Insight Into How To Establish a Pharmaceutical Business in Rwanda

Our guide on establishing a pharmaceutical business in Rwanda highlights that the pharmaceutical industry is well-regulated, leading to the establishment of numerous pharmacies across the country. This proliferation has greatly improved the accessibility of medicine in Rwanda. Additionally, the variety of drugs available in these pharmacies is a significant advantage for the Rwandan medical sector. Some of the most popular pharmacies in Kigali today include Vine Pharmacy, Teta Pharmacy, Mediasol Pharmacy, and Continentale.

The regulatory body for the pharmaceutical industry in Rwanda is the Rwanda Food and Drug Authority (Rwanda FDA), which issues pharmaceutical operation licenses among other required licenses for pharmacy operators.

Before delving into the licensing process, it is important to note that the first step in establishing a pharmaceutical business in Rwanda is incorporating a company. The application for incorporation is submitted online to the Office of the Registrar General. The most commonly registered type of company in Rwanda is the Domestic Private Company Limited by Shares. Although not mandatory, it is recommended to reserve your preferred company name first to ensure its availability upon submission of the application to the Registrar General’s Office.

The incorporation process typically takes 1-2 days, depending on the number of applications at the Registrar General’s Office and the applicant meeting all requirements. The requirements for incorporating a domestic private company limited by shares include:

1. Company name ending with the abbreviation “Ltd” or the word “Limited”
2. Share capital
3. Number of shares and value per share
4. Shareholders and the number of shares owned by each shareholder, with each providing their national ID (for nationals) or passport (for foreigners), contact information, and address
5. Directors of the company, including a Managing Director, a Chairperson of the Board, and other board members, with one director required to be a resident of Rwanda. Each director must provide their ID/passport, telephone number, and address
6. Office address
7. Memorandum of Association and Articles of Association, although a company may choose not to have Articles of Association under Rwandan company law

After the company is incorporated, the applicant can proceed to apply for an operations license, also known as a pharmaceutical license, from Rwanda FDA. The application process for the pharmaceutical license may take up to one month, depending on the applicant meeting all requirements and the number of pending license applications at Rwanda FDA.

The key requirements for applying for a pharmaceutical license include:

1. A duly filled application form
2. RDB company registration and full registration certificates
3. Lease/rent contract for the premises
4. Evidence of payment of prescribed fees to Rwanda FDA
5. Notarized valid license to practice pharmacy, issued by the National Pharmacy Council

These requirements are submitted to Rwanda FDA through its official email. Within 20 days of assessment, a site visit is conducted to verify if the applicant’s premises meet the requirements.

According to Rwanda FDA regulations, the storage areas for a wholesale pharmacy must have a minimum floor area of 60 square meters, a minimum height of 2.5 meters, and the sales and administrative area must have a minimum continuous floor space of 30 square meters. If the premises meet these and other requirements such as construction standards and location, the inspection team issues a premise suitability inspection report.

After a thorough review and assessment of the submitted requirements, a pharmaceutical license is issued to the applicant if everything is in order and conforms to the requirements.

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This guide is intended to provide general information and does not constitute legal advice. For specific legal advice tailored to your situation, please consult with a qualified attorney at Stabit Advocates.