- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Palabras clave > Good Manufacturing Practices (GMP)
- Palabras clave > import/export authorization
- Palabras clave > importation - regulation
- Palabras clave > imported pharmaceutical products
- Palabras clave > marketing authorization
- Palabras clave > medicines registration systems
- Palabras clave > medicines regulation
- Palabras clave > national drug regulation
- Palabras clave > pharmaceutical manufacturing system
- Palabras clave > registration - Foreign Pharmaceutical Manufacturing Company (FPMC)
(2015; 29 pages)
To strengthen the control of imported pharmaceutical products, the GDPA has revised and upgraded the current Registration Rules for Foreign Companies to a guideline will assist those in the field to adhere to Afghanistan laws and regulations during importation activities.
The use of this guideline will help the country move closer to the noble goal of making safe, efficacious, and good- quality pharmaceutical products available to the people of Afghanistan. The GDPA in the MoPH is responsible for compliance and enforcement of this guidance document.
This document replaces the Registration Rules for Foreign Companies for registration of FPMCs. A separate guideline for registering products, called the Medicines Registration Guideline, can be obtained from the GDPA.