Prescription Drugs and Requirements in Nigeria Pharmaceuticals
Prescription drug: A drug requiring a prescription, as opposed to an over-the-counter drug, which can be purchased without one.
What is the difference between prescription drugs and OTC drugs?
A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Here are the main differences between OTC drugs and prescription drugs.
Prescription drugs are:
- Prescribed by a doctor
- Bought at a pharmacy
- Prescribed for and intended to be used by one person
- Regulated by the national drug agency through a process. This is the formal step a drug sponsor takes to ask that the national drug agency of their country consider approving a new drug for marketing in their country. A national drug agency includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured. For more information on the National drug agency process in Nigeria, visit NAFDAC
IMPORTING (Prescription or OTC) PHARMACEUTICAL PRODUCTS INTO NIGERIA
In our article today, we highlight the stages required to import Pharma Products into Nigeria.
Stage 1- INCORPORATION / REPRESENTATION
Investors seeking to import Pharma Products must either register with the Corporate Affairs Commission as a pharmaceutical company or appoint a duly registered pharmaceutical company in Nigeria using a power of attorney, authorising it to act on their behalf. Registration as a pharmaceutical company must comply with the requirements of the Pharmacists Council of Nigeria (“PCN”).
Stage 2- REGISTRATION OF PREMISES
A suitable warehouse or building has to be secured for the storage of the Pharma Products being imported. Such premises must be registered for inspection in accordance with the provisions of the National Agency for Food and Drug Administration and Control (“NAFDAC”) Act and the Inspection, Location and Structure of Pharmaceutical Premises Regulation.
Stage 3- NAFDAC REGISTRATION
Before any pharmaceutical product can be imported into Nigeria, it must have been registered by NAFDAC. This process comprises of two stages:
- an application to bring in samples;
- an application for full registration
Once duly registered, the application shall be valid for 5 (five) years. This stage is highly critical as importation of unregistered Pharma Products is a violation of the provisions of the Act guiding NAFDAC.
Stage 4- CLEARING
Once the Pharma Products have arrived at the ports and are ready to be cleared, an application has to be made to the Port Inspectorate Directorate (PID) of NAFDAC and should be accompanied by shipping documentation, required permits and licenses from PCN and other agency permits. Once the payment of inspection and analysis fees is made, it is to be followed by physical inspection at the port and upon successful vetting, the Pharma Products are released to the warehouse.
Stage 5- ADVERTISING
Finally, it is pertinent for intending importers to know that before the cleared Pharma Products can be advertised, traditionally and via social media, necessary approvals must be gotten from NAFDAC and the Advertising Practitioners Council of Nigeria, via its Advertising Standards Panel Committee. Importers intending to market their Pharma Products should note this stage as NAFDAC may withdraw its certificate of registration from defaulters.
Note
This article is simply a guide for intending investors and importers on prescription drugs and should not be construed as legal advice. Source
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