Author

Olha Sviatenka

Browsing

The European Parliament (EP) has published two draft reports on the Commission’s proposals for a new Pharmaceutical Regulation and Directive. The reports have been drafted by the MEPs assigned as rapporteurs for the Directive (Pernille Weiss, EPP) and for the Regulation (Tiemo W├Âlken, S&D) and will be debated at the Committee for the Environment, Public Health and Food Safety (ENVI) later this month or beginning of November. The report on the Directive is favourable to…

Ukraine has adopted the new law on pharmaceuticals (“Law”) that fundamentally changes the regulatory framework for pharmaceuticals. The Law is largely based on EU laws, although certain provisions, including as regards parallel importation of pharmaceuticals and regulatory data protection, are not aligned with EU laws and may create hurdles for companies operating in the Ukrainian market. The Law will be enacted within 2.5 years after the expiry/lifting of martial law. In this video, we present these and…