These rules regulate the activity of advertising of medicinal products for human use (whether it is about innovative or generic drugs, medications that are issued on prescription or OTC drugs) and include all methods of promotion, including visits of the medical representatives accompanied of handing advertising, advertising in newspapers or magazines, scientific publications, direct advertising by e-mail and other means of electronic communication (websites, webpages, blogs, forums), use of audiovisual products such as films, videos, services data storage.
According to the Regulations, the competent authority regarding the evaluation and approval of promotional materials and any other forms of advertising of medicinal products for human use is the National Agency for Medicines and Medical Devices.
For a drug, advertising must meet the following requirements: to be accurate, balanced, fair, objective and complete to enable those to whom it is addressed to form their own opinion on the therapeutic value of the drug in question; to rely on updated assessment of all relevant evidence and reflect that evidence clearly; to encourage rational drug use by presenting it objectively, without exaggerating its properties, therapeutic qualities; to encourage self-medication or irrational drug use; not to be misleading, subliminal or mislead by distortion, exaggeration, undue emphasis, omission or in any other way; not to suggest that a drug or active ingredient has any merit, quality or special property, if this can not be scientifically documented; not to prejudice respect for human dignity; include discrimination based on race, sex, language, origin, social origin, ethnic identity or nationality; not to affect the image, honor, dignity and privacy of individuals.
It is also forbidden to the general public advertising for medicine which don’t have: a marketing authorization valid in Romania; are issued only on prescription; contain substances defined as narcotics or psychotropic substances, in accordance with the legal provisions in force; are prescribed and dispensed in the health insurance system.
Market Authorization Holder or his representative is responsible for the content of advertising materials developed for a particular drug. It is responsible for training and acts of the medical representatives on the promotion of medicinal products for human use, and the use and distribution of advertising materials.
They also assume responsibility for the design, distribution and use of promotional materials even when the work is done by third parties.
Moreover, it has the obligation to submit for approval to ANMDM all advertising to the general public / patients and putting them on the market only after obtaining the advertising visas.
For failure to comply with the provisions on advertising of medicines issued with or without a prescription, ANMDM applies sanctions in accordance with Art. 836 para. (1) y) of Law no. 95/2006, Title XVII – medicine, as amended and supplemented.