"> Generic drug application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/biosimilar-products"> Biosimilar product application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/drug-master-file"> Submission of Drug Master File </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/plasma-master-file"> Submission of Plasma Master File </a> </li> </ul> </div> <div data-label="6e925ab4-a2e4-4933-8edc-d51e50dafe86" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Special Access Routes (SAR)</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/import-for-patients"> Import and supply of unregistered TP for patient's use </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/consignment-registered"> Import and supply of registered drug on consignment basis </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/special-consignment-by-a-product-registrant"> Special consignment by a product registrant </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/psar-emergency-therapeutic-product"> Pandemic Special Access Route for Supply of Emergency TP </a> </li> </ul> </div> <div data-label="81f2aeb5-71fc-4437-bcbe-363566451aa3" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Major variation (MAV-1) application</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/overview"> Overview of MAV-1 application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/full-evaluation"> Full evaluation route for MAV-1 application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/abridged-evaluation"> Abridged evaluation route for MAV-1 application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/verification-evaluation"> Verification evaluation route for MAV-1 application </a> </li> </ul> </div> <div data-label="2309de76-0cee-4377-bc01-65f576892d9d" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Minor variation (MIV) application </span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/miv/overview"> Overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/miv/submission"> Submit MIV applications </a> </li> </ul> </div> <div data-label="32be46d4-2acb-4aef-8f28-ebb7fb04cd48" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Certification of local dealers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/certificates/gmp-certificate"> Good Manufacturing Practice certificate for local manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/certificates/gdp-certificate"> Good Distribution Practice certificate for local dealers </a> </li> </ul> </div> <div data-label="05c2a122-d4f6-4009-9b51-f2586b1974b7" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Nitrosamine impurities in medicines</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/list-of-impacted-medicines"> List of impacted medicines </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/guidance-for-product-registrants"> Guidance for product registrants </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/test-methods"> Test methods </a> </li> </ul> </div> <div data-label="ebc90580-c276-42ef-981f-bddebc7d94ba" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Certification of local dealers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/certification-of-local-manufacturers/gmp-certificate"> Good Manufacturing Practice certificate for local manufacturers </a> </li> </ul> </div> <div data-label="87ce5044-4900-4e2f-9bd0-9cd5157bbbc0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco retail licence</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/apply"> Apply for a tobacco retail licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/amend"> Amend tobacco retail licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/renew"> Renew tobacco retail licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/cancel"> Cancel tobacco retail licence </a> </li> </ul> </div> <div data-label="62df10a0-59ba-444c-b39d-95df004b8e57" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco import and wholesale licence</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/apply"> Apply for tobacco import and wholesale licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/amend"> Amend tobacco import and wholesale licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/renew"> Renew tobacco import and wholesale licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/cancel"> Cancel tobacco import and wholesale licence </a> </li> </ul> </div> <div data-label="e920cf5a-92be-4b4a-8511-94e6d69e67e6" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration overview</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/overview"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/application"> Application submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/pmc"> Pre-market consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/screening-evaluation-rd"> Screening, evaluation and regulatory decision </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/retain-cancel-transfer"> Retain, cancel or transfer registrations </a> </li> </ul> </div> <div data-label="68687f1e-54ec-4c56-97ca-8a69652bc5ca" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Special Access Routes (SAR)</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/sar/unregistered-CTGTP"> Import and supply of unregistered Class 2 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/sar/registered-ctgtp-on-consignment-basis"> Import and supply of CTGTP on consignment basis </a> </li> </ul> </div> <div data-label="f3731991-e630-4cde-85f6-a2b5a92caffd" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Certification of local dealers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/certification/gmp-certification"> Good Manufacturing Practice certificate for local manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/certification/gdp-certification"> Good Distribution Practice certificate for local dealers </a> </li> </ul> </div> </div> </div> </aside> <div class="hsa-header__overlay"></div> </header> <nav class="hsa-nav"> <div class="hsa-nav__navbar"> <button class="hsa-nav__menu-btn" type="button" aria-controls="navigation-sidebar" aria-label="sidebar_menu-btn"> <span class="hsa-hamburgers m-r:xs"><span class="hsa-hamburgers__lines"></span> </span> <span class="hsa-nav__menu-btn__text">Browse</span> </button> <div class="hsa-breadcrumbs m:0"> <ol> <li><a href="/">Home </a></li> <li><a href="/cosmetic-products">Cosmetic products </a></li> </ol> <div class="hsa-breadcrumbs__crumb-dropdown"> <ul> </ul> </div> </div> <button class="hsa-font-decrease ldsk(d:n)" type="button"><span class="hsa-glyphs--Aminus"></span> <span class="fz:0">Decrease font size</span></button> <button class="hsa-font-increase ldsk(d:n)" type="button"><span class="hsa-glyphs--Aplus"></span> <span class="fz:0">Increase font size</span></button> <button class="hsa-nav__search-btn" type="button" aria-label="search-btn"><span class="hsa-glyphs--search"></span> <span class="hsa-nav__search-btn__text">Search</span></button> <button class="hsa-nav__back-btn" type="button"><span class="hsa-glyphs--chevron-left"></span> <span class="hsa-nav__back-btn__text">Back</span></button> </div> </nav> <main id="content" class="flg:1 bgc:grey-6 z:1" role="main"> <div class="container p-t:4xl p-b:4xl"> <div class="g:12"> <div class="gcol:12 dsk(gcol:8) ord:1"> <div id="main_TB6F372E3007_Col00" class="sf_colsIn" data-sf-element="title" data-placeholder-label="title"> <h1>Regulatory overview of cosmetic products</h1> <p class="hsa-text--summary">Understand the regulatory requirements for cosmetic products, and find out how to submit a product notification before supplying the product in Singapore.</p> </div> <div id="main_TB6F372E3007_Col01" class="sf_colsIn" data-sf-element="content" data-placeholder-label="content"> <div > <div ><h2>What is a cosmetic product</h2> <p>A cosmetic product is defined as any substance or preparation that is intended to be placed in contact with the external parts of the human body, such as the skin, hair, nails, lips or mouth (including gums, teeth and tongue), for the purpose of:</p> <ul> <li>Cleaning them</li> <li>Perfuming them</li> <li>Changing their appearance</li> <li>Correcting body odours</li> <li>Protecting them</li> <li>Keeping them in good condition</li> </ul> <p>Cosmetic products are not:</p> <ul> <li>Injections and eye-drops.</li> <li>Products that are consumed orally, such as tablets, capsules or beverages.</li> <li>Products that are intended for treatment, such as acne treatment creams.</li> </ul></div> </div> <div > <div ><p> <div class="hsa-crosslink"><span class="hsa-text--h3">Still not sure?</span><br /> Refer to our classification guide if you are still unsure of whether your product falls under our cosmetic product category. <a class="hsa-btn size--medium type--primary" href="/cosmetic-products/overview/classification" target="" rel="noopener">Check now</a> </div></p></div> </div> <div > <div ><h2>Cosmetic products regulatory requirements</h2> <p>Cosmetic products supplied in Singapore must comply with the requirements under the <a href="https://sso.agc.gov.sg/Act/HPA2007" data-sf-ec-immutable="">Health Products Act</a> and its <a href="https://sso.agc.gov.sg/SL/HPA2007-S683-2007/" data-sf-ec-immutable="">Health Products (Cosmetic Products - ASEAN Cosmetic Directive) Regulations 2007 (the Regulations).</a></p> <p>The Regulations are in line with the <a target="_blank" href="/cosmetic-products/asean-cosmetic-directive">ASEAN Cosmetic Directive (ACD)</a>, which adopts similar regulatory principles and requirements as the European Union (EU) regulations on cosmetic products.<br /> <br /> For more information on regulatory requirements and guidelines for cosmetic products, please refer to the <a href="/docs/default-source/hprg-cosmetics/guidelines-on-the-control-of-cosmetic-products16447441f2b24350b13b73cdc17081d4.pdf?sfvrsn=251c9caf_0"></a><a href="/docs/default-source/hprg-cosmetics/guidelines-on-the-control-of-cosmetic-products95cce02a6d0f44f6b886e46a5a05922c.pdf?sfvrsn=7399e81c_0"></a><a href="/docs/default-source/hprg-cosmetics/guidelines-on-the-control-of-cosmetic-products_jul21.pdf?sfvrsn=c98ebd83_5"></a><a href="/docs/default-source/hprg-cosmetics/guidelines-on-the-control-of-cosmetic-products_jul21.pdf?sfvrsn=c98ebd83_5"></a><a title="Guidelines On The Control of Cosmetic Products" href="/docs/default-source/hprg-cosmetics/guidelines-on-the-control-of-cosmetic-products_jul21.pdf?sfvrsn=c98ebd83_5">Guidelines On The Control of Cosmetic Products</a>. </p> <p>Suppliers of cosmetic products may refer to the <a title="Advisory for Suppliers - Assessing the Safety and Quality of Cosmetic Products" href="/docs/default-source/hprg-cosmetics/advisory-for-suppliers-of-cosmetic-products_30jul2024.pdf?sfvrsn=de52c816_2">Advisory for Suppliers - Assessing the Safety and Quality of Cosmetic Products</a> for more information on assessing the safety and quality of your products.</p> <h2>Product notification</h2> <p>A <a target="_blank" href="/cosmetic-products/notification">cosmetic product notification</a> usually needs to be submitted before you can sell a cosmetic product in Singapore. This is to facilitate regulatory follow-up should safety concerns arise.</p> <p>However, a notification does not need to be submitted in the following situations:</p> <ul> <li>Your cosmetic product is supplied solely as a sample in connection with any advertising, sponsorship or promotional activity.</li> <li>Your cosmetic product is supplied solely for testing or trial use in connection with any research or development of that product.</li> <li>Your cosmetic product is manufactured by, or in accordance with the specifications of a medical practitioner, and supplied solely by that medical practitioner for the use of patients under his care.</li> </ul></div> </div> <div > <div ><h3>Overview of process to supply cosmetic products in Singapore</h3><table><thead><tr><th>Stages of supplying cosmetic products</th><th>Details</th></tr></thead><tbody><tr><td>Before submitting a product notification</td><td><ul><li>Check that the ingredients in your cosmetic product comply with the requirements of the <a href="/docs/default-source/hprg-cosmetics/annexes-of-the-asean-cosmetic-directive-(updated-dec23).pdf?sfvrsn=a78954b0_2"></a><a href="/docs/default-source/hprg-cosmetics/annexes-of-the-asean-cosmetic-directive-(updated-dec22).pdf?sfvrsn=6f34040b_2"></a><a href="/docs/default-source/hprg-cosmetics/annexes-of-the-asean-cosmetic-directive-(updated-sept24).pdf?sfvrsn=d9ad5df8_3" title="Annexes of the ASEAN Cosmetic Directive" data-sf-ec-document-immutable="true">Annexes of the ASEAN Cosmetic Directive</a></li><li>Check that your product complies with <a href="/docs/default-source/hprg-cosmetics/labeling-requirement-for-cosmetic-product_apr19.pdf?sfvrsn=f1fc8ebd_0" title="labelling requirements">labelling requirements</a>.</li></ul></td></tr><tr><td>Submitting a product notification</td><td><ul><li>Apply for a <a href="/e-services/cris" target="_blank">Client Registration and Identification Service (CRIS) account</a>.</li><li>Submit a new cosmetic product notification through <a href="/e-services/prism/cosmetic-products-oral-dental-gums" target="_blank">PRISM</a>.</li><li>Refer to our guide on the <a href="/cosmetic-products/notification/submit" target="_blank">requirements of a cosmetic product notification</a> to find out how to submit a notification.</li></ul></td></tr><tr><td>After submitting a product notification</td><td><ul><li>Adhere to responsibilities of the company which includes reporting serious <a href="/docs/default-source/hprg-vcb/adverse-events/report-form-for-adverse-event-associated-with-cosmetic-product_updatedfeb2022.pdf?sfvrsn=737564a5_2">adverse effects</a> and <a href="https://form.gov.sg/6420fe986e65530012de55b9" data-sf-ec-immutable="">product defects</a>.  </li><li><a href="/cosmetic-products/notification/amend" target="_blank">Submit amendment</a> to update applicant details, company information or manufacturer details.</li><li><a href="/cosmetic-products/notification/submit">Re-notification</a> is required after one year.</li><li><a href="/cosmetic-products/notification/amend" target="_blank">Cancel notification</a> if you are no longer selling the product.</li></ul></td></tr></tbody></table>  <p> </p></div> </div> <div id="main_C006_Col00" class="sf_colsIn hsa-toggle hsa-card p:0" data-sf-element="Toggle" data-placeholder-label="Toggle"><div id="main_C007_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Ingredient requirements</h1> <h2>Ingredient requirements</h2> <p>Refer to the Annexes of the ASEAN Cosmetic Directive for the most updated list of prohibited and restricted ingredients, including permitted colouring agents, preservatives or UV filters.</p></div> </div> </div><div id="main_C011_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Labelling requirements</h1> <h2>Labelling requirements</h2> <p>The following details should appear on the outer packaging or on the immediate packaging of cosmetic products if there is no outer packaging. The details must be listed in English. Information in other languages, if any, may be used in addition to English and should be the same as the English version.</p> <ol> <li>The name of the cosmetic product and its function, unless it is clear from the presentation of the product.</li> <li>Instructions on the use of the cosmetic product, unless it is clear from the product name or presentation.</li> <li>A full ingredient listing, declared in descending order of weight at the time they are added. <ul> <li>Perfume and aromatic compositions and their raw materials may be referred to by the words “perfume”, “fragrance”, “aroma” or “flavour”.</li> <li>Ingredients in concentrations of less than 1% may be listed in any order after those of concentration of more than 1%.</li> <li>Colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination adopted in Annex IV.</li> <li>For decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the terms “may contain” or “+/-“ be added.</li> <li>The ingredients shall be specified using the nomenclature from the latest edition of standard references (refer to appendix A).</li> <li>Botanicals and extract of botanicals should be identified by its genus and species. The genus may be abbreviated.</li> </ul> </li> <li>Country of manufacture.</li> <li>The name and address of the company or person responsible for placing the product on the local market.</li> <li>The contents given by weight or volume, in either metric or both metric and imperial system.</li> <li>The manufacturer's batch number.</li> <li>The manufacturing or the expiry date of the product in clear terms. The date shall be clearly expressed and shall consist of the day (if applicable), month and year, in that order. <ul> <li>The date of minimum durability shall be the date until which this product, stored under appropriate conditions, continues to fulfil its initial function. It should be preceded by the words “expiry date” or “best before”.</li> <li>Indication of the expiry date shall be mandatory for cosmetic products the minimum durability of which is less than 30 months.</li> </ul> </li> <li>Special precautions to be observed in use, especially those listed in the column “Conditions of use and warnings" in the Annexes of the ASEAN Cosmetic Directive, which must appear on the label as well as any special precautionary information on the cosmetic products. <ul> <li>Member countries may require specific warnings based on local needs for declaration of ingredients from animal origin. In this case: <ul> <li>There must be a statement (of any format) on the product label signalling the presence of ingredients of animal origin.</li> <li>For ingredients of bovine or porcine origin, the exact animal must be declared.</li> </ul> </li> </ul> </li> </ol> <p>Note: The following are not regarded as ingredients:</p> <ul> <li>Impurities in the raw materials used.</li> <li>Subsidiary technical materials used in the preparation but not present in the final products.</li> <li>Materials used in strictly necessary quantities as solvents, or as carriers, for perfume and aromatic compositions.</li> </ul> <p>If the size, shape or nature of the container or package does not permit the particulars above to be displayed, the use of leaflets, pamphlets, hang tags, display panel, shrink wrap, etc. is allowed. However, the following particulars at least should appear on small immediate packaging:</p> <ul> <li>Name of the cosmetic product.</li> <li>Manufacturer's batch number.</li> </ul></div> </div> </div><div id="main_C010_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Advertisements</h1> <h2>Advertisements</h2> <p>Advertisements on cosmetic products:</p> <ul> <li>Cannot claim to modify a physiological process, such as a reversal of hair loss, or to prevent or treat a disease or medical conditions.</li> <li>Can only make claims that are aligned with the definition of cosmetic products, and are justified by scientific data or evidence and/or by the cosmetic formulation or preparation itself.</li> <li>Must only make claims that are aligned with the <a title="Appendix III ASEAN Cosmetic Claims Guidelines" href="/docs/default-source/hprg-cosmetics/appendix-iii-asean-cosmetic-claims-guidelines.pdf?sfvrsn=ee71c947_0">Appendix III ASEAN Cosmetic Claim Guideline</a>, and can be fully substantiated when requested as per the Singapore Code of Advertising Practices (SCAP). Advertising activities should also comply with the principles and guidelines listed in SCAP.</li> </ul></div> </div> </div><div id="main_C022_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Reporting of Adverse Effects, Product Defects and Product Recalls </h1> <h2>Reporting of Adverse Effects, Product Defects and Product Recalls </h2> <p>Serious adverse effects and product defects as well as product recalls relating to cosmetic products have to be reported to HSA. </p> <p>Refer to our <a title="guide" href="/docs/default-source/hprg-cosmetics/guidance_ae-defect-reporting-and-product-recall_cp_1dec2023f3789679278c40f3806db3d1673337246f802f15-2cf4-42be-9000-041790857dc2.pdf?sfvrsn=c7462673_3">guide</a> on reporting adverse effects, product defects and product recalls for more details on how to report.</p></div> </div> </div><div id="main_C009_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Good Manufacturing Practice certification</h1> <h2>Good Manufacturing Practice certification</h2> <p>Cosmetic product manufacturers in Singapore do not require a manufacturer’s licence. However, the manufacturer may apply for a Good Manufacturing Practice (GMP) certificate to facilitate the export of the cosmetic products.</p> <p>Refer to our <a target="_blank" href="/cosmetic-products/good-manufacturing-practice">guide on GMP certification</a> for more details on how to apply.</p></div> </div> </div><div id="main_C008_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Certificate of Free Sale</h1> <h2>Certificate of Free Sale</h2> <p>The Singapore Customs issues the Certificate of Free Sale for goods sold locally. You may refer to the <a href="https://www.customs.gov.sg/eservices/customs-forms-and-service-links" target="_blank" data-sf-ec-immutable="">Singapore Customs</a> website for details on how to apply.</p></div> </div> </div> </div></div> </div> </div> <div class="g:12"> <div class="gcol:12 dsk(gcol:8)"> <div class="p-t:2xl m-b:2xl"> <div id="main_TB6F372E3007_Col02" class="sf_colsIn" data-sf-element="date updated" data-placeholder-label="date updated"> <time class="hsa-text--small m:0 p:0" datetime="2018-10-31" id="pageUpdatedTime">Last updated: <span id="pageUpdated">31 Dec 2018</span></time> <script> var pageTitle = document.title; $(document).ready(function () { $.getJSON('/GetPageModified/' + pageTitle, function (x) { var timeElement = document.getElementById("pageUpdatedTime"); if (timeElement) { timeElement.setAttribute("datetime", x.DateTime); document.getElementById("pageUpdated").textContent = x.DateTimeStr; } }); }); </script></div> <div id="main_TB6F372E3007_Col03" class="sf_colsIn hsa-share" data-sf-element="hsa share" data-placeholder-label="hsa share"> <span class="hsa-share__text" style="color:#667075">Share </span> <a href="http://facebook.com/sharer.php?u=" class="type--inherit hsa-embed-page-link" target="_blank" rel="noopener" aria-label="facebook-share-icon"> <span class="hsa-glyphs--social-facebook fz:2xl m-x:2xs" style="color:#3b5998"></span> </a> <a href="https://twitter.com/intent/tweet?text=Regulatory overview of cosmetic products:" class="type--inherit hsa-embed-page-link" target="_blank" rel="noopener" aria-label="twitter-share-icon"> <span class="hsa-glyphs--twitter fz:2xl m-x:2xs" style="color:#55acef"></span> </a> <a href="https://www.linkedin.com/sharing/share-offsite/?url=" class="type--inherit hsa-embed-page-link" target="_blank" rel="noopener" aria-label="linkedin-share-icon"> <span class="hsa-glyphs--linkedin fz:2xl m-x:2xs" style="color:#55acef"></span> </a> <a href="https://api.whatsapp.com/send/?text=Regulatory overview of cosmetic products:" class="type--inherit hsa-embed-page-link" target="_blank" rel="noopener" aria-label="whatsapp-share-icon"> <span class="hsa-glyphs--whatsapp fz:2xl m-x:2xs" style="color:#55acef"></span> </a> <a href="mailto:?subject=Regulatory overview of cosmetic products&body=" class="type--inherit hsa-embed-page-link" aria-label="mail-share-icon"> <span class="hsa-glyphs--social-mail fz:2xl m-x:2xs c:yellow-1"></span> </a> <a href="#" class="type--inherit hsa-print" aria-label="print-icon"> <span class="hsa-glyphs--print fz:2xl m-x:2xs c:blue-1"></span> </a></div> </div> </div> </div> </div> <section id="main_TB6F372E3007_Col04" class="sf_colsIn hsa-topic-explorer" data-sf-element="hsa topic explorer" data-placeholder-label="hsa topic explorer" role="navigation"> <div class="container"> <div class="hsa-toc var--end-cog"> <h3 class="hsa-text--h2 p-t:0 m-b:l"> <a href="/cosmetic-products" class="type--inherit">Cosmetic products</a> </h3> <ul> <li> <p class="state--ignore-tooltip"> Regulatory overview </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/cosmetic-products/notification">Cosmetic product notification</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/cosmetic-products/asean-cosmetic-directive">ASEAN Cosmetic Directive</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/cosmetic-products/good-manufacturing-practice">Good Manufacturing Practice certification for cosmetic products</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/cosmetic-products/report-adverse-events-of-cosmetic-products">Report adverse events</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/cosmetic-products/fees">Fees and turnaround time</a> </p> </li> <li class="var--cog"> <p class="state--ignore-tooltip"> <a href="/e-services/prism/cosmetic-products-oral-dental-gums">PRISM (Cosmetic products and oral dental gums) </a> </p> </li> <li class="var--cog"> <p class="state--ignore-tooltip"> <a href="/e-services/infosearch">Infosearch</a> </p> </li> </ul> </div> </div> <div class="hsa-sticky-topic-explorer" data-active="false" style="top: inherit; 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