The Hungarian pharmaceutical authority (OGYÉI) recently published a resolution, in which it fined a Hungarian healthcare company in connection with promotional activity.
The infringements established by the OGYÉI in its resolution concerned the following topics:
In line with its previous practice, the OGYÉI categorised the defects found in professional brochures in accordance with the five infringement levels and found that the company violated the law by providing healthcare professionals with brochures containing incomplete or imprecise statements that were not in accordance with the approved summary of product characteristics of the concerned medical aid. Therefore, the OGYÉI found that the brochures were capable of misleading healthcare professionals on the effects of products, which infringes Article 11/B (2) of Act XCVIII of 2006 (Medicines Thrift Act) and Article 6 (2) of Decree No. 3/2009. of the Minister of Health.
OGYÉI examined the documentation of professional events organised by the company and established that in two cases, the company had provided hospitality in excess of the statutory limit set out in Article 14 (2) of the Medicines Thrift Act.
Failure to notify professional events
The OGYÉI found that the company did not register itself on the event notification platform of the OGYÉI and, therefore, did not notify to the OGYÉI the professional events organized by the company during the period under review. Consequently, the OGYÉI established the infringement of Articles 14 (10) and (13) of the Medicines Thrift Act.
The OGYÉI imposed a fine of HUF 12 million (EUR 31,600).
The above are among the common topics that the authority generally focuses on during its investigations. We suggest paying close attention to monitoring compliance with corresponding provisions. If you have any questions in relation to these obligations, contact your CMS client partner or local CMS experts.
Article co-authored by Diána Galambosi.