FAQs

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• Is it possible to obtain an LoA for product authorisation only?
  Yes, with the option to include the refund mechanism or not.
• Would it be possible to limit the LoA for product authorisation to only PT 2 or PT 4?
  No, this is not an option, because the three dossiers (i.e. for PTs 1, 2 and 4) are all based on the same core dossier and only include limited differences.
• Does the LoA for product authorisation include a sub-license?
  No, customers or distributors must obtain their own LoA.
• In case of CMR classification of ethanol, will it be possible to transfer the LoA for ethanol to propan-2-ol or propan-1-ol?
  No, this is not an option. Another LoA must be requested. To this aspect, the applicant bears the same risk as ATF does.
• Will it be possible to receive the list of endpoints for product authorisation?
  Yes, the endpoints are part of the LoA.
• Is it possible to request an LoA for Article 95 without the sub-license?
  Yes, in that case a deduction would be applied.
• Is it an option to exclude sublicensing for an LoA for Article 95 but to allow LoA for affiliates?
  Yes, applicants can issue LoAs for their affiliates, even if sublicensing is excluded. The exclusion of sublicensing only applies to "real" third parties (e.g. customers).
• Will ATF support the applicant to establish technical equivalence?
  Technical equivalence is solely in the responsibility of the applicant. ATF will not disclose the specification of the substance but support the applicant in establishing chemical similarity by enabling an independent lab (e.g. ITEM) to compare those.
• Do pharma grade alcohols fall in the specification set up by ATF?
  ATF will not disclose the specification of the substances, but confirms that the limits in their specifications are equal to or broader than in the Pharm. Eur. specifications.
• In case of Ethanol, is the denaturation part of the dossier?
  No. The denaturation needs to be defined by the applicant at the level of product authorisation. Identity and concentration of the denaturant selected will be discussed between the respective Competent Authority and the applicant.
• If buying an LoA from ATF, is there a difference between LoA for Article 95 listing and for product authorisation?
  ATF offers LoAs for Article 95 listing (including product authorisation) as well as LoAs for product authorisation only (in case the supplier is already included on the Article 95 list). The latter are reduced in price. For details on the current prices, please contact ATFs data submitter maud.grunchard@fieldfisher.com
• Why should we buy an LoA from ATF instead of using the LoA to a third party dossier?
  ATF has prepared the dossiers which have been accepted as complete by the evaluating authorities, have been used for the risk assessment under the BPD/BPR and ultimately has formed and will form the basis for the authorisation of the active substances concerned. The dossiers are unique in this respect and the endpoints, the substance quality, the exposure scenarios and the included risk assessment will constitute the benchmark for the authorisation procedure of biocidal products.