Medicines and medical devices

I-INTRODUCTION

Imports of all Medical Products and Materials are controlled by the Ministry of Health and Public Hygiene through the Directorate of Pharmacy, Medicines and Laboratories (DPML) – Cf. Order No. 2015-166 of 28 September 2015 on the organisation and attribution of the DPML.

Ministry of Health and Public Hygiene

Directorate of Pharmacy, Medicines and Laboratories (DPML)

52, Boulevard de Marseille

BPv5 – Abidjan, Côte d’Ivoire

Tel: (+ 225) 21 35 73 13 / (+225) 21 35 13 24

Email: secretariat@dphm.ci

Website: www.dpml.ci

 

 

II-AUTHORISATION TO IMPORT

Only Health Professionals, as well as Authorized Companies are authorized to import Pharmaceutical and Medical Products and Materials:

  • Pharmaceutical Laboratories.
  • Pharmaceutical Representation and Promotion Agencies – Cf. Approval form for the creation of a pharmaceutical products representation and promotion agency.
  • Wholesalers – Distributors – See the Approval Form for the creation of a Wholesaler-Distributor establishment.
  • Approved Industrial Companies (contact the DPML).
  • Companies for the wholesale marketing of medico-surgical equipment and laboratory reagents – See the Approval Form for the creation of a wholesale marketing company for medico-surgical equipment.
  • Approved wholesale marketing companies of chemical products (contact the DPML).
  • Optics and eyewear companies.
  • Research organisations.
  • Medical organisations.
  • Charitable associations.
  • Local authorities.
  • Development Partners.

 

The procedures to follow to apply for approval, as well as the lists of documents required on this occasion, are available on the website of the DPML – Ministry of Health and Public Hygiene of Côte d’Ivoire.

 

III-DOCUMENTS

  1. Import Declaration Form (IDF)

The Import Declaration Form (IDF) – see IDF example – is compulsory if the value of the goods is higher than five hundred thousand (500,000) CFA francs. The IDF is established online via the transactional site of the Guichet Unique du Commerce Extérieur (GUCE). It is necessary to be registered on the GUCE website as an importer, exporter or forwarder. The documents and information required are as follows:

  • Importer Code (or Occasional Importer Code).
  • Pro-forma or Final Invoice.
  • Mode of transport.
  • Name of the importer’s bank (in Côte d’Ivoire) (for direct debit and exchange authorisation).
  • HS Codes of the products to be imported.

 

In addition, a Preliminary Import Authorisation (API) – (see API procedure below) – is required for:

– Medicines.

– Parapharmaceutical products (cosmetics, food supplements, dietetic products, infant milk and flour, etc.).

– Medical promotional material.

– Medical and Surgical Equipment.

– Laboratory materials and reagents.

– Optical and eyewear equipment.

– Chemicals.

– Raw materials for the manufacture of medicines.

– Primary Packaging Articles for Medicines.

– Semi-finished products.

– Blood products.

– Biological fluids and organs.

 

In addition, medicines intended to be marketed in Côte d’Ivoire are subject to a Marketing Authorisation – see the website of the Directorate of Pharmacy, Medicines and Laboratories – DPML.

 

Food supplements, dietetic or diet products, infant milks and flours intended to be marketed in Côte d’Ivoire are subject to a Marketing Authorisation – see the website of the Direction de la Pharmacie, du Médicament et des Laboratoires – DPML.

 

 

  1. Prior import authorization

 

The Preliminary Import Authorisation (API) is necessary to obtain the Import Declaration Form (IDF). The application for a Preliminary Import Authorisation concerns all the products in the list above – see API Certificate Information Sheet.

 

Procedure for obtaining an API

 

The application is made online through the portal of the GUCE (Guichet du Commerce Extérieur) by the importer or the authorised forwarder:

Start the Import Declaration Form (IDF) procedure on the GUCE website – see IDF procedure above.

 

The system automatically generates an application for a Preliminary Import Authorisation (API) addressed to the Directorate of Pharmacy, Medicines and Laboratories (DPML) of the Ministry of Health and Public Hygiene. The necessary documents are the following:

 

  • Pro forma invoice.
  • List of products to be imported.
  • Valid Approval to Practice (or Provisional Approval to Practice or Ministerial Approval, Certificate of Compliance or Ministerial Agreement).
  • Exceptional cases: The importer must go to the Directorate of Pharmacy, Medicines and Laboratories (DPML) of the Ministry of Health and Public Hygiene with the original documents to
  • Submit the application file for a Preliminary Import Authorisation
  • Pay the fee for obtaining the API, the cost of which is 5,000 F CFA / API – Cf. Order 2001-284/MSP/PPM of 21 August 2001
  • Verification and validation of the file by agents of the Ministry of Health and Public Hygiene and validation of the API.

Time limit for issuing the API: 72 hours

 

  1. Cargo Tracking Form (CTS) procedure

For operations using the maritime route, the exporter, the foreign forwarder and the importer must register the Cargo Tracking Form, via the website of the Ivorian Shippers’ Office (OIC).

At embarkation

Registration of the BSC (see General Import Procedures tab). The necessary documents are the following:

  • Final Invoice.
  • Bill of Lading (B/L) or Air Waybill (AWB) or Consignment note.
  • Packing list.
  • Customs Export Declaration of the country of shipment.
  • Local Insurance Certificate in Côte d’Ivoire.
  • The Import Declaration Form (IDF) or its number.
  • For imports outside the European Union:
  • The Freight Invoice
  • The Certificate of Origin

 

 

  1. Certificate of Value

The Customs Risk, Intelligence and Value Analysis Department (DARRV) checks the shipping documents and issues the Final Classification and Value Report (FCVR) by e-mail to the consignee or freight forwarder within 5 working days of submission of the documents.

 

The freight forwarder completes Form D41 (Sampling Permit: this is an authorisation given by the importer or freight forwarder to Customs to take a sample of the goods for the purposes of quality control or to visually assess the apparent condition of the goods) and physically lodges it with the transport documents (see list above) at the Customs Risk Analysis, Intelligence and Value Division (DARRV) for verification.

 

After examining the file, the DARRV issues a Verification Certificate (VC).

 

Goods with an FOB value of less than one (1) million F CFA and certain other products (see the list of goods not subject to FCVR on the website www.douane.ci) are exempt from the FCVR procedure.

 

As soon as the goods are shipped and all the transport documents for the goods are available (Final Commercial Invoice, Ocean Bill of Lading or Air Waybill, Packing List, Freight Invoice, copy of the IDF and all other available certificates), the freight forwarder must initiate an application for a Certificate of Value.

 

All goods with a FOB value greater than or equal to one (1) million F CFA must obtain a Final Classification and Value Report (FCVR) from the DARRV via the GUCE electronic platform. (Cf. Customs Circular n°2007 of 29 March 2019).

 

The authorised forwarder downloads and fills in the Notice of Deposit (ND).

 

He attaches the documents accompanying the goods (see list above) to the deposit notice and uploads the entire file online on the GUCE platform.

 

After examining the file, the DARRV issues the Certificate of Verification (AD).

 

  1. Customs declaration

 

On arrival

The Customs Declaration must be made by a forwarder appointed by the Importer and approved by Customs (www.douanes.ci). The documents to be given to the forwarder to make the Customs Declaration are the following:

  • Original Bill of Lading (B/L) for sea shipments or Air Waybill (AWB) for air shipments or Consignment note for road shipments.
  • Original Supplier Invoice.
  • Certificate of Insurance.
  • Import Declaration Form (IDF) – via the GUCE website)
  • Freight Invoice.
  • Final Classification and Value Report if the FOB value is equal to or greater than one (1) million F CFA, or the Attestation of Value (AV) if the FOB value is less than one (1) million F CFA, or if the products are excluded from the FCVR; (See the list of goods not subject to the FCVR on the websites www.douane.ci and www.webbfontaine.ci).
  • The Packing List.
  • The Customs receipt if the method of payment of duties and taxes is cash.
  • Cargo Tracking Form (CTS) issued by the ICO.
  • The WAEMU, ECOWAS Certificate of Origin if required.

 

  1. Authorisation for removal from the DPML

Once the customs declaration has been made, a Removal Authorisation (RA) [see Example RA] must be submitted to the DPML for the declared goods.

 

The deadline for obtaining this document is 48 hours after submission (every morning from 7.30 to 10.30). The necessary documents are as follows:

  • The Customs Import Declaration.
  • The original Preliminary Import Authorisation (PIA).
  • Final Invoice.

Cost: 5,000 FCFA (Cf. Order n° 2001-284/MSP/PPM of 21 August 2001)

Delivery time: 24 to 48 hours

 

Period of validity of the DPML’s Authorisation for Removal :

  • 3 weeks for products arriving by land.
  • 2 weeks for products arriving by air.
  • 1 month for products arriving by sea.

 

N.B.: Approved establishments with an API issued by the Directorate of Animal Production (for animal health medicines) pay a fee of CFA F 3,000 for the processing of each file from the Customs.