During the specialized expert evaluation of the registration dossier materials, the Center may send the medicinal product submitted for registration to the authorized laboratory(ies) (AL) in accordance with the scope of accreditation for laboratory testing. Laboratory testing is carried out in accordance with the provisions of Annex 13 to the Procedure for the Expert Evaluation of Materials on Medicinal Products (as amended by MoH order No. 460) to guarantee that the control methods proposed by the applicant and set out in the registration dossier materials are reproducible.After receiving a letter containing recommendations on the need to conduct testing in an AL, the applicant submits to the Center a letter of request regarding referral to an AL, specifying which one, taking into account the availability in the AL where it wishes to conduct the testing of the appropriate equipment, reagents and reference standards, to guarantee that the control methods are reproducible. The time required for laboratory testing is not included in the timelines for expert work.
Regulatory references: http://zakon5.rada.gov.ua/laws/show/z1210-15
