If you have any questions about the compliance requirements of the ITAR agreements listed above or others that are often excluded from the Company`s compliance programs (including obtaining and managing export licenses, tracking values and quantities, and maintaining contractual records), please do not hesitate to contact Torres Law`s lawyers. (c) Declarations required. The following statements must be included in all storage and distribution agreements: Pharmaceutical companies or market authorization holders who market drugs manufactured by a third party require a Wholesale Distribution Authorization (WDA). We help our customers get their license. We check whether the conditions for obtaining a wholesale distribution license are met and whether the GDP rules are respected and, if necessary, if necessary, we support the construction. We create the necessary documents, update and/or develop the quality assurance system (including SOPs), establish documentation on specific batches and much more. We are also happy to approach the licensing authorities and help monitor their (authorisation) inspections. 2. A statement indicating the foreign party. (a) agreements. Agreements (e.g.
B contracts) between the United States and foreign persons for the storage and distribution of defence items must be approved by the Directorate of Commercial Controls in Defence Trade prior to their entry into force. These agreements are limited to unclassified defence items and must include specific distribution, end-use and reporting conditions. Export permits under these arrangements must be obtained prior to the export of defence-related goods, unless an exception under article 123.16(b)(1) of this sub-chapter applies. (4) Specific identification of the country or countries that make up the sales territory. Distribution should be specifically limited to the governments of those countries or to private entities wishing to procure defence items under contract with a government in the distribution territory, or to other authorized entities as determined by the Directorate of Defence Trade Control. Therefore, any deviation from this condition must be fully explained and justified. A Certificate of Non-Transfer and Use (DSP-83) is required to the extent required by the License Agreements in accordance with § 124.9(b).