Norms for evaluating and approving the advertisement for medicinal products of human use

The Order of the Minister of Health no. 194/2015 on approving the norms for evaluating and approving the advertisement for medical products for human use was published in the Official Gazette of Romania, Part I, no. 168 of 11th March 2015.

According to the regulatory document, The National Agency for Medicines and Medical Devices (ANMDM) is the authority competent in evaluating and approving the advertisement materials and any other form of advertisement for the medicinal products for human use, in compliance with the provision of the Law no. 95/2006 regarding the reform in the health field.

The norms regulate the advertisement activity for the medicines for human use (regardless of the fact if they are innovatory or generic, medicines which are issued based on the medical prescription OTC).

It is considered advertisement for medicines (ad) any form of organized activity which has as purpose to inform through direct or indirect methods, as well as any other form of marketing meant to encourage the prescription, distribution, sale, management, recommendation or use of one or more medicines for human use. The advertisement for medicines can be addressed to the health specialists or for the wide public.

The holder of the authorization for placing on the market has the obligation to submit to ANMDM for approval all the advertisement materials addressed to the wide public/patients and to place them on the market only after receiving the visa for advertisement.

The false advertising represents any form of advertisement which, by all means, including the way of presenting, misleads or may mislead any person to whom it is addressed or who comes into contact with it. The form of advertisement should not suggest that a medicine or an active ingredient has any merit, quality or special property, if this fact cannot be proven scientifically.

The comparative advertising represents any form of advertisement which identifies explicitly or implicitly a product through comparative description. The comparative advertising for the wise public is forbidden.

:: The Source:


LinkedIn | Facebook