Key Takeaways
- In Gabon, the only distributors authorised to import medicines in bulk and distribute are the grossistes répartiteurs, who are pharmacy owners in Gabon and are registered by law.
- The Agence du Médicament de la République Gabonaise controls the process of pharmaceutical registration, importation, and distribution through Law 009/2011.
- Each of the products requires obtaining the marketing authorisation (Autorisation de Mise sur le Marché, or AMM) before it can be distributed, with no international mutual recognition of any permits.
- Direct sales of any pharmaceuticals by manufacturers to pharmacies or consumers are prohibited by law – manufacturers can sell their products only via distributors.
- Some of the distributors in Gabon are, for example, Office Pharmaceutique National (OPN), Pharmagabon, and UbipharmGabon.
- It is important to make sure that the licence and distribution chain of the distributor comply with GDP requirements.
The pharmaceutical industry in Gabon may be smaller in comparison to some other countries within the region, but it has a well-structured regulatory framework which determines exactly who is able to import, distribute, and supply the drugs in the country. When trying to get into the Gabonese market, it is important to understand the structure of the regulation since not all companies that refer to themselves as “distributors” are in fact capable of handling pharmaceutical goods legally.
Understanding Gabon’s Pharmaceutical Regulatory Framework
The laws regulating the operations of pharmaceuticals in Gabon are embodied in Law No. 009/2011 governing the regulations of pharmaceutical products in the Gabonese Republic. This law covers the regulations of the production, importation, distribution and dispensing of pharmaceutical products. The regulatory body is the Agence du Médicament de la République Gabonaise (national medicines regulator).
An important aspect of the regulatory system in Gabon is that the law requires that there must be an exclusive right to import and distribute the products only to the licensed wholesalers or grossistes répartiteurs. The manufacturers are not allowed to distribute the products to the pharmacies and consumers; they are only allowed to deal with the licensed wholesale distributors who then distribute to the pharmacies and hospitals.
Who Is Legally Allowed to Operate as a Pharmaceutical Distributor in Gabon?
In the Gabonese law on drugs, the function of grossiste répartiteur is done exclusively by a licensed pharmacist, and technical management of any such wholesale distribution enterprise has to be managed by a licensed pharmacist. It implies that, unlike some other systems in which trading firms may get licenses for distribution, in Gabon, the system is tightly linked to pharmacists.
Where to Find Pharmaceutical Distributors in Gabon
1. The Establishment Records of the National Medicines Regulatory Agency
As all wholesale distributors must be licensed by the Agence du Médicament, it is the best way to check the registered establishment records of the agency to verify which companies have the right to import and distribute medicines in the country.
2. The Known National Wholesale Distributors
The Gabonese pharmaceutical wholesale market comprises a small number of wholesalers. OPN is one of the main wholesalers in the country’s public and semi-public sectors, whereas the private wholesalers such as Pharmagabon and UbipharmGabon can be considered experienced wholesalers providing pharmacies and healthcare facilities with medicines.
3. Involvement of the Ministry of Health and Public Announcements
The Ministry of Health in Gabon is known to get involved directly with importers and wholesalers regarding national policies related to the pharmaceutical industry, such as efforts to cut down on the import of generic products in favour of local production. Announcements and public consultations from the ministry might reveal distributors who are participating in the regulatory and policy process.
4. Pharmaceutical Associations in the Region
Organisations specialising in monitoring pharmaceutical regulations in Francophone African countries issue country-specific guides containing information on the process of importation, licensed firms in Gabon, and regulatory contacts that could be used to identify active distributors.
5. Local Regulatory Consultants and Agents
Due to the complicated registration and import authorisation process in Gabon, many foreign companies have chosen to cooperate with local regulatory consultants and agents who are aware of the requirements of Agence du Médicament and have contacts among licensed distributors.
The Product Registration Process Before Distribution
In order to market any product in Gabon, the product needs to receive a Marketing Authorisation (Autorisation de Mise sur le Marché or AMM) from the Agence du Médicament. The application process has to be supported by a WHO certification scheme for pharmaceutical products, and it usually takes about three months with the involvement of an expert panel in the review process. However, the important fact is that Gabon does not automatically recognise marketing authorisation issued by another country.
What to Verify Before Partnering with a Distributor
- License for wholesale distribution: Ensure the firm is licensed by the Agence du Médicament as a grossiste répartiteur.
- Technical direction by a licensed pharmacist: Check if there is a licensed pharmacist directing the technical activities of the company.
- Good Distribution Practice (GDP): Ask for information regarding storage conditions and temperature control as well as handling, especially for temperature-sensitive drugs.
- Geographical coverage: Find out if the distributor is able to distribute not only in Libreville but also to other regions.
- Experience in the same category of your product: Ensure the distributor has experience in the same therapeutic category or dosage forms as yours.
- Ability to import: Ask for experience in clearing through the port of entry.
Step-by-Step Approach to Finding a Distributor in Gabon
- Ensure that the classification of your product is known, as well as whether it needs to be authorised
- Check which wholesalers are licensed using the database of the country’s regulatory authority and other sources
- Select suitable distributors according to their experience, geographical coverage, and infrastructure
- Check licensing, pharmacist control, and GDP compliance firsthand
- Start the registration of AMM (Marketing Authorisation) at the same time, as distribution cannot start without it
- Negotiate terms of distribution, including import issues, minimum order quantities, payment terms
- Set up an import authorisation procedure
Common Challenges When Entering the Gabonese Market
- Only a few licensed wholesale distributors as opposed to many in other regions
- No mutual acceptance of other countries’ marketing authorisations, necessitating full local registration
- Government policies aimed at favouring locally produced generics over some imported ones
- Limited local lab testing facilities, implying that the imported products will have to undergo testing in another location
- Regulatory inspection requirement for authorised ports of entry that needs to be considered in shipment planning
Frequently Asked Questions on Finding Pharmaceutical Distributors in Gabon
Is it possible to sell directly to pharmacies in Gabon?
No. It is mandatory in Gabonese legislation that only licensed wholesale distributors (grossistes répartiteurs) can act as an exclusive distribution channel to pharmacies, hospitals, and other licensed institutions.
Is there a system of automatic recognition of the marketing authorisation issued by other countries in Gabon?
There is no such system in place in Gabon – all products must go through the AMM registration process with Agence du Médicament.
Which agency regulates the distribution of pharmaceuticals in Gabon?
Agence du Médicament de la République Gabonaise is the national regulatory authority of Gabon responsible for the registration of products and licensing of pharmaceutical institutions.
How long does it take to register a product before its sale?
It takes about three months to review the marketing authorisation, although actual time may differ depending on the quality of the application.
Are there any restrictions in terms of ownership in grossiste répartiteur activity?
The ownership in grossiste répartiteur is legally restricted to licensed pharmacists, while the technical direction of the grossiste répartiteur business should belong to a licensed pharmacist as well.
Conclusion
In finding a distributor for pharmaceutical products in Gabon, there is a need not just to do a general market survey but to find out those companies which are officially licensed as grossiste répartiteur with the guidance of a pharmacist. It is very necessary for someone who intends to enter the market to take his time and ensure that the companies he is considering are within the confines of the law governing registration and distribution in Gabon.
