Why you should buy this report

The report comprises all the necessary information required for the registration of a new medicinal product at the NAFDAC. It is a single end-to-end report to study all the Regulatory aspects with respect to the registration of new drugs in Nigeria. As Africa’s largest economy and highly populated country, Nigeria is hailed as the next frontier for pharma and also is Africa’s largest consumer market. According to a forecast by a research intelligence firm, it was forecasted that the Nigerian pharmaceutical market is expected to grow at a CAGR of 9.1% over the forecast years of 2019-2035. The objective of the report is to provide precise information on the Regulatory landscape of Nigeria so that it enables a Regulatory go-to-market strategy and ensures compliance.

Table of Contents

1. List of Abbreviations
2. Governing Regulatory Body
3. Definition and Categorization
4. Registration Requirements
   1. Registration Process for a New Medicinal Product
      1. General Information Regarding Registration
      2. Product Registration Process
   2. Requirements for Submission
   3. Language Requirements of the Documentation and Correspondence:
   4. General Information for Renewal
   5. Renewal Registration Timelines
5. Variations
   1. General Information for Variations
   2. Variations Timelines
   3. Change of the Applicant (owner): transfer of rights to the registration certificate
6. Agency Registration Fees and Validity
7. Labeling Requirements
8. Advertising Requirements
9. Pharmacovigilance
10. GMP Recognition or GMP inspection
11. Authorized Representative
12. Import Requirements
13. References

Summary

• The report details the registration process for a new medicinal product at Nation Agency for Food and Drug Administration and Control (NAFDAC)
• Provides information for labeling (primary and secondary packaging labels) for pharmaceutical products
• The report underlines the regulations levied on the import and also the requirements of a legal representative
• Provides precise information on health authority fees, along with the timelines and modes of submission
• Includes information on advertising requirements, pharmacovigilance, GMP inspection/recognition
• Provides additional information on the variation fillings and timelines, the validity of registration and renewal process