Regulatory affairs

Dr. Cornelia OttContact: +49 5121 92879 21Send an E-mailDr. Cornelia Ott
Contact: +49 5121 92879 21
Send an E-mail
Our Regulatory Affairs team acts in the framework of Regulation (EC) No. 1107/2009 to prepare, submit and follow-up on plant protection product applications.

We guide you through the regulatory process in all of the European Union member states and the associated countries.

Consulting services

  1. Consultation on questions regarding application and authorization procedures with EU authorities
  2. Supervision of applications up to product authorization and beyond


Technical capabilities

  1. Compilation of dossiers in the CADDY.xml format
  2. Submission and administration of applications in Germany via the electronic applicant portal with Germany as Zonal Rapporteur Member State, Concerned Member State, or mutual recognition
  3. Submissions via PPPAMS (Plant Protection Products Application Management System) e.g. obligatory required for emergency applications according to Article 53 of Regulation (EC) No. 1107/2009
  4. Creation and submission of poison centre notifications (PCN)


Applications

  1. Preparation of national addenda for product approval and re-approval according to Regulation (EC) No. 1107/2009
  2. Preparation of product labels including translations and adaptions according to national requirements
  3. Technical translations of Safety Data Sheets (SDS) from EU languages into German
  4. Review of classifications according to Regulation (EC) No. 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation)


Submission

  1. Submission of applications for authorization in all member states of the European Union and associated countries

You can take advantage of individual services or a full-service package according to your needs.

Meet Our Team!