International Journal of Drug Regulatory Affairs
  • Year: 2020
  • Volume: 8
  • Issue: 4

Donation of contraceptive products through special import permits: A case study in Zambia and Nigeria

  • Author:
  • Courtney Stachowski, Noxolo Magubane, Mbavhalelo Jade Tshikosi, Wilberto Robles
  • Total Page Count: 6
  • Page Number: 55 to 60

WCG Cares, 701 Palomar Airport Road, Suite 300, Carlsbad, CA, 92011

*Corresponding author Tel.: +1-858-314-4025, E-mail address: cstachowski@wcgcares.org (Courtney Stachowski)

Online published on 24 May, 2021.

Abstract

Introduction: Securing a special import permit for the donation of an unregistered contraceptive product can be a viable option to import the product in an expedited manner. However, this process can be difficult due to varying country requirements and the availability of accurate and timely information. Case description: This paper will explore the process for securing import permits for donated contraceptive products in Zambia and Nigeria, comparing national guidelines to applicant experiences and providing recommendations to future applicants. Discussion and evaluation: In practice, application requirements and timelines for special import permits in Zambia and Nigeria differed from national guidelines. Despite these differences, special import permits can be secured more quickly than formal product registration, which is a slower but more sustainable solution. Conclusion: Due to a lack of comprehensive and up-to-date guidelines online for some low- and middle-income countries (LMICs), the regulatory community is encouraged to share their experiences with special import permit application processes.

Keywords

Contraceptives, Donations, Import Permits, Medicines, National Regulatory Authorities' (NRAs), Registrations, Regulatory, Regulatory Affairs, Zambia Medicines Regulatory Authority (ZAMRA), National Agency for Food and Drug Administration and Control (NAFDAC)