Guide to dossier content for active substance and product in the EU

This course will guide you through the content of an active substance dossier and a product dossier according to EC 1107/2009, including structure overview, what is presented in each document of the dossiers, classification and detailed information about the sections on physical/chemical properties, efficacy, analytical methods, toxicology, residue, environmental fate, ecotoxicology and other relevant sections.

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Course overview

This course gives an overview of the dossier content of an active substance dossier and a product dossier. You will gain knowledge about Regulation EC 1107/2009, EC 283/2013 and EC 284/2013 and how a dossier of an active substance and a plant protection product is structured in the EU. 

You will learn about the data requirements, the structure of an active substance dossier including Document N1, the structure of a product dossier including the dRR and what information must be presented in each document/section of the dossier. 

You will also be acquainted with knowledge about the content of the sections on physical/chemical properties, efficacy, analytical methods, toxicology, residue, environmental fate and ecotoxicology including a limited introduction to some of the risk assessments involved.

The course is designed for:

  • Newly employed Regulatory Affairs Officers and Managers

  • Industry professionals that need an overview of the approval process without being too detailed

  • Regulatory Affairs professionals from outside Europe that would like to get to know how the regulatory framework in Europe works

  • Industry professionals that would like to try to see the bigger picture and the legal context

Course Curriculum

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AgroTraining Group courses are fully online, available on-demand, and developed by industry experts with decades of experience in their subject area.

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Course price: £299

The course price is per person and includes benefits like:

  • 3 modules that divide further into multiple bite-size lessons.

  • Discussion forums, where you can ask questions and interact with the trainer.

  • No deadlines for revisiting the content.

Meet the course trainer

Marianne Thuen Jakobsen is an Independent Regulatory Consultant with extensive experience in both EU regulations as well as Sub-Saharan African regulations for agrochemicals.

Following 10 years in the industry working as a Patent officer, QA specialist and Regulatory Specialist, Marianne set up her own regulatory consultancy in 2016. Through the consultancy projects, she facilitates approvals for plant protection products in the EU and Subsaharan Africa, and gets involved in complex regulatory cases.


Registering multiple people from your team?


We consider team discounts for groups of 4+ people registering from the same company.

If you are interested in training your team, get in touch via the form and we'll help you with the invoices, group discount and anything else you might need.

If this course doesn't fully suit your current needs, we can deliver an in-house training course that's tailored specifically to your team's needs and the current project they might be working on. 

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