In a recently published resolution, the Hungarian pharmaceutical authority (OGYÉI) fined a family-owned Hungarian pharmaceutical company after the authority found that their professional brochures were incompliant with the law.
In line with its previous practice, the OGYÉI categorised the defects found in the professional brochures in accordance with the infringement levels listed below with the cases under point one considered the least serious:
The date of completion or the date the document was last updated is missing or inaccurate.
The price information is missing in the case of products reimbursed by the social security system.
The exact source and/or date of the publication of the quotations, tables and other illustrations are not indicated or the symbol indicating that a medicinal product is under close scrutiny and/or the warning text is missing.
The written documentation is not precise, verifiable or up-to-date. Quotations, tables, charts or other illustrations taken from other scientific source are not presented in line with the original source.
Defects listed in point four are so severe that they seriously mislead the persons qualified to prescribe or supply regarding the expected effects of the medicinal product.
The pharmaceutical company violated the law by providing healthcare professionals with brochures containing statements that were not in accordance with the approved summary of product characteristics of the concerned medicinal products.
The OGYÉI imposed a fine of HUF 2 million (EUR 5,500).
For further information on the Hungarian pharmaceutical industry, contact your CMS client partner or local CMS experts.
Article co-authored by Diána Galambosi.