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Trusted regulatory support for agrochemical companies across CEE markets. Tailored solutions. Clear compliance steps

Get expert guidance from Artemisa’s regulatory specialists on navigating Regulation (EC) No. 1107/2009 and placing your plant protection product on the EU market. Learn exactly what your company needs for a successful PPP authorization, before you invest time or resources.



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    Plant Protection Products

    Plant Protection Product Registration

    Successful registration of a plant protection product requires more than a technically complete dossier. It requires the right regulatory strategy, an understanding of country-specific requirements and effective management of the registration process from planning through authorisation.

    At Artemisa, we support manufacturers and distributors with plant protection product registrations across Central and Eastern Europe, Southeast Europe, Türkiye and emerging markets. Our strength lies in combining regulatory expertise with local knowledge. We understand the legislation, but equally important, we understand how regulatory processes work in practice in the markets we cover.
    • Preparing new registrations
    • Expanding into additional markets
    • Managing an established portfolio
    • Turning complex requirements into clear pathways to market
    EU Registration

    Plant Protection Product Registration in the EU

    Plant protection products in the European Union are regulated under Regulation (EC) No. 1107/2009. While the regulatory framework is harmonised at EU level, registrations are managed through national competent authorities, and practical requirements can differ between Member States. Local knowledge therefore remains important even within a harmonised regulatory system.

    Artemisa supports clients with:
    • Zonal Authorisations
    • Mutual Recognition
    • National Authorisations
    • Extensions of Authorisation
    • Renewals / Maintenance of Registration Validity
    • Administrative changes of existing Registration Certificates
    • Emergency Authorisations
    • Other national regulatory procedures
    Beyond the EU

    Expanding Beyond the EU

    Entering markets outside the EU can create valuable commercial opportunities, but the regulatory pathways may differ significantly from those companies are familiar with in Europe. Artemisa supports plant protection product registrations across Albania, Armenia, Azerbaijan, Bosnia and Herzegovina, Egypt, Georgia, Kazakhstan, Kosovo, Moldova, Montenegro, North Macedonia, Serbia, Türkiye, Ukraine and Uzbekistan. Each of these markets has its own regulatory framework, documentation requirements, authority expectations and administrative procedures. Our local experts help clients understand these differences, identify the appropriate regulatory pathway and manage the registration process step by step.
    How it works: Get in Touch, Assess & Plan, Prepare & Execute, Follow Through & Support
    THE PROCESS

    How it works

    Local Expertise

    Across Our Markets

    Regulatory requirements are defined by legislation. How they are implemented in practice is often determined locally. Our team members and trusted local regulatory experts provide country-specific knowledge, native-language communication and practical understanding of national authority expectations.
    EU Countries

    Baltics, Bulgaria, Croatia, Czech Republic, Greece, Hungary, Italy, Poland, Romania, Slovakia, Slovenia

    Southeast Europe (SEE) & Türkiye

    Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia, Serbia, Türkiye

    Emerging markets

    Armenia, Azerbaijan, Egypt, Georgia, Moldova, Ukraine, Kazakhstan, Uzbekistan

    FAQ

    Frequently Asked Questions

    Depending on the product, existing authorisations and target markets, possible routes may include zonal authorisation, Mutual Recognition and other national procedures. The appropriate strategy should be assessed based on the individual product and intended markets.

    Yes. We can assess the target markets, coordinate country-specific requirements and manage submissions and authority communication across multiple countries through one centrally coordinated project.

    Yes. We support plant protection product registrations across EU markets as well as national regulatory procedures in Albania, Armenia, Azerbaijan, Bosnia and Herzegovina, Egypt, Georgia, Kazakhstan, Kosovo, Moldova, Montenegro, North Macedonia, Serbia, Türkiye, Ukraine and Uzbekistan.

    This depends on the country. Non-EU markets operate under their own national regulatory frameworks and may have different data and documentation requirements. We assess the existing regulatory package against local requirements and identify what can be used and what additional information may be needed.

    Legislation defines the regulatory framework, but administrative requirements, authority expectations, communication practices and practical implementation can differ significantly between countries. Local expertise helps anticipate these differences and manage the process more effectively.

    Depending on the procedure and country, our local regulatory experts can support communication with competent authorities, follow up on applications and coordinate responses during the evaluation process.

    Yes. For multi-country projects, a dedicated Artemisa project manager can coordinate local experts, documentation, submissions, timelines and reporting, providing the client with one central point of contact.

    Planning a Plant Protection Product Registration?

    Whether you are entering a new market, expanding an existing authorisation or managing registrations across several countries, our experts can help you identify the right regulatory pathway and manage the process from strategy to execution.