The Centre for Import and Export Control (CIEC) of the Food and Drugs Authority (FDA) is mandated by Sections 99 and 118 of the Public Health Act 2012 (Act 851) to regulate the importation and exportation of food, drugs, cosmetics, household chemical substances, medical devices, tobacco, and tobacco products, as well as blood and blood products.

The FDA believes that unregistered imported and exported products compromise the health and safety of the consuming public. Thus, it has declared zero tolerance for the importation and exportation of unregistered products and the CIEC’s operations are carried out at all the various ports of entry and exit to ensure control.

The CIEC, coordinates activities relating to the issuance of permits at these ports:

• Hamile in the Upper West Region
• Tumu in the Upper West Region
• Kulumbungu in the Upper East Region
• Pulmakom in the Upper East Region
• Gonokrom in the Bono Region
• Akanu Border in the Volta Region
• Aflao Border in the Volta Region
• Takoradi Port in the Western Region
• Elubo border in the Western Region
• Tema Seaport in the Greater Accra Region
• Kotoka International Airport (KIA) in the Greater Accra Region

Importation of pharmaceutical products is however restricted to Tema Port and the Kotoka International Airport.

WHY FDA’s OPERATIONS AT THE PORTS ARE IMPORTANT

The FDA has a presence at all the ports of entry and exit for the following reasons:

To ensure that imported regulated products that reach the consuming public are safe, of good quality and efficacious (in the case of drugs);

To ensure that registered imported regulated products are of the same standards as when they were registered;

To identify unregistered imported regulated products for registration;

To regulate products earmarked for export;

To license custom bonded warehouses for regulated products.

HOW DOES THE FDA FUNCTION AT THE PORTS?

To enable the FDA to meet its set objectives, the Authority has set out five main operational functions that encapsulate the FDA’s activities at the Port.

These are the:

1. Permit Control: which manages Import and Export Permits on the Integrated Customs Management System (ICUMS) Platform.
2. Import Operations: Import Inspections and Post Clearance Activities (Re-work – Re-bagging/ Repackaging, Relabeling, Sorting and Safe Disposal).
3. Export Operations: Export Inspections and Issuance of Certificate of Free Sale and Manufacture.
4. Customs Bonded Warehouse Inspections and Licensing: Ensure adherence to regulations where importers defer payment of duties and taxes for their goods to be kept under customs control in a government or private owned warehouse.
5. Quality Assurance and Inspection Control (QAIC): this includes Mini Laboratory Services, Quality Management Systems per ISO 9001:2015, inspection of Uncleared Cargo Listed (UCL) for auction and Consumer Complaint Investigations.

FDA REGULATED PRODUCTS: WHAT IMPORTERS MUST KNOW

• Ensure you have registered the product prior to importation (refer to FDA’s website for more details on the registration process).
• Furnish your clearing agent with all relevant information on the registered product(s) ahead of time.
• Ensure you have secured allocation for the importation of medicinal narcotic and psychotropic substances before importing same.
• Importers of raw materials for the manufacture of FDA regulated products should have their manufacturing facilities licensed or must be registered as an importer of the raw materials.
• Remember, FDA import and export permits are valid for one year. Process your import permit application ahead of time.
• The Superintendent Pharmacist is responsible for the import/export of pharmaceutical and biological products and is liable for professional misconduct if FDA regulations are not adhered to.

FDA REGULATED PRODUCTS: WHAT EXPORTERS MUST KNOW

• Submit your letter of intent for the export of FDA regulated products to the FDA’s Head Office, Accra, FDA Heights, Tema, or any of FDA’s Regional Offices across Ghana.
• Ensure the following documents are attached to your letter of intent:
• Packing list indicating product details and quantities.
• Commercial invoice
• Copy of FDA product registration certificate
• Certificates of analysis of the products
• Phytosanitary reports (where applicable)

NOTE:

• For every consignment of palm oil to be exported, the products must be tested for the presence of Sudan IV dye before export.
• All FDA regulated products being exported must always be accompanied by the following:
• Approved Export Permit
• Manufacture and Free Sale Certificate

WHAT CLEARING AGENTS OF FDA-REGULATED PRODUCT NEED TO KNOW

• Clearing Agents do not have to wait for their consignment to arrive before applying for a permit.
• Ensure that the IMPORTER has acquired the appropriate and valid FDA product registration number(s) or certificate(s).
• Select the appropriate permit type and clearly state the purpose for importing the product(s).
• Always input correct product registration numbers and product information in the application system.
• Ensure you have made all your payments for the consignment to be cleared. (Check www.fda.gov.gh for the fee schedule).
• Application for permits for personal effects should be made online on the ICUMS system by choosing FDA Permit FD16 Personal Effects Permit.
• The FDA’s verification fees can be paid using any of the payment options provided by the Government of Ghana at www.portal.ghana.gov.gh and via FDA Mobile Money Platforms. Please contact FDA offices for Mobile Money numbers.

NOTE:

• The FDA issues IMPORT PERMITS NOT CLEARING PERMIT for regulated products.
• Verification and final release of consignments by the FDA can only be done when the permit is approved.

USE THE FOLLOWING

1. Cash
2. Momo (*222*1060#)
3. Transfer – Direct Bank Transfer
4. Only Banker’s Draft payable to FDA
5. gov
6. Card Payment (POS) scan QR code available at the front office.

NB: For MoMo payments, please indicate as reference the name of your company and the service being paid for. e.g., ABC Limited, Registration

COMMON ERRORS BY APPLICANTS

Submitting incorrect manufacturer/ applicant/ importer name and address.

Submitting incorrect product name(s) and registration number(s).

Submitting incorrect or incomplete product descriptions.

Attaching the wrong packing list/ bill of lading to the online application.

Completing the wrong permit application forms eg. choosing food permit instead of medical devices import permit.

THINGS TO NOTE

The FDA has declared ZERO TOLERANCE FOR UNREGISTERED IMPORTED PRODUCTS.

Items declared as product samples must comply with the FDA sample schedule.

The FDA does not allow “trial of the market” for regulated products. This may compromise the safety of consumers.

The FDA will re-export or confiscate and dispose of any unregistered regulated products imported into the country in commercial quantities without prior registration approval.