Pharma Compliance Programs
The 24th Amendment of the Pharmacists Ordinance [New Version], 1981, effective as of October 2016, introduced a major reform in the enforcement mechanisms of the pharmaceutical regulation.
For the first time, office holders in pharmaceutical companies are exposed to personal criminal liability if they in supervision and prevention of violations, and the companies themselves are exposed to administrative financial sanctions for various violations of regulatory provisions.
In light of the new reform, pharmaceutical companies are advised to adopt and implement a special compliance program for the relevant provision, as is done in other fields of law. The implementation of effective compliance programs may significantly reduce the companies' and their employees' exposure to the new risks.
To read the full update (Hebrew), click here.