REQUIREMENTS FOR IMPORTING PHARMACEUTICAL PRODUCTS INTO NIGERIA

Aderonke Alex-Adedipe

According to the UN International Trade Statistics Database, importation of products by Nigerians increased from N132.6 million to N159 million between May to June,2020. This indicates that in spite  of the decrease in economic activities brought on by the Coronavirus pandemic, importation still remains pivotal in Nigeria. One significant group of products that have gained traction, especially in the wake of the pandemic are pharmaceutical products (“Pharma Products”). 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:

  1. an application to bring in samples;
  2. 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 and should not be construed as legal advice. You may contact us if you have enquiries with respect to the foregoing at [email protected]

To read more articles on importation of goods into Nigeria, click here . You can also learn more about NAFDAC requirements to set up a restaurant in Nigeria by clicking here.

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Aderonke Alex-Adedipe has been in active legal practice for over a decade. She has extensive experience advising local and foreign financial institutions on project finance transactions, which cut across various sectors. She also advises local and foreign investors on the Nigerian business environment- regulatory requirements, business formation, corporate structures, investment incentives, immigration, local content requirements and general corporate commercial transactions. She has acted in conjunction with both indigenous and international law firms in advising on several commercial transactions. Aderonke has co-authored the Nigerian chapter for several notable international publications on Acquisition Finance and Commercial Law, including Getting the Deal Through. She also contributed to the text on Banking, Theory, Regulation and Law Practice which was edited by Dr. Dapo Olanipekun. Aderonke was recently recognised by IFLR 1000, a guide to the world’s leading financial law firms, as a Highly Regarded Lawyer in the Project Finance, Oil and Gas and Real Estate sectors. Aderonke was also recognised by the Esquire Nigerian Legal Awards as one of the 40 outstanding lawyers under the age of 40 who have distinguished themselves and are clearly setting new standards in the legal sector. She was previously a Partner at Strachan Partners where she was in charge of the firm’s Transactions department. Aderonke holds a Bachelor of Laws degree from Obafemi Awolowo University and a Master of Laws degree from George Washington University. She is a member of the Nigerian Bar Association.

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