- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Palabras clave > Active Pharmaceutical Ingredient - API
- Palabras clave > finished pharmaceutical products - FPPs
- Palabras clave > marketing authorization
- Palabras clave > medicines registration
- Palabras clave > preparation of product dossiers
- Palabras clave > registration of medicinal products
- Palabras clave > registration of pharmaceuticals
- Palabras clave > enregistrement des médicaments
(2013; 28 pages)
The purpose of Drug Registration is to ensure that a pharmaceutical product has been adequately tested and evaluated for safety, efficacy and quality, and that the product information provided by the manufacturer is accurate. It also allows the pharmaceutical product to be placed on the market until the registration period for the product has expired.
The Pharmacy Board of Sierra Leone has developed and adopted the Guidelines for the registration of medicinal products for Human use.
These guidelines are intended to facilitate the registration process of medicinal products, and are meant to be adopted and implemented by all stakeholders intending to market medicinal products in Sierra Leone.
The overall goal of these guidelines is to achieve the highest practicable standards of the quality of medicinal products imported into Sierra Leone and in addition to ensure the safety, quality and efficacy of these products for the protection of public health as envisaged by the Pharmacy and Drugs Act.