[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-171417-105":3,"detail-sidebar-cat-1-en-105":81,"doc-detail-171417-en":127},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":74,"head_meta":76,"extra_data":78,"updated_unix":80},105,"en","application-form-for-registration-of-herbal-medicinal-product-2-2","APPLICATION-FORM-FOR-REGISTRATION-OF-HERBAL-MEDICINAL-PRODUCT-2-2","","Registration application checklist and form template for an herbal medicinal product submitted to the Ghana Food and Drugs Authority. It specifies document counts for label and packaging materials and package inserts, forwarding and customs handling through the local agent, and provides fields for product identity, dosage form, strength, color, country of origin, applicant and manufacturer details, and local agent information. Includes declarations, signatures, dates, official stamp, and appendices covering product details, ingredient lists, manufacturing procedure controls, shelf-life, stability data, certificate of analysis, and required label text elements such as indications, dosage, contraindications, adverse reactions, precautions, pregnancy/lactation, overdose, interactions, and storage conditions.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/forms/","Forms",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/application-form-for-registration-of-herbal-medicinal-product-2-2/171417/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/application-form-for-registration-of-herbal-medicinal-product-2-2/171417.png","ImageObject",442,249,{"name":42,"@type":43},"Rhys","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-10-23","2026-09-01",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",9,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What documents and samples must be submitted for the herbal medicinal product registration?","Question",{"text":63,"@type":64},"Submit 4 copies of label and packaging material and 4 copies of the package insert (submitted in duplicate), following the FDA sample schedule. Samples and printed matter should be forwarded to the Board through the local agent.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"Which product and applicant details are required in the form?",{"text":68,"@type":64},"The form requires the product name, dosage form, strength, colour, commercial presentations, country of origin, applicant name, business address, phone/fax/e-mail, manufacturer name and premises address, postal address, and local agent name and contact information.",{"name":70,"@type":61,"acceptedAnswer":71},"What information must be provided in Appendix II regarding manufacturing and shelf-life?",{"text":72,"@type":64},"Appendix II requires raw material origin and controls to prevent foreign matter, a brief manufacturing procedure summary, estimated shelf-life, stability data and justification, and an acceptable certificate of analysis from a recognised public analyst, plus toxicological, pharmacological and clinical information and therapeutic effects.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},171417,1791239686,{"code":4,"msg":82,"data":83},"success",[84,89,94,99,104,109,113,118,123],{"id":85,"doc_module":22,"doc_module_name":25,"category_name":86,"show_sort_weight":87,"slug":88},11,"Presentations",90,"presentations",{"id":90,"doc_module":22,"doc_module_name":25,"category_name":91,"show_sort_weight":92,"slug":93},12,"Resumes",80,"resumes",{"id":95,"doc_module":22,"doc_module_name":25,"category_name":96,"show_sort_weight":97,"slug":98},14,"Invoices",70,"invoices",{"id":100,"doc_module":22,"doc_module_name":25,"category_name":101,"show_sort_weight":102,"slug":103},15,"Posters",60,"posters",{"id":105,"doc_module":22,"doc_module_name":25,"category_name":106,"show_sort_weight":107,"slug":108},16,"Social Media",50,"social-media",{"id":110,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":111,"slug":112},17,40,"forms",{"id":114,"doc_module":22,"doc_module_name":25,"category_name":115,"show_sort_weight":116,"slug":117},18,"Letters",30,"letters",{"id":119,"doc_module":22,"doc_module_name":25,"category_name":120,"show_sort_weight":121,"slug":122},21,"Paper Templates",5,"papers-templates",{"id":124,"doc_module":22,"doc_module_name":25,"category_name":125,"show_sort_weight":4,"slug":126},158,"General","general-158",{"code":4,"msg":82,"data":128},{"doc_id":79,"user_id":129,"nickname":42,"user_avatar":130,"doc_module":22,"category_id":110,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":136,"language":137,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":12,"update_tm":141,"read_time":30},687207024643,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","CHECKLIST\nAPPLICANT’S \t \t \t \t \t \t \t \t                 FDA\nCHECK LIST \t \t \t \t \t \t \t                                   CHECK LIST\nSAMPLES (AS PER FDA’S SAMPLE SCHEDULE\n4 COPIES OF LABEL & PACKAGING MATERIAL\n4 COPIES OF PACKAGE INSERT\n(To be submitted in duplicate)\nAddressed to: THE CHIEF EXECUTIVE\nFOOD AND DRUGS AUTHORITY\nP.O.BOX CT 2783 CANTONMENTS-ACCRA GHANA.\nSamples and printed matter should be forwarded to the Board through the local agent; customs duty and clearance to be effected by the applicant in all instances.\nName of Herbal Medicinal Product; ………………………………………………………\nDosage Form: ………………………Strength: ……………………Colour:..……………… Commercial Presentation (s): ………………………………………………………………... Country of Origin: …………………………………………………………………………...  Name of Applicant: ………………………………………………………………………….\nBusiness Address: …………………………………………………………………………….\n…………………………………………………………………………………………………..\nPhone:……………………. .……..  Fax:………………………………….\ne-mail:………………………………………………………………………\nName of Manufacturer:…………………………………………………………………………\nPremises Address ……………………………………………………………………………… ………………………………………………………………………………………………….\nPostal Address:………………………………………………………………………………… Phone:………………………………………… Fax:….…………………………………..\ne-mail………………………………………………………………………………………….\nName of Local Agent: …………………………………………………………...................\nBusiness Address: ………………………………………………………………………….\nPhone: ………………………………………  Fax: …………………………………………\ne-mail: ………….…………………………………………………………………………….\nApplication fee paid………………………………………………………………………….\nDeclaration:\nI/We, the undersigned, hereby declare that all information contained herein and in the appendices is correct and true.\nName: …………………………………………………………\nPosition: ………………………………………………………\nSignature: …………………………………………………\nDate: ….……………………………\nOfficial Stamp\nAPPENDIX 1\nPRODUCT DETAILS\nName of Medicine…………………………………………………………………………….\nName of Applicant……………………………………………………………………………\nDosage Form…………………….. Strength………………… Colour…………………….\n(1) List all active ingredients used as illustrated in the table below:\n(1) List all non-active ingredients as illustrated in the table below:\n(3) \tList any ingredient(s) liable to cause dependence and/or listed in the UN lists of psychotropic and narcotic drugs.\n…………………………………………………………………………………………………\n…………………………………………………………………………………………………\nAPPENDIX II\nPARTICULARS OF MANUFACTURING PROCEDURE AND RELATED CONTROLS\nOrigin or source of the raw materials, steps taken to prevent presence of foreign matter (sand, stones, insects, etc.)\n………………………………………………………………………………………………………………………\n…………………………………………………………………………………………………………………………\n………………………………………………………………………………………………………………………\n…………………………………………………………………………………………………………………………\n……………………………………………………………………………………………………………………..\nGive a brief summary of the manufacturing procedure.\n…………………………………………………………………………………………………………………………\n…………………………………….………………………………………………………...........................\n………………………………………………………………………………………………………………………..\n…………………………………………………………………………………………………………………………\n…………………………………………………………………………………………………………………………\n…………………………………………………………………………………………………………………………\n…………………………………………………………………………………………………………………………\nState estimated shelf-life of the medicine.\n…………………………………………………………………………………………………\nProvide stability data and justification on which shelf-life has been predicted.\n…………………………………………………………………………………………………\nAn acceptable certificate of analysis testifying that the medicine is of proven quality and issued by a recognised public analyst.\n………………………………………………………………………………………………\nAttach toxicological, pharmacological and clinical information, as well as therapeutic effects of the herbal preparation.*\n……………………………………………………………………………………………..\n*Refer to FDA Guidelines for Registration of Herbal Medicinal Products\nAttach text of labels and other written materials available with the herbal/homeopathic medicine, including the underlisted information.\ni. \tIndication ii. \tDosage and administration iii. \tContraindications iv. \tAdverse reactions v. \tPrecautions\nvi. \tUse in pregnancy and lactation vii. \tTreatment of over dosage viii.","cbCaia1uUx3f51Tz","https://ap.wps.com/l/cbCaia1uUx3f51Tz","docx",93780,7,"English","# Checklist & submission requirements\n## Applicant, product and business details\n# Declaration, signature and official stamp\n# Appendix I: Product details\n## Active and non-active ingredients\n## Dependence- or psychotropic/narcotic-listed ingredients\n# Appendix II: Manufacturing procedure and related controls\n## Raw material origin and foreign-matter prevention\n## Manufacturing summary\n## Shelf-life and stability justification\n## Certificate of analysis and quality proof\n## Toxicological, pharmacological and clinical information\n## Label and written materials requirements","[{\"question\":\"What documents and samples must be submitted for the herbal medicinal product registration?\",\"answer\":\"Submit 4 copies of label and packaging material and 4 copies of the package insert (submitted in duplicate), following the FDA sample schedule. Samples and printed matter should be forwarded to the Board through the local agent.\"},{\"question\":\"Which product and applicant details are required in the form?\",\"answer\":\"The form requires the product name, dosage form, strength, colour, commercial presentations, country of origin, applicant name, business address, phone/fax/e-mail, manufacturer name and premises address, postal address, and local agent name and contact information.\"},{\"question\":\"What information must be provided in Appendix II regarding manufacturing and shelf-life?\",\"answer\":\"Appendix II requires raw material origin and controls to prevent foreign matter, a brief manufacturing procedure summary, estimated shelf-life, stability data and justification, and an acceptable certificate of analysis from a recognised public analyst, plus toxicological, pharmacological and clinical information and therapeutic effects.\"}]","APPLICATION-FORM-FOR-REGISTRATION-OF-HERBAL-MEDICINAL-PRODUCT-2-2 | DOCX",1788282752]