Commission Implementing Regulation (EU) 2017/12Show full title

CHAPTER 1 ADMINISTRATIVE INFORMATION

The administrative information shall comprise two parts, one providing the administrative data and the second providing a summary of the evaluation proposed by the applicant/requestor.

The following details shall be included:

• Part 1 — Administrative data:

  • name of the substance for review, using international non-proprietary name (INN) where attributed;

  • name and address of the applicant/requestor;

  • name and address details of the applicant/requestor contact point for all correspondence related to the application;

• Part 2 — Summary of the evaluation proposed by the applicant/requestor:

  • name of the substance for review, using INN where attributed;

  • clarification on whether the substance is used in the product as active ingredient, excipient, preservative, etc.;

  • summary of anticipated pattern of veterinary use (target species, major indications, dose-regimen);

  • information on any applications to other Union or international bodies, the dates of these applications and the outcome;

  • summary of the findings:

    • relevant no-observed (adverse) effect levels (NO(A)EL) or an accepted alternative for the safety evaluation,

    • reference to relevant study,

    • uncertainty factor proposed,

    • Acceptable Daily Intake (ADI) proposed, or an alternative in accordance with Article 6 of Regulation (EC) No 470/2009,

    • marker residue (where relevant),

    • MRLs proposed (where relevant),

    • method of analysis proposed (including limit of quantification and reference, where relevant).