The parallel export of medicinal products from Bulgaria is regulated in the latest Bill amending the Medicinal Products for Human Use Act

10 March 2014

 

 

 

A Bill amending the Medicinal Products for Human Use Act (“MPHUA”) entered into force on March 8, 2014. The Bill regulates the parallel export of medicinal products, introduces new obligations of market authorization holders regarding withdrawal of medicinal products, envisages setting-up of an Expert Council on Retail Sale of Medicinal Products, and implements Directive 2012/26/EC concerning the urgent-action procedure at European Union level.

Under MPHUA holders of licenses for wholesale distribution may engage in parallel export (including to other Member States of the European Union) of medicinal products included in the Positive Drug List, after submitting a notification to the Executive Drug Agency (“EDA”) on a case-by-case basis. The EDA executive director may refuse to grant permission for parallel export if there is want of the medicinal product to be exported or a temporary want might arise as a result of the export, or the want of the medicinal product may endanger the life and health of Bulgarian citizens. If the executive director does not object to the parallel export within 30 days after the notification has been filed, the export is deemed permitted. Each violation of the above rules is subject to a financial sanction in the amount of EUR 25,000 to EUR 50,000. In case of a repeated violation, the fine rises from EUR 50,000 to EUR 100,000.

Further details of the Bill will be provided in our Pharma Newsletter.