Medicine Registration Guidelines


These guidelines are intended to ensure that medicines marketed in Afghanistan are safe, efficacious, and of good quality; assist applicants with the preparation of applications for the registration of multisource (generic) products by providing clear general guidance on the format of the dossiers; provide guidance on technical and other general data requirements. The guidelines are intended to promote effective and efficient processes for the development and submission of applications for registration of a product by applicants and the subsequent evaluation process of the General Directorate of Pharmaceutical Affairs.