RESOURCES

GUIDELINES

Guidelines

Guidelines

wdt_ID wdt_created_by wdt_created_at wdt_last_edited_by wdt_last_edited_at S/N Category Sub Categorgy Guideline Name
1 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 04:45 PM 1 Drug and Nutraceticals Products Allopathic Products Guideline on Variations
2 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 04:48 PM 2 Drug and Nutraceticals Products Allopathic Products FDA Reliance Guideline on Regulatory Decision Making
3 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 05:05 PM 3 Drug and Nutraceticals Products Allopathic Products Guideline on Donation of Drugs
4 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 05:06 PM 4 Drug and Nutraceticals Products Allopathic Products Guideline on Conducting Bioequivalence Studies
5 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 05:27 PM 5 Drug and Nutraceticals Products Allopathic Products Guidelines on Parallel Importation of Medicinal Products
6 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 05:30 PM 6 Drug and Nutraceticals Products Allopathic Products Guidelines on Registration of Allopathic Drugs
7 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 05:37 PM 7 Drug and Nutraceticals Products Allopathic Products Guidelines on Registration of Allopathic Drugs-Quality
8 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 05:40 PM 8 Drug and Nutraceticals Products Allopathic Products Guidelines on Emergency Use Authorization of Medical Products
9 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 05:41 PM 9 Drug and Nutraceticals Products Allopathic Products Guideline on FDA Public Assessment Report
10 Kelvin 15/01/2025 04:22 PM Kelvin 15/01/2025 05:42 PM 10 Drug and Nutraceticals Products Allopathic Products Guideline on Labelling of Drugs

Drug and Nutraceticals Products

Guidelines for the Registration of Allopathic Products

Guideline on Variations
FDA Reliance Guideline on Regulatory Decision Making
Guideline on Donation of Drugs
Guideline on Conducting Bioequivalence Studies
Guidelines on Parallel Importation of Medicinal Products
Guidelines on Registration of Allopathic Drugs
Guidelines on Registration of Allopathic Drugs-Quality
Guidelines on Emergency Use Authorization of Medical Products
Guideline on FDA Public Assessment Report
Guideline on Labelling of Drugs
Guidelines on Naming of Medicinal Products
Guidelines on Registration of Orphan Drugs
Guideline on Registration of Allopathic Medicines Considered for Small Scale Manufacture
Guidelines on Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products
Guideline on Registration of UK Generics
Guideline for Importation of Drugs
Guideline on the Registration of Medicinal Products Classified for Fast Track Processing
Guideline on the Withdrawal, Cancellation or Suspension of Marketing Authorization of Drugs
Process Flow and Timelines for Medicinal Product (Fast Tack) Registration(1)
Process Flow and Timelines for Medicinal Product Variation
Process Flow and Timelines for Medicinal Product Registration
Process Flow and Timelines for Medicinal Product Re-Registration

Safety Monitoring

Guidelines for Adverse Reaction Reporting

Guidelines for Adverse Reaction Reporting

Clinical Trials

Guidelines for Clinical Trials

Guideline for Conduct of Clinical Trial During Emergencies
Guideline for Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices in Ghana
Guidelines for Conduct of Clinical Trials with Paediatric Population
Guidelines on Good Clinical Practice in Ghana
Guidelines on the Content and Procedure for Development and Publication of Public Assessment Reports for Clinical Trial Applications

Guidelines for Facility Licence

Guidelines/ Codes of Practices for Slaughter House/ Slabs, Transportation of Meat, Meat Markets or Shops, Meat Processing & Cold Storage Facilities
Guideline for Conducting cGMP Inspection on Herbal Manufacturing Facilities Located in Ghana
Guideline for Licensing of Food Manufacturing Facility
Guideline for the Establishment of a Food Processing Plant
Waiver for cGMP Inspections of Pharmaceutucal Products, Innovator Vaccines & Biological Product Manufacturers
Guideline for Licensing of Premises for Manufacturing Cosmetics & Household Chemical Substances

Guidelines for the Registration of Food/ Nutrition/ Dietary Supplements

Guidelines for the Registration of Food/ Nutrition/ Dietary Supplements
Guideline on Registration of Veterinary Nutritional Dietary Supplement

Guidelines for the Veterinary Product Registration

Guideline on Registration of Veterinary Medicinal Product
Product Literature Standard for Veterinary Products

Herbal & Homeopathic Medicines

Guidelines for the Herbal & Homeopathic Product

Guidelines for Registration of Herbal Medicine
FDA Reliance Guideline on Regulatory Decision Making

Medical Devices, Cosmetics & Household Chemicals Registration

Cosmetics & Household Chemicals

Guideline for Parallel Importation of Cosmetics & Household Chemicals
Guideline for Registration of Cosmetics & Household Chemicals
Guideline for Labelling Requirements
Registration Requirements for Imported Cosmetic Product
Registration Requirements for Local Cosmetic Products

Medical Devices Registration

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 & Refurbished Medical Equipment
Guidelines for Disposal of Unwholesome Product
Guidelines for Product Recall
Guidelines for Registration of Homemade Face Masks
Guidelines for the Registration of Medical Devices

Tobacco & Substances Of Abuse

Guidelines For The Registration Of Tobacco & Substances Of Abuse

A Guide for Managers on the Prohibition of Smoking in Public Areas
Guidelines for Importation of Controlled Substances
Guidelines for Sales, Supply and Use of Controlled Substances
Guidelines for Labelling of Tobacco Products
Guidelines for the Registration of Tobacco & Tobacco Products
Specifications for Designated Smoking Areas
Specifications for No - Smoking Sign

Food Products

Imported Food Products

General Labelling Requirement
Guidelines For Labelling Food And Food Ingredients Derived From GMOS
Guidelines For Registration As An Importer Of Food
Sample Schedule
Guidelines For Repackaging Of Food Products
Laboratory Reporting Format
Imported Parameters
Labeling Requirements For Infant Formula And Follow-Up Formula
Registration Requirements - Imported Food Products Sample Schedule