cGDP definition

cGDP means the then current standards for all good distribution practices relevant to any product hereunder, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, (b) European Directive 2013/C 68/01 and Eudralex 4, (c) WHO TRS 957 Annex 5, (d) USP <1079>, (e) any state or other local laws or regulations governing the licensing of distributors or manufacturers of pharmaceutical products or medical devices, and (f) the equivalent applicable laws in any relevant country, each as may be amended and applicable from time to time.
Sample 1
cGDP means the European current good distribution practice standards on the distribution of products, including requirements for transport, storage, distribution and wholesale as specified by Applicable Laws of the relevant Countries at the time of distribution conducted in accordance with this Agreement.
Sample 1
cGDP means all laws, regulations, and industry practices relating to the handling, warehousing, and shipping of Products, including, the current Good Distribution Practices as specified in the most current versions of the United States Code of Federal Regulations (the CFR) or their replacement, and any other applicable laws, guidelines and/or regulations, including MSD’s reasonable requirements made in good faith relating to the warehousing and distribution for the Products (to the extent such MSD requirements are disclosed in writing to Distributor).
Sample 1

More Definitions of cGDP

cGDP means Good Distribution Practice as defined in all applicable legislation and guidelines, including (in respect of countries in the Territory in the EU) directive 94/C 63/03 and associated guidelines;
Sample 1
cGDP means all applicable standards relating to current distribution practices of medicinal products for human use, as required:
Sample 1

Related to cGDP

  • GDP or “Gross Domestic Product” for the purposes of this LOA means the expenditure side value of all goods and services produced in British Columbia for a given year as stated in the BC Economic Accounts;

  • GDPR means the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

  • EU GDPR means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC.

  • MGD means million gallons per day. "mg/l" means milligrams per liter. "ug/l" means micrograms per liter. "ng/l" means nanograms per liter. "S.U." means standard pH unit. "kg/day" means kilograms per day.

  • tpd means tonnes per day.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Development Plan has the meaning set forth in Section 3.2.

  • Procurement Plan means the Recipient’s procurement plan for the Project, dated April 2, 2010, and referred to in paragraph 1.16 of the Procurement Guidelines and paragraph 1.24 of the Consultant Guidelines, as the same shall be updated from time to time in accordance with the provisions of said paragraphs.

  • Development Plans has the meaning set forth in Section 3.2.

  • Integrated Development Plan means a plan formulated and approved as envisaged in Section 25 of the Municipal Systems Act 2000, as amended.

  • Project Scope means the description or activity of work to be accomplished on the project.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Project Management Plan means the management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;