Good Distribution Practice definition

Good Distribution Practice or “GDP” - distribution in accordance with the principles and guidelines of good distribution practice as in force from time to time in the Territory, or any part thereof, relating to the warehousing, storage and physical distribution of medicinal products established by the applicable Competent or Regulatory Authority.

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Good Distribution Practice or “GDP” means all applicable then-current good distribution practice standards that promote the safety and integrity of the pharmaceutical supply chain, including European Commission Directives 2001/83/EC (to combat counterfeit medicines) and 2003/94/EC (good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use), and 2011/62/EU (EU Falsified Medicines Directive) and any implementing acts, delegated acts and guidance thereunder, including the European Commission Guideline 2013/C 343/01 on Good Distribution Practice of medicinal products for human use and the European Commission Guideline 2015/C 95/01 on principles of Good Distribution Practice of active substances for medicinal products for human use, or in any similar set of laws, regulations, rules, or practices that are applicable in countries where development activities are or will be carried out under this Agreement or in parts of the Territory in which Product will be sold, including WHO Guidelines;

Good Distribution Practice means the EC Guidelines of Good Distribution Practice on Medicinal Products for Human Use (2001/83/EC) or equivalent Laws in the Territory.

Examples of Good Distribution Practice in a sentence

• Destruction of stock remaining at CA site is to be performed by CG, in accordance with Good Manufacturing Practice, Good Distribution Practice, Good Clinical Practice and in accordance with any National Regulatory requirement.

• Destruction of stock remaining at CA site is to be performed by CG, in accordance of Good Manufacturing Practice, Good Distribution Practice and in accordance with any National Regulatory requirement.

• All quality-relevant matters for pharmaceutical contract products, including compliance with the guidelines of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), shall be regulated in a separate agreement (QAA / Quality Assurance Agreement).

• To specify the roles and responsibilities of the respective parties thereby ensuring compliance to Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01).

• Sponsor is responsible for packing and shipping of Study Drug (IMP) in a proper manner, so that quality and storage conditions are maintained during transport until arrival and receipt at receiver, safety is ensured and that all applicable regulations are met including The Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (GDP) chapter 7 and 9.

More Definitions of Good Distribution Practice

Good Distribution Practice means the applicable principles and guidelines for good distribution practice of drugs and medicinal products, as such principles and guidelines are amended, implemented and supplemented from time-to-time, including without limitation those set out in Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use, based on Article 84 and Article 85b(3) of Directive 2001/83/EC.

Good Distribution Practice means, to the extent applicable, the then-current Good Distribution Practice Guidelines issued by the European Commission to ensure that the level of quality determined by GMP is maintained throughout the distribution network, as set forth in Commission Guidelines 2013/C 343/01 and any and all related Directives, as may be amended from time to time.

Good Distribution Practice or “GDP” shall mean the then-current standards for Distribution activities as set forth by the World Health Organization and Applicable Law, as amended from time to time.

Good Distribution Practice means the guidelines for the proper distribution of medicinal products for human use in the Territory, including in accordance with 21 CFR 210/211 and USP 1079, as each may be amended from time to time.

Good Distribution Practice means the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive;

Good Distribution Practice means distribution practice as set out in the Guidelines on Good Distribution Practice of Medicinal Products for Human Use in the European Community (94/C 63/03) issued by the European Commission.

Good Distribution Practice means that practice of purchasing, storing and shipping a regulated pharmaceutical product and billing to and collecting from customers for a regulated pharmaceutical product in accordance with legal requirements and the standards and customary industry commercial practices.