The new document on data protection by the European Commission is available (Technical Guidelines on Data Protection according to Regulation (EC) No. 1107/2009, 2019/C 229/01). This official document updates the previous SANCO guidance document on data protection (SANCO/12576/2012-rev. 1.1, 1 February 2013) providing a better understanding of the data protections scenarios for active substances and products. Scenario no. 18 for active substance data is included to consider the period of protection for new active substance data submitted with the application for a new product authorisation.
If you want assistance or advice on any aspect of Data Protection under Regulation (EC) No. 1107/2009 the Kerona Scientific team will be happy to help. Contact us at email@example.com or call on +353 1 849 5284.