GMP Regulations definition

GMP Regulations means the applicable Laws and guidances for current Good Manufacturing Practices promulgated by the FDA under the FDCA or PHS Act, applicable EU or EU Member State Law, or under the European Union guidelines to Good Manufacturing Practice for medicinal products and any other applicable Governmental Entity in each jurisdiction where any member of the Company Group or a Third Party acting on its behalf is undertaking a clinical trial or any manufacturing activities as of or prior to the Completion.
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GMP Regulations means the applicable laws and regulations, as may be amended from time to time, for current Good Manufacturing Practice, which have been promulgated by (i) the FDA under the United States Federal Food, Drug and Cosmetic Act, 21 C.F.R. §210 et seq., (ii) the European Medicines Agency or under the European Union guide to Good Manufacturing Practice for medical products and (iii) any other applicable Regulatory Authorities in each jurisdiction where the Company, or a third party acting on its behalf, is undertaking or has undertaken a clinical trial or any manufacturing activities as of or prior to the Effective Time;
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GMP Regulations means the applicable Legal Requirements for current Good Manufacturing Practices promulgated by the FDA under the FDCA, the European Medicines Agency or under the European Union guide to Good Manufacturing Practice for medical products and any other applicable Governmental Body in each jurisdiction where the Company or a third party acting on its behalf is undertaking a clinical trial or any manufacturing activities as of or prior to the Effective Time.
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Examples of GMP Regulations in a sentence

  • The content of this document should not be regarded as the only interpretation of the GMP Regulations, nor does it intend to cover every conceivable case.

  • With the exception of Pharmacists whose university courses may include modules on GMP Regulations, a good knowledge of applicable regulations is usually obtained through training and experience.

  • Chart 1.0: GMP Regulations Applicable to Licensable Activities F =Fabricator P/L =Packager/Labeller I =Importer (MRA and non-MRA) D =Distributor W =Wholesaler T =Tester ★ - Where applicable depending on the nature of the activities.

  • The present edition of this document includes recent regulatory amendments, clarification of existing requirements, and an update of the table Chart 1.0: GMP Regulations Applicable to Licensable Activities.

  • Since January 1, 2019, all manufacturing operations conducted by or for the benefit of the Company have been conducted in accordance with GMP Regulations in all material respects.

  • These additional health-care related requirements are embodied in the European standard EN 46001 and in the draft GMP Regulations of the USA, Japan and Canada.

  • To the extent required by applicable Laws, all manufacturing operations conducted for the benefit of any member of the Company Group with respect to any product or product candidate being used in human clinical trials have been conducted in accordance with GMP Regulations, except where the failure to so comply would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.

  • Table 1: GMP Regulations (Division 2) Applicable to API Activities1Section1.

  • Undertaking 5: All data received from Conceptus in regard to Essure (including clinical investigation records) prior to the acquisition as well as copies of any audits/inspections performed by the Defendants or their agents to ensure compliance with CGMP Regulations (FDA) or GMP Regulations (Health Canada) Undertaking 6: A copy of all the adverse reactions reported to Conceptus around July 2013.

  • If CONTRACT GIVER further wishes that any special regulations or directives are followed, that are not generally known and recognized under the above GMP Regulations, CONTRACT GIVER shall notify CONTRACT LABORATORY correspondingly and the Parties shall discuss in good faith how to proceed.” CONTRACT LABORATORY's approved facilities are duly authorized by the appropriate authorities for the activities that are subject to this Quality Agreement.


More Definitions of GMP Regulations

GMP Regulations means the applicable Laws and regulations, as may be amended from time to time, for current Good Manufacturing Practices, which have been promulgated by (i) the FDA under the FDCA, as set forth in 21 C.F.R., Parts 210 and 211, (ii) the European Medicines Agency or under the European Union guide to Good Manufacturing Practice for medical products and (iii) any other applicable Regulatory Authorities in each jurisdiction where the Company or any of its Subsidiaries, or a third party acting on their behalf, is undertaking or has undertaken a clinical trial or any manufacturing activities with respect to the Company Products as of or prior to the Acceptance Time.
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GMP Regulations means Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use regulations;
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GMP Regulations shall have the meaning given to that term in Clause 6.1.18(8);
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GMP Regulations means the applicable Legal Requirements for current Good Manufacturing Practices for human biopharmaceutical products promulgated by the FDA under the FDA Act and the Public Health Service Act, 42 U.S.C. § 201 et seq., or by any other applicable Governmental Body under similar Legal Requirements in each jurisdiction where the Company or a third party acting on its behalf is undertaking a clinical trial or any manufacturing activities as of or prior to the Effective Time (including, for example, 21 C.F.R. Parts 210 and 211).
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GMP Regulations means the applicable laws and regulations, as may be amended from time to time, for current Good Manufacturing Practice, which have been promulgated by (i) the FDA under the United States Federal Food, Drug and Cosmetic Act, 21 C.F.R. §210 et seq., (ii) the European Medicines Agency
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GMP Regulations means the current good manufacturing practices promulgated by the FDA, as amended, including those currently set out in Parts 210 and 211 of Title 21 of the Code of Federal Regulations. [***] Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
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Related to GMP Regulations

  • 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.

  • 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.

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

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

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

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

  • 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);

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

  • UCITS Regulations means the European Communities (Undertakings for Collective

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

  • OFAC Regulations means the regulations promulgated by OFAC, as amended from time to time.

  • SEBI ICDR Regulations means Securities and Exchange Board of India (Issue of Capital and Disclosure Requirements) Regulations, 2018, as amended;

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

  • CIP Regulations has the meaning provided in Section 9.07.

  • TRADES Regulations means the regulations of the United States Department of the Treasury, published at 31 C.F.R. Part 357, as amended from time to time. Unless otherwise defined herein, all terms defined in the TRADES Regulations are used herein as therein defined.

  • the 2002 Regulations means the Traffic Signs Regulations and General Directions 2002;

  • WHFIT Regulations Treasury Regulations section 1.671-5, as amended.

  • 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;

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

  • FHA Regulations Regulations promulgated by HUD under the National Housing Act, codified in 24 Code of Federal Regulations, and other HUD issuances relating to FHA Loans, including the related handbooks, circulars, notices and mortgagee letters.

  • Radio Regulations means the Radio Regulations annexed to, or regarded as being annexed to, the most recent International Telecommunication Convention which may be in force at any time.

  • the 2001 Regulations means the Water Supply (Water Quality) Regulations 2001[63];

  • Conduct Regulations means the Conduct of Employment Agencies and Employment Businesses Regulations 2003;

  • EEA Regulations means the Immigration (European Economic Area) Regulations 2006.

  • Regulations means the Income Tax Regulations promulgated under the Code, as such regulations may be amended from time to time (including corresponding provisions of succeeding regulations).