A. This Code owes its origin to the determination of AIFP* to secure universal acceptance and adherence to high ethical standards in the marketing of prescription- only medicinal products.
B. This Code regulates promotion of prescription-only medicinal products towards authorised persons, promotional activities of pharmaceutical companies towards healthcare professionals and the communication with them as well as mutual relations between pharmaceutical companies and healthcare professionals or healthcare organisations. This Code also regulates mutual relations patient organisations and competent authorities.
C. This Code is not intended to control or regulate the provision of non-promotional medical, scientific and factual information, nor is it intended to control or regulate activities directed towards the general public which relate solely to non-prescription medicinal products.
D. This Code shall not apply to the following: the labelling of medicinal products and accompanying package leaflets; correspondence, possibly accompanied by material of a non-promotional nature, factual, informative announcements and reference material relating, for example, needed to answer a specific question about a particular medicinal product; to pack changes, adverse-reaction warnings as part of general precautions, provided they include no medicinal product claims; non-promotional information relating to human health or diseases; activities which relate solely to non-prescription medicinal products; non-promotional general information about companies (such as information directed to investors or to current/prospective employees), including financial data, descriptions of research and development programmes, and discussion of regulatory developments affecting a company and its products.
E. Acceptance and observance of the Code is a condition of membership of AIFP, whereby a Member of AIFP must comply with both the content and the spirit hereof. The Members of AIFP must ensure that all employees and/or agents acting on their behalf, including all their affiliates and subsidiaries are fully conversant with, and
obey the provisions of this Code.
F. The Members of AIFP shall be liable for discharging of their duties imposed hereunder, even if they commission other parties (e.g. medical representatives, sales forces, consultants, market research companies, advertising agencies etc.) to design, implement or engage in activities covered by this Code on their behalves or account.
In addition, the Members shall always take reasonable steps to ensure that any third party they commissioned to design, implement or engage in activities covered by this Code but that do not act on behalf of the Member of AIFP (e.g. joint ventures, licensees etc.) comply with this Code.
G. Pharmaceutical companies being not Members of AIFP are hereby invited to accept and observe this Code.
H. The Code shall be supervised and exercised by the Ethical Committee. The Ethical Committee may issue interpretation from time to time in order to construe certain sections of the Code. Complaints concerning alleged breaches of the Code should be reported to the Ethical Committee.
I. A major guiding principle of this Code is that, whenever a promotional claim* is made for a medicinal product, it shall be accompanied by the Product Information* in Slovak language.
J. Failure to comply with this Code will result into sanctions being imposed under provisions of the Operating Procedures. Adherence to this Code in no way reduces Members’ responsibilities to comply with the Slovak legislation and Codes which they are bound to obey.
K. In respect of the applicable laws, AIFP must facilitate the Members’ awareness of and education about this Code, including providing guidance to the Members in order to prevent breaches of this Code.
L. Promotion and interaction which take place within Europe must comply with applicable laws and legal regulations and the Member association National code of the country in which the promotion or interaction takes place.
The Glossary of definition of terms used herein forms an Annex hereto. Where the term
referred to in the Glossary is herein used for the first time, it shall be marked by use of an