Extra data protection Minor uses according art.51 1107/2009
Some examples have been provided for illustrative purposes below. Please note that additional data protection must be claimed and substantiated in the application in accordance with the requirements.
1. Product A was authorised in NL in 2014. Article 51 extension for minor uses applied for by the authorisation holder for cherry, plum, cress, celery and teff in 2016.
Three studies in two reports were supplied in support of the extension: an ecotox study for birds in cherry and a study on residues in cress and celery, both of which are being used to reach a positive decision on the application. How much data protection will an authorisation holder receive if the requested extension is approved? Possible answers:
- Assuming that the full additional data protection has not yet been given for this product, 2x3 months or 3x3 months additional data protection can be granted. If, for example, the cress residue information can be extrapolated from the celery residue information, 1x3 months’ additional data protection will be given based on the celery data and 1x3 additional months based on the data supplied for cherry.
- If the data for cress cannot be extrapolated from celery, three studies have been carried out and have been submitted for three different uses and 3x3 months’ additional data protection will be given if the full two years (for a low-risk product) or three years of additional data protection have not yet been given. If the maximum additional data protection has already been given for this product, no more additional data protection will be given.
- If 33 months of additional data protection have already been obtained for previous extensions for minor uses with Article 51, only 1x3 months of additional data protection will be given. This is because the maximum additional data protection that can be given for products other than low-risk products is 36 months (3 years), or in the case of a low-risk product: if 24 months of additional data protection have already been obtained for previous extensions for minor uses with Article 51, only 1x3 months of additional data protection will be given. This is because the maximum additional data protection that can be given for low-risk products (Article 59(1) subparagraphs 4 and 5) is 24 months (2 years).
2. Product B was authorised in NL in 2000. Article 51 extension for minor uses applied for by the authorisation holder for cherry, plum, cress, celery and teff in 2016.
Other data provided as in example 1. How much data protection will an authorisation holder receive if the requested extension is approved?
Answer: Five years after a product has been authorised, no more additional data protection will be given for extensions for minor uses with Article 51 (Article 59(1) subparagraph 5).
3. Product C was authorised in NL in 2014.
Article 51 extension for minor uses applied for by STBT for cherry, plum, cress, celery and teff in 2016. Other data provided as in example 1. How much data protection will the authorisation holder receive if the requested extension is approved?
Answer: STBT is not the authorisation holder, so no additional data protection will be given (Article 59(1) subparagraph 5)
4. Product D was authorised in NL in 2014.
Article 51 extension for minor uses applied for by the authorisation holder for cherry, plum, cress, celery and teff in 2016. Three studies in two reports were supplied in support of the extension: an ecotox study for birds in cherry and a study on residues in cress and celery, both of which are being used after which a it is decided to reject the application. How much data protection will an authorisation holder receive when a decision is made on the requested extension?
Answer: As the requested extensions cannot be granted, the studies are regarded as not having been used, so no additional data protection will be given.