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Gambia Application Forms

The document outlines the application process for marketing authorization (registration) of medicines in The Gambia, detailing required information such as product type, manufacturer, marketing authorization holder, and local representative. It includes sections for product composition, indications, pharmacological category, and necessary enclosures. The applicant must certify the accuracy of the information provided and comply with agency requirements.

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Zulfiqar Hussain
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32 views4 pages

Gambia Application Forms

The document outlines the application process for marketing authorization (registration) of medicines in The Gambia, detailing required information such as product type, manufacturer, marketing authorization holder, and local representative. It includes sections for product composition, indications, pharmacological category, and necessary enclosures. The applicant must certify the accuracy of the information provided and comply with agency requirements.

Uploaded by

Zulfiqar Hussain
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

MEDICINES CONTROL AGENCY

Off Bertil Harding Highway, Kotu East, Kanifing Municipality, P.O. Box 3162, Serekunda, The Gambia,
Website: www.mca.gm; E-mail: [email protected]; Tel. No.: +2204380632

APPLICATION FOR MARKETING AUTHORISATION (REGISTRATION)


OF MEDICINES

☐ Generic Medicine ☐ New Chemical Entity (New Active Substance)


☐ Biological ☐ Herbal Medicinal Product ☐ Veterinary Medicine
Proprietary name of the product
International Non-Proprietary Name (INN):

Route of Administration
Dosage form / strength

MANUFACTURER

Name.

Premises/Business Address

Tel
Email Website

MARKETING AUTHORISATION HOLDER (MAH)

Name.

Premises/Business Address

Tel
Email Website

LOCAL REPRESENTATIVE (if applicable)

Name

Address + Full Contact Details

Annex 1 - Guideline for Marketing Authorisation (Registration) of Medicines


MCA-F-112/01, Version 5 – 17 January 2025 Page 1 of 4
Application for Marketing Authorisation (Registration) of Medicines MCA The Gambia

Tel
Email Website

QUALIFIED PERSON FOR PHARMACOVIGILANCE (QPPV)

Name

Address + Full Contact Details

Tel
Email Website

STATUS OF APPLICANT

☐ Manufacturer ☐ MAH ☐ Local Representative ☐ Importer


☐ Other (specify)

COMPOSITION OF PRODUCT:
(name and quantity of active (pharmaceutical) ingredients & excipients)

INDICATIONS AND DOSAGES:

PHARMACOLOGICAL CATEGORY/PHARMACOTHERAPEUTIC GROUP/ATC


CODE:

MARKETING AUTHORISATION (MA)/REGISTRATION IN OTHER COUNTRIES


(Pending or approved):

Annex 1 - Guideline for Marketing Authorisation (Registration) of Medicines


MCA-F-112/01, Version 5 – 17 January 2025 Page 2 of 4
Application for Marketing Authorisation (Registration) of Medicines MCA The Gambia

PACKAGE SIZES AND PRESENTATION

DISPENSING CATEGORY (tick as applicable):

☐ Prescription Only Medicines (POM) ☐ Pharmacy Only Medicine (PM)


☐ Over The Counter Medicines (OTC) ☐ Controlled Drug (CD)
MISCELLANEOUS (Special Conditions, etc.)

ENCLOSURES (tick what is applicable)


☐ CTD Dossier ☐ Manufacturing Licence ☐ GMP Certificate
☐ Container labels ☐ SmPC ☐ Package insert
☐ MA/Registration certificate(s) from country of origin and others, as applicable
☐ Risk management plan (if applicable)
☐ Samples # ☐ Other

DECLARATION:
I, the undersigned certify that the information in the accompanying documentation
concerning the application for marketing authorisation (registration) of the medicine
indicated herein is true and reflects the total information available.
I also agree that I am obliged to comply with the requirements of the Agency
related to the stated product at any time in the future.

Name of Applicant:

Position/Designation and relation to MAH:

Address and Contact Details:

Signature of Applicant: Date:

Annex 1 - Guideline for Marketing Authorisation (Registration) of Medicines


MCA-F-112/01, Version 5 – 17 January 2025 Page 3 of 4
Application for Marketing Authorisation (Registration) of Medicines MCA The Gambia

OFFICIAL USE

Application no:
Comments

Annex 1 - Guideline for Marketing Authorisation (Registration) of Medicines


MCA-F-112/01, Version 5 – 17 January 2025 Page 4 of 4

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