Pharmaceutical speciality means any drug industrially prepared, protected or not by a
patent, presented unded a specific conditioning and characterized by a special denomination.
Article: 42
A National Commission meant for drugs registration is established. An order issued by the
Minister responsible for health shall determine its members and functioning.
Article: 43
Any generic drug and any pharmaceutical speciality put on the local market shall submitted
to prior recording by the Minister responsible for Health. Application for registration shall
be submitted for consultation to the Commission of Drug Registration whose composition
and functioning shall be determined by an order issued by the Minister responsible for
Health
Application for registration shall be sent to the Minister responsible for Health. It shall be
accompanied by the payment of a fee whose amount shall be determined by an order issued
Prime Minister.
Article: 44
Recording will only be granted to generic drugs and pharmaceutical specialties for which
the manufacturer can justify among other things therapeutic interest, their innocuousness in
normal conditions of use and of their intrinsic quality.
That recording shall be issued for period of five years. However, within the framework of
the public invitation to tenders, the drugs which has been accepted, if it is not recorded, shall
be automatically recorded for a period limited to the duration of the deal set up in the
invitation to tenders.
Modes of recording will be determined by a Presidential order.
Any rectification of one of the technical constituent elements of the recording file should be
subject to a new application to the Minister responsible for health.
Article: 45
The list of recorded generic drugs and pharmaceutical specialties shall be published each
year in the Official Gazette of the Republic of Rwanda by the Minister responsible for Heal
Article: 46
Recording of a generic drug or of a pharmaceutical speciality shall leave full responsibility
of the manufacturer towards third parties
Article: 47
When there are reasons for considering that effects of a drug could present an immediate
danger to public health, the Minister responsible for Health can in consultation with the
recording commission and on basis of a justified decision, postpone the delivery of that drug
for a period of six months.
Withdrawal of the drug can be pronounced by the Minister responsible for Health after the
manufacturer or his/her representative has been invited to give all explanation.