Enhancement of Regulatory Procedures on Medicinal Products in Serbia – Patients Information Requirements
Providing reliable information on medicinal products to professionals and the general public is a precondition for successful implementation of rational pharmacotherapy. On the other hand, unreliable and unapproved information can cause inappropriate use and abuse of medicinal products, which can seriously endanger public health. Due to the fact that drugs advertising in Serbia had previously not been compliant with the Summary of Product Characteristics (SPC) and scientific evidence, control and approval of promotional material became mandatory since May 2010, and is carried out by the Medicines and Medical Devices Agency of Serbia. V. Radonjić, M. Bogdanović, I. Kapetanović Čampar And D. Mišković of the Medicines and Medical Devices Agency of Serbia, Belgrade present their experience with regard to performing this task here.
http://jforcs.com/jcs/wp-content/uploads/2013/04/Enhancement-of-Regulatory-Procedures-on-Medicinal-Products-in-Serbia-Patient-Information-Requirements.pdf