| Russian | English |
| лицензия, выданная регулирующим органом | regulatory licence (Alexander Matytsin) |
| лицензия регулирующего органа | regulatory licence (Alexander Matytsin) |
| направление перечня патентов в регулирующие органы | regulatory patent listing (Patent Listing. Following Vertexs exercise of the Option for a Collaboration Target, Vertex will have the sole right, but not the obligation, to submit to all applicable Regulatory Authorities patent information pertaining to each applicable Product pursuant to 21 U.S.C. SS 355(b)(1)(G) (or any amendment or successor statute thereto), any similar statutory or regulatory requirement enacted in the future regarding biologic products, or any similar statutory or regulatory requirement in any non-U.S. country or other regulatory jurisdiction; provided that Vertex shall not be permitted to provide any such information with respect to CRISPR Platform Technology Patents without CRISPRs prior written consent. Moonranger) |
| регулирующие органы | regulatory authorities (TermCommittee) |
| регулирующий орган | regulating authority |
| соблюдение требований регулирующих органов | regulatory compliance (Georgy Moiseenko) |
| эксклюзивные права, предоставленные регулирующим органом | regulatory exclusivity (means any period of regulatory data protection or market exclusivity or similar regulatory protection afforded by the Regulatory Authorities in a jurisdiction, including any such periods listed in the FDA's Orange Book or periods under national implementations of Article 10 of Directive 2001/EC/83 (as amended), and all international equivalents, and any exclusivity afforded by restrictions on the granting by a Regulatory Authority of Marketing Approval to market a generic product. Moonranger) |
