Ghana

All images from the US CIA World Factbook

Territory – Ghana
Food and Drugs Authority
Language – English

GUIDELINES

AGRO PRODUCTS AND BIOSAFETY

· GUIDELINE FOR LICENSING AGRO-PRODUCE PACKAGING AND STORAGE FACILITIES

ANIMAL PRODUCTS

· GUIDELINES/CODES OF PRACTICES FOR SLAUGHTER HOUSES/SLABS, TRANSPORTATION OF MEAT, MEAT MARKETS OR SHOPS, MEAT PROCESSING AND COLD STORAGE FACILITIES

BIOLOGICAL PRODUCTS

· GUIDELINES FOR APPLICATION TO IMPORT UNREGISTERED BIOLOGICAL PRODUCT FOR A NAMED PATIENT

· GUIDELINES FOR EMERGENCY USE AUTHORIZATION OF A MEDICAL PRODUCT IN GHANA

· GUIDELINES FOR LICENSING BLOOD FACILITIES AND BLOOD PRODUCTS LISTING

· GUIDELINES FOR REGISTRATION OF BIOLOGICAL PRODUCTS

· GUIDELINES FOR REGISTRATION OF BIOSIMILAR PRODUCTS

· GUIDELINES FOR REGISTRATION OF PLASMA DERIVED MEDICINAL PRODUCTS

· GUIDELINES FOR REGISTRATION OF SNAKE ANTIVENOMS

· GUIDELINES FOR REGISTRATION OF VACCINES

· GUIDELINES FOR REGISTRATION OF VETERINARY BIOLOGICAL PRODUCTS

· GUIDELINES FOR REPORTING VARIATIONS TO BIOLOGICAL PRODUCTS

· REGULATORY FRAMEWORK FOR BLOOD, BLOOD COMPONENTS AND BLOOD PRODUCTS

CENTRE FOR IMPORT AND EXPORT CONTROL

· EXPORT PERMIT AND CLEARANCE OF COSMETICS, MED DEVICES AND HOUSEHOLD CHEMICAL SUBSTANCES GUIDELINES

· EXPORT PERMIT AND CLEARANCE OF FRESH FRUITS AND VEGETABLES GUIDELINE

· EXPORT PERMIT AND CLEARANCE OF PALM OIL GUIDELINES

· EXPORT PERMIT AND CLEARANCE OF PHARMACEUTICAL PRODUCTS GUIDELINE

· EXPORT PERMIT AND CLEARANCE OF PREPACKAGED FOODS

· EXPORT PERMIT OF FROZEN MEAT, FISH, AND OTHER AQUATIC INVERTEBRATES GUIDELINES

· GUIDELINES FOR PERSONAL EFFECT

· GUIDELINES IMPORTERS REGISTRATION

· IMPORT PERMIT AND CLEARANCE OF COSMETICS MED DEVICES AND HOUSEHOLD CHEMICALS SUBSTANCES

· IMPORT PERMIT AND CLEARANCE OF PHARMACEUTICAL PRODUCTS GUIDELINE

· IMPORT PERMIT AND CLEARANCE OF PREPACKAGED FOOD GUIDELINE

· IMPORT PERMIT FOR FRESH FRUITS AND VEGETABLES GUIDELINES

· IMPORT PERMIT FOR FROZEN MEAT, FISH, AND OTHER AQUATIC INVERTEBRATES GUIDELINES

CLINICAL TRIALS

· CLINICAL TRIAL MANUAL (RCORE)

· GUIDELINES FOR AUTHORIZATION OF CLINICAL TRIALS IN GHANA

· GUIDELINES FOR CONDUCT OF CLINICAL TRIALS WITH PAEDIATRIC POPULATION

· GUIDELINES FOR TRIALS IN EMERGENCIES.

· GUIDELINES ON GOOD CLINICAL PRACTICE IN GHANA

COSMETICS AND HOUSEHOLD CHEMICAL SUBSTANCES

· GUIDELINE FOR PARALLEL IMPORTATION OF COSMETICS AND HOUSEHOLD CHEMICALS

· GUIDELINE FOR REGISTRATION OF COSMETIC AND HOUSEHOLD

· GUIDELINE LABELLING REQUIREMENTS

· REGISTRATION REQUIREMENTS FOR IMPORTED COSMETIC PRODUCT

· REGISTRATION REQUIREMENTS FOR LOCAL COSMETIC PRODUCT

DRUG EVALUATION AND REGISTRATION

· FDA RELIANCE POLICY

· FDA VARIATION GUIDANCE

· GUIDELINE FOR DONATION OF DRUGS

· GUIDELINE FOR SMALL SCALE MANUFACTURERS OF ALLOPATHIC DRUGS

· GUIDELINES FOR CONDUCTING BIOEQUIVALENCE STUDIES

· GUIDELINES FOR IMPORTATION OF DRUGS

· GUIDELINES FOR PARALLEL IMPORTATION OF MEDICINAL PRODUCTS

· GUIDELINES FOR REGISTRATION OF ALLOPATHIC DRUGS

· GUIDELINES FOR REGISTRATION OF ALLOPATHIC DRUGS-QUALITY

· GUIDELINES FOR REGISTRATION OF UK GENERICS

· GUIDELINES FOR REGISTRATION OF VETERINARY MEDICINAL PRODUCTS

· GUIDELINES FOR REGISTRATION OF VETERINARY NUTRITIONAL-DIETARY SUPPLEMENTS

· GUIDELINES FOR STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENTS AND FINISHED PHARMACEUTICAL PRODUCTS

· GUIDELINES FOR THE CANCELLATION SUSPENSION OF MARKETING AUTHORIZATION OF DRUGS

· GUIDELINES FOR THE REGISTRATION OF MEDICINAL PRODUCTS CLASSIFIED FOR FAST TRACK PROCESSING

· GUIDELINES ON LABELLING OF MEDICINAL PRODUCTS

· GUIDELINES ON REGISTRATION OF ORPHAN DRUGS

· PRODUCT LITERATURE STANDARD FOR VETERINARY PRODUCTS

· SAMPLE SCHEDULE FOR REGISTRATION AND RE-REGISTRATION OF PRODUCTS

· TEMPLATE LABELLING

· TEMPLATE PATIENT INFORMATION LEAFLET

· TEMPLATE QUALITY INFORMATION SYSTEM(QIS)

· TEMPLATE QUALITY OVERALL SUMMARY: PRODUCT DOSSIER (QOS-PD)

· TIMELINES FOR MEDICINAL PRODUCT RE-REGISTRATION

· TIMELINES FOR MEDICINAL PRODUCT REGISTRATION

DRUG INSPECTORATE

· GUIDELINE FOR GDP AND GSP INSPECTION OF STORAGE FACILITIES

· GUIDELINE FOR GMP INSPECTION OF MANUFACTURING FACILITIES

· GUIDELINE-LICENSING PHARMACEUTICAL AND HERBAL MANUFACTURING FACILITIES

· GUIDELINE-LICENSING WHOLESALE DISTRIBUTORS OF PHARMACEUTICAL PRODUCTS, HERBAL MEDICINES AND FOOD SUPPLEMENTS

· GUIDELINES FOR CONDUCTING cGMP INSPECTION OF HERBAL MANUFACTURING FACILITIES LOCATED IN GHANA

· WAIVERS FOR cGMP INSPECTIONS OF PHARMACEUTICAL PRODUCTS, INNOVATOR VACCINES AND BIOLOGICAL PRODUCT MANUFACTURERS

DRUG MARKET SURVEILLANCE

· GUIDELINES FOR ADVERTISEMENT OF DRUGS, MEDICAL DEVICES, COSMETICS AND HOUSEHOLD CHEMICALS

· GUIDELINES FOR PRODUCT RECALL

· GUIDELINES FOR SAFE DISPOSAL OF UNWHOLESOME PRODUCTS

FOOD ENFORCEMENT

· GUIDELINES FOR LICENSING OF FOOD MANUFACTURING FACILITY

· GUIDELINES FOR THE ADVERTISEMENT OF FOOD

· GUIDELINES FOR THE ESTABLISHMENT OF A FOOD PROCESSING PLANT

· GUIDELINES FOR THE ESTABLISHMENT OF A FOOD STORAGE FACILITY

· GUIDELINES FOR THE LICENSING OF A FOOD STORAGE FACILITIES

FOOD EVALUATION AND REGISTRATION

· FOOD PRODUCT CATEGORY & PARAMETER REQUIREMENTS FOR IMPORTED FOOD PRODUCT REGISTRATION

· FOOD PRODUCT CATEGORY & PARAMETER REQUIREMENTS FOR LOCAL FOOD PRODUCT REGISTRATION

· GENERAL LABELLING REQUIREMENTS

· LABELING REQUIREMENTS FOR INFANT FORMULA & FOLLOW-UP FORMULA

· LABORATORY REPORTING FORMAT

· REGISTRATION REQUIREMENTS FOR IMPORTED FOOD

· REGISTRATION REQUIREMENTS- LOCALLY MANUFACTURED FOOD PRODUCT

· SAMPLE SCHEDULE

· TEST PARAMETER REQUIREMENTS FOR FOOD PRODUCT REGISTRATION

FOOD MARKET SURVEILLANCE

· GUIDELINE FOR THE SAFE DISPOSAL OF UNWHOLESOME FOOD PRODUCTS

· GUIDELINES FOR REPACKAGING OF FOOD PRODUCT

FOOD SAFETY MANAGEMENT

· CODE OF HYGIENIC PRACTICE FOR FOOD SERVICE ESTABLISHMENT

· FOOD SERVICES ESTABLISHMENT INSPECTION CHECKLIST/REPORT

· GUIDELINES FOR HANDLING FOOD POISON OUTBREAKS

· GUIDELINES FOR THE LICENSING OF A FOOD SERVICE ESTABLISHMENT

· MANUAL FOR FOODBORNE DISEASE SURVEILLANCE IN GHANA

· NATIONAL FOOD SAFETY EMERGENCY RESPONSE PLAN

HERBAL MEDICINE

· GUIDELINE FOR REGISTRATION OF HERBAL MEDICINAL- PRODUCTS

· GUIDELINES FOR REGISTRATION OF HOMEOPATHIC MEDICINES

· GUIDELINES FOR THE REGISTRATION OF FOOD SUPPLEMENTS

MEDICAL DEVICES

· GUIDELINE FOR DONATION OF MEDICAL DEVICES

· GUIDELINE FOR IMPORTATION OF MEDICAL DEVICES

· GUIDELINE FOR NAMING OF MEDICAL DEVICES

· GUIDELINE FOR REGISTRATION OF SOFTWARE AS MEDICAL DEVICE

· GUIDELINE FOR USED AND REFURBISHED MEDICAL EQUIPMENT

· GUIDELINES FOR ADVERTISEMENT OF DRUGS, MEDICAL DEVICE, COSMETIC AND HOUSEHOLD CHEMICALS

· GUIDELINES FOR AUTHORISATION FOR EMERGENCY USE RDTs FOR SARS-CoV-2 VIRUS

· GUIDELINES FOR DISPOSAL OF UNWHOLESOME PRODUCT

· GUIDELINES FOR PRODUCT RECALL

· GUIDELINES FOR THE REGISTRATION OF HOMEMADE FACEMASKS

· GUIDELINES FOR THE REGISTRATION OF MEDICAL DEVICES

MEDICAL DEVICES, COSMETICS & HOUSEHOLD CHEMICAL SUBSTANCES INSPECTORATE

· GUIDELINE FOR LICENSING OF PREMISES FOR MANUFACTURING COSMETICS AND HOUSEHOLD CHEMICAL SUBSTANCES

· GUIDELINE FOR LICENSING OF PREMISES FOR MANUFACTURING MEDICAL DEVICES

· GUIDELINE FOR LICENSING OF PREMISES FOR THE STORAGE AND DISTRIBUTION OF COSMETICS AND HOUSEHOLD CHEMICAL SUBSTANCES

· GUIDELINE FOR USED AND REFURBISHED MEDICAL EQUIPMENT

· GUIDELINES FOR LICENSING OF PREMISES FOR THE STORAGE AND DISTRIBUTION OF MEDICAL DEVICES

SAFETY MONITORING

· ADVERSE REACTION REPORTING FORMS

· FDA PRIVACY POLICY FOR INDIVIDUAL CASE SAFETY REPORTS

· GUIDELINES FOR ADVERSE REACTION REPORTING

· GUIDELINES FOR CONDUCTING PHARMACOVIGILANCE INSPECTIONS

· GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE

· GUIDELINES FOR SAFETY MONITORING OF MEDICINAL PRODUCTS

TOBACCO AND SUBSTANCE OF ABUSE

· A GUIDE FOR MANAGERS ON THE PROHIBITION OF SMOKING IN PUBLIC PLACES

· GUIDELINES FOR IMPORTATION OF CONTROLLED SUBSTANCES

· GUIDELINES FOR SALES, SUPPLY AND USE OF CONTROLLED SUBSTANCE

· GUIDELINES FOR THE LABELLING OF TOBACCO PRODUCTS

· GUIDELINES FOR THE REGISTRATION OF TOBACCO AND TOBACCO PRODUCTS

· SPECIFICATIONS FOR DESIGNATED SMOKING AREAS

· SPECIFICATIONS FOR NO-SMOKING SIGN

PUBLICATIONS

11TH TRAINING PROGRAMME FOR QUALIFIED PERSONS FOR PHARMACOVIGILANCE

12TH TRAINING PROGRAMME FOR QUALIFIED PERSONS FOR PHARMACOVIGILANCE

13TH TRAINING PROGRAMME FOR QUALIFIED PERSONS FOR PHARMACOVIGILANCE

3RD EXPRESSION OF INTEREST (EOI) FOR MEDICAL PRODUCTS FOR THE ECOWAS JOINT ASSESSMENT PROCEDURE UNDER THE WEST AFRICA MEDICINES REGULATORY HARMONIZATION (WA-MRH)

ADVANCEMENT OF TOBACCO CONTROL IN GHANA BARRIERS & OPPORTUNITIES – A BRIEF SITUATION REPORT

APPLICATION FORM FOR 2022 VIRTUAL ANNUAL GOOD CLINICAL PRACTICE TRAINING

ARTICLE – WORLD NO TOBACCO DAY 2023

CLINICAL TRIAL REGISTRY

CODE OF PRACTICE FOR SALES

COVID-19 VACCINE SAFETY MONITORING STRATEGY

COVID-19 VACCINES GRANTED EMERGENCY USE AUTHORIZATION (EUA) BY THE GHANA FOOD AND DRUGS AUTHORITY (FDA)

EFFECTS OF THE USE OF POLYETHYLENE FOR PACKAGING FANTE KENKEY

EXECUTIVE INSTRUMENT 167

EXECUTIVE INSTRUMENT 168

FAPAR – PUBLIC ASSESSMENT REPORT TABLE TO APPLICANTS

FAQs ON R21 MALARIA VACCINE

FDA CLIENT SERVICE DELIVERY CHARTER

FDA Holds Maiden Stakeholder Meeting on Regulatory Activities and 2022 Performance

FDA PRIVACY POLICY FOR INDIVIDUAL CASE SAFETY REPORTS

FDA RELIANCE POLICY

FDA’s EMERGENCY USE AUTHORISATION FOR MEDICAL PRODUCTS

FOOD AND DRUGS AUTHORITY DRAFT GUIDELINES COMMENTS SHEET

FOURTH UPDATE ON THE SAFETY MONITORING OF MEDICINES FOR THE TREATMENT OF COVID-19 FROM 1ST APRIL TO 31ST AUGUST 2020

FREQUENTLY ASKED QUESTIONS ON COVID-19 VACCINE SAFETY (Ghana)

GUIDELINES FOR EMERGENCY USE AUTHORIZATION OF MEDICAL PRODUCTS IN GHANA

Guidelines For Haemovigilance in Ghana

GUIDELINES FOR THE PUBLICATION OF GMP INSPECTION REPORT

GUIDELINES FOR THE RETAIL AND WHOLESALE OF CONTROLLED SUBSTANCES

HARMFUL EFFECTS ON TOBACCO

HUMAN RESOURCE POLICY FRAMEWORK & MANUAL, Ghana Public Services

JOINT COVID-19 VACCINE SAFETY REVIEW COMMITTEE

LIST OF APPROVED ADVERTISEMENTS (DRUGS) – JANUARY TO JUNE 2023

LIST OF APPROVED ADVERTS (JANUARY TO DECEMBER 2022)

LIST OF CONTROLLED SUBSTANCES REGULATED BY FOOD AND DRUGS AUTHORITY

LIST OF COVID-19 APPROVED MEDICAL DEVICES FOR EMERGENCY USE

LIST OF FDA REGISTERED COVID-19 ANTIGEN RAPID DIAGNOSTIC TEST KITS

LIST OF LICENSED ANIMAL PRODUCTS COLD STORAGE FACILITIES

LIST OF LICENSED BLOOD FACILITIES IN GHANA

LIST OF LICENSED FOOD STORAGE FACILTIES

LIST OF LICENSED FOREIGN FOOD MANUFACTURING FACILITIES

LIST OF LICENSED FOREIGN MEDICAL DEVICES COSMETICS AND HOUSEHOLD CHEMICAL SUBSTANCES MANUFACTURING FACILITIES

LIST OF LICENSED FOREIGN PHARMACEUTICAL MANUFACTURING FACILITIES

LIST OF LICENSED LOCAL AGRO PRODUCTS PACKHOUSES

LIST OF LICENSED LOCAL ANIMAL FEED MANUFACTURING FACILITIES

LIST OF LICENSED LOCAL ANIMAL PRODUCTS PROCESSING FACILITIES

LIST OF LICENSED LOCAL FEED WAREHOUSE FACILITIES

LIST OF LICENSED LOCAL FOOD MANUFACTURING FACILITIES

LIST OF LICENSED LOCAL MEDICAL DEVICES COSMETICS AND HOUSEHOLD CHEMICAL SUBSTANCES (MDCHC) MANUFACTURING FACILITIES

LIST OF LICENSED MDCHC STORAGE FACILTIES

LIST OF LICENSED MEAT SHOP FACILITIES

LIST OF LICENSED PHARMACEUTICALS STORAGE FACILITIES

LIST OF MARKETING AUTHORISATION HOLDERS WHO HAVE UNDERGONE GOOD PHARMACOVIGILVANCE PRACTICE INSPECTION

LIST OF PCR CENTERS IN GHANA

LIST OF QUALIFIED PERSONS FOR PHARMACOVIGILANCE

MADE-IN-GHANA POLICY BRIEF

MALARIA VACCINE IMPLEMENTATION PROGRAM UPDATE APRIL 2020

MALARIA VACCINE IMPLEMENTATION PROGRAMME JULY UPDATE

MARKET AUHTORISATION HOLDERS COMPLIANT WITH SECTION 125 OF THE PUBLIC HEALTH ACT, ACT 851

NATIONAL FOOD SAFETY EMERGENCY RESPONSE PLAN(FOSERP)

NATIONAL FOOD SAFETY POLICY

National Haemovigilance Framework for Ghana

NOTICE OF VACANCY FOR A PATHOLOGIST

NOTICE TO IMPORTERS AND MANUFACTURERS OF PHARMACEUTICAL, FOOD AND COSMETIC PRODUCTS

PICTORIAL HEALTH WARNING (PHWs) IMPLEMENTATION ON TOBACCO AND TOBACCO PRODUCTS PACKAGES

PUBLIC NOTICE

Qualified Persons for Pharmacovigilance with Good Standing

RESTRICTED LIST OF PHARMACEUTICAL PRODUCTS

SAFETY MONITORING OF MALARIA VACCINE (7TH UPDATE)

SAFETY MONITORING OF THE MALARIA VACCINE (UPDATE NO.4)

SUMMARY ON BERC-AFRICA PROJECT FUNDED BY EUROPEAN AND DEVELOPMENT COUNTRIES CLINICAL TRIALS PARTNERSHIP(EDCTP)

SUMMARY REPORT R21 MALARIA VACCINE (RECOMBINANT ADJUVANTED)

Terms of Reference to recruit a consultant for the CEPI LASSA ML enhancement 2d

THE ROLE AND PARTNERSHIP OF THE FOOD AND DRUGS AUTHORITY (FDA) WITH THE AFRICAN CONTINENTAL FREE TRADE AREA (AfCFTA)

WAIVERS FOR CURRENT GOOD MANUFACTURING PRACTICES (cGMP) INSPECTIONS FOR PHARMACEUTICAL PRODUCTS, INNOVATOR VACCINES AND BIOLOGICAL PRODUCTS

WEARING OF DOUBLE FACE MASKS FOR COVID-19 PREVENTION IN THE WAKE OF EMERGING NEW SARS-COV-2 VARIANTS – THE FDA’s PERSPECTIVE

WORLD NO TOBACCO DAY 2023 E-FLYERS