Tissue Establishment Registration definition

Tissue Establishment Registration means, in the case of a BioD Company, such BioD Company’s registration with the FDA as a human cells, tissue, and/or cellular and tissue-based product establishment pursuant to 21 CFR Part 1271.
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Examples of Tissue Establishment Registration in a sentence

  • Accessed at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm• Human Cell and Tissue Establishment Registration.

  • Additionally, Registration Monitors may access the Blood Establishment Registration (BER) and Human Cell and Tissue Establishment Registration System (HCTERS) on Inside FDA at http://inside.fda.gov:9003/CBER/default.htm to verify firm registration information.

  • COFEPRIS office requires the use of a Spanish template, the English template is used as a source of reference for Transplant Centers to use for completion of the Spanish version.o English Template attached.o Spanish Template attached.• FDA Human Cell and Tissue Establishment Registration (HCTERS) for transplant center.

  • The infrastructure losses amounted to $9.7 billion.2 The floods exposed the extent of poverty and deprivation of a very large segment of the rural populace neglected by the policy makers for the last 64 years.

  • HCT/P establishments register through the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS) or by submitting Form 3356 via mail or FAX.

  • Seller has filed and currently maintains and has maintained during all applicable periods its Tissue Establishment Registration in accordance with 21 CFR Part 1271 with the FDA as a processor and distributor of human cells, tissues and cellular- and tissue-based products (HCT/Ps).

  • The Section’s Vision is described in the Divisional Business Plan and Annual Audit Plan.

  • For CBER: If voluntarily registered, send notification to the Tissue Establishment Registration Monitor who will update HCTERS accordingly.

  • In paragraph (c)(1) by removing the words "Center for Biologics Evaluation and Research (HFM-775), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue Establishment Registration Coordinator" and by adding in their place the words "Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg.

  • G112, Silver Spring, MD 20993-0002, ATTN: Tissue Establishment Registration Coordinator".

Related to Tissue Establishment Registration

  • Business registration means a business registration certificate issued by the Department of the Treasury or such other form or verification that a contractor or subcontractor is registered with the Department of Treasury;

  • Company IP Registrations means all Company Intellectual Property that is subject to any issuance, registration or application by, to or with any Governmental Authority or authorized private registrar in any jurisdiction, including issued patents, registered trademarks, domain names and copyrights, and pending applications for any of the foregoing.

  • Product Registrations means all registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, or sale of the Product within the Geographic Territory, including all Applications in existence for the Product as of the Closing Date.

  • International registration plan means a reciprocal agreement of member jurisdictions that is endorsed by the American association of motor vehicle administrators, and that promotes and encourages the fullest possible use of the highway system by authorizing apportioned registration of fleets of vehicles and recognizing registration of vehicles apportioned in member jurisdictions.

  • Special Registration means the registration of (A) equity securities and/or options or other rights in respect thereof solely registered on Form S-4 or Form S-8 (or successor form) or (B) shares of equity securities and/or options or other rights in respect thereof to be offered to directors, members of management, employees, consultants, customers, lenders or vendors of the Company or Company Subsidiaries or in connection with dividend reinvestment plans.

  • international registration means the registration of a mark effected under the Agreement or the Protocol or both, as the case may be;

  • Registration Books means the records maintained by the Trustee pursuant to Section 2.08 for the registration and transfer of ownership of the Bonds.

  • Food establishment means an operation where food is processed, packed, canned, preserved, frozen, fabricated, stored, prepared, served, vended, sold, or offered for sale. Food establishment includes, but is not limited to, a food processor, a food warehouse, a food service establishment, a vending machine location, and a retail grocery. Food establishment does not include any of the following:

  • catering establishment means a restaurant, canteen, club, public house, school, hospital or similar establishment (including a vehicle or a fixed or mobile stall) where, in the course of a business, food is prepared for delivery to the ultimate consumer and is ready for consumption without further preparation;

  • Marijuana establishment means a marijuana cultivation facility, a marijuana testing facility, a marijuana product manufacturing facility, or a retail marijuana store.

  • Provisional registration means a building official, plan reviewer, or inspector who is registered subject to his or her completion of the amount of training, education, and experience required by the commission and the appropriate advisory board and described in section 1007(2).

  • Direct Registration System means the system for the uncertificated registration of ownership of securities established by The Depository Trust Company ("DTC") and utilized by the Depositary pursuant to which the Depositary may record the ownership of ADRs without the issuance of a certificate, which ownership shall be evidenced by periodic statements issued by the Depositary to the Holders entitled thereto. For purposes hereof, the Direct Registration System shall include access to the Profile Modification System maintained by DTC which provides for automated transfer of ownership between DTC and the Depositary.

  • Registration decal means an adhesive sticker produced by the department and issued by the

  • Cannabis establishment means a cannabis cultivator, a cannabis manufacturer, a cannabis wholesaler, or a cannabis retailer.

  • Advanced practice registered nurse means an advanced

  • Book-Entry Registration Settlement in "same-day" funds, to the extent practicable. REMIC residual certificates will not be issued in book-entry form, unless authorized by the Seller.

  • main establishment means: (a) as regards a controller with establishments in more than one Member State, the place of its central administration in the Union, unless the decisions on the purposes and means of the processing of personal data are taken in another establishment of the controller in the Union and the latter establishment has the power to have such decisions implemented, in which case the establishment having taken such decisions is to be considered to be the main establishment; (b) as regards a processor with establishments in more than one Member State, the place of its central administration in the Union, or, if the processor has no central administration in the Union, the establishment of the processor in the Union where the main processing activities in the context of the activities of an establishment of the processor take place to the extent that the processor is subject to specific obligations under this Regulation;

  • educational establishment means any school, college or other educational body designated by the Minister by order either specifically or by reference to a class, for the purposes of this Act;

  • First Source Register means the DOES Automated Applicant Files, which consists of the names of District of Columbia residents registered with DOES.

  • Exchange Registration shall have the meaning assigned thereto in Section 3(c) hereof.

  • Registration Filing Date means the date that is sixty (60) calendar days after the Effective Date.

  • Public Register means the College’s register that is available to the public.

  • Registered Nurse (RN) means an individual licensed pursuant to Iowa Code chapter 152.

  • Original Registration Rights Agreement has the meaning set forth in the recitals to this Agreement.

  • Marihuana establishment means a marihuana grower, marihuana safety compliance facility, marihuana processor, marihuana microbusiness, marihuana retailer, marihuana secure transporter, or any other type of marihuana-related business licensed by the department.

  • Commercial establishment means a place of business which is at all times equipped with sufficient tables and seats to accommodate twenty-five persons at one time, and the licensed premises of which conform to the standards and specifications of the division.