Nigeria

General

Country: Nigeria
Geographic region: West Africa
Income level (World bank): Lower middle income
Population (women 15-49 years) in millions, 2015: 41,4
Are condoms (male/female) regulated in the country? yes
If yes, describe the applicable regulation or directive: Guidelines for registration of imported medical devices in Nigeria NAFDAC/RR/007/00
Condom classification (medical device, medicines, others): Medical device
National competent (regulatory) authority: National Agency for Food And Drug Administration and Control (NAFDAC)

Essential Medicines List

Condoms on EML? yes
Female condoms specified on EML? no
EML Version (year): 2010

Registration Requirements

Applicant eligibility: Manufacturer or authorised local representative
Administrative documents: "Written application; Evidence of trademark approval; Certificate of business incorporation (of the importing country). All documents should be authenticated by Nigerian Embassy in the country of origin. "
Technical documents: "Certificate of manufacture; Free sale certificate; Certificate of analysis"
Sample: Sample of product and labeling materials
Timeline: 60 days after submission of sample
Registration Fee: N 250,000 + 5% vAT
Validity of registration: 5 years
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