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NAFDAC Registration In Nigeria

AS LEGAL PRACTITIONERS, ONE OF PRIMARY COMMITMENT IS TO HELP YOU SECURE NAFDAC REGISTRATION FOR YOUR PRODUCTS WITHOUT HITCHES.

TO GET STARTED:

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F.A.Q ON NAFDAC REGISTRATION IN NIGERIA

The National Agency for Food and Drug Administration and Control (NAFDAC) has made it easier for businesses in Nigeria to register their products with the agency. This is as a result of the automated product administration and monitoring system (NAPAMS) created by the agency. Product registration with NAFDAC usually brings up different questions and requests. In this article we try to provide answers to Frequently asked questions (FAQ) on NAFDAC Registration in Nigeria.

Q: Why do I need to register with NAFDAC?

A: NAFDAC is the body responsible for regulation and control of the manufacture, production, importation, exportation, distribution, advertisement, sale and use of certain products in Nigeria. As long as you intend to put up these products for the consumption of the general public, you must register with NAFDAC.

Q: What are the products that can be registered with NAFDAC?

A: There are three broad categories of products that can be registered with NAFDAC namely; food, cosmetics and drugs. It is mandatory to register any packaged product that falls under any of these categories.

Q: I want to register my product with NAFDAC. Where do I start and how do I go about it?

A: In order to register a product with NAFDAC, you must first critically examine the guidelines applicable to the product and fulfill all requirements and conditions attached. Afterwards, you may go online to:

https://www.nafdac.gov.ng/our-services/product-registrationevaluation/.

Process for NAFDAC Registration is detailed below;

You prepare and submit your application form together with all supporting documents.
You make payment as assessed.
The documents are verified and a date for inspection of facility is fixed.
The inspection of the facility/ sampling of products is done, followed by laboratory analysis of the product.
Final vetting and approval meeting follow.
Then the NAFDAC Registration Number and certificate of registration is issued.
Q: What are the supporting documents I need to submit?

A: The documents for NAFDAC Registration include:

Company Registration Documents
Trademark
Product Label
Fumigation Certificate
Food Handler’s certificate / Medical Fitness Certificate for Production staff, this should include the following: Sputum test, stool test, Urinary test, Widal test, Hepatitis B test.
Batch Formulation.
Site use Agreement (Where applicable)
One vetting Sample and three labels
Copy of Receipt of Payment for production registration
SOPs for production, distribution /Recall, Quality assurance, Cleaning of equipment, receiving of packaging materials, Personal Hygiene, Water analysis (where applicable) and for cleaning of the environment (for small-scale enterprises)
List of raw material and their source(s)
Certificate of analysis of raw materials (optional for micro scale)
Certificate of analysis of finished products (optional for micro scale)
A signed and endorsed certificate of Pharmaceutical Product (for drug products)
Original copy of the Power of Attorney from the product manufacturer (if imported).
Letter of invitation from manufacturer to inspect factory abroad, full names and site of plant (where applicable)
Permit to import samples (for imported products)
Certificate of Free Sale (for imported products)
Q: What are the things I need to put in place before approaching NAFDAC to register my product?

A: The following include the necessary steps to take before approaching NAFDAC for registration of a product:

Ensure that your business is duly registered with Corporate Affairs Commission (CAC)
Ensure that you have your trademark registration (although optional for micro-scale enterprises)
Design and prepare your product label/packaging material according to the relevant regulations.
Ensure that your personnel have and meet the NAFDAC requirements with respect to education, experience, good sanitation and hygiene habits as well as medical tests.
Ensure that your building or facility and equipment meet the required standards.
Ensure that all raw or packaging materials are of good quality and standard.
Q: How long does it take to get NAFDAC number?

A: The timeline is always within ninety (90) working days for food products and 120 working days for drug products but may exceed this stipulated time.

Company Registration In Nigeria
Q: Must I register the products I’m importing as well?

A: Yes. In order to register the product, you must first get approval from NAFDAC to import into Nigeria. You must also be armed with the necessary documents to register the imported products.

Q: My business is small and still growing, do I need to register what I’m producing with NAFDAC?

A: As long as you are selling packaged products that fall into Food, Cosmetics and Drugs categories YOU HAVE TO REGISTER. NAFDAC categorizes enterprises into micro-scale, small-scale and large-scale enterprises depending on the size of your venture.

Q: What is a micro-scale enterprise?

A: Micro scale enterprise is an enterprise or business entuty with not more than five (5) employees. It must have a facility or building that is purpose-built or adapted with minimum of a designated standard room that is not open directly to any source of contamination. However, there are products that cannot be registered under this scope. These include Meat and meat products (except dried), poultry and poultry products, fish and fish products (except dried), Milk & dairy products, packaged cooked rice, beans or fresh vegetables, baked potatoes, Beverages, Packaged water.

Q: What is a small-scale enterprise?

A: Small scale enterprise is an enterprise or a business unit with 1 to 10 employees. Its building can be purpose built or adapted. It must also have adequate space, capacity and equipment for its intended product (s) for registration.

Q: How can I know that a product has been registered with NAFDAC?

A: Do a quick search on the NAFDAC registration portal at nafdac.gov.ng/our-services/registered-products/

Q: Do I need to renew my certificate after it’s been issued?

A: Yes, the certificate has to be renewed after 5 years of issue and subsequently

Q: Whether a Foreign company or manufacturer can register his product with NAFDAC?

A: A foreign company or manufacturer can only register his products through a Nigerian applicant or agent duly authorized by the foreigner to act on his behalf

Product Registration & Regulation – NAFDAC Registration & Regulation Section e-Registration NAFDAC e-Certificate Enrollment Manual Application Forms/Templates Advert Schedules Pre-Shipment Inspection & Testing Agents Registered Products Database Registration & Regulations FAQs Clinical Trial FAQs Guidelines Regulations About Registration & R...

APT.

*Lagos Nurtw (First Brt) Cooperative Society Ltd v. Lagbus Asset (Mgt) Ltd (2021) LPELR-52744(CA)*

_Whether failure/neglect of a party to file an application for summary judgment alongside the originating process/writ of summons affects the substantive jurisdiction of the court_

Now, the gravamen of the appellant’s chief grievance, indeed its trump card on the issue, is that respondent’s application for summary judgment, which sired the lower Court’s decision that ignited the appellant’s application that parented the appeal, did not accompany the originating process filed on 25th September, 2012 as ordained/decreed by the provision of Order 11 Rule 1 of the High Court Rules displayed above.
The appellant’s foremost grudge is that the respondent’s failure/neglect to file its application for summary judgment alongside the originating process, the writ of summons, drained the lower Court of the jurisdiction to entertain it, a fortiori its grant of judgment in favour of the respondent.
​Jurisdiction, a mantra in adjudication, connotes the authority/power of a Court to determine a dispute submitted to it by contending parties in any proceeding, see Ajomale v. Yaduat (No. 1) (1991) 5 SCNJ 172; Mobil Pro. Co. Unltd. v. LASEPA (2002) 18 NWLR (Pt. 798) 1;Ndaeyo v. Ogunnaya (1977) 1 IM SLR 300; Ebhodaghe v. Okoye (2004) 18 NWLR (Pt. 905) 472; Garba v. Mohammed (2016) 16 NWLR (Pt. 1537) 144; A.-G., Kwara State v. Adeyemo (2017)1 NWLR (Pt. 1546) 210;Isah v. INEC (2016) 18 NWLR (Pt. 1544) 175;

Angadi v. PDP (2018) 15 NWLR (Pt. 1641) 1. The case-law categorises/classifies jurisdiction into two facets, videlicet: procedural jurisdiction and substantive jurisdiction. In Ndayako v. Dantoro (2004) 13 NWLR (Pt. 889) 187 at 219, Edozie, JSC, incisively and graphically, declared:
It is noteworthy that a distinction must always be drawn between two types of jurisdiction viz – jurisdiction as a matter of procedural law and jurisdiction as a matter of substantive law. Whilst the litigant can waive the former, no litigant can confer jurisdiction in the Court where the Constitution or a statute or any provision of the common law says that the Court shall have no jurisdiction. A litigant may submit to procedural jurisdiction of the Court e.g. where a writ has been served outside jurisdiction without leave. See, also, A. – G., Kwara State v. Adeyemo (2017) 1 NWLR (Pt. 1546) 210; Achonu v. Okuwobi (2017) 14 NWLR (Pt. 1584) 142; Oko v. State (2017) 17 NWLR (Pt. 1593) 24; Zakirai v. Muhammad (2017) 17 NWLR (Pt. 1594) 181; Kurma v. Sauwa (2019) 3 NWLR (Pt. 1659) 247; BPE v. Dangote Cement Plc. (2020) 5 NWLR (Pt. 1717) 291.
Flowing from this magisterial pronouncement, in the ex cathedra authority, it is my view that a party’s (claimant’s) failure to file an application for summary judgment along with the originating process, writ of summons, resides within the perimeter of procedural jurisdiction which is submissive to acquiescence/waiver by an adversary or, at best, a curable irregularity. In other words, such a failure has no romance with substantive jurisdiction, usually donated to the Court by substantive statutes, the Constitution and other legislations, that is rebellious to waiver/acquiescence by an opponent. The High Court Rules, which warehouse the provision of Order 11 Rule 1, that is allegedly infracted fall within the commodious domain of subsidiary enactments, see Section 37 of the Interpretation Act, Cap I 23, Laws of the Federation of Nigeria, 2004; Unilag v. Aigoro (1984) 15 NSCC 745; Agip (Nig.) Ltd. v. Agip Petroli Int’l (2010) 5 NWLR (Pt. 1187) 34; Oyegun v. Nzeribe (2010) 7 NWLR (Pt. 1194) 577; G.M.O.N. & Sons Co. Ltd. v. Akputa (2010) 9 NWLR (Pt. 1200) 143. They do not bestow jurisdiction on a Court of law. Source of jurisdiction of Court is statutory.

It is the Constitution and legislations that do, see Dada v. Ogunremi (1962) 2 SCNLR 417; State v. Onagoruwa (1992) 2 SCNJ (Pt. 1) 1; Afribank (Nig.) Plc. v. Akwara (2006) 5 NWLR (Pt. 974) 619; Onuorah v. KRPC Ltd. (2005) 6 NWLR (Pt. 921) 393; Mailantarki v. Tongo (2018) 6 NWLR (Pt. 1614) 69; Mainstreet Bank Capital Ltd. v. Nig RE (2018) 14 NWLR (Pt. 1640) 423; Nduul v. Wayo (supra); Okorocha v. UBA Plc (2018) 17 NWLR (Pt. 1649) 441; APC v. Umar (2019) 8 NWLR (Pt. 1675) 564. Since the alleged faux pas, respondent’s failure to make its application for summary judgment a companion/appendage of the writ of summons, roams within the firmament of procedural jurisdiction, the lower Court was not disrobed of the requisite jurisdiction to entertain the application. The appellant’s counsel’s scintillating argument on this seemingly terminal point, with due reverence, is disabled from birth. It cannot fly!

We cannot agree less, your lordships.