Regulatory Information definition

Regulatory Information means information, whether or not presented as a document, related to transport of cargo in the territory of the Union, including by way of transit, which is to be made available by an economic operator concerned in accordance with the provisions referred to in Article 1(2) in order to prove compliance with the relevant requirements of the acts concerned;

Regulatory Information. We have the following authorisations and registrations:

Regulatory Information means (a) all correspondence and submissions between Seller or any of the Divesting Entities and any United States Governmental Authority, including the FDA and the DEA, with respect to the Transferred Governmental Authorizations, including any reports, filings, or notices submitted to any Governmental Authority to support, maintain or obtain such Transferred Governmental Authorizations; and (b) records and data from all clinical and pre-clinical studies and trials conducted or being conducted by or on behalf of Seller or any of the Divesting Entities, which concern the Products and are (i) described in the Governmental Authorizations, (ii) the subject of a post-marketing requirement as imposed by the FDA or the subject of a post-marketing commitment to the FDA, or (iii) listed on Section 1.01(e) of the Disclosure Schedules; in each case of (a) and (b) to the extent not already in the possession or control of Purchaser. For the avoidance of doubt, Regulatory Information shall include a complete copy of the Product NDAs.

Examples of Regulatory Information in a sentence

• SBI Card Most Important Terms and Conditions are also available at xxx.xxxxxxx.xxx Important Regulatory information - The Card is valid for use both in India as well as abroad.

• SP8979 page 5 Yours sincerely, ING Bank N.V., Amsterdam Title : Our reference: SP8979 Annex: Regulatory information The European Market Infrastructure Regulation (EMIR) is a European Union regulation aiming to reduce the risks posed to financial systems by Over- the-Counter (OTC) derivative transactions.

• Published in the DOF on September 10, 2012 NOM-137-SSA1-2008 Regulatory information – general labeling specifications that medical devices must exhibit, whether of national manufacture or of foreign origin.

• By : ING Bank N.V. By : ING Bank N.V. Name : Xxxxxx xxx Xxxxxxxx Name Xxxx-Xxxxx van der Xxxxx Title : COO Commercial Banking Title Head of Financial Markets NL Accepted and confirmed: ING Ref.25567160 page 4 By Name Title Annex: Regulatory information The European Market Infrastructure Regulation (EMIR) is a European Union regulation aiming to reduce the risks posed to financial systems by Over-the-Counter (OTC) derivative transactions.

• Regulations US Dot IATA DGR ImDG Code UN No. UN1170 UN1170 UN1170 Hazard Class 3 3 3 Shipping Name Ethanol solution Ethanol solution Ethanol solution Packing Group III III III Packing Method B1,IB2,T4,TP4 Y344,355,366 P001,LP01,IBC03,T2,T P1 Section 15-REGULATORY INFORMATION Regulatory information : None.

More Definitions of Regulatory Information

Regulatory Information means know-how, trade secrets, procedures, information, technology, experimental data, pre-clinical, non-clinical and clinical data, clinical safety, post-market safety, efficacy or comparative data, including without limitation raw or patient data, and any and all material information or reports relating to the development, registration, manufacture and commercialization of a Product that is reasonably necessary or required for Regulatory Approval of a Product. For illustration, Regulatory Information includes, but is not limited to draft and final copies of all NDAs and INDs that are to be submitted or have been submitted by JT and Gilead or their respective Affiliates to the regulatory authorities, including, without limitation, the FDA or EMA, and that are included in other NDAs and INDs for a Product filed by either Party or its Affiliates, together with all material subsequent correspondence and data submissions relating to the foregoing, and all improvements or inventions made or obtained by either Party or its Affiliates, which are reasonably necessary or required to the formulation of a Product or the manufacture, development and registration of a Product.

Regulatory Information has the meaning specified in Section 2.14(a).

Regulatory Information means information, whether or not presented in the form of a document, that is related to the transport of goods in the territory of the Union, including of goods in transit, which is to be made available by an economic operator

Regulatory Information means copies of the Product Registrations, together with copies of related correspondence between any Seller Group Company or Group Company and the applicable Governmental Authority, current approved packaging and any other existing files and dossiers, in each case relating to the Product Registrations and/or to the underlying data or information used to support, maintain or obtain marketing authorization of the underlying Product;

Regulatory Information means information held by NHS England in connection with—

Regulatory Information means pre-clinical, clinical, manufacturing and testing data, protocols, and chemical, pharmacological, toxicological, pharmaceutical, physical, analytical, safety, efficacy, bioequivalency, quality assurance, quality control and other information and data relating to any investigations, trials and/or the preparation, submission and prosecution of one or more applications filed in connection with obtaining regulatory approval for any product, including but not limited to, with respect to GLAUKOS, information relating to preliminary investigations and the preparation, submission and prosecution of one or more applications filed in connection with obtaining regulatory approval for the iStent® (a/k/a G1 device), iStent Inject™ (a/k/a G2 device), and iStent Supra™ (a/k/a G3 device) including but not limited to FDA application materials, safety and efficacy data, clinical trial protocols and reports, statistical analyses, communications with the FDA, etc.

Regulatory Information means, to the extent in existence at the Completion Date or that is generated from time to time up to and including the TSA Expiration Date and in the Control of the Seller, the information which is listed in Exhibit 4 in the form in which it is held by or on behalf of the Seller: