MCA-F-115/01, Version 1 – 19 April 2021 — Related Product Registration Application — complete version 1 form
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Contents
MEDICINES CONTROL AGENCY
MCA
THE GAMBIA
MEDICINES CONTROL AGENCY
Kairaba Avenue, K.S.M.D. Pipeline, The Gambia. Telephone: (+220)4380632, www.mca.gm
RELATED PRODUCT REGISTRATION APPLICATION
Medical Device ☐ In-vitro Diagnostic ☐ Household Chemical Substance ☐
Cosmetic ☐ Other ☐ (Specify)
Renewal ☐ MCA Product Registration Number
Name of Product
Description of Product
MANUFACTURER
Name.
Premises/Business Address
Tel Email Website
RESPONSIBLE PERSON
Name.
Premises/Business Address
Tel Email Website
APPLICANT
Name
Address + Full Contact Details
Tel Email Website
STATUS OF APPLICANT
Manufacturer ☐ Responsible Person ☐ Importer ☐ National Representative ☐
Other ☐ (please specify)
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Related Product Registration Application MCA The Gambia
IF MEDICAL DEVICE: NA ☐
General Medical Device ☐ Medical Equipment ☐ Implantable Medical Device ☐
(Specify)
INTENDED USE / INDICATIONS:
IF IN-VITRO DIAGNOSTIC: NA ☐
Kit ☐ Reagent ☐ Other ☐ (Specify)
TEST PURPOSE
IF COSMETIC OR HOUSHOLD CHEMICAL SUBSTANCE NA ☐
Ingredients:
CLAIM(S)
PACKAGE SIZE/NET WEIGHT/LENGTH/VOLUME/NUMBER OF UNITS
MISCELLANEOUS (Special Conditions, etc.)
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Related Product Registration Application MCA The Gambia
ENCLOSURES (mark as X)
Instructions for use ☐ Technical documentation ☐ Labels ☐
Declaration of Conformity ☐ Product Verification and Validation Documents ☐
Registration certificate(s) from country of origin and others, where applicable ☐
Other Documents ☐
DECLARATION:
I, the undersigned certify that the information in the accompanying documentation concerning
the application for 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
products at any time in the future.
Name of Applicant:
Position/Designation:
Address and Contact Details:
Signature of Applicant: Date:
OFFICIAL USE
Application no:
Comments
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