Compiling your Product Dossier for NAFDAC Registration | Two-Minute Lesson

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product dossierOne of the main requirements for applying to the National Agency for Food and Drug Administration and Control (NAFDAC) for permission to introduce your products into the Nigerian market is to submit copies of your product dossier.

As a manufacturer who seeks to obtain NAFDAC registration in Nigeria, you are expected to prepare and provide technical documentation detailing how each product was developed, designed and manufactured. Generally most product dossiers for pharmaceuticals, that are submitted to NAFDAC, are expected to be in line with the International Conference on Harmonization (ICH) Common Technical Document (CTD) format and should include some of the information outlined below.

  • Language: All documents presented in the dossier must be submitted in English. If the original document is in a foreign language, an English translation must be provided to NAFDAC as part of your dossier.

  • Name of Product/approved generic or brand names: You must provide the name of your product and if your product has an International Non-proprietary Name (INN), scientific name or a brand name, you should provide this information in your dossier. Where a brand name is used, you must also provide the generic name which should be conspicuous in character and written alongside the brand name. For example, if the brand name is Glucophage, you will also write the generic name “metformin”. Again, if the brand name is Cadbury Bournvita, you will also state “chocolate drink” as the type of product.

  • Product description and packaging: The dossier should contain information that allows NAFDAC reviewers obtain a general understanding of the design applied to the product. It should also include a description of the critical ingredients that make up the product and the functions of the product.

  • Strength per unit dosage, dosage form and units of measure: You must provide composition and formulation information for each of the ingredients. You must also include the Net contents of essential ingredients in metric weight units in case of solids and metric volume in case of liquids.

  • Regulatory Situation in other Countries: List the countries in which this product has been granted marketing authorization. Also state if your application for marketing the product has been rejected, deferred or withdrawn from any market worldwide.

  • Sites of manufacture: State the name, street address and description of each facility where any aspect of manufacture (design, synthesis, production, sterilization, packaging, warehousing, quality control) occurs and indicate the activity performed at each site and any alternative manufacturers. You may also provide a site plan highlighting production areas and the number of employees at the site. If raw materials are not considered critical to your product, it may not be necessary to include the sites of supply of raw materials.

  • List all key suppliers: You should provide the name and street address of all key suppliers and a description of the ingredient/product/service supplied for the manufacture of your product. You should also provide details of the documented procedures used for the purchasing and verification of ingredients/products/services sourced from these suppliers. In addition, if you hold a certificate issued by a conformity assessment body and related to the quality management system, it is a good idea to include a certified copy as part of your product dossier.

  • Stability testing for your shelf life claims: When you specify a “Best by, Best before or Use by date”, you must provide detailed information on stability testing studies to support the claimed shelf life. It is advisable to perform testing on at least three different lots manufactured under conditions that are similar to routine production conditions. The selected testing lots do not need to be consecutive lots.

  • Standard Operating Procedures/Manufacturing procedure and Formulation: If the product is produced in your factory premises, you must outline the Standard Operating Procedures (SOP) for production, quality control, cleaning of factory equipment and premises etc. You should also provide an outline of the manufacturing procedure for the finished product, including the procedure for packaging the product and information relating to formulation for a typical batch and for an administration unit.

  • Specifications: The manufacturer must have carried out relevant investigations to support any performance claims and must provide a complete study protocol, method of data analysis, study report and conclusion. Detailed information must be provided to allow NAFDAC assess the validity of the information. References to relevant international or published standards or guidelines that have been applied in the production of the data should be provided. This portion of the dossier should also include a review of relevant published literature regarding the product or substantially similar products.

  • Clinical evidence and evaluation: Where a manufacturer makes any clinical claim, it is necessary to hold clinical evidence of such claims.

  • Labelling: Labelling should include at least the following:

  1. The name of the product, your name and address as the manufacturer or the name of the company or individual responsible for placing the product in the Nigerian market.
  2. A list of the active ingredients (using INNs if applicable) showing the amount of each ingredient present in a dosage unit, and a statement of the net contents of the container, e.g. number of dosage units, weight or volume;
  3. The batch number, which you have assigned to the product;
  4. The expiry date in an uncoded form and any warnings/precautions. For example, you must state if your product is not to be used by pregnant and lactating mothers;
  5. Any special storage conditions or handling precautions that may be necessary;
  6. Directions for use, and any warnings or precautions that may be necessary;
  7. The names of any excipients known to be a safety concern for some patients. For example, if your product contains gluten, you should state so clearly on the label.

This article was originally published as part of NLIPW Patents Vol. 1 No 6. on November 14, 2013. The articles is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances.

 

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About Ufuoma Akpotaire 178 Articles
Ufuoma is a Senior Editor and Director of Regulatory Policy at NLIPW. She assists clients in the protection of copyrights, trademarks and patents. She counsels clients regarding validity and infringement matters and has experience acting against the infringement of IP and addressing counterfeit issues. She holds a Masters degree (LL.M.) from Columbia Law School, New York and a law degree from the University of Nigeria (LL.B. Honors). She is admitted to practice law in Nigeria and in the State of New York. Ufuoma cut her teeth in the intellectual property practice groups of some of the largest law firms in Nigeria and has years of experience working with major non-profit organizations in New York. Email: uakpotaire@nlipw.com