Record-keeping obligations of germinal product establishments
Article 103
1. Operators of germinal product establishments shall keep and maintain records containing at least the following information: (a) the breed, age, identification and health status of donor animals used for the production of germinal products; (b) the time and place of collection, and the processing and storage, of germinal products collected, produced or processed; (c) the identification of the germinal products together with details of their place of destination, if known; (d) the documents required to accompany germinal products arriving at or leaving the establishment in question in accordance with Article 162 and Article 164(2) and any rules adopted pursuant to Article 162(3) and (4); (e) where relevant, the results of clinical and laboratory tests; (f) laboratory techniques used. 2. Establishments presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1. 3. Operators of germinal product establishments shall keep the records provided for in paragraphs 1 and 2 on their establishment and: (a) make them immediately available to the competent authority on request; (b) retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.