{"id":8972,"date":"2025-11-27T08:38:55","date_gmt":"2025-11-27T07:38:55","guid":{"rendered":"http:\/\/localhost\/pwic.gouv.ci\/?p=8972"},"modified":"2025-11-27T09:43:31","modified_gmt":"2025-11-27T08:43:31","slug":"importation-of-pharmaceutical-products-into-ci","status":"publish","type":"post","link":"https:\/\/www.gucecotedivoire.ci\/pwic\/en\/importation-of-pharmaceutical-products-into-ci\/","title":{"rendered":"Importation of pharmaceutical products into CI"},"content":{"rendered":"\t\t
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All imports of pharmaceutical products into C\u00f4te d’Ivoire are subject to prior authorisation issued by the AIRP. Applications must be submitted by post to the Director General of the AIRP, dated and signed by the responsible pharmacist and on the letterhead of the applicant establishment.<\/p>

Only establishments approved and\/or recognised by the AIRP are eligible for an import authorisation.<\/p>

Pharmaceutical products covered by the import application must have a marketing authorisation or a temporary authorisation for use.<\/p>

In special circumstances, a special import authorisation is issued to certain establishments and\/or for certain categories of pharmaceutical products.<\/p>

The import authorisation application process varies depending on the type of establishment and the nature of the pharmaceutical product covered by the import application.<\/p>

Prior authorisation for import must be obtained before the pharmaceutical products are shipped from their country of origin.<\/p>

Promotional material, like pharmaceutical products, is subject to prior authorisation.<\/p>

Upon arrival at the points of entry, the AIRP reserves the right to carry out an import inspection to verify compliance with the prior authorisation application.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\tImportation of pharmaceutical products and biomedical equipment by wholesale distributors: Annual Import Authorisation (AAI)\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<\/h3>\r\n\r\n <\/div>\r\n\r\n
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1. Authorised pharmaceutical establishments<\/strong><\/p>

Wholesale distributors.<\/p>

2. Required documents<\/strong>
Two (02) copies of the import authorisation application letter (according to the template in the appendix);
A copy of the previous Annual Import Authorisation (AAI), if applicable.<\/p>

Products subject to international control (psychotropic substances, narcotics, precursors) and pharmaceutical products with a short expiry date and\/or without marketing authorisation are governed by specific provisions.<\/p><\/div>\r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \r\n

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\r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\tImportation of pharmaceutical products, biomedical equipment and chemicals by other establishments: Prior Import Authorisation (PIA)\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<\/h3>\r\n\r\n <\/div>\r\n\r\n
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1. Authorised pharmaceutical establishments:<\/strong>
\u00a0 \u00a0o Pharmaceutical representation agencies;
\u00a0 \u00a0o Pharmaceutical laboratories;
\u00a0 \u00a0o Wholesale distributors;
\u00a0 \u00a0o Manufacturers;
\u00a0 \u00a0o Medical and surgical equipment sales companies;
\u00a0 \u00a0o Chemical sales companies;
\u00a0 \u00a0o Depositories;
\u00a0 \u00a0o Wholesale import and export distributors (DGIE);
\u00a0 \u00a0o Pharmacies;
\u00a0 \u00a0o Hospitals and clinics;
\u00a0 \u00a0o Organisations and institutions.<\/p>

2. Required documents:<\/strong>
\u00a0 \u00a0\u2022 Two (02) copies of the import authorisation application letter (as per the template in the appendix);
\u00a0 \u00a0\u2022 Two (2) copies of the invoice including:
\u00a0 \u00a0 \u00a0o The name and address of the supplier (shipper);
\u00a0 \u00a0 \u00a0o The name, address and functional telephone number of the importing establishment (consignee); The applicant must be the consignee;
\u00a0 \u00a0 \u00a0o The invoice number and date;
\u00a0 \u00a0 \u00a0o The description (trade name + INN where applicable), quantity and price (unit and total) of the products.
\u00a0 \u00a0 \u00a0 o A copy of the valid approval issued by the AIRP, if applicable;
\u00a0 \u00a0\u2022 Quality document(s) (certificate of analysis or certificate of conformity):
\u00a0 \u00a0 \u00a0o Drawn up on the letterhead of the organisation that carried out the quality control;
\u00a0 \u00a0 \u00a0o Bearing the document number, signature and stamp of the organisation that carried out the quality control;
\u00a0 \u00a0 \u00a0o Specifying the description of the product on the invoice, the batch number, the expiry date and the tests carried out.<\/p>

    • \u00a0<\/li><\/ul><\/li><\/ul>

      N.B : Les DGIE et d\u00e9positaires doivent fournir les AMM et les certificats de lib\u00e9ration de lots des produits import\u00e9s.<\/strong><\/p>

      La quantit\u00e9 d\u2019\u00e9chantillons m\u00e9dicaux destin\u00e9s \u00e0 \u00eatre import\u00e9s dans le cadre d'une demande d'enregistrement est de 30 maximum, pour le renouvellement 05 maximum et pour les variations, 05 maximum. Ils doivent \u00eatre des \u00e9chantillons identiques au mod\u00e8le vente.<\/p><\/div>\r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \r\n

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      \r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\tImportation of products under international control (narcotics, precursors, psychotropic substances): Official Import Authorisation (OIA)\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<\/h3>\r\n\r\n <\/div>\r\n\r\n
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      Authorised pharmaceutical establishments<\/strong>
      \u00a0 \u00a0\u2022 Wholesale distributors;
      \u00a0 \u00a0\u2022 Companies selling chemical precursors;
      \u00a0 \u00a0\u2022 Organisations and institutions;
      \u00a0 \u00a0\u2022 Health programmes;
      \u00a0 \u00a0\u2022 Agri-food and cosmetics industries.<\/p>

      Required documents<\/strong><\/p>

      A complete application for official import authorisation includes:<\/p>

      \u00a0 \u00a0- The import authorisation application letter in two (02)
      copies (according to the template in the appendix);
      \u00a0 \u00a0- Two AOI application forms, which can be downloaded from the AIRP website, www.airp.ci,
      or obtained from the AIRP headquarters.<\/p>

      N.B.: For unregistered products, a Special Import Authorisation<\/strong>
      (ASI) is required in addition to the Official Import Authorisation (AOI).<\/strong><\/p><\/div>\r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \r\n

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      \r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\tOnline importation of pharmaceutical products, biomedical equipment and chemicals: Online Import Authorisation (AI online).\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<\/h3>\r\n\r\n <\/div>\r\n\r\n
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      Authorised pharmaceutical establishments:<\/strong>
      \u00a0 \u00a0\u2022 Agri-food and cosmetics industries;
      \u00a0 \u00a0\u2022 Companies selling medical and surgical equipment;
      \u00a0 \u00a0\u2022 Companies selling chemical products.<\/p>

      Required documents:<\/strong>
      \u00a0 \u00a0\u2022 Two (02) copies of the letter requesting import authorisation (according to the model in the appendix);
      \u00a0 \u00a0\u2022 A copy of the valid approval issued by the AIRP, if applicable;
      \u00a0 \u00a0\u2022 Quality document(s) (certificate of analysis or certificate of conformity):
      \u00a0 \u00a0 \u00a0 - Drawn up on the letterhead of the organisation that carried out the quality control;
      \u00a0 \u00a0 \u00a0 - Bearing the document number, signature and stamp of the organisation that carried out the quality control;
      \u00a0 \u00a0 \u00a0 - Specifying the name of the product on the invoice, the batch number, the expiry date and the tests carried out.<\/p><\/div>\r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \r\n

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      \r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\tImportation of pharmaceutical products without marketing authorisation or with a short expiry date: Special Import Authorisation (ASI)\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<\/h3>\r\n\r\n <\/div>\r\n\r\n
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      a- Authorised pharmaceutical establishments:<\/strong>
      \u00a0 \u00a0\u2022 Wholesale distributors;
      \u00a0 \u00a0\u2022 Wholesale importers and exporters (DGIE);
      \u00a0 \u00a0\u2022 Private pharmacies.<\/p>

      b- Required documents:<\/strong>
      \u00a0 \u00a0\u2022 Two (02) copies of the import authorisation application letter (according to the template in the appendix);
      \u00a0 \u00a0\u2022 Two (2) copies of an invoice showing:
      \u00a0 \u00a0 \u00a0 - The name and address of the supplier (shipper);
      \u00a0 \u00a0 \u00a0 - The name and address of the importing entity (consignee); the applicant must be the consignee;
      \u00a0 \u00a0 \u00a0 - The invoice number and date;
      \u00a0 \u00a0 \u00a0 - The description (trade name + INN where applicable) and quantity of the products;
      \u00a0 \u00a0 \u00a0 - The batch number;
      \u00a0 \u00a0 \u00a0 - The date of manufacture and expiry date, where applicable (in the case of products with a short expiry date).<\/p><\/div>\r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \r\n

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      \r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\tImportation of pharmaceutical products by individuals: Personal use (individual ASI)\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<\/h3>\r\n\r\n <\/div>\r\n\r\n
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      a- Authorised pharmaceutical establishments:
      - Natural persons;
      - Legal persons;
      - State-approved structures to which the AIRP does not issue approval.<\/p>

      b- Required documents:
      \u2022 Two (02) copies of the letter requesting import authorisation (according to the model in the appendix);
      \u2022 A prescription and\/or invoice (for natural persons);
      An invoice (for legal persons) in duplicate (2).
      The invoice must include the following information:
      - The name and address of the importing organisation (recipient); the applicant must
      be the recipient;
      - The invoice number and date;
      - The description (trade name + INN where applicable) and quantity of the
      products;
      - The batch number;
      - The date of manufacture and expiry date, where applicable.<\/p>

      \u2022 Quality documents (certificate of analysis), mainly for legal entities.<\/p><\/div>\r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \r\n

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      \r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\tImportation of pharmaceutical products and\/or biomedical equipment for donation purposes\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<\/h3>\r\n\r\n <\/div>\r\n\r\n
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      a- Authorised pharmaceutical establishments<\/strong>
      - Non-governmental organisations;
      - Charitable associations;
      - Religious establishments;
      - State structures (presidency, prime minister's office, embassy, town hall, general councils, etc.).
      All these structures must be recognised and authorised by the Ministry of Health.<\/p>

      b- Required documents<\/strong>
      A complete application for authorisation to import donations includes:
      \u2022 Two (02) copies of the letter requesting authorisation to import (according to
      the model in the appendix);
      \u2022 Two (02) copies of the invoice or complete list of pharmaceutical and\/or biomedical equipment donations to be imported, specifying:
      - The International Nonproprietary Name (INN);
      - The quantities;
      - The form and presentation;
      - The batch number;
      - The expiry date (minimum one year from the date of arrival on Ivorian territory).
      \u2022 The donation certificate, duly dated and signed by the donor organisation;
      \u2022 The list of beneficiary establishments;
      \u2022 A letter of acceptance of donations by the beneficiaries;
      \u2022 An administrative document certifying that the Departmental Health Directorate\/Regional Directorate has been informed of the donation and agrees to assume responsibility for it, monitor it and ensure its proper use.<\/p>

      For NGOs:
      - A copy of the public service agreement between the organisation and the Ministry of Health;
      - Registration in the Official Journal or, failing that, the association's declaration receipt;
      - The NGO's articles of association, specifications or annual action plan;
      - The NGO's location(s) and the locations of its premises.<\/p>

      Donated pharmaceutical products must be unopened, safe, new and of good quality.<\/p><\/div>\r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \r\n

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      \r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\tImporting advertising material\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<\/h3>\r\n\r\n <\/div>\r\n\r\n
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      a- Authorised pharmaceutical establishments<\/strong>
      - Pharmaceutical representation and\/or promotion agencies;
      - Pharmaceutical laboratories.<\/p>

      b- Required documents<\/strong>
      \u2022 The advertising authorisation decision or advertising authorisation notification issued by the AIRP;
      \u2022 The letter of application for import authorisation in two (02) copies (according to the model in the appendix);
      \u2022 The list of names of medical representatives and supporting documents for their employment (copy of the employment contract or certificate of employment + copy of an identity document);
      \u2022 The annual allocation of medical samples and promotional material for the medical representative(s);
      \u2022 A copy of the valid marketing authorisation\/approval for the medicines\/other pharmaceutical products covered by the advertising application;
      \u2022 The import plan for year n+1, completed in accordance with the template available on the AIRP website:
      \u00a0 \u00a0- Two hard copies;
      \u00a0 \u00a0- Two digital copies (USB stick).
      \u2022 A copy of the valid approval issued by the AIRP.<\/p>

      The application for prior authorisation to import advertising material follows the granting of advertising authorisation.
      Free samples of pharmaceutical products intended for promotional purposes must bear the words \u2018Free medical sample\u2019 - \u2018Not for sale\u2019 printed indelibly on the box.
      Products subject to international control (psychotropic substances, narcotics, precursors), heat-sensitive products and injectable products must not be used for promotional purposes.<\/p><\/div>\r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n \r\n

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      \r\n\t\t\t\t\t\t\r\n\t\t\t\t\t\t\tImportation of medicines intended for clinical research (clinical trials)\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<\/h3>\r\n\r\n <\/div>\r\n\r\n
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      a- Authorised pharmaceutical establishments<\/strong>
      Clinical trial sponsors.<\/p>

      b- Required documents<\/strong>
      \u2022 The letter requesting authorisation to import, in two (02)
      copies (according to the model in the appendix);
      \u2022 The invoice in two (2) copies, including:
      \u00a0 - The name and address of the supplier (shipper);
      \u00a0 - The name, address and functional telephone number of the importing organisation (consignee); The applicant must be the consignee;
      \u00a0 - The invoice number and date;
      \u00a0 - The description (trade name + INN where applicable), quantity and price (unit and total) of the products.
      \u2022 The clinical trial authorisation;
      \u2022 The quality document(s) (certificate of analysis or certificate of conformity):<\/p>

      All import authorisation applications must be accompanied by the receipt for the fees set by the AIRP.<\/p>

      Upon receipt of the import authorisation application, as specified above, the AIRP will verify that the requirements have been met.<\/p>

      If the application meets the prescribed requirements, the AIRP will issue an import authorisation.<\/p>

      The import authorisation is valid for three (3) months, renewable once, and is issued for a single import.<\/p>

      In the exceptional case of products under international control, the maximum period of validity is six (6) months.<\/p>

      In the case of partial imports, a new application for import authorisation must be submitted to the AIRP.<\/p>

      If the application does not meet the import requirements, the applicant will receive a notification of rejection or request for additional information or fees, clearly stating the reason(s).
      Applications are processed within 72 hours of submission.<\/p><\/div>\r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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