Guidelines and Forms

GHANA

Guidelines for GMP Inspection – Jan 2018

Variation Guidelines-Oct 2016

Registration form class II-IV Medical Device-171130

Registration form class I Medical Device-171130

Ghana Guidelines for registration of veterinary supplements – 170811

Ghana Product Label Template-Veterinary – 170811

Ghana Guidelines for registration of veterinary medicinal products – 170811

Ghana GDP Guideline 170508

Ghana Guidelines for QPPV 170120

Ghana Guidelines for QPPV-3 160501

Ghana Guidelines for Safety Monitoring of Products 160501

Ghana Guidelines for Adverse Reaction Reporting 161228

Guidelines for Safety Monitoring of Products V2

Guidelines for QPPV

Guidelines for Adverse Reaction Reporting

Ghana Guidelines for Adverse Reaction Reporting 160501

Ghana Guidelines for QPPV-3 160501

Ghana Guidelines for Safety Monitoring of Products 160501

Application for registration of biological products

Application form for registration renewal of biological products

Application form for the registration of allopathic drug CTD – Mar 2013

Application for variation

Application form for variations to a biological product – 2015

Guidelines Biological products

Guidelines for conducting clinical trials of medicines, food supplements, vaccines and medical devices in Ghana

Guidelines for conducting pharmacovigilance inspections

Guideline for importation of medical device

Guideline for importation of medical device REG

Guidelines for licensing blood facilities and blood products listing – 2016

Guideline for reporting adverse reaction

Guidelines for selection of qualified person for pharacovigilance

Guidelines for surveillance of adverse events following immunization in Ghana

Guidelines for the advertisement of drugs, herbal medicines, cosmetics, medical devices & household chemicals

Guidelines for conducting bioequivalence studies

Guidelines for registration of allopathic drugs (human & veterinary) – CTD Format

Guidelines for registration of world health organization (WHO) pre-qualified biological products

Guidelines for stability testing of active pharmaceutical ingredients and finished pharmaceutical products

Sample schedule for registration

Template labeling

Template patient information

Template summary of product characteristics

ARCHIVED

Variation guidelines for allopathic medicines

Registration of medical device – 2013

Ghana Guidelines for Adverse Reaction Reporting 160501

Guidelines for QPPV V2

Guidelines for Safety Monitoring of Products V1

Guidelines for Adverse Reaction Reporting V2

Guidelines for Adverse Reaction Reporting V3

Guidelines for QPPV V3

Guidelines for Safety Monitoring of Products

 

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