NAFDAC & Regulated Products
NAFDAC product registration in Nigeria
AIO Law assists manufacturers, brand owners and businesses with the Nigerian legal and regulatory requirements involved in registering and maintaining regulated products.
Our work can include requirements assessment, documentation review, labelling issues, applications, regulatory correspondence, responses to compliance queries, renewals and product variations.
- Product category
- Manufacturing location
- Formulation
- Regulatory classification
- Current NAFDAC requirements
Foreign manufacturers
Registering a product from outside Nigeria?
A foreign manufacturer entering Nigeria may encounter requirements relating to local representation, manufacturer documentation, product information, labelling and other category-specific regulatory materials.
We help clients understand the applicable requirements before the application progresses, reducing avoidable uncertainty later in the process.
Requirements are not identical across product categories. They depend on the product, where it is manufactured, its formulation and classification, and NAFDAC's current requirements.
Product categories
Regulated products we assist with.
Food & Beverage
Packaged foods, beverages and related products.
Cosmetics
Skin care, hair care, fragrance and personal-care products.
Supplements & Nutraceuticals
Dietary supplements and nutraceutical products.
Herbal Products
Herbal and related products.
Medical Devices
Devices subject to NAFDAC regulation.
Services
Legal and regulatory support across the product lifecycle.
Initial Regulatory Assessment
Establish the pathway before preparing documents.
- Product classification
- Applicable regulatory pathway
- High-level requirements
- Existing-registration review where relevant
Documentation
Getting the regulatory file in order.
- Manufacturer documentation
- Product information
- Supporting regulatory documents
- Powers of attorney/representation documents where applicable
- Document consistency review
Product & Label Review
Regulatory and legal review of product information and labels.
- Ingredients/composition consistency
- Product description
- Label information
- Artwork issues
- Regulatory statements
This is a legal and regulatory review. AIO Law does not provide laboratory, scientific or product-safety testing services.
Applications
Progressing the application within the agreed scope.
- Application preparation/support
- Submission coordination
- Supporting documents
- Application monitoring
Regulatory Queries
When NAFDAC raises questions.
- Compliance directives
- Requests for clarification
- Documentation gaps
- Product-information inconsistencies
- Responses and remediation
Post-Registration
Keeping registrations current.
- Renewals
- Variations
- Changes to formulation
- Changes to manufacturer
- Changes to artwork/labels
- Other post-registration regulatory work where applicable
Process
A structured product-registration process.
- 01
Product assessment
Tell us what the product is, where it is manufactured and whether it has previously been registered in Nigeria.
- 02
Requirements review
We identify the current documentation and regulatory requirements applicable to the proposed registration.
- 03
Preparation
Documentation, product information and relevant application materials are reviewed and prepared.
- 04
Application & regulatory process
The appropriate application is progressed and regulatory correspondence handled within the agreed scope.
- 05
Queries and completion
Where the regulator raises questions or compliance requirements, we assist with the legal/regulatory response and required next steps.
Timelines depend on the product, the completeness of documentation and the regulator’s processes. We do not quote fixed NAFDAC timelines.
Questions
NAFDAC registration: common questions.
Can a foreign manufacturer register a product in Nigeria?
Yes. Foreign manufacturers can register regulated products, generally acting through a Nigerian representative or applicant. The specific requirements depend on the product category.
What documentation is required?
Typically manufacturer documentation, product information, label artwork and category-specific supporting documents. Some documents may need to be notarised or legalised.
Can AIO Law review our product labels?
Yes. We review label information and artwork for regulatory and legal consistency. We do not provide laboratory or scientific testing.
What happens if NAFDAC raises a compliance query?
We review the query, identify what is required and assist with the legal and regulatory response and any remediation within the agreed scope.
Can you assist with renewals and variations?
Yes, including changes to formulation, manufacturer, artwork or labels where these require regulatory action.
Can the matter be handled while we are outside Nigeria?
Many product-registration matters can be instructed and managed remotely, with documents exchanged electronically where appropriate.
Related workstreams
Manufacturers entering Nigeria often also need
Start an enquiry
Send us your product details.
Tell us what the product is, where it is made and what you need. We will review the matter and confirm the appropriate next step.