From September 2023, Staphyt Regulatory Affairs department is present in Serbia with the recruitment of a new Regulatory Affairs consultant, Ana Vidakovic. Staphyt is now able to support manufacturers to comply with the regulatory requirements in place at the national level in Serbia.
This new country enlarges and reinforces Staphyt’s presence across Europe! See where we can support your registration process in Europe.
Welcome Ana Vidakovic!
Possessing a Master’s degree in Plant Protection, Ana’s professional journey embarked in the Regulatory sector in 2020, allowing her to gain valuable expertise in crafting essential documentation for the registration of plant protection products within the EU. Simultaneously, she actively participated in the registration process for plant protection products in Serbia, addressing the complexities of regulatory demands.
Establishing a close working relationship with Serbia’s main regulatory authority, the Plant Protection Directorate, has empowered Ana to facilitate local submissions on behalf of our clients.
Even if not a part of the EU, Serbia holds membership in the EPPO, following its guidelines.
Serbia exhibits notable disparities from EU regulations in certain key aspects:
- In Serbia, the registration of a plant protection product necessitates a distinct type of Registration report, diverging from the EU’s requirements.
- Registration for a plant protection product on a major crop in Serbia mandates four efficacy trials, out of which two trials must be conducted within Serbia, while the remaining two can be executed in EU countries.
- Streamlining the registration process for a product already approved in the EU involves the submission of a Climate Comparability report, demanding mutual recognition.
- Unlike the EU, Serbia does not mandate the submission of a Comparative Assessment for the active substances that are candidates for substitution, and this document holds no legal recognition in Serbian law.
It’s noteworthy that Serbia is poised to align itself with EU laws in the near future, as per the official announcement. This impending convergence is set to reshape the regulatory landscape and streamline procedures for the registration of plant protection products in Serbia.
For any questions about registration in Serbia or in the EU, please contact: contact@staphyt.com
