Marketing of pharmaceuticals products in Croatia

Zagreb, 31 October 2017

After joining European Union, Croatia has agreed to implement the regulatory framework of the pharmaceuticals market. There is an instability with respect to the unified compliance due to extensive regulation, the interest of the general public, and the publicity surrounding the industry.

The legal framework on pharmaceuticals distribution is governed by the Croatian Regulation on Medicine Advertisement (the “CRMA”), which provides several permitted marketing activities as well as the advertising towards the general public, the organization of promotional events attended by the persons authorized to prescribe medicines, and the organization of professional conferences.

The content of the advertisement of medical products to the general public must first be examined and approved by the compliance experts due to the numerous restrictions imposed by CRMA. Prohibited content may include for example the provision that the advertised medicine guarantees success in treating a specific illness or is better than other similar products destined to cure the same illness.

The Ethical code of the EFPIA (European Federation of Pharmaceutical Industries and Associations) is applicable to any events organized by the professionals acting in the pharmaceutical market in Croatia.

A failure to comply with the provisions of the law is sanctioned with fines that range from EUR 13,000 to EUR 20,000. These fines were put in place as an incentive for the pharmaceutical companies to carefully monitor their legal compliance. In addition to the fines, the pharmaceutical company may suffer damages to its reputation.