NAFDAC prohibits registration of certain imported drugs

Nigeria

A directive issued by the National Agency for Food and Drug Administration and Control (NAFDAC) has come into force.

NAFDAC Decree 15 of 1993 provides that any processed food, drug, drug product, cosmetic, medical device or water manufactured, imported, exported, advertised, sold or distributed in Nigeria must be registered with NAFDAC. One of the prerequisites for registration with NAFDAC is that any related trademark must have been registered with the Nigerian Trademark Registry.

The new directive stipulates that NAFDAC will no longer allow the registration of certain imported drugs. It is therefore likely to affect many pharmaceutical mark owners.

The directive includes the following provisions:

  • Over-the-counter (OTC) drugs, such as analgesics, blood tonics, vitamins and anti-malaria products will no longer be registered (for further information, see schedule below).

  • A drug registration will be valid for only 10 years (five years in the first instance and a single renewal period of five years).

  • All drugs must be produced locally, with effect from 2013.

  • Orphan drugs, which are specialized drugs for the diagnosis and/or treatment of rare diseases or conditions (eg, drugs used in the treatment of cancer), are exempted from the requirement of local production by 2013.

  • NAFDAC will not process renewal applications filed more than three months after the expiration of the initial registration.

  • The NAFDAC registration number must be affixed on every imported product prior to sale in Nigeria. Goods that fail to meet this requirement will be destroyed.

  • All products submitted for registration must have an indication of where the registration number (when granted) will be affixed.

  • All drug products (eg, capsules, tablets or caplets) must carry the manufacturer's identification mark.

  • Registration of toothbrushes is now optional.

Folasade Laniyan, Jackson, Etti & Edu, Lagos

Schedule

The following OTC drugs are prohibited from importation into Nigeria, with effect from January 2004:

  • Paracetamol,

  • Ampicillin capsules,

  • Ciprofloxacin tablets,

  • Amoxicillin capsules,

  • Piroxicam capsules,

  • Ibruprofen,

  • Indomethacin,

  • Tetracycline,

  • Cotrimoxazole,

  • Metronidazole,

  • Ampicillin plus Cloxacillin capsules,

  • Cyproheptadin,

  • Sulphodoxin plus Pyremathamine,

  • Chloroquin tablets,

  • Diclofenac-Sodium tablets,

  • Nimeluside, and

  • multivitamins.
This list is not exhaustive.

Other banned products that fall within the purview of NAFDAC are:

  • sorghum,

  • biscuits,

  • spaghetti and noodles,

  • poultry and poultry products,

  • sugar and confectionery (candy or chocolates),

  • beer (bottled and canned),

  • drinking water (spring or sparkling),

  • toilet rolls,

  • importation of vegetable oil in bulk,

  • toothpicks in any form,

  • fruit juice (it may be imported as fruit concentrates in drums but not in retail packaging),

  • wheat flour, and

  • cassava or cassava products (where imported through a land border).

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