Ministerial Ordinance on Standards for Post-Marketing Surveillance and Testing of Veterinary Medical Products No. 33, 2005.

This Ministerial Ordinance, consisting of 10 articles, shall be read as applied pursuant to the provisions of Article 83, paragraph 1 of the Act on Ensuring Quality, Effectiveness and Safety of Pharmaceuticals, Medical Devices. This Ordinance prescribes by the reference survey post-marketing and those related to the test (excluding those stipulated in the Ministerial Ordinance on Standards for Implementation of Clinical Trials for Veterinary Drugs, Ministry Ordinance No. 75 of the Ministry of Agriculture, Forestry and Fisheries in 1997). The matters to be determined aim at defining "post-marketing surveillance", meaning a manufacturer or distributor of a pharmaceutical product that is intended exclusively for animals or use-results survey or post-marketing clinical trial conducted by a person who has obtained a special approval for foreign manufactured drugs, etc. (as defined in paragraph 4). In order to carry out post-marketing surveillance, manufacturers and distributors must prepare a business procedure manual for post-marketing surveillance that describes specific procedures. The following matters shall be stipulated in the usage-results survey implementation plan: 1. purpose of the investigation; 2. number of facilities and the number of cases scheduled for investigation; 3. animals to be surveyed; 4. survey methods; 5. survey periods; 6. items to be investigated; 7 items and methods for analysis; 8. other necessary items.