Law No. 2017-541 of 3 August 2017 on the regulation of the pharmaceutical sector establishes the institutional and functional framework for the pharmaceutical sector regulatory system in order to guarantee the use of accessible, safe, effective and high-quality pharmaceutical products.
The import and export of pharmaceutical products must be carried out in accordance with good practices.
These guidelines aim to explain the entire process for applying for authorisation to import or export pharmaceutical products. They also define the responsibilities of the parties involved.
Authorisation for removal: this is an official document issued by the Regulatory Authority that allows the importer to collect imported health products stored at the port, land borders or airport.
Import authorisation: this is an official document issued by the AIRP prior to the shipment of pharmaceutical products or promotional material, authorising the entry of said products into the country. Also known as API.
Donation: The act of giving or transferring something that one owns and, in particular, the act of giving pharmaceutical products to someone, an institution or a charity; the thing or sum thus given, a gift.
Biomedical equipment: All devices and objects used for the care of patients and for the analysis, diagnosis and treatment of diseases and injuries.
Pharmaceutical products: any medicine intended for human or veterinary use as defined in Law No. 2015-533 of 20 July 2015 on the practice of pharmacy and other health products for human use, in particular medical gases, dressings, products and articles for medical use listed in the pharmacopoeia or presented in a sterile form, medical devices, products derived from traditional pharmacopoeia, reagents and consumables for medical biology analysis laboratories, food supplements and cosmetic products with claims.
Advertising of medicines: Advertising of medicines for human use means any form of information, including canvassing or inducement, aimed at promoting the prescription, supply, sale or consumption of such medicines, with the exception of information provided by healthcare professionals in the course of their activities.
Emergency situation: An emergency situation is a situation that presents an immediate risk of serious harm to health, life, property or the environment.
Emergency situation: An emergency situation is a situation that presents an immediate risk of serious harm to health, life, property or the environment.
PURPOSE
This document serves as a guide for the import and export of pharmaceutical products in Côte d’Ivoire, in compliance with regulatory requirements.
SCOPE
It applies to establishments that have been granted a licence to operate by the AIRP. The import or export of pharmaceutical products is carried out in accordance with AIRP guidelines and recognised rules of good practice. The AIRP may issue a special authorisation to import pharmaceutical products to any establishment, organisation or individual on an exceptional basis.
For certain pharmaceutical products subject to additional restrictions under other laws, regulations or conventions, such as the Convention on Narcotic Drugs, an official import authorisation is required. For certain pharmaceutical products subject to additional restrictions under other laws, regulations or conventions, such as the Convention on Narcotic Drugs, an official import authorisation is issued.
All importers are required to ensure that they meet all requirements relating to the import and export of pharmaceutical products in Côte d’Ivoire.
The following are subject to import/export requirements:
- Medicines with a marketing authorisation or a special use authorisation;
- Inputs, in particular active ingredients, excipients, semi-finished products and packaging materials used in the manufacture of pharmaceutical products;
- Advertising material;
- Pharmaceutical products that are donated;
- Medicines manufactured in Côte d’Ivoire.
Pharmaceutical products that are in prolonged short supply in Côte d’Ivoire and have equivalents authorised abroad are eligible for special importation after submission of an application to the AIRP.
The AIRP may adjust import or export volumes to adapt to developments related to a shortage situation.
Pharmaceutical products that do not meet the above requirements are excluded and cannot obtain an import or export authorisation.
POINTS OF ENTRY FOR PHARMACEUTICAL PRODUCTS
All shipments of pharmaceutical products must be made exclusively through the following designated points of entry:
- Felix Houphouët Boigny International Airport;
- Land customs offices;
- The Autonomous Port of Abidjan;
- The port of San-Pedro.
Address: Cocody-Riviera Bonoumin, Rue I 89, Quartier Avocatier
Email: secretariat@airp.ci
Tel.: +225 27 22 22 01 55
Postal address: 08 BP 3535 ABIDJAN 08
Website: www.airp.ci
