S.L. 437.47 Art. 23Examination of application found under regulations 12 and 13.

In order to examine the application submitted pursuant to regulations 12 to 13D, the Veterinary Services -

(1) shall check that the documentation submitted in support of the application complies with regulations

12 to 13D and ascertain whether the conditions for the issue of the marketing authorisation have been fulfilled;

(2) may submit the medicinal product, its starting materials and if necessary intermediate products or other constituent materials for testing by an Official Medicines Control Laboratory or a laboratory that has designated for that purpose by the Veterinary Services, in order to ensure that the testing methods employed by the manufacturer and described in the application documents, in accordance with regulation 12(3)(i), are satisfactory;

(3) may similarly check, in particular through consultation of a national or European Union reference laboratory, that the analytical method used for detecting residues presented by the applicant for the purposes of regulation 12(3)(j), second indent is satisfactory;

(4) may, where appropriate, require the applicant to provide further information as regards the items listed in regulations 12, 13A, 13B, 13C and 13D. Where the Veterinary Services take this course of action, the time-limits specified in regulation 21 shall be suspended until the further data required have been provided. Similarly, these time-limits shall be suspended for any period which the applicant may be given to provide oral or written explanations.