AmPharMA

Code of Ethics Of the Research-based Pharmaceutical Industry in Bulgaria

June 2008

Introduction

American Pharmaceutical Manifacturerers Association (APMA or the Association) is a representative body of the research-based pharmaceutical industry in Bulgaria. The Association unites the manufacturers and marketing authorization holders, operating on the Bulgarian market and signed this Code of Ethics, investing in the development of the pharmaceutical industry through synthesis and formulation of medicinal products containing innovative active pharmaceutical substances.

The Association of the research-based pharmaceutical manufacturers in Bulgaria (APMA or the Association) is a representative body of the research-based pharmaceutical industry in Bulgaria. The Association unites the manufacturers and marketing authorization holders, operating on the Bulgarian market and signed this Code of Ethics, investing in the development of the pharmaceutical industry through synthesis and formulation of medicinal products containing innovative active pharmaceutical substances.

The main priority of the association and its members is to contribute to the protection and provision of health and human life, assuring access for Bulgarian patients to quality, safe and effective medicinal products for prevention, diagnostic testing, and treatment of diseases. . In order to provide for accurate, objective and fair information which to assure rational prescription and reasonable use of medicinal products, the pharmaceutical manufacturers and the marketing authorization holders distribute among the representatives of the healthcare profession specialized information about the product collected in the process of the research and development activities, as well as from the experience obtained during the treatment of diseases. The aim of this promotional activity is introduction to the merits and characteristics of the specific medicinal product through appropriate educational and marketing means. The pharmaceutical manufacturers and marketing authorization holders organize their advertising and promotional activities regarding medicinal products, subject to prescription, as well as regarding their interactions with the healthcare professionals, in compliance with the regulations of the Bulgarian legislation in effect. While the trial, manufacturing, marketing and control on pharmaceuticals are subject of extensive regulation, the advertising and promotion of medicinal products cannot be extensively arranged through legal regulations. Due to that reason, the pharmaceutical companies are brought together around a Code of Ethics (the Code of Ethics or the Code) and oblige themselves to conduct their activity relating to the advertising and promotion of pharmaceuticals, subject to prescription, as well as regarding their interactions with the healthcare professionals, in compliance with the provisions of the present Code.

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