813.12OBPFederal Council OrdinanceAug 1, 2005Original source
If the protection period specified in Article 28 has expired, the applicant may request that the data from an existing authorisation be used by the Notification Authority for his benefit, if he provides evidence:
where the protection period has expired for data on the active substance used: that it is technically equivalent to the active substance in a biocidal product already authorised, including the degree of purity and the nature of any impurities;
where the protection period has expired for data on the biocidal product:
1. that it is the same as the biocidal product already authorised, or
2. that the differences are not significant in relation to the risk assessment and the active substances are technically equivalent as defined in letter a.
The Notification Authority shall issue a general ruling, published in the Federal Gazette. It shall inform the holder of the existing authorisation and, if known, the owner of the data on the active substance or the biocidal product.
Depending on the particular case, the applicant shall submit the following data to the Notification Authority:
all the data required for the identification of the biocidal product, including its composition;
the data required to identify the active substance and to establish technical equivalence;
the data required to demonstrate that the biocidal product is comparable to the authorised biocidal product with regard to risks and efficacy.
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