Biocontrol Products

Regulatory Support for Biological Plant Protection Products

Biocontrol products are becoming an increasingly important part of modern and sustainable crop protection, providing growers with new tools to manage pests and diseases while supporting the transition towards more sustainable agriculture.

At Artemisa, we support companies developing and commercialising biological plant protection products with regulatory strategy, registration and market access across the markets we cover. Biological plant protection products follow the plant protection product regulatory framework, but their specific characteristics require appropriate regulatory expertise and an understanding of the applicable data and assessment requirements.

Our experts help clients navigate these requirements and manage the registration process from early regulatory planning through authorisation and post-authorisation support.
Regulatory Strategy

Regulatory Expertise for Biocontrol Products

Biocontrol products may include solutions based on microorganisms, semiochemicals, basic substances and other biological approaches to crop protection. Although these products follow plant protection product registration procedures, their biological characteristics can influence the data requirements and the way individual areas of the dossier are assessed.

A well-planned regulatory strategy therefore starts with understanding the active substance, product characteristics, intended uses, available data and target markets.

Artemisa can support you with:
  • Regulatory strategy and registration planning
  • Assessment of applicable data requirements
  • Data gap analysis
  • Review of available studies and documentation
  • National dossier preparation
  • Registration and submission support
  • Country-specific requirements
  • Communication with competent authorities
  • Multi-country project coordination
  • Post-authorisation and lifecycle support
Our Approach

From Regulatory Strategy to Market Access

Artemisa combines specialised regulatory knowledge with practical local expertise to support the process from initial assessment through successful registration.
Looking Ahead

A Regulatory Framework in Evolution

The regulatory environment for biocontrol products is evolving. Biological plant protection products currently follow the plant protection product regulatory framework, while European institutions and industry stakeholders continue working towards regulatory approaches that better reflect the specific characteristics of biological solutions and facilitate their availability to growers.

Artemisa follows these developments closely, helping clients understand both the requirements applicable today and regulatory changes that may influence future registration strategies.
Local Expertise

Across Our Markets

Even within a common regulatory framework, practical procedures, national requirements and authority expectations can differ between countries. Our team and network of local regulatory experts combine country-specific knowledge with central project coordination, helping clients manage registrations across multiple markets through one coordinated approach.
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

Biological plant protection products follow the applicable plant protection product regulatory framework. However, the nature of the active substance and product may result in different data requirements and assessment considerations.

Not necessarily. The applicable data requirements depend on the type and characteristics of the active substance and formulated product. An early assessment of available data can help identify which requirements apply and where additional information may be needed.

Artemisa provides regulatory support for biological plant protection solutions, with the appropriate strategy and requirements assessed according to the individual active substance, product and intended uses.

The regulatory framework is evolving, with ongoing initiatives aimed at facilitating and accelerating market access for biocontrol products. Companies should nevertheless base current registration strategies on the requirements and procedures in force at the time of application.

Yes. We can review the available regulatory package, identify potential data gaps and help develop an appropriate registration strategy for the intended markets.

No. Regulatory frameworks and registration requirements for biocontrol products can differ significantly between countries outside the EU. An EU registration strategy, dossier or existing authorisation may provide a useful basis, but it cannot automatically be assumed that the same requirements or procedures will apply in another market. Artemisa's local experts can assess the applicable national requirements, evaluate how existing data and documentation can be used, identify potential additional requirements and develop a country-specific registration strategy.

Yes. Artemisa provides regulatory support for biocontrol products across a number of non-EU markets, including Albania, Armenia, Azerbaijan, Bosnia and Herzegovina, Egypt, Georgia, Kazakhstan, Kosovo, Moldova, Montenegro, North Macedonia, Serbia, Türkiye, Ukraine and Uzbekistan. Regulatory frameworks and requirements can differ significantly between these markets. Through our team and network of local regulatory experts, we can support country-specific regulatory assessments, registration strategy, documentation and submission preparation, authority communication and follow-up throughout the registration process.

Yes. Artemisa can centrally coordinate multi-country registration projects while involving local regulatory expertise in the individual target markets.

Bringing a Biocontrol Product to Market?

Whether you are developing a new biological plant protection solution, preparing a registration or expanding an existing product into additional markets, our experts can help you develop and execute the appropriate regulatory strategy.