Agrochemicals
Agrochemicals
The first re-registration process of 7 active substances was covered by
Commission Regulation (EC) 737/2007 (or Annex I Renewal (AIR) project).
The second round of 31 active substances was covered by Commission
Regulation (EC) 114/2010 (or AIR2). APC assisted its clients with their
active substance re-registrations under these regulations. Although the
second part of the renewal procedure started while Directive 91/414/EEC
still applied, the decisions on renewals will be taken under Regulation (EC)
No.1107/2009 and active substances will have to meet the approval criteria
laid out in that Regulation.
Under the third phase of the renewal programme (AIR3), notifiers are required
to inform the EU Commission of their intention to support their active substances
no later than 3 years before the expiry of the approval.
APC is able to help companies with the preparation of the application, updating statement and
supplementary dossier. We can help by identifying where additional studies and risk assessments will be
required in order to comply with new regulatory requirements.
SECTOR
Sector
In addition to needing to comply with the current scientific standards, under 1107/2009, one of the new
requirements is to complete a literature search of scientifically peer reviewed literature related to the active
substance. APC can assist our clients through:
• Data Mining
Using specialised data mining software, many search terms can be incorporated simultaneously to create
a unique searchable database for the active substance. This focused search will determine the number of
studies that require further evaluation.
• Rapid evaluation for relevance and reliability
Given the potentially large number of studies available in the public literature APC proposes a two-stage
evaluation process. Firstly, only the titles and abstracts are evaluated and summarised in a tabular
format. Full study summaries are then only produced for those papers where the endpoint from the
scientific paper appears to be more critical than the corresponding EU endpoint. The reliability of the
evaluated studies are then assessed according to the Klimisch scoring system.
• Literature review report
The study summaries (tabulated and full summaries) are then compiled into a single literature review
report which can be submitted as part of the dossier.
Forward Thinking
APC can also help with registration of new active substances in Europe.
We are able to recommend and initiate dialogue with Rapporteur Member
States (RMS) using our worldwide offices and local consultant network to
complete the assessment of your active substance.
Our team of experts can conduct a data gap analysis to determine which studies will be
necessary at the first tier of testing. We can also place and monitor studies on your behalf
and compile these into a dossier for submission. We offer post-submission support to answer
any questions that arise during the review of your active substance.
APC can help you achieve National, EU and International Registrations to help you maximise
your global sales potential by delivering timely and cost effective solutions in all aspects of
the regulatory process.
APC . Cromwell Office Park . York Road . Wetherby . LS22 7SU . United Kingdom
Tel: +44 (0)1937 587962
Email: [email protected]
www.apc.eu.com