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.
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