FOOD AND DRUGS AUTHORITY

APPROVED FEES AND

REVENUE ITEMS CHARGES (GH¢)

Verification Fee for Imported Regulated Products

Food 0.80% of CIF Value

Vessel Loads of Food (wheat, rice, sugar, fish, etc) 0.25% of CIF Value

Drugs 1.80% of CIF Value

Medical Devices 1.30% of CIF Value

Cosmetics and Household Chemicals Substances 0.50% of CIF Value

Food Supplements 1.30% of CIF Value

Veterinary Products 1.30% of CIF Value

Registration/Re-registration of Regulated Products

Food

Imported Food Products -

1 - 30 Product(s) 150.00

31 - 500 Products 120.00

501 - 1000 Products 100.00

More than 1000 Products 80.00

Raw Materials for Processing ONLY -

Locally Manufactured Food Products

Cottage Industry 50.00

Small Scale Industry 150.00

Medium Scale Industry 200.00

Large Scale Industry 300.00

Raw Materials for Processing ONLY -

Drugs

Imported Drugs
Cedi Equivalent of USD$
Allopathic Medicinal Products 240.00 per annum
Cedi Equivalent of USD$
Allopathic new Chemical Entities 360.00 per annum
Cedi Equivalent of USD$
Herbal Products 240.00 per annum

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 Cedi Equivalent of USD$
Veterinary Medicines 120.00 per annum
Cedi Equivalent of USD$
Orphan Drug 60.00 per annum
Cedi Equivalent of USD$
Biological Products 100.00 per annum

Hard Gelatin Capsules -

Active Pharmaceutical Ingredient -

Locally Manufactured Drugs

Allopatic Medicinal Products 400.00

Veterinary Products 120.00

Herbal Products 360.00

Orphan Drugs 100.00

MINISTRY OF HEALTH

FOOD AND DRUGS AUTHORITY

APPROVED FEES AND
REVENUE ITEMS CHARGES (GH¢)

Medical Devices

Imported Medical Devices

Cedi Equivalent of USD$
Class IV Medical Devices 160.00 per annum
Cedi Equivalent of USD$
Class III Medical Devices 160.00 per annum

Medical Devices

Imported Medical Devices

Cedi Equivalent of USD$
Class II Medical Devices 100.00 per annum
Cedi Equivalent of USD$
Class I Medical Devices 60.00 per annum

Local Medical Devices 250.00 per annum

Cosmetics and Household Chemicals Substances

Imported Products
Cedi Equivalent of USD$
1 - 30 Product(s) 50.00 per annum
Cedi Equivalent of USD$
31 - 500 Products 30.00 per annum
Cedi Equivalent of USD$
501 - 1000 Products 20.00 per annum

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 Cedi Equivalent of USD$
> 1000 Products 5.00 per annum

Cosmetics and Household Chemical Substances Raw Materials -

Tooth Paste -

Detergent Powder -

Wipes (baby, facial etc) -

Detergent Liquid -

Mosquito Coil -

Mosquito Spray -

Soap (Toilet and Laundry) -

Cosmetic and Household Chemicals -

Locally Manufactured Cosmetics and Household Chemical Substances

Cottage Industry 100.00

Small Scale Industry 200.00

Medium Scale Industry 250.00

Large Scale Industry 300.00

Food Supplements

Imported Food Supplements

100.00 per product per annum
1 - 50 Product(s)
Cedi Equivalent of USD$
51 - 100 Products 70.00 per product per annum
Cedi Equivalent of USD$
More than 100 Products 60.00 per product per annum

Raw Materials -

Locally Manufactured Food Supplements 120.00

Tobacco and Tobacco Products

Cedi Equivalent of USD$
Product Registration (per flavour) 15,000.00

Product Inspection at Port -

MINISTRY OF HEALTH

FOOD AND DRUGS AUTHORITY

APPROVED FEES AND
REVENUE ITEMS CHARGES (GH¢)

Registration Application Forms and Log Books - Cold Chain Monitoring 5.00

Food and Drugs Authority Products Registration Related Services

Label Evaluation

Pre-registration (per product, per variant) 100.00

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Product Name Search

1 - 5 products 50.00

6 - 10 products 100.00

11 - 20 products 200.00

More than 20 products 300.00

Scientific Advice Meeting

Cedi Equivalent of USD$
Foreign (per meeting) 500.00 per activity

Local (per meeting) -

Variations

Foreign
Cedi Equivalent of USD$
Major 500.00
Cedi Equivalent of USD$
Minor 300.00

Variations

Local

Major 200.00

Minor 100.00

Request for Product Information

1 Category 200.00

2 - 5 Categories 500.00

More than 5 Categories 1,000.00

Replacement of Registration Certificate -

Review of Product Information Per Product 600.00

Replacement of Lost Receipts -

Brand Name Reservation 50.00

Facility Inspection

Local Facility Inspections

Large Scale Industry 600.00

Medium Scale Industry 300.00

Small Scale Industry 200.00

Cottage Industry 50.00

Page 477
 Cedi Equivalent of USD$
Good Manufacturing Practice audit and licensing of manufacturing facilities in the free zones enclave 5,000.00

MINISTRY OF HEALTH

FOOD AND DRUGS AUTHORITY

APPROVED FEES AND
REVENUE ITEMS CHARGES (GH¢)

Facility Inspection

Food, Drugs, Medical Devices, Cosmetics and Household Chemical Substances

Foreign Good Manufacturing Practice Audit

Cedi Equivalent of USD$
Africa 4,000.00
Cedi Equivalent of USD$
Outside Africa 7,500.00
Cedi Equivalent of USD$
Tobacco and Tobacco Products 20,000.00

Pharmaceuticals (Allopathic and Veterinary)

Large Scale Industry 3,000.00

Medium Scale Industry 2,000.00

Small Scale Industry 1,000.00

Cedi Equivalent of USD$
Good Manufacturing Practice audit and licensing of manufacturing facilities in the free zones enclave 5,000.00

Herbal

Large Scale Industry 500.00

Medium Scale Industry 400.00

Small Scale Industry 300.00

Cottage Industry 200.00

Cedi Equivalent of USD$
Facilities in the Free Zones Enclave 5,000.00

Medical Devices, Cosmetics and Household Chemical Substances

Large Scale Industry 400.00

Medium Scale Industry 200.00

Small Scale Industry 100.00

Cottage Industry 50.00

Cedi Equivalent of USD$
Facilities in the Free Zones Enclave 5,000.00

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Storage Facility License Inspections

Food, Drugs, Medical Devices, Cosmetics and Household Chemical Substances

Cold Storage and Dry Warehouse Facilities

Large Scale Industry 800.00

Medium Scale Industry 500.00

Small Scale Industry 240.00

Cottage Industry 120.00

Inspection for cold storage facilities for veterinary service permit 800.00

Bonded Warehouse

Category A (Greater than 750m2) 10,000.00

Category B (50 - 750m2) 5,000.00

MINISTRY OF HEALTH

FOOD AND DRUGS AUTHORITY

APPROVED FEES AND
REVENUE ITEMS CHARGES (GH¢)

Storage Facility License Inspections

Food, Drugs, Medical Devices, Cosmetics and Household Chemicals

Food Service Facility Licence Inspections

Large Scale 600.00

Medium Scale 140.00

Small Scale 120.00

Cottage Scale 60.00

Tobacco and Tobacco Products Per Flavor

Large Scale Industry 30,000.00

Medium Scale Industry 15,000.00

Small Scale Industry 10,000.00

Food and Drugs Authority Facility License Related Activity

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Needs Assessment of Facilities

Food
Cedi Equivalent of USD$
Large Scale Industry 300.00
Cedi Equivalent of USD$
Medium Scale Industry 150.00
Cedi Equivalent of USD$
Small Scale Industry 100.00
Cedi Equivalent of USD$
Cottage Industry 50.00

Drugs, Cosmetics, Medical Devices and Household Chemical Substances

Cedi Equivalent of USD$
Large Scale Industry 1,500.00
Cedi Equivalent of USD$
Medium Scale Industry 1,000.00
Cedi Equivalent of USD$
Small Scale Industry 500.00
Cedi Equivalent of USD$
Cottage Industry 250.00

Review and Approval of Facility Floor Plans - Drug Industrial Support

Large Scale Facilities -

Medium Scale Facilities -

Small Scale Facilities -

Cedi Equivalent of USD$
Review and Approval of Facility Floor Plans 300.00

License for Food Distribution Vans 60.00

Cedi Equivalent of USD$
Review of Documents for Facility License 2,000.00

Clinical Trial Authorisation and Monitoring

Foreign Clinical Trial Authorization

Cedi Equivalent of USD$
Industry Funded (Phase I) 15,000.00
Cedi Equivalent of USD$
Industry Funded (Phase II) 12,000.00
Cedi Equivalent of USD
Industry Funded (Phase III) 10,000.00
Cedi Equivalent of USD$
Bioequivalence 3,000.00
Cedi Equivalent of USD$
Investigator (local) phases III & IV 7,000.00

MINISTRY OF HEALTH

FOOD AND DRUGS AUTHORITY

APPROVED FEES AND
REVENUE ITEMS CHARGES (GH¢)

Clinical Trial Authorisation and Monitoring

Foreign Clinical Trial Authorization

Cedi Equivanlet of USD$
Research Institution funded 5,000.00

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 Cedi Equivalent of USD$
Academic Trial 2,000.00
Cedi Equivalent of USD$
Clinical Trials of other products 7,000.00

Clinical Trial Authorisation and Monitoring

Local Clinical Trial Authorization

Bioequivalence 2,000.00

Academic Trial 500.00

Clinical Trials of other products 5,000.00

Non-Routine Good Clinical Practice Inspection

Cedi Equivalent of USD$
Industry Funded (Phase 1) 7,000.00
Cedi Equivalent of USD$
Industry Funded (Phase II) 5,000.00
Cedi Equivalent of USD$
Industry Funded (Phase III) 3,000.00

Investigator (local) phase III and IV 2,500.00

Cedi Equivalent of USD$
Bioequivalence (Foreign / External Inspections) 20,000.00

Bioequivalence (Local inspection) 3,000.00

Pharmacovigilance inspection 300.00

Clinical Trial Protocol Amendment

Industry phase I - III

Cedi Equivalent of USD$
Foreign 1,000.00

Local 500.00

Biological Product

Permit to Import or Export a Biological Specimen

Individual (single lab confirmatory test sample) 200.00

Commercial or Research and Development 2,000.00

Permit to Import or Export a Biological Specimen 200.00

Blood Facility License Inspection

Class I Facility 500.00

Class II Facility 1,000.00

Class III Facility 1,500.00

Class IV Facility 3,000.00

Annual Facility Compliance 500.00

Advertisement Approvals

Page 481
Food, Drugs, Medical Devices, Cosmetics and Household Chemicals

Advertisement Application Per Script, Per Language, Per Medium, 600.00

Fast Track Advertisement Application Per Script, Per Language, Per Medium 1,800.00

MINISTRY OF HEALTH

FOOD AND DRUGS AUTHORITY

APPROVED FEES AND
REVENUE ITEMS CHARGES (GH¢)

Laboratory Testing Services

Request for Analysis

Drugs Medical Devices, Cosmetics, Household Chemicals (Local) 1,300.00

Cedi Equivalent of USD$
Microbiology Sterility Test (Foreign) per sample 300.00

Microbiology and Food Chemistry (Local) per sample 600.00

Microbiology (Local NGO)

Cedi Equivalent of USD$
Full Monograph (Regulatory Agencies) per sample 900.00
Cedi Equivalent of USD$
Full Monograph (Industry - foreign) per sample 1,300.00

Full Monograph (Industry - local) per sample 1,300.00

Sudan Dye Analysis 600.00

Fomalin in fish 100.00

In Vitro Diagnostic Device (IVD) analysis for Medical Devices 2,500.00

Equipment Verification at Site 2,000.00

Condom Sampling and Testing

Cedi Equivalent of USD$
Samples less than 30 1,500.00
Cedi Equivalent of USD$
Samples more than 30 1,300.00

Laboratory Testing Sevices

Re-Analysis of Registration Products

Allopathic Drugs per sample 200.00

Herbal Products 150.00

Medical Devices, Cosmetics, Household Chemical Substances 150.00

Accelerated Stability Testing

Page 482
First Year 3,000.00

Subsequent Year 1,000.00

Additional Certificate 200.00

Long-Term Stability Testing

1 Year 5,000.00

2 Years 3,000.00

More than 3 Years 2,000.00

Safe Disposal

Expired, Unwholesome, Damaged Products

Less than 1 Metric Tons 600.00

1 – 5 Metric Tons 1,200.00

6 – 10 Metric Tons 1,800.00

11 – 15 Metric Tons 2,500.00

15 – 25 Metric Tons 3,500.00

25 – 50 Metric Tons 4,000.00

50 – 100 Metric Tons 5,000.00

More than 101 Metric Tons 6,000.00

Undefined quantities 0.5% of the cost of products

MINISTRY OF HEALTH

FOOD AND DRUGS AUTHORITY

APPROVED FEES AND
REVENUE ITEMS CHARGES (GH¢)

Administrative Charges (Per Offence)

Manufacture, Importation, Sale and Distribution of Food Drugs Authority Non-conforming Regulated Products

Large Scale Industry

High Risk Hazard 50,000.00

Medium Risk Hazard 35,000.00

Low Risk Hazard 25,000.00

Medium Scale Industry

High Risk Hazard 25,000.00

Medium Risk Hazard 15,000.00

Low Risk Hazard 10,000.00

Small Scale Industry

High Risk Hazard 10,000.00

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Medium Risk Hazard 5,000.00

Low Risk Hazard 2,000.00

Re-Scheduling of Inspection

Local Pharmaceutical Plant 1,000.00

Local Herbal Plant 500.00

Non-Compliances or Prohibitions for Tobacco and Tobacco Products

Selling Tobacco to minors 25,000.00

Selling smokeless tobacco or any toy, confectionery or a product that resembles a tobacco product 500.00

Allowing a person to smoke in a non-smoking area 1,000.00

Smoking in a public transport 2,000.00

Manufacturing, importing, selling, distributing, supplying or retailing of unregistered tobacco and tobacco products. 200.00
Manufacturing, importing, selling, distributing, supplying or retailing of smokeless tobacco or any toy, confectionery or a
product that resembles a tobacco product 25,000.00
Designating part(s) of the outdoor licensed area of the premises for smoking and drinking, other than in compliance with
requirements for designated smoking area 25,000.00

Failing to ensure that at a designated smoking area, no services, entertainment is provided 1,000.00

Failing to display a no smoking signage in a public area. 2,000.00

Failing to display a designated signage in a smoking area 1,000.00

Selling cigarette in a packet other than 10 and 20 sticks per pack 1,000.00

Selling or exposing a child to tobacco or its use 5,000.00

Sale of illicit tobacco or tobacco product 1,000.00

Sells or offers for sale a tobacco product without an approved health warning
25,000.00

Advertisements and Promotions of Tobacco & Tobacco Products; and Sponsorship of Programmes by Tobacco companies 25,000.00

Smoking in a private vehicle carrying a child and/or pregnant woman 25,000.00

Conducting Clinical Trials Without Food and Drugs Authority Approval

Individual investigator 10,000.00

Student 2,000.00
Cedi Equivalent of USD$
Studies using unregistered products (Foreign) 2,000.00

Studies using unregistered products (Local) 1,500.00

Amendments to studies using unregistered products 200.00

Cedi Equivalent of USD$
Industry 20,000.00
Cedi Equivalent of USD$
Research Institution 15,000.00

MINISTRY OF HEALTH

FOOD AND DRUGS AUTHORITY

APPROVED FEES AND
REVENUE ITEMS CHARGES (GH¢)
Non-adherence to Clinical Trial Authorization Requirements / Timelines / Implementation of Unapproved Protocol
Amendments.

Critical 25,000.00

Major 15,000.00

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Minor 5,000.00

Airing of Unapproved Advertisements 25,000.00

Administrative Charges (Per Offence)

Permit for movement of Salt

Uniodated Salt (local) 20.00

Uniodated Salt (extractive) 240.00

Export Certificates

Certificate of Free-sale and Manufacture 200.00

Certificate of Pharmaceutical Products (per product) 50.00

Certificate of Export 200.00

Certificate for Palm oil Export 600.00

Supervision Activities

Supervising Operations (per officer, per day) - Relabelling, Repackaging, Sorting etc. 300.00

Sorting of Bulk Cargo 2% of CIF Value

Training Services

Good Manufacturing Practices (GMP) 100.00

Good Hygienic Practices (GHP) 100.00

Good Warehouse Practices (GWP) 100.00

Specialised Trainings

Food Safety Supervisors' Course (3 Days) - Introductory Level - Per Person 500.00

Food Safety Supervisors' Course (3 Days) - Intermediate Level - Per Person 500.00

Food Safety Supervisors' Course (3 Days) - Advance Level - Per Person 800.00

Hazard Analysis Critical Control Points -Introductory Level-Per Person 600.00

Hazard Analysis Critical Control Points -Advance Level-Per Person 800.00

Hazard Analysis Critical Control Points System Validation and Issue of Certificate - Small Scale - 3 Years 500.00

Hazard Analysis Critical Control Points System Validation and Issue of Certificate - Medium Scale - 3 Years 1,000.00

Hazard Analysis Critical Control Points System Validation and Issue of Certificate - Large Scale - 3 Years 2,000.00

Hazard Analysis Critical Control Points System -Training, Installation and Issue of Certificate - Small Scale - 3 Years 2,500.00

Hazard Analysis Critical Control Points System -Training, Installation and Issue of Certificate - Medium Scale - 3 Years 5,000.00

Hazard Analysis Critical Control Points System -Training, Installation and Issue of Certificate - Large Scale - 3 Years 10,000.00

Renewal of Hazard Analysis Critical Control Points Certificate - Small Scale - 3 Years 500.00

Renewal of Hazard Analysis Critical Control Points Certificate - Medium Scale - 3 Years 1,000.00

Renewal of Hazard Analysis Critical Control Points Certificate - Large Scale - 3 Years 2,000.00

Installation of Food Stafey and Management System ([Link] Analysis Critical Control Points) 10,000.00

Page 485
Renewal of Food and Drugs Authority Installed Food Safety Management System Certificate

Small Scale 500.00

Medium to large scale Company 1,000.00

Audit and issuance of Food Safety Management System Certificates to Company with pre-installed systems 2,000.00

MINISTRY OF HEALTH

FOOD AND DRUGS AUTHORITY

APPROVED FEES AND
REVENUE ITEMS CHARGES (GH¢)

Exemption Certificates

VAT Exemption Recommendation Letter 100.00

Procurement of Goods and Services

Registration of Service Providers

Supplier of Services 200.00

Supplier of Goods 200.00

Page 486