Products for distribution and sale.

CFR · 2024-01-01 · US · Title 9

An application for a U.S. Veterinary Biological Product Permit to import a biological product for Distribution and Sale shall be accompanied by supporting material necessary to satisfy the requirements provided in this section. (a) A permit shall not be issued unless the conditions under which the biological product is to be prepared or the methods to be used are such as to reasonably insure that the product is pure, safe, potent, and efficacious. (1) Two copies of blueprints of the producing foreign establishment shall be submitted with the application unless satisfactory plans are on file with Animal and Plant Health Inspection Service from a previous application. The production facilities to be used for each product prepared at the establishment shall be designated. (2) The manufacturer shall submit written authorization for properly accredited inspectors to inspect without previous notification, and at such times as may be demanded by the aforesaid inspectors, all parts of the establishment in which biological products shall be prepared, all processes of (3) The manufacturer shall furnish written assurance that a biological product to be imported for Distribution and Sale shall be prepared under the supervision of a person competent by education and experience to handle all matters pertaining to the preparation of such product and that each biological product shall be prepared in accordance with the regulations applicable to the product or in a manner acceptable to the Ad

official document · source cfr-2024 · id 9:§ 104.5