Good Distribution Practices definition

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.

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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.

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.

Examples of Good Distribution Practices in a sentence

• Provider shall further ensure that all products in its warehouses are stored using Good Distribution Practices (GDP) in order that, among other things, inventory is free of insects, rodents or dust, and that cases are properly sealed to avoid damage.

• 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.

• In conducting its obligations under this Agreement, each party further agrees to comply in all means with the current applicable Good Clinical Practices, Good Manufacturing Practices and Good Distribution Practices and apply a high standard of ethics.

• 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.

• GxP" shall mean the good practice regulations in the pharmaceutical industry, including Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices and Good Distribution Practices (GMP, GLP, GCP and GDP).

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.

Good Distribution Practices means the FDA’s standards for the distribution of drugs, biological products, medical devices and combination products including those set forth in applicable FDA regulations and applicable guidance issued by FDA and any comparable foreign standards as applicable.

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.

Good Distribution Practices or "GDP" means, as relevant to the SIIPL Product, the then-current good distribution practices and similar rules, regulations and guidelines, as amended from time to time, applicable to the proper handling, transport, storage, importation, marketing, promotion, sale and distribution of pharmaceutical products in the SIIPL Territory.

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.

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.

Good Distribution Practices. , “GDP” or “cGDP” means the then current good distribution practices for medicinal products, as applicable at the time of distribution of the COVID Vaccine, as set forth in the EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01), as amended and revised from time to time;