Drug Regulation Laws definition

Drug Regulation Laws means Laws regulating drugs and pharmaceutical products, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et. seq. (the “FFDCA”), the Prescription Drug Marketing Act of 1987, the federal Controlled Substances Act, 21 U.S.C. §801 et. seq., and any guidance documents and policy and procedural manuals issued by the FDA.
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Drug Regulation Laws means Applicable Laws regulating drugs and pharmaceutical products, such as the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et. seq., the Prescription Drug Marketing Act of 1987, the Controlled Substances Act, 21 U.S.C. § 801 et. seq., and policies issued by the FDA, each as in effect and as amended from time to time.
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Drug Regulation Laws means Laws regulating the distribution of biologics, drugs and pharmaceutical products, including the FFDCA, the Prescription Drug Marketing Act of 1987, the federal Controlled Substances Act, 21 U.S.C. § 801 et. seq., and policies issued by the FDA, as well as similar Laws in the OUS Territory, each as in effect and as amended from time to time.
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Examples of Drug Regulation Laws in a sentence

  • Each Party shall, and shall cause its Affiliates to, comply with all Applicable Laws pertaining to the Development, Manufacture and Commercialization of the Licensed Products, including applicable Drug Regulation Laws, Clinical Investigation Laws and Health Care Laws.

  • See also, American Enterprise Institute for Public Policy Research, Proposals to Reform Drug Regulation Laws.

  • EXECUTION VERSION comply with all Applicable Laws pertaining to the Development, Manufacture and Commercialization of the Licensed Products, including applicable Drug Regulation Laws, Clinical Investigation Laws and Health Care Laws.

  • The rewiring requirements are based on defect recorded caused by aging factors on wiring after the aircraft reaches 20 years in service.

  • American Enterprise Institute for Public Policy Research, Proposals to Reform Drug Regulation Laws, supra note 11.


More Definitions of Drug Regulation Laws

Drug Regulation Laws means Applicable Laws regulating drugs and pharmaceutical products, such as the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et. seq., the Prescription Drug Marketing Act of 1987, the Controlled Substances Act, 21 U.S.C. § 801 et. seq., and policies issued by the FDA, each as in effect and as amended from time to time. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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Drug Regulation Laws. Drug Regulation Laws means Laws regulating drugs and pharmaceutical products, including the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., the Prescription Drug Marketing Act of 1987, the Federal Controlled Substances Act, 21 U.S.C. § 801 et seq., and policies issued by the FDA, and similar *Confidential Treatment Requested. Omitted portions filed separately with the Commission. Laws of the EMEA or other countries or jurisdictions in the Territory, each as in effect and as amended from time to time.
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Drug Regulation Laws means Applicable Laws regulating drugs and pharmaceutical products, such as the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et. seq., the Prescription Drug Marketing Act of 1987, the Controlled Substances Act, 21 U.S.C. § 801 et. seq., and policies issued by the FDA, each as in effect and as amended from time to time. 1.67 “EMA” means the European Medicines Agency or any successor agency for the EU. 1.68 “European Union” or “EU” means the countries of the European Economic Area, as it is constituted on the Amended Effective Date and as it may be modified from time to time after the Amended Effective Date. 1.69 “Exclusivity Term” has the meaning set forth in Section 12.1. 1.70 “Executive Officers” means (a) for Arrowhead, the Chief Executive Officer of Arrowhead or any executive officer of Arrowhead delegated authority by the Chief Executive Officer with respect to any particular matter; and (b) for GSK, the Chief Scientific Officer of GSK, or any executive officer of GSK delegated authority by the Chief Scientific Officer of GSK with respect to any particular matter. In the event that the position of any of the Executive Officers identified in this Section 1.70 no longer exists due to a corporate reorganization, corporate restructuring or the like that results in the elimination or modification of the identified position, the applicable Executive Officer shall be replaced with another senior
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Related to Drug Regulation Laws

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • Data Protection Laws and Regulations means all laws and regulations, including laws and regulations of the European Union, the European Economic Area and their member states, Switzerland and the United Kingdom, applicable to the Processing of Personal Data under the Agreement.

  • EP Regulations means The Environmental Permitting (England and Wales) Regulations SI 2016 No.1154 and words and expressions used in this permit which are also used in the Regulations have the same meanings as in those Regulations.

  • TUPE Regulations means the Transfer of Undertakings (Protection of Employment) Regulations 2006, as amended.

  • EU Data Protection Laws means EU Directive 95/46/EC, as transposed into domestic legislation of each Member State and as amended, replaced or superseded from time to time, including by the GDPR and laws implementing or supplementing the GDPR;

  • PPPFA Regulations means the Preferential Procurement Regulations, 2017 published in terms of the PPPFA.

  • FCC Regulations means the regulations duly and lawfully promulgated by the FCC, as in effect from time to time.

  • EU Regulation means a regulation within the meaning of Article 288 of the Treaty on the Functioning of the European Union;

  • ISA Regulations means The Individual Savings Account Regulations 1998, as amended or replaced from time to time.

  • CDM Regulations means the Construction (Design and Management) Regulations 2015;

  • CFTC Regulations means the rules and regulations promulgated by the CFTC, as amended.

  • UCITS Regulations means the European Communities Undertakings for Collective Investment in Transferable Securities) Regulations, 2011 (S.I. No. 352 of 2011) (as amended consolidated or substituted from time to time) and any regulations or notices issued by the Central Bank pursuant thereto for the time being in force.

  • Anticorruption Laws means the U.S. Foreign Corrupt Practices Act of 1977, or any other anticorruption or anti-bribery Applicable Law applicable to the Company or any of the Company Subsidiaries.

  • Anti-Corruption Laws means all laws, rules, and regulations of any jurisdiction applicable to the Borrower or its Subsidiaries from time to time concerning or relating to bribery or corruption.

  • HIPAA Regulations means the regulations promulgated under HIPAA by the United States Department of Health and Human Services, including, but not limited to, 45 C.F.R. Part 160 and 45 C.F.R. Part 164.

  • the 2000 Regulations means the Water Supply (Water Quality) Regulations 2000(b); "the 2001 Regulations" means the Water Supply (Water Quality) Regulations 2001(c);

  • Data Protection Laws means EU Data Protection Laws and, to the extent applicable, the data protection or privacy laws of any other country;

  • SEBI Listing Regulations means SEBI (Listing Obligation and Disclosure Requirements) Regulations, 2015, as amended

  • EU Data Protection Law means (i) prior to 25 May 2018, Directive 95/46/EC of the European Parliament and of the Council on the protection of individuals with regard to the processing of Personal Data and on the free movement of such data ("Directive") and on and after 25 May 2018, Regulation 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of Personal Data and on the free movement of such data (General Data Protection Regulation) ("GDPR"); and (ii) Directive 2002/58/EC concerning the processing of Personal Data and the protection of privacy in the electronic communications sector and applicable national implementations of it (as may be amended, superseded or replaced).

  • Sanctions Laws and Regulations means any sanctions, prohibitions or requirements imposed by any executive order (an “Executive Order”) or by any sanctions program administered by OFAC.

  • Privacy Regulations means the Privacy and Electronic Communications (EC Directive) Regulations 2003 as amended in 2004, 2011, 2015 and 2016 and as may be further amended from time to time;

  • the 1997 Regulations means the Zebra, Pelican and Puffin Pedestrian Crossing Regulations 1997.

  • SBE Regulations means the written regulations and procedures adopted pursuant to this chapter for procurement of Supplies, Services and Public Works.

  • Listing Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

  • Anti-Corruption Law means, with respect to any Affected Person, the FCPA and any law, rule or regulation of any jurisdiction concerning or relating to bribery or corruption that are applicable to such Affected Person.

  • Council Regulation means Council Regulation (EC) No. 2100/94 of 27th July 1994 on Community plant variety rights;