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In Nigeria, drugs and pharmaceutical products are subject to stringent labeling requirements, overseen by the National Agency for Food and Drug Administration and Control (NAFDAC). Compliance with these requirements is essential, as a NAFDAC license is mandatory for importing any regulated pharmaceuticals into the country.
Proper labeling ensures that consumers and healthcare providers receive accurate and complete information about a product’s uses, dosage, potential side effects, warnings, and other important details. This clarity empowers informed treatment decisions, helping users understand the risks, benefits, and contraindications of medications. All drugs and pharmaceutical products, whether manufactured locally or imported, must adhere to these labeling standards to be eligible for NAFDAC registration.
General Labelling Information
The labelling of a drug product must not refer to any international or national body except permitted by the Agency. Information on the label must be prominent, distinct legible and written in English Language.
Manufacturer Details Requirements
Labelling for drugs and pharmaceutical products in Nigeria must include specific information about the manufacturer. This includes:
- Manufacturer’s Information: The name, full address, and location of the manufacturer must be clearly indicated. If the drug is produced under a contract manufacturing agreement, the labelling must reflect this relationship, using phrases such as “Manufactured by…” or “Manufactured for…”.
- Site Address for Larger Containers: For containers above 5ml (or equivalent volume), the site address of the manufacturer must be displayed on all packaging.
- Packaging Components: Packaging must also clearly list essential product details, including the drug’s name, active ingredient(s), strength, and dosage form.
These requirements ensure transparency and traceability, supporting safe and informed use of pharmaceutical products.
Brand and Generic Name Requirements
For pharmaceutical products in Nigeria, both the brand (proprietary) and generic (common) names must be displayed on all packaging, with specific guidelines to ensure clarity and compliance:
Principal Display Panel:
Both brand and generic names must appear prominently on the principal display panel of the packaging.
For single active ingredient drugs, the generic name should be placed near the brand name.
Dosage Form and Strength:
The generic name on the principal display panel should be immediately followed by the drug’s pharmaceutical dosage form, its strength (in mg, g, etc.), and any applicable compendia standard.
Any claim regarding compliance with an official compendia standard must be accurate.
Multiple Active Ingredients:
For drugs with multiple active ingredients, the generic names of each should appear on the principal display panel. If space is limited, this information may be displayed on the information panel.
When only the brand name is present for a multi-ingredient drug, quantitative details of each ingredient should be clearly visible on the panel.
Textual Presentation:
When the generic or common name appears alongside the brand name in text, they should be displayed together for clear identification.
These requirements ensure consumers receive essential information on both brand and generic elements, helping support safe and informed medication use.
Net Content Requirements for Drug Labelling
Drug labels must clearly indicate the net content of the product on the outer label, specifying quantity in appropriate units, based on the drug’s form:
Unit and Measurement:
For tablets, vials, capsules, ampoules, and similar dosage forms, the net content should be indicated by the numerical count.
For solid, semi-solid, or viscous drugs, the content should be listed by weight (in kg or g).
For liquid drugs, the content should be listed by volume (in liters, milliliters, or cubic centimeters).
Co-Packaged Drugs:
When a drug contains multiple components (e.g., tablets, capsules, ampoules) packaged together, labels must clearly specify the quantity of each component. This should be displayed with a plus sign (+) between components and enclosed in brackets.
Descriptions should start with terms like “Co-pack” or “Combipack” to clarify the packaging type.
If multiple co-packs are within a single package, the total number of co-packs must also be indicated.
These requirements ensure that both healthcare providers and consumers have an accurate understanding of the drug’s contents, supporting safe and effective use.
Brand Name/Trademark Requirements for Drug Labelling
Drug labels must follow specific guidelines when using a brand name or trademark to ensure transparency and prevent consumer confusion:
Accurate Representation:
The brand name or trademark should be included on the label but must not mislead consumers about the nature, quality, or ingredients of the drug product.
The brand name must be unique and not resemble any existing registered product to avoid confusion.
Consistency in Product Lines:
If a drug is registered as part of a product line with multiple formulations containing similar active ingredients, at least one active ingredient should remain consistent across the line.
To differentiate each product, the brand name should include a “differentiating suffix” that clearly indicates the product’s specific formulation or intended use.
Example:
A pharmaceutical company marketing a range of pain relievers under the brand “PainGo” could use “PainGo Forte” for a stronger formulation containing Ibuprofen and Paracetamol, while “PainGo Relief” could indicate a milder version with Ibuprofen and caffeine.
These guidelines ensure that consumers can distinguish between different products within a brand, promoting safe and informed drug use.
NAFDAC Registration Number display Requirements
The NAFDAC registration number (NAFDAC Reg No.) must be clearly displayed on labels, as follows:
The outer and inner label of a drug product should clearly show the NAFDAC registration number (NAFDAC Reg No.). Labels are required as part of the registration documents; therefore, it is okay to only indicate a space where the NAFDAC Reg No. will be included after registration of the drug product. A drug product that has up to three packaging, tertiary, secondary and the primary packaging, the registration number may be shown on only the tertiary and secondary packaging alone.
Identification Mark requirements for drug and pharmaceutical products
Identification marks on tablets, capsules, caplet and similar dosage forms should be traceable to the holder of a certificate or the manufacturer, except:
- Drug products intended for use in a clinical trial investigation or bio-equivalence studies.
- Radiopharmaceutical drug products
- Drug products with product size, shape, physical characteristics which make imprinting technologically infeasible or impossible
- Drug administered solely in controlled healthcare settings.
If a drug product falls under any of the above category, a letter of exemption should be written to NAFDAC.
Labelling of Dispensing Measure
Packages of liquid medicines for children must include a proper measuring device, such as a spoon or syringe, with markings for accurate dosage.
Package Insert
Prescription only drugs shall be accompanied with a package insert with the relevant information and any other information required by the NAFDAC or other regulatory body.
Labelling of Parenteral Preparations
The labelling of injectable drug products should be such that it provides adequate information to healthcare practitioners and other users, to ensure safe and proper use of therapeutic agents, including:
- The name of the product
- Percentage content of the drug in liquid preparations
- Amount of active drug ingredients (for drug powder form)
- Volume of liquid to be added for reconstitution
- The route of administration
- Storage conditions
- Batch or lot number
- Manufacture or expiry date
- The full name and address of manufacturer
- Preparations intended for use in dialysis, hemofiltration, irrigation or any other use shall bear the statement, “not intended for intravenous injection”.
Injections for veterinary use should be indicated as such and include the withdrawal period.
Labelling of Non-nutritive sweeteners
The labels and package insert of all packaging contents for over the counter drugs containing an approved non-nutritional sweetener should be clearly written on the label including its identity, quantity in milligram per dosage and any precaution or warning.
Warning for Children
The labelling of all drug products shall include the following warning statement:
“Keep This Medicine Out of Reach of Children”
Labelling of Prescription and Over-The-Counter Drugs (OTC)
A prescription only drug is a treatment that must be prescribed by a doctor and is not licensed for sale to the general public while over-the-counter medicines are sold directly to a consumer without a requirement for a prescription from a healthcare professional. The labels of prescription only drugs as well as over-the-counter drugs should contain the following:
- Generic or common name of the product
- Dosage form and strength
- Listing of active drug ingredients
- Net content
- Storage conditions
- Batch or lot number
- Manufacture or expiry date
- The full name and address of manufacturer/Certificate holder
- Warning for children
- Route and frequency of administration (OTC drugs)
- A statement to the effect that a physician should be consulted if symptoms persists
- For topical drug products, the statement: “For External Use Only” or “For rectal or “Vaginal Use Only”
- The statement, “For Veterinary Only Use”
In addition, the leaflet of all prescription only use drugs should contain the following:
- The description of the drug
- Clinical pharmacology
- Indications and usage
- Contra-indications
- Interactions
- Warnings, precautions and adverse reactions
- Drug abuse and dependence (where applicable)
- Symptoms of overdose and treatment
- Dosage and administration
- The preparation for use
- Presentation, storage conditions and any other useful information.
The wrapper or carton of a bottle, jar or other immediate container of a drug should bear the above information required to be on the label. A leaflet may be used where all the required information cannot be contained on the labels.
Furthermore, OTC drugs should not be labelled as treatment, preventive or cure for any diseases, disorders or abnormal states as identified in the first schedule of the Food and Drugs Act, 2004.
Labelling of Drugs in 5cm Containers, Blister Packs and Bulk Packages
A drug packed in a container that is 5cm or its equivalent or less should indicate the following:
- The brand name, where applicable
- The generic or common name
- Lot or batch number
- Net content (drugs in 5cm and in bulk packages)
- Manufacture and expiry dates
- Manufacturer’s name
- Name and location of distributor or vendor (drugs in bulk packages)
- Storage conditions (drugs in bulk packages)
- NAFDAC registration number
- The statement “Caution: For Bulk Drugs Manufacturing Purposes Only” (for drugs in bulk packages).
Content of Ingredients Under Composition
The list of all active and inactive ingredients in all drug products must be on the label or the package insert.
An ingredient that is a derivative or preparation of a substance and the generic or common name does not indicate it as such, the label should indicate alongside the generic or common name that the drug is a derivative or preparation of such parent substance.
A quantitative list of preservatives present in sterile drugs should be indicated by their common or generic names.
Expiry Dates, Batch or Lot Number
The expiry date of a drug product should be determined by an appropriate stability testing as approved by NAFDAC, considering the shelf life of the product; and must also reflect the storage conditions of the product as determined by the stability testing. The expiry date of a drug product must also be shown on both the immediate container and the outer packaging (if present), unless it’s easily visible through the outer package.
If it is a co-packaged product, the expiry date should be based on the component with the shortest shelf life.
The batch or lot number on all labels should be indicated alongside the expiry dates and the labels should be capable of yielding the complete manufacturing history of the drug product.
Score Line Information Requirement for Scored Tablets
If a tablet has a break line, the label must state whether the break-line is functional and can be split into equal halves for proper dosage as mentioned in the dosage instructions. Alternatively, if the break-line is not functional, the label should clarify that it is only there to make swallowing easier and not for dividing the tablet into equal doses.
Conclusion
Labelling of drug products helps prevent misuse and potential harm. Therefore, information required to be on labels should not contain any statement which is false, misleading or exaggerated as to cause a misinterpretation.
Failure to comply with the above labelling requirements attracts a fine of eight hundred thousand naira (N800,000) for individuals, and five million naira (N5,000,000) or a prison term of 1year or both.
Beyond avoiding penalties, complying with these requirements helps differentiate genuine products from counterfeit ones, protecting both consumers and the integrity of the pharmaceutical industry.
Kindly reach out to us with your enquiries on NAFDAC registration and labelling requirements.
Also read about the labeling requirements for processed and pre-packaged foods and beverages.