Since the first publication of the guidance document SANCO/2010/1370 on the renewal of authorisations, much experience has been gained by industry, the member state regulatory authorities and the Commission. The lessons learned are reflected in amendments to the document which now appears as rev 14. Further revision is expected in 2017. It is timely to remind applicants that Article 43 dossiers for the re-registration of plant protection products must be submitted within 3 months of the date of the renewal of an active substance. In theory the zonal rapporteur member state (zRMS) should complete its assessment within 6 months and concerned member states complete evaluation within a further 3 months. In practice we know that these timelines are not being met. The reasons for delay are various, including lack of resources on the part of MSs and the quality of applications submitted. Industry has limited influence over the former, however is able to influence the latter.
How can we help?
JSC have a wealth of experience in compiling Article 43 submissions and routinely prepare high quality applications meeting the procedural requirements set out in the guidance document. We are aware of all of the latest developments and can apply the new risk assessment criteria that are now relevant in specialist areas. As part of the package we can provide guidance to clients on strategy development, using our experience and latest trends in the industry.
JSC are able to complete all the necessary administrative steps and documents and can address all aspects of the submission including justification for any GAP changes, justification for Category 4 delayed submission and preparing and develop applicant information for use in comparative assessment.
In particular we are able to develop justification for delayed submissions (Category 4) in the case of data matching studies and where new guidance and/or new or revised endpoints have been set.
For advice and further information on Article 43 submissions and the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, email@example.com
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