LAW N°12/99 RELATING TO THE PHARMACEUTICAL ART
Title I. GENERALITIES
According to the terms of this Law, Pharmaceutical Art shall mean any act aimed at
preparing, manufacturing, quality controlling, conditioning, preserving, and dispensing,
even without charge, of drugs or other Pharmaceutical products.
The Pharmaceutical Art shall be practiced according to the Law and National policy as shall
be determined by the Government on the proposal of the Minister responsible for Health.
However, this Law shall not affect acts performed by traditional practitioners within the
framework of traditional medicine practice, which is governed by a specific law.
For the purpose of this Law, drug shall mean, any substance, preparation or composition
presented as having preventive or curative properties towards human or animal diseases as
well any products means to be given to man or animal with the aim of establishing a medical
diagnosis, restoring correcting or modifying organic or psychic functions.
As for pharmaceutical product, it shall mean namely: 1. Drugs intended for human and
veterinary medicine use;
3. Sterile and non sterile medico-surgical material, dressing material and all the items
presented as being in accordance with pharmacopoeias recognized in Rwanda;
4. Products and reagents conditioned for public sale and which, without being referred
paragraph 1, are however intended for medical or pregnancy diagnosis;
5. Insecticides and acaricides intended for being applied to man or animal;
6. Products intended for maintenance or application of eye contact lenses.
For the purpose of this Law, magistral preparation shall mean any drug extemporaneously
prepared in pharmacy on a duly authorized practioner's prescription and intended for a
For the purpose of this Law, medicinal preparation means any drug prepared in pharmacy
according to indications of pharmacopoeia or of the national form and dispensed to the
patients of that pharmacy.
Blood and derived products are subject of a particular legislation
Preparation, manufacturing quality control, conditioning, preserving, export or distribution
of dietetic, cosmetic and hygienic products as well as non-medicinal control products shall
not be governed by this Law.