Entrepreneurs who are into the manufacturing of food or drugs would readily agree that a major hurdle they had to cross was getting their product registered by the regulatory authority which, in this case, is the National Agency for Food and Drug Administration [NAFDAC].
For these entrepreneurs and those who want to venture into manufacturing freshly, the NAFDAC challenge is something better prepared for than wished away. This is because they cannot legitimately carry on such trade without the appropriate registration of the product(s) by NAFDAC which must continue to safeguard public health by ensuring that only safe and right quality foods, medicines, cosmetics, medical device, chemicals, detergents and packaged water are manufactured, imported, exported, advertised, distributed, sold and used in Nigeria.
Mrs. Christiana Obiazikwor is the Chief Public Relations Officer, NAFDAC. She says because the product registration process of NAFDAC is stringent, persons who require to go through it often view the process as very tasking and may complain of frustration. She says the major reason is lack of working information on what is required. “This could lead to wasted time and energy, as the unprepared applicant goes back and forth,” she says. This SuccessDigest’s special report takes you into the world of NADAC and shows you what you can do to easily obtain the agency’s registration for your product and do your business with peace of mind instead of falling short of the law and risking severe consequences.
Overview Of NAFDAC
Obiazikwor says NAFDAC is mandated to regulate and control the importation and exportation, manufacture, advertisement, sales and use of food, drugs, cosmetics, chemical, medical devices and packaged water.
Obiazikwor says, “Currently, NAFDAC registers products in two categories: drugs and food. Drugs include medical devices, vaccines, chemicals and pesticides, veterinary products, nutriceuticals and supplements, herbal preparations and cosmetics.”
|Destruction of fake and expired products by NAFDAC.|
Obiazikwor affirms that Products may be manufactured locally or imported. She says an application for registration can only be initiated by the Nigerian manufacturer, for a locally manufactured food or drug product. In the case of a product manufactured outside Nigeria, she says application must be by a Nigerian representative of the foreign manufacturer and this must be a registered company or an individual.
“In effect, the applicant must be based in Nigeria and is expected to possess the capacity to control the circulation of the product. The representative of a foreign manufacturer must however have a duly executed Power of Attorney from the manufacturer (signed by company MD, GM, Chairman or President) appointing and authorizing him to act in that capacity and specifying the name(s) of the product(s),” she says.
Though the specific documentations vary for different drugs and food categories, Obiazikwor says the general procedure is similar and, broadly, is a two-stage process:
1. Application for approval to bring in samples – not applicable if locally manufactured
2. Application for full registration of product – applies whether locally manufactured or imported
Procurement Of Samples Requirement – Imported Products
The registration process will require samples of the product. NAFDAC therefore grants special authorization to import such samples. Simply apply to NAFDAC for a written authorization to import samples. Also ensure that other documents required for clearing and taking delivery of samples are obtained, particularly Certificate of Analysis issued by the manufacturer and Certificate of Manufacture and Free Sale issued by the appropriate regulatory authority in the country of origin. Samples must also conform to stipulated product labeling regulations.
Requirements For Application For Full Registration Of Product – Imported Or Locally Manufactured Product
This starts with the procurement of the relevant registration application form for each product – NAFDAC approval is granted for each specific product. This simply means that two products from the same source will still require different approvals and numbers. In fact, two different packages of the same products are processed as different products. The application form is also available at NAFDAC’s offices or online at NAFDAC’s website. The completed form is to be submitted to the registration division of the agency.
You fill the application form and write an application letter. Your application letter must contain the name of the manufacturer and brand name of the product.
The completed application form with the application letter for each product should be returned to NAFDAC registration department with the following items:
- Five copies of written report for the product
- Sample of the products. Three packets. (drugs, food or cosmetics)
- Name and copies of the current license of your company’s superintendent/production chemist or pharmacists.
- The registration license obtained from Pharmacists Council of Nigeria (PCN) that permits you to use your factory for drug production or a license obtained from relevant professional body.
You will need to pay an amount of money as registration fee at NAFDAC designated bank. The amount paid for registration differs with respect to each product. You will find below the registration fees paid for each product class.
- Pharmaceutical drugs produced in Nigeria cost —- N25, 000 to N70, 000.
- Herbal drugs cost ———————————————- N10, 000 to N20, 000
- Packaged Foods cost ————————————— N40, 000
- Bottled Water cost ——————————————– N50, 000
- Sachet Water cost ——————————————– N30, 000
- Cosmetics cost ———————————————— N40, 000
- Pesticides/Chemicals cost ——————————– N40, 000
Finally, if you want your products to be approved quickly by NAFDAC, you will need to fix a date and invite them to inspect your factory and production facilities.
Key Requirements (For Drugs)
1. Application is on single product basis
2. Written application stating name of manufacturer and name (and brand, if applicable) of product
3. Completed NAFDAC registration application form (Form D-REG/001)
4. Certificate of Incorporation with the Corporate Affairs Commission, if a company
5. Five (5) copies of the product dossier
6. Three (3) packs of the products samples
7. Notarised original copy of the duly executed Power of Attorney from the product manufacturer (imported product)
8. Certificate of Manufacture issued by the competent health or regulatory authority in country of origin and authenticated by the Nigerian Mission in that country (if foreign import). Where there is no Nigerian mission, The British High Commission or an ECOWAS country Mission will authenticate.
9. If contract-manufactured, Contract Manufacturing Agreement, properly executed and notarized by a Notary Public in the country of manufacture.
10. Current World Health Organisation Good Manufacturing Practice Certificate for the manufacturer, authenticated by the Nigerian Mission.
11. Certificate of Pharmaceutical Products (COPP) duly issued and authenticated
12. Current Superintendent Pharmacists license to practice issued by the Pharmaceutical Council of Nigeria
13. Premises Registration License from Pharmacists Council of Nigeria (PCN)
14. Certificate of Registration of brand name with trademark registry in the Ministry of Commerce here in Nigeria
15. Letter of invitation from manufacturer to inspect factory abroad, stating full name and location of plant
16. The applicable fee payable only if documents are confirmed to be satisfactory.
Nutriceuticals, medical devices and other regulated drug products have similar requirements, with minor variations.
The requirements are generally similar
Food – packaged water
Any company in Nigeria that wants to sell bottled or sachet water displaying an approved NAFDAC registration number must apply to the agency. The company needs to submit samples of its products for testing and agree to display an expiry date on its packaging. Once it has a NAFDAC number it can market its sachet product as ‘pure water’.
In order to qualify for NAFDAC registration, the company must be formally incorporated, and its water product must have a trademark registration. It must have a business premises for water production that conforms to generally accepted manufacturing practices. The company is also required to retain a water analyst to oversee its production process.
NAFDAC labs will test the water samples provided by the company for purity. The agency carries out tests to establish the alkalinity of the water, and also to check for the presence of any elements harmful to human health.
The packaged water industry in Nigeria has been subject to significant criticism over its safety. NAFDAC itself has also come under fire for failing to adequately police the industry. Some companies are known to submit fake samples in order to pass NAFDAC tests and gain a registration number, but then sell untreated tap water labeled as pure. Other companies merely imprint an entirely fake NAFDAC number on their packaging.
Some Important Questions And Answers
How long does it take to get NAFDAC registration?
Obiazikwor says, “I can say it will take three months, if all requirements are met as and when due. Getting your product registration certificate takes a maximum of six (6) months after the date of approval to be ready. You can also register your product yourself without knowing anybody in NAFDAC or going through an agent.”
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.
What is NAFDAC’s website and e-mail address?
Can I do test marketing of my product before registration?
No, test marketing of food products are not permitted.
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.
When is the product likely to come out of the laboratory?
Six — Eight weeks
For a small scale business, when is the right time/stage to start processing your registration?
Obiaziakwor says, “If I may say this, there are ample benefits in starting with NAFDAC, even at the conceptualization stage, but people are fond of running away from us and they have tagged us as an unfriendly organisation. NAFDAC can put you through your business.”
What is the penalty for those who flout NAFDAC laws?
Obiazikwor says, “For example, more than N20 billion worth of counterfeit drugs, unwholesome foods and other substandard regulated products have been confiscated and destroyed since Dr. Paul Orhii assumed office.
“For the first time in the history of Nigeria and even worldwide, NAFDAC recently got the Federal High Court in Lagos to pass 14 years jail term on each of the two production staff of Barewa Pharmaceutical Company, which had manufactured the deadly ‘My Pikin’ Teething Mixture (Drug) that killed 84 Nigerian children in 2008 shortly before Dr. Paul Orhii assumed office.
“NAFDAC has secured five other major convictions of fake drug offenders, while more than 124 cases are currently pending in court. More than 70 other counterfeit product offenders are currently under investigation.
“Anybody who has lived in Nigeria or monitored the events here in recent years will definitely know that NAFDAC is one government agency that has shown full commitment to executing its mandate without fear or favour. NAFDAC is empowered by the relevant laws to ensure that no processed food shall be manufactured in, imported into, exported from, or advertised, sold or distributed in Nigeria, without NAFDAC’s approval.
“To do so will be in breach of the law and NAFDAC has shown it has no sympathy for such offenders. The prescribed penalties are stiff, including forfeiture of the goods. As NAFDAC has continually demonstrated, applying the full weight of the law is not an option it shies away from. If you are serious about the business you propose to engage in, the sensible way is to fully comply with the regulatory requirements.
“So, in this wise, defaulters will always find themselves to blame – to be forewarned is to be forearmed.”