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Home Registration

REGISTRATION AND REGULATORY AFFAIRS DIRECTORATE

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How long is the registration process?
How do I begin the process of registration?
Where is the NAFDAC registration Office?
Whom do I call to report a complaint?
What is NAFDAC?s website and e-mail address?

HOW LONG WILL IT TAKE TO REGISTER MY FOOD PRODUCT?
IS THERE ANY CONCESSION IN REGISTRATION TARIFF FOR VARIANTS OF IMPORTED FOOD PRODUCTS?

HOW LONG WILL IT TAKE FOR MY PRODUCT REGISTRATION CERTIFICATE TO BE READY?

CAN I DO TEST MARKETING OF MY PRODUCT BEFORE REGISTRATION?

WHAT IS THE AGENCY DOING ABOUT THE LITERING OF THE ENVIRONMENT WITH EMPTY SACHET PACKAGING?
CAN PEOPLE NOT JUST PUT NAFDAC NUMBER THAT DOES NOT EXIST ON THEIR OWN?
HOW DO I KNOW THE GENUINE NAFDAC NO.?

WHERE CAN I FIND THE LIST OF REGISTERED PRODUCTS?

WHERE DO I REPORT ANY NEFARIOUS ACTIVITY WHEN PEOPLE ARE TRYING TO FAKE NAFDAC REGULATED PRODUCT?

CAN I REGISTER MY PRODUCT MYSELF WITHOUT KNOWING ANYBODY IN NAFDAC OR GOING THROUGH AN AGENT?

HOW DO I KNOW THAT THE NAME I WANT TO USE FOR REGISTRATION OF MY PRODUCT WILL BE ACCEPTED BY NAFDAC?

WHEN IS THE PRODUCT LIKELY TO COME OUT OF THE LABORATORY?

WHY CAN?T OUR PRODUCT WHICH IS AN INTERNATIONAL PRODUCT BE ACCEPTED AS SOLD ALL OVER THE WORLD.

HOW AND WHERE ARE CLINICAL TRIALS CONDUCTED?

WHAT ARE THE REQUIREMENTS TO CONDUCT CLINICAL TRIALS IN NIGERIA?

ARE CLINICAL TRIALS DIRECTLY SUPERVISED BY NAFDAC?

DO FOREIGN DRUGS GET SUBJECTED TO CLINICAL TRIALS BEFORE THEY ARE ALLOWED FOR USE IN THE COUNTRY?

HOW MANY STUDY SITES ARE CLINICAL TRIALS ARE SUPPOSED TO BE CONDUCTED?

DO NAFDAC CHOOSE INVESTIGATORS TO CONDUCT CLINICAL TRIALS?
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HOW MANY PEOPLE ARE SUPPOSED TO PARTICIPATE IN CLINICAL TRIALS?

HOW MUCH DOES IT TAKE TO CONDUCT CLINICAL TRIAL IN NIGERIA?

HOW MANY DRUGS ARE CURRENTLY UNDERGOING CLINICAL TRIALS NOW?

LIST OF BANNED FOOD COLOURS AND / OR ADDITIVES.

CODEX LIST OF FOOD CONTAMINANTS AND MAXIMUM LIMIT IN DIFFERENT CATEGORIES OF FOODS

How long is the registration process?

Three months if all requirements are met as and when due.

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How do I begin the process of registration?

You begin with the purchase of the relevant registration application form from the NAFDAC office closest to you and pick up the applicable guidelines.

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Where is the NAFDAC registration Office?

In Lagos, with the following addresses.

(a) NAFDAC Central Laboratory Complex

3/4 Oshodi ? Apapa Expressway, Oshodi ? Lagos.

(for Registration and Regulatory Affairs Directorate, Legal Unit, Establishment Inspection Directorate, Food Laboratory, Narcotics and Controlled Substances Directorate).

(b) NAFDAC Central Drug and Vaccines Laboratory (CDVL)

Edmund Crescent, Yaba ? Lagos (for Drug Laboratory and Ports Inspection Directorate).

(c) NAFDAC Enforcement Directorate.

Ahmadu Bello Way (Behind Nigerian Air Force Camp by Legico B/stop), Victoria Island - Lagos.

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Whom do I call to report a complaint?

Call the Director (Registration and Regulatory Affairs) on 01-4748627, 01- 4772452

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What is NAFDAC?s website and e-mail address?

Website: www.nafdac.gov.ng

E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

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HOW LONG WILL IT TAKE TO REGISTER MY FOOD PRODUCT?

THE REGISTRATION OF FOOD PRODUCTS TAKES MAXIMUM OF THREE(3) MONTHS PROVIDED ALL DOCUMENTS AND OTHER REQUIREMENTS AS STATED IN THE FOOD REGISTRATION GUIDELINES ARE FOUND TO BE SATISFACTORY.

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IS THERE ANY CONCESSION IN REGISTRATION TARIFF FOR VARIANTS OF IMPORTED FOOD PRODUCTS?

YES, REGISTRATION OF FOOD VARIANTS E.G. FLAVOUR, COLOUR, E.T.C. HAVE CONCESSIONARY TARIFF CHARGES.

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HOW LONG WILL IT TAKE FOR MY PRODUCT REGISTRATION CERTIFICATE TO BE READY?

PRODUCT REGISTRATION CERTIFICATES TAKES A MAXIMUM OF SIX(6) MONTHS AFTER THE DATE OF APPROVAL TO BE READY.

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CAN I DO TEST MARKETING OF MY PRODUCT BEFORE REGISTRATION?

NO, TEST MARKETING OF FOOD PRODUCTS ARE NOT PERMITTED.

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WHAT IS THE AGENCY DOING ABOUT THE LITERING OF THE ENVIRONMENT WITH EMPTY SACHET PACKAGING?

THE AGENCY ENSURES THAT THE SACHET PACKAGING BEARS THE LOGO & INSCRIPTION ?DISPOSE PROPERLY: AND IT IS THE RESPONSIBILITY OF THE MINISTRY OF ENVIRONMENT AT STATE AND LOCAL GOVERNMENT LEVEL TO ENSURE PROPER WASTE DISPOSAL.

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CAN PEOPLE NOT JUST PUT NAFDAC NUMBER THAT DOES NOT EXIST ON THEIR OWN?

Yes they do. But they are fake numbers. And they also claim they are going to secure NAFDAC Registration Number very soon. But this is not true.

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HOW DO I KNOW THE GENUINE NAFDAC NO.?

Cross check from NAFDAC website, NAFDAC green pages and from NAFDAC offices in all the states of the Federation.

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WHERE CAN I FIND THE LIST OF REGISTERED PRODUCTS?

Gazzette, NAFDAC green pages and NAFDAC website, also NAFDAC offices in Nigeria.

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WHERE DO I REPORT ANY NEFARIOUS ACTIVITY WHEN PEOPLE ARE TRYING TO FAKE NAFDAC REGULATED PRODUCT?

Report to any NAFDAC office and Enforcement Directorate in Lagos. Call NAFDAC hotlines.

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CAN I REGISTER MY PRODUCT MYSELF WITHOUT KNOWING ANYBODY IN NAFDAC OR GOING THROUGH AN AGENT?

Yes.

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HOW DO I KNOW THAT THE NAME I WANT TO USE FOR REGISTRATION OF MY PRODUCT WILL BE ACCEPTED BY NAFDAC?

Write formally to NAFDAC for clearance of Name which can hold for 2 weeks only.

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WHEN IS THE PRODUCT LIKELY TO COME OUT OF THE LABORATORY?

6-8 weeks

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WHY CAN?T OUR PRODUCT WHICH IS AN INTERNATIONAL PRODUCT BE ACCEPTED AS SOLD ALL OVER THE WORLD.

Because products must comply with the labelling regulations developed to meet the needs of Nigeria.

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HOW AND WHERE ARE CLINICAL TRIALS CONDUCTED?

Clinical trials are conducted in accordance with good clinical practice (GCP) and are conducted in research institutions.

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WHAT ARE THE REQUIREMENTS TO CONDUCT CLINICAL TRIALS IN NIGERIA?

The requirements for clinical trials can be obtained from our website: www.nafdacnigeria.gov.ng.

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ARE CLINICAL TRIALS DIRECTLY SUPERVISED BY NAFDAC?

Yes.

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DO FOREIGN DRUGS GET SUBJECTED TO CLINICAL TRIALS BEFORE THEY ARE ALLOWED FOR USE IN THE COUNTRY?

Yes. Particularly if the drug does not have adequate and well documented use in black population or it has some race specific properties or its efficacy, safety and usefulness needs to be proven in our population.

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DO NAFDAC CHOOSE INVESTIGATORS TO CONDUCT CLINICAL TRIALS?

No. Sponsors and applicants are responsible for the choice of their trial investigators.

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HOW MANY STUDY SITES ARE CLINICAL TRIALS ARE SUPPOSED TO BE CONDUCTED?

At least two centers.

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HOW LONG DOES IT TAKE TO CONDUCT CLINICAL TRIALS?

It depends on t a number of factors, some of which are:

? The design of the trial.

? The nature of the investigational product.

? The investigational product.

? The rate of recruitment of trial participants, etc.

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HOW MANY PEOPLE ARE SUPPOSED TO PARTICIPATE IN CLINICAL TRIALS?

The number of participants to be involved in a study depends on the phase of the study (I, II, III or IV) and the trial design.

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HOW MUCH DOES IT TAKE TO CONDUCT CLINICAL TRIAL IN NIGERIA?

The applicant need to pay NAFDAC N200, 000.00 plus 5% VAT for imported products and N50, 000.00 plus 5%VAT for local and herbal products. Other monetary expenses related to the conduct of the trial are handled between the sponsors and the investigators.

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HOW MANY DRUGS ARE CURRENTLY UNDERGOING CLINICAL TRIALS NOW?

Five products.

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LIST OF BANNED FOOD COLOURS AND / OR ADDITIVES.

This is in accordance with Codex, EU, and FDA list of Banned Colours and / or food additives. This is usually downloaded On www.codexalimentarius.net, www.fda.gov , and www.eu.net .

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CODEX LIST OF FOOD CONTAMINANTS AND MAXIMUM LIMIT IN DIFFERENT CATEGORIES OF FOODS

This is in accordance with Codex, EU, and USFDA position on maximum limit of contaminants in foods. However, in some cases it depends on country?s position as some external factors can contribute to high values of contaminants in foods. These values can be downloaded on the websites given above..

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Last Updated on Wednesday, 26 May 2010 09:06