Article 105th for generic drugs belonging to the non prescription drug management, the applicant shall be in the "drug registrationapplication form" "additional items marked with" non prescriptionitems.
106th application of a generic drug is also according to the management of prescription and over-the-counter drugs, the applicant can choose according to prescription or non prescription drug application.
Article 107th belongs to the following situations, the applicant mayin the "drug registration application form" "additional items marked with" non prescription drugs, in conformity with the relevant provisions of the non prescription drugs, according to a nonprescription drug approval and management; not in conformity with the relevant provisions of the non prescription drugs,according to prescription drug approval and management.
(a) determined by the State Food and Drug Administration of nonprescription drugs to change form, but does not change theindications or functions, dosage and route of administration of thedrug;
(two) new compound preparation composed of non prescription drugs active ingredients is determined by the State Food and drug administration.
Application of 108th non prescription drug registration, thepharmaceutical directions and labels shall comply with therelevant provisions of the non prescription drugs.
109th imported drugs are non prescription drugs, suitable forpharmaceutical import declaration and approval procedures,production and its technical requirements and non prescription drugs within the same.