When is renewal of authorisation needed?

EU authorisation of an active substance (AS) for PPP applications generally expires after ten years. Well in advance of this deadline, the applicant must start preparation for the renewal process for the AS itself, and eventually any products containing it. Once an AS’s renewal of approval is achieved, there’s a three-month window to complete applications for products’ renewal of authorisation. This whole cycle is an onerous and time-consuming process with peaks and troughs in resource requirement.

Dictated by Article 43 of Regulation No 1107/2009, renewal of authorisation involves preparation of an extensive dossier concerning the product and its use. For small PPP businesses with limited experience of the regulation, or larger players with capacity constraints, meeting these obligations within the necessary timeframe can be a challenge. The process is very resource intensive at the outset, so finding ways to overcome or eradicate this bottleneck are key.

Based on our experience handling renewals of authorisation for PPP clients, we’ve identified three steps that help streamline the process. Focussing on upfront planning, predicting requirements and getting a head-start on preparation ensures critical information is ready when it’s needed. This methodical, insight-led approach makes dossier preparation less arduous and increases the chances of a successful outcome.

1. Upfront planning for PPP renewal of authorisation

The European Commission states that:

Following renewal of approval of an active substance, all plant protection products containing that active substance must also undergo a renewal assessment to make sure that products comply with the updated assessment of the active substance and with new scientific and technical knowledge.

For companies that support the AS renewal this might be viewed as a straightforward two-stage process. However, companies whose products contain the AS but do not directly support the renewal process need to keep track of renewal status to avoid being caught off guard. The EU’s program of renewals, known as the AIR program, publishes dates and other key information here.

We recommend beginning the groundwork for a PPP renewal of authorisation at least a year before its AS renewal date. Scientific and technical guidance related to PPP use may have evolved significantly since the previous authorisation. Any changes will need to be addressed, so conducting a data gap analysis at this stage gives an early indication of the likely scale of the task ahead.

It’s also useful to conduct a preliminary risk assessment. Acceptable risk at this stage can then underpin more detailed modelling of likely requirements related to a product’s current registered use. These early steps extend the window for preliminary data generation, providing an opportunity to mitigate against any issues the renewal of authorisation might encounter.

2. Predicting likely data requirements

AS submissions for renewal of approval are made at least three years before the expiry of the previous approval. This marks the start of a lengthy procedure where the application is first reviewed by the appointed Rapporteur Member State (RMS) then peer reviewed by the European Food Safety Authority (EFSA). Once EFSA issues its conclusions on whether the AS is expected to meet the approval criteria, it’s handed over to the European Commission and Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) for a final decision. The full procedure is outlined here.

Once the EFSA Conclusion is published, it can be leveraged to confirm or get a head start on generating further new data for a product’s renewal of authorisation. Any conclusions made at this stage are likely to be reflected in conditions later set down by SCoPAFF. So, from this point, it’s possible to predict new requirements and their scientific parameters with a fairly good level of accuracy.

While it’s not possible to say for sure how long AS renewal of approval will take – and it can be 5+ years – the EFSA Conclusion indicates that the end of the process is in sight. From this point, it’s likely to be up to a further nine months before the decision on approval is taken. Working proactively now presents an opportunity to double or triple the official three-month window to prepare renewal of authorisation dossiers for products containing the AS.

3. Early preparation of dossiers

PPP renewal of authorisation dossiers can take around 400 hours to prepare. A great depth and breadth of information is required, and it needs to be articulated clearly and concisely to enable a seamless review process. It may be possible to repurpose some content from earlier submissions, but most documents will need to be newly written in line with current templates, guidance and dossier format using the recent scientific data evaluation.

Allocating specific tasks to individuals, departments or trusted third parties is essential, and the earlier this can happen the better. Work can start in earnest soon after the EFSA Conclusion is published.

When it comes to new scientific requirements, such as providing evidence of a product’s safe use in specific environments, expert guidance can be invaluable. In some cases, there may be a potential concern which can only be allayed with evidence from a new study. On the other hand, some issues might be sufficiently addressed in existing published literature that’s publicly available. It may even be possible to waive some data requirements altogether if they’re not directly relevant to the product and its intended use. Taking time to properly assess and rationalise the information that’s needed can prevent wasted effort and ensure resources are properly focused.

An evolving PPP landscape

Environmental and human safety protection is high on the EU’s agenda, and PPP regulatory requirements are becoming more stringent in response to this over time. The onus is on manufacturers to prove that their products are not harmful and to give clear parameters for their safe use. In this context, renewal of authorisation needs to be properly resourced and strategically planned.

PPP renewal of authorisation is complex and time-consuming, so getting an early start is essential.

If you need help, TSG has a wealth of experience and expertise in the planning and preparation of dossiers. Contact us at [email protected] to find out more.