HSA | Good Manufacturing Practice certificate for local manufacturers

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data-guid="27da00ef-00ec-4790-9d18-6916d678ecfd"> International collaboration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/standards-for-medical-devices" data-guid="e78eb821-29c2-4555-a644-bd437bffb1f8"> Standards for Medical Devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/guidance-documents" data-guid="de28c215-08d1-44a5-af83-ef489b2105fe"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/fees" data-guid="557d7609-331a-47bd-95e5-d4e9fe4cbdac"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="02a741e1-7ebb-4de5-aa7a-bfeafb1a2f0f" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Therapeutic products</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/overview" data-guid="2cd88bdd-846b-4d7d-ba3f-58efc47f49d6"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="1bb793b7-6ebc-4614-ab26-f3486e8d47b8"> Register your product </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="382c3665-f125-4dbd-aa45-33855a4edecc"> Apply for post-approval variation </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="c7d36f32-24f2-4341-852f-879820bd2f95"> Reclassify your product </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="610292f3-004d-4e6e-8995-c25be4a1273b"> Dealer's licensing and certification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retain-cancel-or-transfer-therapeutic-product-registrations" data-guid="51a7ad22-338f-49ae-9336-c385884fdd1f"> Retain, cancel or transfer product registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/rmp" data-guid="73570827-4fc4-4805-b778-0c6ed71d542c"> Risk management plan requirements </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/adverse-events" data-guid="dfc7cd0c-0dd2-4789-bc57-430dce08bca8"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/defect-reporting-recall" data-guid="1e2b6d48-7d73-43f6-ae20-d64c8dcd364b"> Report or recall defective products </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="25fc1ebe-32a2-4170-ae07-309d697d35e5"> Retail pharmacy licensing </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="efa56797-fabe-4d38-810f-4cd825fa6486"> Clinical trials </a> </li> <li class="link" data-content=""> <a 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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"> Diploma in Nursing Scholarship </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><div class="hsa-img--ellipsis" tabindex="0"></div></li> <li><a href="/therapeutic-products/dealers-licence">Dealer's licensing and certification </a></li> <li><a href="/therapeutic-products/dealers-licence/certificates">Certification of local manufacturers, importers and wholesalers </a></li> </ol> <div class="hsa-breadcrumbs__crumb-dropdown"> <ul> <li><a href="/therapeutic-products">Therapeutic products</a></li> </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>Good Manufacturing Practice certificate for local manufacturers</h1> <p class="hsa-text--summary">Find out how you can apply for the voluntary GMP certificate for local manufacturers.</p> </div> <div id="main_TB6F372E3007_Col01" class="sf_colsIn" data-sf-element="content" data-placeholder-label="content"> <div > <div ><div dir="ltr"> <h2> Overview </h2> <p> Good Manufacturing Practice (GMP) certification is a voluntary scheme offered to local manufacturers of the following products, interested to be certified for conformity with relevant GMP standards by us: </p> <ul> <li>Therapeutic products</li> <li>Chinese proprietary medicine </li> <li>Active pharmaceutical ingredients </li> <li>Cosmetic products</li> <li>Medicated oils and balms</li> </ul> <p> To apply for a GMP certificate, you must be authorised by your company to do so as the person responsible, such as managing director, QA/QC manager or production manager. </p> <h2> GMP certification audit </h2> <p> After our GMP auditors have completed the GMP certification audit and find that your company has demonstrated satisfactory compliance with the required GMP standard, we will issue the certificate in the name of your company as registered with the <a href="https://www.acra.gov.sg/home/" target="_blank">Accounting and Corporate Regulatory Authority</a>. The scope of certification is normally determined by the scope of the actual audit that was performed at the manufacturing facility and the types of dosage forms or range of products being manufactured. </p> <p> A GMP certificate is valid for three years from the date of assessment and cannot be renewed or amended. Upon expiry, you will need to submit a new application if you are still interested in re-certification. GMP audits will apply. </p> <table> <thead> <tr> <th> Products manufactured </th> <th>GMP standard used to conduct the certification audit</th> </tr> </thead> <tbody> <tr> <td> <ul> <li>Therapeutic products </li> <li>Chinese proprietary medicines </li> <li>Medicated oils and balms</li> </ul> </td> <td> <p>Please refer to <a href="https://www.hsa.gov.sg/therapeutic-products/dealers-licence/gmp-gdp">HSA | Good Manufacturing Practice and Good Distribution Practice Standards</a></p> <p> </p> </td> </tr> <tr> <td> <p> Active pharmaceutical ingredients </p> </td> <td> <p>Please refer to <a href="https://www.hsa.gov.sg/therapeutic-products/dealers-licence/gmp-gdp">HSA | Good Manufacturing Practice and Good Distribution Practice Standards</a></p> </td> </tr> <tr> <td> <p> Cosmetic products </p> </td> <td> <p><a href="/docs/default-source/hprg/cosmetic-products/guide-mqa-016.pdf?sfvrsn=304a5f40_4" target="_blank" title="GMP Guidelines for Manufacturers of Cosmetic Products">GMP Guidelines for Manufacturers of Cosmetic Products<em class="hsa-glyphs--pdf"></em><span>242 KB</span></a></p> </td> </tr> </tbody> </table> <h2>Documents required </h2> <p> A Site Master File must be attached in the application. For information on the preparation of a Site Master File, refer to the relevant guidance notes: </p> <ul> <li><a href="https://www.picscheme.org/layout/document.php?id=129" target="_blank">Guidance Notes for Pharmaceutical Manufacturers on Preparation of a Site Master File</a> (for therapeutic products, chinese proprietary medicine, active pharmaceutical ingredients) </li> <li><a href="/docs/default-source/hprg-ald/guide-mqa-018.pdf?sfvrsn=ef0c1104_4" title="Guidance Notes on Preparation of a Site Master File for Manufacturer of Cosmetic Products" target="_blank">Guidance Notes on Preparation of a Site Master File for Manufacturer of Cosmetic Products<em class="hsa-glyphs--pdf"></em><span>235 KB</span></a><em></em> (for cosmetic products)</li> </ul> </div></div> </div> <div > <div ><h2>Fees and turn-around-time</h2> <p>Refer to <a href="/therapeutic-products/fees">Certification fees and <abbr data-original-title="<p>Working days from the date of receipt of application. Excludes ‘stop-clock time’ for clarification requests and additional information.</p>" style="margin: 0px; padding: 0px; border-bottom: 0.0625rem dashed #7e898e;">turn-around-time</abbr></a> for more information.</p></div> </div> <div > <div ><h2>How to apply </h2> <p> Submit your application through <a href="/e-services/prism/therapeutic-products" target="_blank">PRISM</a>. Ensure you have the following before you access the e-service: </p> <ul> <li> <a href="/e-services/cris" target="_blank">CRIS</a> company account </li> <li> <a href="https://www.corppass.gov.sg/cpauth/login/homepage?TAM_OP=login" target="_blank">Corppass</a> or <a href="/e-services/hsa-pin" target="_blank">HSA PIN</a></li> </ul> <p>If you encounter technical issues, e-mail the <a href="mailto:helpdesk@hsahelp.gov.sg">HSA helpdesk</a> or call 6776 0168 (from 7.00 am to midnight daily).</p></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=Good Manufacturing Practice certificate for local manufacturers:" 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 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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="/therapeutic-products" class="type--inherit">Therapeutic products</a> </h3> <ul> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/overview">Regulatory overview </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/register">Register your product</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/variation-application">Apply for post-approval variation</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/reclassification">Reclassify your product</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/dealers-licence">Dealer's licensing and certification</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/retain-cancel-or-transfer-therapeutic-product-registrations">Retain, cancel or transfer product registration</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/rmp">Risk management plan requirements</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/adverse-events">Report adverse events</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/defect-reporting-recall">Report or recall defective products </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/retail-pharmacy-licence">Retail pharmacy licensing</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/clinical-trials">Clinical trials </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/product-consultation">Product consultation </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/advertisements">Advertisements and promotions </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/cpp-sls">CPP and SLS</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/international-collaboration">International collaboration</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/medicines-quality-and-compliance-monitoring">Medicines quality and compliance monitoring</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/approvals-and-post-reg-actions">Listing of approvals and post-registration actions</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/guidance-documents">Guidance documents </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/fees">Fees and turnaround time</a> </p> </li> <li class="var--cog"> <p class="state--ignore-tooltip"> <a href="/e-services/prism/therapeutic-products">PRISM (Therapeutic products) </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; bottom: -464px;"> <button class="hsa-sticky-topic-explorer__btn" type="button" style="order: 1;"> Content in this section <span class="hsa-sticky-topic-explorer__btn__action"> <span class="hsa-sticky-topic-explorer__btn__action__text">show</span> <span class="c:blue-1 hsa-glyphs--chevron-up" style="transform: rotate(0deg);"></span> </span> </button> <div class="hsa-sticky-topic-explorer__content container" style="order: 2; opacity: 0;"> <div class="hsa-toc var--end-cog"> <h3 class="hsa-text--h2 p-t:0 m-b:l"> <a href="/therapeutic-products" class="type--inherit">Therapeutic products</a> </h3> <ul> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/overview">Regulatory overview </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/register">Register your product</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/variation-application">Apply for post-approval variation</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/reclassification">Reclassify your product</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/dealers-licence">Dealer's licensing and certification</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/retain-cancel-or-transfer-therapeutic-product-registrations">Retain, cancel or transfer product registration</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/rmp">Risk management plan requirements</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/adverse-events">Report adverse events</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/defect-reporting-recall">Report or recall defective products </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/retail-pharmacy-licence">Retail pharmacy licensing</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/clinical-trials">Clinical trials </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/product-consultation">Product consultation </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/advertisements">Advertisements and promotions </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/cpp-sls">CPP and SLS</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/international-collaboration">International collaboration</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/medicines-quality-and-compliance-monitoring">Medicines quality and compliance monitoring</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/approvals-and-post-reg-actions">Listing of approvals and post-registration actions</a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/guidance-documents">Guidance documents </a> </p> </li> <li> <p class="state--ignore-tooltip"> <a href="/therapeutic-products/fees">Fees and turnaround time</a> </p> </li> <li class="var--cog"> <p class="state--ignore-tooltip"> <a href="/e-services/prism/therapeutic-products">PRISM (Therapeutic products) </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> </section> </main> <div > <div ><div class="hsa-pre-footer"><div class="container p-y:s tab(p-y:s)"><div class="g:12 d:f fld:r 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