Importing Pharmaceutical Drugs And Medical Devices Into Ghana
The article presents an overview of the statutory requirements and guidelines for importing drugs and medical equipments into Ghana. It is intended to serve as a quick reference for companies planning on importing drugs or medical devices into Ghana.
Generally, a company must obtain an import license from the Food and Drugs Board in Ghana before importing any drugs or medical equipments into the country. However, all drugs and medical equipments must first be registered by the regulating agency before they can be imported into Ghana. Thus, before a company imports drugs or medical equipment for commercial purposes, it must first import samples into the country for the purposes of complying with the prior registration requirement. Once registration has been obtained, the company can then go through the process of obtaining an import license to import the products in commercial quantities.
The importation of pharmaceutical drugs and medical devices is governed by the Food and Drug Law, 1992 (PNDCL 305B) as amended by the Food and Drug (Amendment) Act, 1996 (Act 523) and the Food and Drugs Board Guidelines.
In Ghana, only corporate bodies duly registered and licensed to commence business under the laws of Ghana are permitted to import drugs and medical devices for commercial purposes. However, registered wholesale pharmaceutical companies licensed by the Ghana Pharmacy Council may be allowed to import reasonable quantities for retail in their shops only. In addition, registered medical practitioners and veterinarians may also be allowed to import drugs and medical devices for use in their professional practice.
Notwithstanding the general restrictions on the importation of drugs and medical equipments, corporate bodies are allowed to import samples of these products into the country for the purposes of complying with the prior registration requirement of the Food and Drugs Board.
Under the rules, all products imported must have at least 60% of its shelf-life remaining on arrival at a port in Ghana. However, with respect to products with a shelf life of 24 months, the product must have at least 80% of its shelf-life remaining by the time it arrives at a port in Ghana.
Companies applying for an import license must complete the appropriate forms and submit all required documents in triplicate to the regulatory agency. Usually, after the license fee has been paid, the processing time ranges from 8 to 10 working days. Once granted, the import permit shall be valid for one year from the date of issue and shall be renewed on a yearly basis.
The above notwithstanding, any statute governing importation procedures generally, shall apply to drugs and medical devices too. Thus, companies must also take steps to comply with the Export and Import Act, 1995 (ACT 503) and the Export and Import (Amendment) Act, 2000 (Act 585).
AUTHOR: AB Lexmall & Associates
