(2009; 37 pages)
This document lays down guidelines for the distribution of pharmaceutical products. Depending on the Egyptian MOH & CAPA legislation on pharmaceuticals , food supplements, medicated cosmetic products , medical devices, this guide may also be applicable for veterinary products administered to food-producing animals.
This document does not cover the distribution of materials such as pharmaceutical starting materials (active pharmaceutical ingredients (API) and excipients), reagents, solvents, process aids, intermediate products, packaging materials and labelling materials. The principles for the distribution of starting materials were laid down in the WHO guidance “Good trade and distribution practices for pharmaceutical starting materials”. Different models for the distribution of pharmaceutical products are used in different countries and sometimes within the same country, for example, in the public and the private sector.
These guidelines are intended to be applicable to all persons and companies involved in any aspect of the distribution of pharmaceutical products from the premises of manufacture to the point of supply to health establishments, e.g. private pharmacies, hospitals and clinics, for supply to patients. This includes all parties involved in trade and distribution, pharmaceutical manufacturers, including the manufacturers of finished products, brokers, suppliers, distributors, wholesalers, traders, transport companies and forwarding agents. The relevant sections of the guidelines should also be considered for implementation by, among others, governments, regulatory bodies, international organizations and donor agencies, certifying bodies, as well as all parties including health care workers involved in any aspect of the trade and distribution of pharmaceutical products.
The guidelines can also be used as a tool in the prevention of the distribution of counterfeit and substandard medicines. It should, however, be noted that these are general guidelines which may be adapted to suit the prevailing situations and conditions in individual countries...