APPLICATION-FORM-FOR-REGISTRATION-OF-HERBAL-MEDICINAL-PRODUCT-2-2

Sep 1, 2026

Upload by Rhys

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.

LanguageEnglish

CategoryForms

FormatDOCX

Pages7

Reading Time3 min

AccessFree to download

Checklist & submission requirements

Applicant, product and business details

Declaration, signature and official stamp

Appendix I: Product details

Active and non-active ingredients

Dependence- or psychotropic/narcotic-listed ingredients

Appendix II: Manufacturing procedure and related controls

Raw material origin and foreign-matter prevention

Manufacturing summary

Shelf-life and stability justification

Certificate of analysis and quality proof

Toxicological, pharmacological and clinical information

Label and written materials requirements

CHECKLIST APPLICANT’S FDA CHECK LIST CHECK LIST SAMPLES (AS PER FDA’S SAMPLE SCHEDULE 4 COPIES OF LABEL & PACKAGING MATERIAL 4 COPIES OF PACKAGE INSERT (To be submitted in duplicate) Addressed to: THE CHIEF EXECUTIVE FOOD AND DRUGS AUTHORITY P.O.BOX CT 2783 CANTONMENTS-ACCRA GHANA. Samples 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. Name of Herbal Medicinal Product; ……………………………………………………… Dosage Form: ………………………Strength: ……………………Colour:..……………… Commercial Presentation (s): ………………………………………………………………... Country of Origin: …………………………………………………………………………... Name of Applicant: …………………………………………………………………………. Business Address: ……………………………………………………………………………. ………………………………………………………………………………………………….. Phone:……………………. .…….. Fax:…………………………………. e-mail:……………………………………………………………………… Name of Manufacturer:………………………………………………………………………… Premises Address ……………………………………………………………………………… …………………………………………………………………………………………………. Postal Address:………………………………………………………………………………… Phone:………………………………………… Fax:….………………………………….. e-mail…………………………………………………………………………………………. Name of Local Agent: …………………………………………………………................... Business Address: …………………………………………………………………………. Phone: ……………………………………… Fax: ………………………………………… e-mail: ………….……………………………………………………………………………. Application fee paid…………………………………………………………………………. Declaration: I/We, the undersigned, hereby declare that all information contained herein and in the appendices is correct and true. Name: ………………………………………………………… Position: ……………………………………………………… Signature: ………………………………………………… Date: ….…………………………… Official Stamp APPENDIX 1 PRODUCT DETAILS Name of Medicine……………………………………………………………………………. Name of Applicant…………………………………………………………………………… Dosage Form…………………….. Strength………………… Colour……………………. (1) List all active ingredients used as illustrated in the table below: (1) List all non-active ingredients as illustrated in the table below: (3) List any ingredient(s) liable to cause dependence and/or listed in the UN lists of psychotropic and narcotic drugs. ………………………………………………………………………………………………… ………………………………………………………………………………………………… APPENDIX II PARTICULARS OF MANUFACTURING PROCEDURE AND RELATED CONTROLS Origin or source of the raw materials, steps taken to prevent presence of foreign matter (sand, stones, insects, etc.) ……………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………….. Give a brief summary of the manufacturing procedure. ………………………………………………………………………………………………………………………… …………………………………….………………………………………………………........................... ……………………………………………………………………………………………………………………….. ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… State estimated shelf-life of the medicine. ………………………………………………………………………………………………… Provide stability data and justification on which shelf-life has been predicted. ………………………………………………………………………………………………… An acceptable certificate of analysis testifying that the medicine is of proven quality and issued by a recognised public analyst. ……………………………………………………………………………………………… Attach toxicological, pharmacological and clinical information, as well as therapeutic effects of the herbal preparation.* …………………………………………………………………………………………….. *Refer to FDA Guidelines for Registration of Herbal Medicinal Products Attach text of labels and other written materials available with the herbal/homeopathic medicine, including the underlisted information. i. Indication ii. Dosage and administration iii. Contraindications iv. Adverse reactions v. Precautions vi. Use in pregnancy and lactation vii. Treatment of over dosage viii.

FAQs

What documents and samples must be submitted for the herbal medicinal product registration?

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.

Which product and applicant details are required in the form?

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.

What information must be provided in Appendix II regarding manufacturing and shelf-life?

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.

Sep 1, 2026

Upload by Rhys