AN INSIGHT ON WHAT IT TAKES TO ESTABLISH A PHARMACEUTICAL BUSINESS IN RWANDA

AN INSIGHT ON WHAT IT TAKES TO ESTABLISH A PHARMACEUTICAL BUSINESS IN RWANDA BY YOUR BEST LAWYERS IN RWANDA

The Pharmaceutical Industry in Rwanda is well regulated which has prompted the establishment of many pharmacies in Rwanda. In addition, the establishment of many pharmacies, we would say have contributed a great deal to the easy accessibility of medicine in Rwanda. It also suffices to mention that due to the establishment of many pharmacies, there is variety of drugs in stock in these pharmacies which is a plus for the Rwandan Medical Sector. The most popular pharmacies in Kigali as of today include but are not limited to Vine Pharmacy, Teta Pharmacy, Mediasol Pharmacy, Continentale among others.

The regulator of the Pharmaceutical Industry in Rwanda is Rwanda Food and Drug Authority (Rwanda FDA).  Rwanda FDA is in charge of issuing the pharmaceutical operations licences among other licences required by Pharmacy Operators.

Before jetting into the licensing bit of it, it is worth noting that the very first step of establishing a pharmaceutical business in Rwanda is by incorporation of a company. The application for incorporation of a company 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.  Normally, even though it is not mandatory, it is recommendable for one to first reserve ones preferred company name such that one is assured of possession of such a name upon submission of the application to the Registrar General’s Office.

The incorporation process of a company in Rwanda can take a period of 1-2 days depending on the number of applications at the Registrar General’s office and the fact that the applicant fulfills all requirements.

The requirements for incorporation of a domestic private company limited by shares include the following;

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 number of shares owned by each shareholder. Each shareholder provides his or her National ID for Nationals and Passport for Foreigners, contact and address
5. Directors of the Company. Among the Directors, one becomes a Managing Director and another becomes the Chairperson of the Board and the rest become members of the Board. In addition, one of the Directors must be a resident in Rwanda. In the same regard, each director provides his or her ID/Passport, telephone number and address
6. Office Address
7. Memorandum of Association and Articles of Association. According to the Rwandan Company law, a company can opt not to have Articles of Association.

After incorporation of the company, the applicant proceeds to apply for the Operations licence also known as Pharmaceutical Licence at Rwanda FDA. The application for the pharmaceutical licence may take a period of up to 1 month if the applicant possesses all the requirements and depending on the pending licence applications at Rwanda FDA.

The key requirements for application of a Pharmaceutical Licence include but are not limited to;

1. Dully filled Application Form
2. RDB Company Registration and Full Registration Certificates
3. Lease/rent contract of the premise/house
4. Evidence of payment of prescribed fees to Rwanda FDA
5. Notarised Valid Licence to practice Pharmacy Profession issued by National Pharmacy Council

The above mentioned requirements are submitted to Rwanda FDA through its Official email. It suffices to mention also, that within a period of twenty days of Rwanda FDA assessment of the application, a site visit is carried out to cross check if the premises of the applicant meet the requirements.

According to the Rwanda FDA regulations on the requirements for the size of “for example” a wholesale pharmacy, it is stipulated therein that for an establishment dealing with human medicines or medical equipment, the storage areas shall have minimum floor area of 60 square meters and minimum height  of 2.5 meters from the floor to the ceiling and the sales and administrative area shall have  minimum continuous floor space of 30 square meters.

In the event that the Rwanda FDA finds that the premises of the applicant correspond with the above mentioned size requirements among other requirements such as standards of constructions, and location, the said team of Inspectors issues a premise suitability Inspection report of the applicant’s premises.

That said, after thorough review and assessment of the requirements as submitted by the applicant and if all is in order and conforms with the requirements, a pharmaceutical licence shall be issued to the applicant.

At Stabit Advocates, we as the best Lawyers in Rwanda have a team of professionals who are ready to assist you 24/7 with setting up your Pharmaceutical business in Rwanda right from company incorporation to facilitation in the process of application for a pharmaceutical licence. Feel free to contact us using the contact details below.

Drafted and Drawn by;

Stabit Advocates Rwanda – The Best Lawyers in Rwanda

Email: info@stabitadvocates.com

Tel: +250789366274

Website: www.stabitadvocates.com