Application Form for Herbal Products

 REPUBLIC OF LIBERIA A. T. C. Building, Opposite J-Mart
Randall Street, Monrovia
PRODUCT REGISTRATION APPLICATION FORM FOR HERBAL PRODUCTS FOR OFFICIAL USE ONLY: Date of Receipt of Application __________________________________________________________________ Application Number __________________________________________________________________________ In completing this form and preparing of dossiers for submission to the Authority, the applicant is advised to refer to the guidelines on registration of Herbal Medicines for human use. 1. Product Information 1.1. Product Name: ____________________________________________________________________ 1.2. Therapeutic indications for the product _________________________________________________________________________________
_________________________________________________________________________________ 1.3. Pharmaceutical Dosage Form Information 1.3.1.
Dosage and Route of Administration __________________________________________________________________________
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__________________________________________________________________________ 1.3.2.
Container, closure and administration devices __________________________________________________________________________
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__________________________________________________________________________ 1.3.3.
Commercial presentation (Pack Size): __________________________________________________________________________
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__________________________________________________________________________ 1.3.4.
Storage conditions: __________________________________________________________________________
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__________________________________________________________________________ 1 1.3.5.
Category of Distribution: Pharmacy Herbal Medicines (to be sold in Pharmacy only) Prescription Only Medicine General sales herbal medicine (OTC) Other Information ____________________________________________________ = 2. Product Composition Product Name (INN) Ingredients (i) (ii) (iii) (iv) (v) (vi) (vii) (viii) Reason for inclusion Qty/Unit Reference Standard 3. Status of Registration in Country of Origin Registered; Date of Registeration ___________________________________________ Not Registered; Reasons: _________________________________________________ _____________________________________________________________________________ 4. Registration Status in other Countries: Country Status a. Registered Pending b. “ “ c. “ “ d. “ “ e. Rejected Where rejected, state reasons.__________________________________________________________ Attach sopporting documents where applicable 2 5. Other information (i) Withdrawn (by applicant before Registration) Country ________________________________________________________________ Date of withdrawal _______________________________________________________ Reason(s) for withdrawal __________________________________________________ Proprietary Name ________________________________________________________ (ii) Withdrawn (by applicant after registration ____________________________________ Country ________________________________________________________________ Reason for withdrawal ____________________________________________________ (iii) Action by competent Authority Suspended Revoked Cancelled Withdrawn Reason(s) ___________________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________________ 6. Applicant’s information Name: _____________________________________________________________________________ Physical Address: ____________________________________________________________________ ___________________________________________________________________________________ Postal Address: ______________________________________________________________________ ___________________________________________________________________________________ ___________________________________________________________________________ Country: ___________________________________________________________________________ ___________________________________________________________________________________ Phone: ______________ Fax: ________________ Mobile: __________________ Email:___________ 7. Distributor’s/Local Agent’s Information(who must be appointed by applicant and submit evidence of power of attorney) Name: _______________________________________________________________________ Physical Address: ______________________________________________________________ Phone: ______________ Fax: ____________ Mobile: ____________ Email: _____________________ 3 8. Manufacturer(s), site(s) for the Pharmaceutical dosage form Name (each site invloved in the Activity – Dosage form Site Physical Name manufacture of the dosage compounding (for each stage address, addresses, forms) where applicable including phone, country qualifications labeling of the personel 9. Source(s), manufacturer(s) of Active Pharmaceuticals ingredient(s) Name: _____________________________________________________________________________ Physical Address: ____________________________________________________________________ Postal Address: ______________________________________________________________________ ___________________________________________________________________________________ Country: ___________________________________________________________________________ Phone: ______________ Fax: ____________ Mobile: ____________ Email: _____________________ 10. Declaration by Applicant: I, the undersigned do hereby certify that all information in this form and all accompanying documents are correct and to the point. I further declare that I have examined all statements and attest to their accuracy. I also agree that I am obliged to adhere to the provisions of the LMHRA which relate to the registration of herbal medicines. All documentation referenced in this submission is available during GMP inspection. Name: ______________________________________________________________ Signature: ___________________________________________________________ Position in Company: __________________________________________________ Date: _____________________ Official Seal 4