Veterinary Drugs Control Act Article 14-3

With prior approval of the central competent authority, sample veterinary drugs from trial production by academic research institutes or veterinary drug manufacturers may be exempt from seeking product registration and/or license; an exclusive label issued by the central competent authority shall be affixed to the container of sample drug indicating that it has been approved for trial production and it must not be used for other purposes.Field study of a sample veterinary drug mentioned in the preceding Paragraph shall not start until approval of the central competent authority is obtained.Regulations for the sample veterinary drug mentioned in Paragraph 1 (its application procedure, required documents, criteria for approval, the trial production facility, and how to affix the label) and regulations for the field study mentioned in the preceding Paragraph (application procedure, required documents, criteria for approval) and rules to follow are to be prescribed by the central competent authority.