SUBMISSION OF THE DOSSIER Sample Clauses

SUBMISSION OF THE DOSSIER. 4 The manufacturer requests a certificate by submitting a copy of a dossier in English (preferably) or 5 French according to the CTD format and including the relevant part of the Quality Overall 6 Summary (QOS), and an application form duly filled in (see 7), together with samples of 7 commercial batches and fees. 8 The documentation to be provided by the manufacturer is described in specific documents 9 published by EDQM for the evaluation of the chemical purity, for TSE risk assessment, for herbal 10 drugs and preparations (see 7). For products bearing a risk of transmitting animal spongiform 11 encephalopathy agents, and for which a specific monograph exists in the European Pharmacopoeia, 12 the applicant may apply for a certificate concerning the general monograph Products with risk of 13 transmitting agents of animal spongiform encephalopathies as well as for the specific monograph, 14 or may wish only to apply for a certificate concerning the general monograph. Where no specific 16 evaluation should be supplied.
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Related to SUBMISSION OF THE DOSSIER

  • Submission of Tender The tender shall be submitted online in two part, viz., technical bid and financial bid. All the pages of bid being submitted must be signed and sequentially numbered by the bidder irrespective of nature of content of the documents before uploading.

  • SUBMISSION OF TENDERS 3.01 The tenderer, should submit tenders after studying the entire tender document and instructions to the tenderer's carefully, visiting the sites, for satisfying himself of the local conditions, locations, accessibility of sites, nature, extent and character of operation, may obtain all clarifications before the tendering. Submission of tender implies that the tenderer has obtained all the clarifications required by him. No claim on ground of want of knowledge, thereafter, in such respect will be entertained. The tenderer should quote rates both in figures as well as in words in Rupees per MT Per Km for different movement slabs and in Rupees per MT., for wagon handling in the two separate formats of Schedule No. II. Tenderers have to tender the rates for transportation, only on slab rates irrespective of existence of truck union. Truck operators union / Transport Cooperatives which are registered with the registrar, Firms and Societies of the respective states to be supported with a notarized copy of the valid Registration certificate can also participate in the tenders directly but they shall have to tender the rates on slab rate basis. For tenderers other than registered truck operators unions / transport cooperatives, it shall be the responsibility of the tenderer to deal with the union if existing at any rake point. Tenderer shall have to arrange the movement as per the movement plan on rake to rake basis. Increase in transportation rates during the contract period or extended period of contract shall be considered only if there is increase in diesel rate by Government of India. The increase shall be allowed as per the formula given in the relevant clause of General terms and conditions of the tender document. The same formula shall be applicable for Truck operators unions / Transport Cooperatives also.

  • SUBMISSION OF BID Bids may be submitted via the electronic submission portal at: xxxxx://xxx.xxxxxxxxxx.xxx/buyer/691, or in the Procurement Division; Internal Operations Centre II, 000 X. Xxxxx Xxxxxx; 0xx Xxxxx, Xxxxxxx, XX 00000, prior to the submission deadline. Bids will be opened per the public meeting notice. If bid will be mailed or hand delivered, ensure it is secured in a sealed envelope, addressed as follows: ORANGE COUNTY PROCUREMENT DIVISION Internal Operations Centre II 000 X. Xxxxx Xxxxxx, 0xx Xxxxx Xxxxxxx, Xxxxxxx 00000 Bidders must indicate on the sealed envelope the following:

  • Submission of Bids When the Scheduling Coordinator on behalf of the Participating Generator submits a Bid for Ancillary Services, the Participating Generator will, by the operation of this Section 4.3.1, warrant to the CAISO that it has the capability to provide that service in accordance with the CAISO Tariff and that it will comply with CAISO Dispatch Instructions for the provision of the service in accordance with the CAISO Tariff.

  • SUBMISSION OF PROPOSALS Proposals will be submitted to the attention of Xx. Xxxxxx Xxxxxx-Green, via e- mail at XXX.Xxxxxxxxxxx@xxxxxxxXXX.xxx no later than 5:00 p.m. Central, Wednesday, March 10, 2021.

  • Submission of Grievance 1. Before a submission of a written grievance, the aggrieved party must attempt to resolve the grievance informally with the grievant's immediate supervisor.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum.

  • SUBMISSION OF DOCUMENTS 3.0 There shall be two part bidding system for this tender The parties should submit their tenders in two separate sealed envelopes marked I and II. These envelopes are to be put up in an outer main envelope. Envelops I and II should contain the following;-

  • Review by the Association of Procurement Decisions The Procurement Plan shall set forth those contracts which shall be subject to the Association’s Prior Review. All other contracts shall be subject to Post Review by the Association.

  • Submission of Grievances A. Any employee or group of employees shall have the right to present a grievance. No employee or group of employees shall be hindered from or disciplined for exercising this right.

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