Background
The EU has recently introduced a new technical guidance document for validation requirements and assessment of analytical methods in support of the registration of plant protection products, SANTE/2020/12830.
The guidance replaces two existing EU guidance documents: SANCO 3029/99 rev.4, dated July 2000 (methods in support of pre-registration data, now referred to as risk assessment methods) and SANCO 825/00 rev 8, dated November 2010 (methods in support of post registration control).
The guidance came into force in the EU on March 1st, 2021 and has been directly applicable to products authorised under the EU regime since that date.
HSE has undertaken an assessment of the new guidance, considered its implications, and concluded that it is suitable for use under the GB regime.
Therefore, the adoption of the guidance document for the generation and assessment of active substance and product data under the GB regime has been agreed.
Action
The guidance document will apply to all applications made to HSE in support of GB active substance approvals and GB plant protection product authorisations from 1 November 2021.
If applicants wish to submit applications using SANTE/2020/12830 before this date, this will also be acceptable.
View the guidance document SANTE/2020/12830 rev 1.
Contact
Any queries should be directed to CRDInformationManagement@hse.gov.uk
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