Plants

Procedure to apply for authorisation of a PPP

Procedure to apply for authorisation of a PPP

A zonal system of authorisation operates in the EU to enable a harmonised and efficient system to operate.

The EU is divided into 3 zones; North, Central and South. Member States assess applications on behalf of other countries in their zone and sometimes on behalf of all zones.

Regulation (EU) 1107/2009 sets out the requirements, procedure and timeframes for authorisation of Plant Protection Products (PPPs).

Applicants, Member States, the European Commission and the European Food Safety Authority (EFSA) can be involved in the process of authorisation.

There are different types of application that can be submitted depending on the intended use of the PPP, the Member State(s) for which the PPP is required and the regulatory status of any existing authorisations. These are explained in further detail here:

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First authorisation of a PPP (PPPAMS ready to use)

Mutual Recognition (PPPAMS ready to use)

Amendment or withdrawal of an existing authorisation

Renewal of authorisation

Emergency authorisation (PPPAMS ready to use)

Application for Minor Uses

Parallel trade permits

Assessment of technical equivalence

Under EU rules, it takes up to 1.5 years from the date of application to the granting, amendment or withdrawal of on authorisation. This time varies depending on how complex and complete the application is and the type of application.

How are applications for PPPs submitted?

Applicants who wish to have a PPP authorised in the EU must submit their applications to Member States via the Plant Protection Products Application Management System (PPPAMS). This online system manages the workflow of applications and will populate an EU wide public database of authorised PPPs.

Dossiers are not submitted via the PPPAMS and other manual processes (e.g. invoicing/charging and evaluation work) in each Member State compliment the System.

The PPPAMS manages the workflow of applications, enabling applicants and Member States to communicate with each other through the application process, primarily by changing the status of the application.

The PPPAMS can send notifications for information and action based upon status changes through the application process.

How does the PPPAMS link to the actual application process in Member States?

The PPPAMS does not replace the processes that exist in Member States; it works alongside the other electronic and manual processes that Member States operate outside of the PPPAMS. In the sections above that explain the different application types for PPPs, you will find tables providing an overview of what steps happen inside and outside of the PPPAMS

Each Member State has their own procedures and below is a list with links to national procedural guidelines.

Member State procedural guidelines

Fees

Member States charge a fee to applicants to carry out the work required for evaluating an application.

Fees vary between Member States. Further information is available directly from Member States. You can find contact details here .

Draft Registration Report

All applications (new product, amendment and renewal) for PPPs should be made in the form of a draft Registration Report (dRR).

The dRR is split into 3 sections:

  • Part A – risk management
  • Part B – data evaluation and risk assessment
  • Part C – confidential information

Further Guidance on the use of dRR can be found in the folder "Dossier and draft assessment report".

Guidance

To learn more on how to prepare and submit applications, please go to Guidelines on Active Substances and Plant Protection Products. Authorised system users can access a comprehensive help system within the PPPAMS.