The Code of Ethics herein stipulates the principles and the rules that the Companies are obliged to observe during performance of promotion and advertising activities with respect to prescription-only pharmaceuticals intended for healthcare professionals and permitted by the Bulgarian law, as well as the principles and the rules, which the Companies are obliged to observe in their interactions with the healthcare professionals.
The adoption and observance of this Code of Ethics is a mandatory condition for membership to the association and each member is liable not to violate the regulations and the spirit of this code. The member-companies of ARPharM are obliged to acquaint with the Code of Ethics the authorised by them legal entities or natural persons, which perform promotion or advertising of their medicinal products.
Any natural person, being a representative of a Company, shall confirm to the obligation to follow the Code of Ethics by placing his/her signature. Other pharmaceutical manufacturers or the marketing authorization holders, not being members of ARPharM, could adopt and adhere to the regulations of the present Code.
The application and observance of the Code is an obligation of any and all companies that have adopted it. The observance of the Ethical Code is controlled by the Ethics Commission at ARPharM (The Commission). Any claims related to probable violations of the Code shall be referred to the Commission. The Commission could issue decisions intended to assist in interpretation of the provisions of the Code when required or when the Commission has been approached. The interpretative decisions are obligatory concerning the meaning of the interpreted provision since the date on which the Companies are informed or since the date provided in it.
A key principle of the Code is that any statement or message connected with advertising and promotion of pharmaceuticals should be compliant with the Summary of product characteristics (SPC) approved in Bulgaria.
The proceedings taken to determine a violation and impose sanctions are held before the Commission in line with the procedure and the rules established in the Code.
The adherence to the regulations of this Code of Ethics shall not relieve the members of ARPharM and the companies towards which it is compulsory, from the responsibility to observe the regulations of the Bulgarian legislation, the legislation of the European Union and other relevant codes of international organizations and/or companies.