Good Distribution Practices definition

Good Distribution Practices or “GDP” shall mean the current (at a given time) standards, practices and procedures regarding the distribution of pharmaceutical products promulgated or endorsed by a Regulatory Authority and all Applicable Laws with respect thereto, as defined further or otherwise in the Distribution Agreement or a quality agreement ancillary thereto.
Sample 1Sample 2Sample 3
Good Distribution Practices or “GDP” means the regulatory standards and principles and guidelines of good distribution practice as in force from time to time relating to the warehousing, storage and physical distribution of medicinal products established by the relevant Regulatory Authority, including without limitation the guidelines for Good Distribution Practice as promulgated in “Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use” (2013/C 343/01), as amended from time to time.
Sample 1Sample 2Sample 3
Good Distribution Practices or “GDPs” shall mean Applicable Laws and Regulations that apply to the distribution of Product in the Territory (including Good Storage Practices (“GSPs”)). Where no such laws and regulations exist in the Territory related to GDP, then these standards shall be established with reference to Good Distribution Practices for Pharmaceutical Products as published in Annex 5, WHO Technical Report Series 957, 2010 and the EU guidelines on Good Distribution Practice of Medicinal Products for Human Use 94C 63/03 and any successor documents to the above.
Sample 1Sample 2

Examples of Good Distribution Practices in a sentence

  • The Principal Recipient shall comply with, and shall ensure that its Sub-Recipients comply with the WHO Guidelines for Good Storage Practices and Good Distribution Practices for Pharmaceutical Products.

  • Without limiting the foregoing, this includes compliance with the requirements of Directive 2001/83/EC and Directive 2011/62/EU relating to medicinal products for human use and the Guidelines on Good Distribution Practices of Medicinal Products for Human Use and any subsequent Good Distribution Practices directives, guidelines or legislation which may come into force in connection with active pharmaceutical ingredients.

  • This year’s inspection target of 2,000 facilities could not be achieved because NDA inspectors had to prioritize Good Distribution Practices (GDP) licensing inspections of wholesalers from January to April, 2017.

  • You trade in respect and accordance with the Good Distribution Practices.

  • The Implementing Organization shall ensure that all Sub-Grantees and/or Sub-contractors comply with the WHO Guidelines for Good Storage Practices and Good Distribution Practices for Pharmaceutical Products.

  • The Agent undertakes to handle and store the Products in accordance with Good Distribution Practices (GDP) and as directed by MOTIVA, and to distribute the Products in conformity with the FEFO principle (first expired - first out).

  • GDP/GSP/GTP Good Distribution Practices, Good Storage Practices, Good Transportation Practices cGMP Current Good Manufacturing Practice EU directive 2003/94/EC; the E.U. and PIC/S Guide to GMP (The rules governing medicinal products in the European Union, Volume IV); cGMP includes as per guidance definition GDP, GSP, GTP etc.

  • Licensee shall formulate, manufacture, package, store, sell, distribute or perform any other activities according to applicable good practices of industry including without limitation Good Manufacturing Practices, Good Distribution Practices any other Applicable Laws.

  • Licensee shall formulate, manufacture, package, store, package, formulate, sell, distribute or perform any other -businessesactivities according to applicable good practices of industry including without limitation Good Manufacturing Practices, Good Distribution Practices, Good Storage Practices or any other Applicable Laws.

  • This TD Agreement also governs the responsibilities for Good Distribution Practices (“GDP”) as specified in the EU Commission’s Guidelines on Good Distribution Practices (“GDP Guidelines”), as amended from time to time (current version of 5 November 2013 / 2013/C 343/01).


More Definitions of Good Distribution Practices

Good Distribution Practices or “GDP” means those practices and standards which are part of GMP and that require that medicinal products are consistently stored, transported and handled under suitable condition as required by the product specification and that are set forth in the European Union Guidelines on GDP of Medicinal Products for Human Use (94/C 63/03), and any subsequent or future revisions of such guidelines.
Sample 1Sample 2
Good Distribution Practices means all applicable current good distribution practices for the distribution or supply or pharmaceuticals, including, as applicable, European Directive 2001/83/EC and the EU Guidelines on Good Distribution Practice of Medicinal Products (2013/C 68/01) and the PRC Good Supply Practices of Pharmaceutical Products as released by the NMPA in 2000, or its subsequent versions.
Sample 1
Good Distribution Practices or “Good Supply Practices” (“GDP” or “GSP”) means all applicable current Good Distribution or Supply Practices including, as applicable, WHO TRS 957 Annex 5 and the equivalent Applicable Laws and Industry Codes in any relevant country, each as may be amended and applicable from time to time.
Sample 1
Good Distribution Practices means the then-current standards for good distribution practice as promulgated under Applicable Law, including 21 C.F.R. Parts 210 and 211.
Sample 1
Good Distribution Practices. “GDP” or “cGDP” means the then-current good distribution practices required by Swissmedic, as set forth in the TPA, as amended, and the regulations and ordinances promulgated thereunder, for the distribution (including acquisition, stockage, storage, and offering) of pharmaceutical materials, and comparable Applicable Law related to the distribution of pharmaceutical materials in jurisdictions outside of Switzerland, including (i) the European Commission Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01) and, regarding active pharmaceutical ingredients, (ii) EudraLex Volume 4 Part II on Basic Requirements for Active Substances used as Starting Materials.
Sample 1
Good Distribution Practices or "GDP" has the meaning set forth in the Quality Agreement. "Government Official" means: (i) any officer or employee of: (a) a government, or any department or agency thereof; (b) a government-owned or controlled company, institution, or other entity, including a government-owned hospital or university; or (c) a public international organization (such as the United Nations, the International Monetary Fund, the International Committee of the Red Cross, and the World Health Organization), or any department or agency thereof; (ii) any political party or party official or candidate for public or political party office; and (iii) any person acting in an official capacity on behalf of any of the foregoing. "HIPAA" means United States Health Insurance Portability and Accountability Act of 1996, as amended from time to time. "IND" means the Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent CONFIDENTIAL Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025 Page 3 [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not material and (II) would be competitively harmful if publicly disclosed.
Sample 1

Related to Good Distribution Practices

  • Certification Practice Statement means a statement issued by a Certifying Authority to specify the practices that the Certifying Authority employs in issuing Digital Signature Certificates;

  • ISO-NE Practices means the ISO-NE practices and procedures for delivery and transmission of energy in effect from time to time and shall include, without limitation, applicable requirements of the NEPOOL Agreement, and any applicable successor practices and procedures.

  • Federal Trade Commission Act means the Federal Trade Commission Act of 1914.

  • Group practice means a group of two or more health care providers legally organized as a partnership, professional corporation, or similar association:

  • Equal Credit Opportunity Act means the Equal Credit Opportunity Act, as amended.

  • Fair Credit Reporting Act The Fair Credit Reporting Act of 1970, as amended.

  • fraudulent practices which means any act or omission, including a misrepresentation, that knowingly or recklessly misleads, or attempts to mislead, a party to obtain a financial or other benefit or to avoid an obligation; and

  • fradulent practice means a misrepresentation or omission of facts in order to influence a procurement process or the execution of contract;

  • Licensed health care practitioner means a physician, as defined in Section 1861(r)(1) of the Social Security Act, a registered professional nurse, licensed social worker or other individual who meets requirements prescribed by the Secretary of the Treasury.

  • Credit reporting agency means a corporation that carries on a credit reporting business.

  • Good Industry Practices means the practices that would be adopted by, and the exercise of that degree of care, skill, diligence, prudence and foresight that reasonably would be expected from, a competent contractor in the international oil and gas industry experienced in performing work similar in nature, size, scope and complexity to the Work and under conditions comparable to those applicable to the Work, where such work is subject to, and such contractor is seeking to comply with, the standards and codes specified in the Contract or (to the extent that they are not so specified) such national or international standards and codes as are most applicable in the circumstances, and the applicable Law.

  • Best management practices (BMP) means schedules of activities, prohibitions of practices, maintenance procedures, and other management practices to prevent or reduce the pollution of waters of the United States. BMPs include treatment requirements, operation procedures, and practices to control plant site runoff, spillage or leaks, sludge or waste disposal, or drainage from raw material storage.

  • Credit report means any written, oral, or other communication of

  • Good Laboratory Practices or “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the United States, as they may be updated from time to time).

  • Employment Practices means any wrongful or unfair dismissal, denial of natural justice, defamation, misleading representation or advertising, unfair contracts, harassment or discrimination (sexual or otherwise) in respect of employment by the Insured.

  • coercive practices means harming or threatening to harm, directly or indirectly, persons, or their property to influence their participation in a procurement process, or affect the execution of a contract;

  • Best Practices means a term that is often used inter-changeably with “evidence- based practice” and is best defined as an “umbrella” term for three levels of practice, measured in relation to Recovery-consistent mental health practices where the Recovery process is supported with scientific intervention that best meets the needs of the Client at this time.

  • Best Management Practices (BMPs means schedules of activities, prohibitions of practices, maintenance procedures, and other management practices to prevent or reduce the pollution of waters of the state. BMPs also include treatment requirements, operating procedures, and practices to control site runoff, spillage or leaks, sludge or waste disposal, or drainage from raw material storage.

  • Good Practice means such practice in the processing of personal data as appears to the Commissioner to be desirable having regard to the interests of data subjects and others, and includes (but is not limited to) compliance with the requirements of this Act;

  • Employment Practices Wrongful Act means any actual or alleged:

  • Active practice means post-licensure practice at the level of licensure for which an applicant is seeking licensure in Virginia and shall include at least 360 hours of practice in a 12-month period.

  • Affordable Care Act means, collectively, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010.

  • CER Act means the Canadian Energy Regulator Act (Canada), and regulations thereunder, all as amended or replaced from time to time.

  • obstructive practices which means harming or threatening to harm, directly or indirectly, persons to influence their participation in a procurement process, or affect the execution of a contract;

  • Respiratory care practitioner means a person who is

  • Health care practitioner means an individual licensed