NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Labelling of Investigational Medicinal Products
Ministry of Health, Nigeria
Labelling is an important and integral part of the approval of a medicinal product. This also applies to the Investigational Medicinal Product (IMP) in Clinical Trials (CTs). The purpose of regulatory labelling requirements for investigational medicinal products (IMPs) in Clinical Trials (CTs) is to provide added value regarding the protection of the subjects, Identification of the IMP, traceability of the IMP, proper use of the IMP, identification of trial and proper documentation of the trial.
Process Flow
Department of Drug Evaluation and Research ⬤
Office of the Director General NAFDAC ⬤
Office of the Permanent Secretary, Ministry of Health ⬤
Office of the Minister of State for Health ⬤
Office of the minister for health ⬤
Federal Executive Council ⬤
NAFDAC Drug Evaluation & Research (DER) Directorate Guidelines for Labelling of Investigational Medicinal Products Current Version
January 2022
Labelling is an important and integral part of the approval of a medicinal product. This also applies to the Investigational Medicinal Product (IMP) in Clinical Trials (CTs). The purpose of regulatory labelling requirements for investigational medicinal products (IMPs) in Clinical Trials (CTs) is to provide added value regarding the protection of the subjects, Identification of the IMP, traceability of the IMP, proper use of the IMP, identification of trial and proper documentation of the trial.
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