NAFDAC PRODUCT

REGISTRATION
PROCESS AND
COMPANY
REGISTRATION
ISAAC AYUBA
 Notarized declaration
Power of Attorney
Certificate of Manufacture and Free Sale
Certificate of Analysis
Registration
GMP Inspection Invitation Letter
Requirement Evidence of Business Incorporation
s- Evidence of Trademark registration
Documents  Product Label
Product Dossiers
MSDS
 Registration
Documents Explained
 It is a declaration to be completed (typed)
and signed by The Managing Director –
Declarant
The declaration will contain the list of all the
Notarized products to be registered

Declaratio It will be finally notarized by a Notary

n Public in Nigeria.

There is a template provided by NAFDAC

for this
 A Public Notary in the country of
origin must notarize this.

It should define the owner of the brand

name.
Power of
Attorney  It should also specify that 
• Your Nigerian company subsidiary 
• or any registration holder company
• is authorized to register the product in Nigeria
on their  behalf 
 This must be authenticated by the Nigerian
Embassy in the country of origin
Be issued by a relevant Regulatory body in the
Certificate country of manufacture.

of Indicate the name of the manufacturer and

products to be registered.
Manufactur In addition, the council for international trade
e and Free promotion should certify it.

Sale Certificate of free sale may be separated from that

of manufacture in some countries. 
Whichever, they must meet the above
requirements.
 The certificate of analysis must be
presented on a letter-headed paper of
the Company Quality Control
Laboratory where the sample was
Certificate tested/evaluated 

of Analysis
This must not necessary be
authenticated by the Nigerian
Embassy in the country of origin
GMP • This is a letter of invitation from the manufacturer

Inspection to NAFDAC through the Representative stating

access to the factory by NAFDAC officials for
inspection on the manufacturing process of the
Invitation product to be registered 

Letter
 This must be registered  with the Trademarks,
Patents and Designs Registry of the  Federal
Ministry of Industry, Trade and Investment of
Nigeria

Trademark The trademarks will be registered in the name

and address Your COMPANY
Registratio
n
It will be done in Nigeria
 Evidence of Business
Incorporation of the importing
company with the Corporate
Affairs Commission (CAC) in
Business Nigeria
Incorporatio
It will be done in Nigeria
n
 It is to be designed and
submitted during
registration
Product
Label It must follow a particular
layout and format that is
specified by NAFDAC. 
 Unlike other Documents, this one does
not need to be authenticated by the
Nigerian embassy, however, 

It must follow a particular layout and

Product format that is specified by NAFDAC. 
Dossiers
Contain all information about the
product i.e. Chemical, physical and
biological information 
Registration Documents Obtaining Responsibility

Documents Responsibility 
Power of Attorney Manufacturer
Certificate of Manufacture and Free Sale Manufacturer
Certificate of Analysis Manufacturer
GMP Inspection Invitation Letter Manufacturer
Evidence of Business Incorporation Third Party
Evidence of Trademark registration Third Party
Product Label Manufacturer
Product Dossiers Manufacturer
 Registration Process

Laboratory Product Approval Issuance of Notification

Application Documentation Import Permit
Analysis Meeting
A written application Submission of documents Import Permit of product After the successful vetting Upon satisfactory For products approved at the
addressed to NAFDAC (All the originals and 2 sample shall be issued after a of product labels, documentation review, meeting, a Notification of
Completion of an Online sets of photocopies) successful screening of laboratory samples are satisfactory GMP of the Registration is issued to the
Application form for each documentation and review of submitted for analysis and production facility and applicant while compliance
product on NAFDAC supporting documents satisfactory laboratory directive is issued to those
vetting
website The product sample will be analysis of the product, not approved
submitted to the NAFDAC products are presented for
laboratory for vetting Approval Meetings
If there is no compliance
issue the product will be
approved or otherwise
 Registration Timeline
Time (Weeks)
S/N Activity WK WK1
WK1WK2WK3WK4 WK5WK6 WK7 WK8
9 0
1 Submission of Documents to NAFDAC
2 Processing of Documents by NAFDAC
3 Import Permit
4 Sample Submission to the laboratory
5 Laboratory Analysis
6 Approval Meeting
7 Certificate Issuance

Note that we can only be sure of activity 1 to 5, as no one controls activity 7 as the meeting is fixed by the
management of NAFDAC and the meetings will hold whenever they deem fit, as a result completion could extend by
at most 4 weeks after the products have come out from the Laboratory
 General Cost
S/No Item
1 Field Trial
2 Product Registration
3 Import permit for Samples 115
4 Analysis of Samples
Penalty for expired
5 1310
certificate
6 Factory GMP
7 Trademark
 Government  Consulting Fees (USD)
Frequency Details
fees(USD)  /Product 
 To be determined, it Every time there is a Field trials must be carried out with NAFDAC approved
975 depends on the research new Active Ingredient Research Institute, if NAFDAC determines that the active
institute  to be registred ingredient involved has never been registered in Nigeria.
Main cost for the activity covers Certificate and
1000 450 Once
Administrative charges
Nil Once This is amount paid per imported product sample
250 Nil Once Laboratory cost for analysis
After expiration of This is paid  during renewal if your certificate expires before
Nil
certificate commencement of renewal
NAFDAC is expected to visit and inspect the manufacturing
site and thereafter, issue a GMP certificate for the plant.
Payment is made and NAFDAC will then fix a time to visit
the location, the company is allowed to commence
11,814 Nil Every 5 years
registration before NAFDAC visits the site, however if they
visit and they have any issues, the registration will be sus
pended and the company asked to comply before they can go
on with using the registrations again.
Each product is expected to have  a trademark certificate
100                               70   7 years 
issued by the Ministry of Trade
 Cost per Product
Government Consulting
S/No Item Details
fees(USD) Fees (USD)

Product Main cost for the activity covers Certificate

1 1000 450
Registration and Administrative charges
Import permit This is amount paid for permit to import
2 115 Nil
for Samples samples for the laboratory.
Analysis of
3 250 Nil Laboratory cost for analysis
Samples

Each product is expected to have  a trademark

4 Trademark  100 70 certificate issued by the Trademark office in
the  Ministry of Trade and Investment.
 Company Registration Cost
Government Consulting
S/No Item FrequencyDetails
fees(USD) Fees/Service
Limited Liability
Company
The minimum share capital
1 (Without a 200Nil Once
required is 1 million
Foreign
Director)
Annual Return First payment will be due 18
2 2525 Annual
Filling months after registration
The minimum share capital
required is 10 million. The
foreigner most provide his means
Limited Liability
of identification (Passport) in case
Company (With
3 800Nil Once he is not resident in Nigeria and if
Foreign
he is using a Nigerian address, he
Director)
must provide his business permit.
Most have atleast 1 Nigerian
Director
Cost Excel Sheet

Microsoft Excel
Worksheet