Additional considerations for imports of veterinary medicinal products
Article 40
1. To comply with the obligation set out under Article 97(7) of Regulation (EU) 2019/6, the certification by the qualified person can only occur after a physical importation has taken place. The site of physical importation and the site of the qualified person responsible for the certification/confirmation shall be authorised in accordance with Article 88(1) of Regulation (EU) 2019/6. 2. Sampling of the imported product shall be fully representative of the batch. Samples required for the testing of the imported batch as well as reference and/or retention samples may either be taken after arrival in the Union or at the manufacturing site in the third country in accordance with a documented procedure. Responsibilities in relation to the sampling shall be defined in a written agreement between the manufacturing sites. Any samples taken outside the Union shall be shipped under equivalent transport conditions as the batch that they represent. 3. Where sampling is performed in a third country manufacturing site, the documented procedure referred to in paragraph 2 shall be justified in accordance with quality risk management principles and shall include at least the following elements: (a) audits of the manufacturing activities, including sampling, at the third country manufacturing site and evaluation of subsequent transportation steps of both the batch and samples to ensure that the samples are representative of the imported batch; (b) a comprehensive analysis supporting the conclusion that samples taken in the third country are representative of the batch after importation, including at least the following: — a description of the sampling process; — a description of the transport conditions of the sample and the imported batch; any differences shall be justified; — comparative analysis of samples taken in the third country and samples taken after importation. In case of discrepancies or out of trends, these shall be documented and investigated; — consideration of the time interval between sampling and importation of the batch and generation of data to support appropriate defined limits; (c) a random periodic analysis of samples taken after importation shall be performed to justify ongoing reliance on samples taken in a third country; (d) the conditions of storage and transport of the finished product and the samples, shall be checked before certifying any batch; (e) batch documentation supplied by the third country manufacturing site shall be in a format and language that is understandable for the importer; (f) relevant ordering and delivery documentation shall be available for inspection at the manufacturing site responsible for certification; (g) where batches are subdivided and partial quantities are imported separately, reconciliation of the quantities shall be verified and documented. Any discrepancy shall be investigated under the responsibility of the qualified person responsible for the certification of the batch; (h) the manufacturing site responsible for certification shall ensure that an ongoing stability programme is in place and that reference and retention samples have been taken. The ongoing stability programme may be carried out at the third country manufacturing site. 4. The manufacturing site responsible for certification shall qualify the third country manufacturer and conduct periodic monitoring, including by means of on-site audits, to ensure compliance with good manufacturing practice and the terms of the marketing authorisation.