License applications.

CFR · 2024-01-01 · US · Title 9

(a) (2) When a person conducts more than one establishment, a separate application shall be made for each establishment. (3) Whenever subsidiaries are to operate in an establishment for which license application is made, the applicant shall apply for permission for such subsidiaries to operate in the establishment and furnish therewith a complete statement regarding the relationship between the applicant and the subsidiaries. (4) Facilities documents, prepared as prescribed in part 108 of this subchapter, shall accompany the application for license unless previously filed with Animal and Plant Health Inspection Service. (5) Each application for a U.S. Veterinary Biologics Establishment License shall be accompanied by an application for one or more U.S. Veterinary Biological Product Licenses and the supporting documents required by paragraph (b)(2) of this section. (6) A new application shall be made when a change of ownership, operation, or location of an establishment occurs; or prior to the expiration of a U.S. Veterinary Biologics Establishment License issued for an interim period of time. (b) (2) Each application for a U.S. Veterinary Biological Product License shall be supported by: (i) At least two copies of an Outline of Production prepared in accordance with §§ 114.8 and 114.9 of this subchapter; and (ii) At least three copies of test reports and research data sufficient to establish purity, safety, potency, and efficacy of the product; and (iii) Legends prepared as p

official document · source cfr-2024 · id 9:§ 102.3