Centralised procedure Sample Clauses

Centralised procedure. When a marketing authorisation is granted following the centralised procedure, it is valid for the entire EU market. It is granted in accordance to Regulation (EC) No. 726/2004. The ap- plication will be submitted to the EMA, which is the authority responsible for the evaluation, and once it has been granted it confers the same rights and obligations in each of the Mem- ber States as a marketing authorisation granted by a Member State. It can, therefore, be commercialised in any of them. Under this procedure, the EMA will assign the procedure number. Some medicinal products are included in the mandatory scope of the Centralised procedure. We list such human medicinal products below: 1. Medicinal products developed by means of one of the following biotechnological processes:  Recombinant DNA technology,  Controlled expression of genes coding for biologically active proteins in prokaryo- tes and eukaryotes including transformed mammalian cells,  Hybridoma and monoclonal antibody methods. 2. Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products. 3. Medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No. 141/2000 4. Medicinal products for human use containing a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Community, for which the therapeutic indication is the treatment of any of the following diseases:  acquired immune deficiency syndrome,  cancer,  neurodegenerative disorder,  diabetes,  auto-immune diseases and other immune dysfunctions,  viral diseases. Most centralised procedures are for innovative medication but they are not the only ones. Some other type of medicinal products could choose this procedure as an optional proce- dure. It could be the case also for some generic products. When a product is authorised under the centralised procedure, a procedure number is allo- cated. Under this procedure number one to several medicinal products can be authorised. Amongst these medicinal products we can find different strengths, pharmaceutical dose forms and different packages of the same active substance. Usually the same marketing au- thorisation holder (MAH) requests MA for several formats of the same active substance. In this case, different EU Authorisation numbers exist in relation to a same Brand name...

Related to Centralised procedure

  • BILLING PROCEDURE a. The Contractor shall submit, not more than semi-monthly, properly completed A-19 vouchers (the "voucher") to one of the following: The Department of Children, Youth, and Families Attn: ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ PO Box 40970 Olympia WA 98504-0970 Or, email a scan of an original, signed A-19 voucher directly to the DCYF Contract Manager at ▇▇▇▇▇.▇▇▇▇▇▇▇▇@▇▇▇▇.▇▇.▇▇▇ b. Payment to the Contractor for approved and completed work shall be made by warrant or Electronic Funds Transfer by DCYF and considered timely if made within 30 days of receipt of a properly completed voucher. Payment shall be sent to the address designated by the Contractor and set forth in this Contract. c. Each voucher must clearly reference the DCYF Contract Number and the Contractor's Statewide Payee Registration number assigned by the Office of Financial Management (OFM). d. Properly completed vouchers and attachments completed by the Contractor must contain the information described in Exhibit A under the Section titled "Compensation and Voucher Payment".

  • Hearing Procedure A. The Personnel Commission may conduct hearings of appeals or may appoint a hearing officer to conduct the hearing and report findings and recommendations to the Commission. If the Personnel Commission orders a hearing, said hearing shall be held in closed session. The employee shall be given written notice of his or her right to have the complaints or charges heard in an open session rather than closed session pursuant to Government Code section 54957. The notice shall be delivered to the employee personally or by mail at least twenty-four (24) hours before the time for holding the closed session. B. Hearings shall be conducted in the manner most conducive to determination of the truth, and neither the Commission nor its hearing officer shall be bound by technical rules of evidence. Decisions made by the Commission shall not be invalidated by any informality in the proceedings. C. The Personnel Commission or its hearing officer shall determine the relevancy, weight, and credibility of testimony and evidence. It shall base its findings on the preponderance of evidence. D. Each side will be permitted an opening statement (Board first) and closing arguments (employee first). The Board shall first present its witnesses and evidence to sustain its charges and the employee will then present his witnesses and evidence in defense. E. Each side will be allowed to examine and cross-examine witnesses. F. Both the Board and the employee will be allowed to be represented by legal counsel or other designated representation. The employee may, at his/her option, be represented by legal counsel and/or union representation, or any other person designated by the employee. If the employee files an appeal, the employee shall be required to attend the Commission Appeal Hearing, even if the employee’s designated representative appears on his/her behalf. If the employee fails to appear, the employee will be deemed to have forfeited his/her rights to further appeal and the Personnel Commission shall allow the Board of Trustee’s disciplinary action to stand. G. The Commission may, and shall, if requested by the Board or the employee, subpoena witnesses and/or require the production of records or other material evidence. H. The Commission may, prior to or during a hearing, grant a continuance for any reason it believes to be important to its reaching a fair and proper decision. I. Whether the hearing is held in a public or Executive Session, the Commission, after it concludes the hearing, may deliberate its decision in Executive Session. No persons other than members of the Commission, its counsel, and the Director of Personnel shall be permitted to participate in the deliberations. If the Personnel Director or any staff was a witness in the proceedings, he shall also be barred from the Commission's final deliberations. J. The Commission shall render its judgment in an open session as soon after the conclusion of the hearing as possible and in no event later than fourteen (14) days. Its decision shall set forth which charges, if any, are sustained and the reasons therefore. K. The Commission may sustain or reject any or all of the charges filed against the employee. It may sustain, reject, or modify the disciplinary action invoked against the employee. It may not provide for discipline more stringent than that invoked by the Board. L. The Commission order of judgment will be filed with the Governing Board and the charged employee and shall set forth its findings and decision. If a dismissal is not sustained, its order shall set forth the effective date the employee is to be reinstated which may be any time on or after the date of disciplinary action.

  • Procedure If any action is brought against an Underwriter, a Selected Dealer or a Controlling Person in respect of which indemnity may be sought against the Company pursuant to Section 6.1, such Underwriter, such Selected Dealer or Controlling Person, as the case may be, shall promptly notify the Company in writing of the institution of such action and the Company shall assume the defense of such action, including the employment and fees of counsel (subject to the reasonable approval of such Underwriter or such Selected Dealer, as the case may be) and payment of actual expenses. Such Underwriter, such Selected Dealer or Controlling Person shall have the right to employ its or their own counsel in any such case, but the fees and expenses of such counsel shall be at the expense of such Underwriter, such Selected Dealer or Controlling Person unless (i) the employment of such counsel at the expense of the Company shall have been authorized in writing by the Company in connection with the defense of such action, or (ii) the Company shall not have employed counsel to have charge of the defense of such action, or (iii) such indemnified party or parties shall have reasonably concluded that there may be defenses available to it or them which are different from or additional to those available to the Company (in which case the Company shall not have the right to direct the defense of such action on behalf of the indemnified party or parties), in any of which events the reasonable fees and expenses of not more than one additional firm of attorneys selected by such Underwriter (in addition to local counsel), Selected Dealer and/or Controlling Person shall be borne by the Company. Notwithstanding anything to the contrary contained herein, if any Underwriter, Selected Dealer or Controlling Person shall assume the defense of such action as provided above, the Company shall have the right to approve the terms of any settlement of such action which approval shall not be unreasonably withheld.

  • 000 GRIEVANCE PROCEDURE 7. 100 It is agreed that it is the spirit and intent of this Agreement to adjust grievances promptly. All grievances, including discharge for just cause, but not those pertaining to jurisdictional disputes that may arise on any work covered by this Agreement, must be initiated within fifteen (15) working days of the incident by either the employee in Step I or the Local Union in Step II and shall be handled in the following manner:

  • Formal Grievance Procedure 1. In the event that a complaint cannot be resolved informally, the parties shall pursue the first step in the formal grievance procedure before making any application for arbitration, unless the College and the AAUP agree in writing to alter the procedure or waive one or more of the steps by proceeding directly to arbitration. 2. Upon written request of the AAUP Contract Compliance Officer, the College shall submit any requested documents in its possession which may be necessary for investigation of the grievance. The College shall deliver such documents as soon as is reasonably possible, but no later than seven (7) days after receipt of a written request. 3. Internal Steps in the Procedure a. Step One: The Director of Human Resources (1) Within thirty (30) days of when the AAUP learns of, or in the exercise of reasonable diligence should have learned of, an alleged violation of the provisions of this Agreement, the AAUP shall submit to the Director of Human Resources a completed Faculty Grievance Form or a dated, signed, written description of the grievance, clearly labeled "grievance" containing substantially the same information as provided for on the Faculty Grievance Form. (2) Within eight (8) days of receipt of the written grievance, the Director of Human Resources shall convene a meeting to discuss the grievance. Such meeting shall include the grievant(s) and/or the designated representative(s) of the AAUP and shall be scheduled at a time which is mutually convenient to the parties. (3) The Director of Human Resources shall attempt to determine the facts pertaining to the grievance and shall notify the grievant and the AAUP in writing of his/her decision within eight (8) days in a Grievance Disposition Form or in a document containing substantially the same information as contained in a Grievance Disposition Form, which shall include written details of the reasons which support the decision. (4) Within eight (8) days after receipt of the disposition of the Director of Human Resources, the AAUP may appeal the decision in writing to the College Grievance Officer, by submitting a Grievance Disposition Reaction Form or a document containing substantially the same information as contained in a Grievance Disposition Reaction Form. (5) By agreement, the parties may decide to advance the grievance to step two of the procedure, or to appeal directly to arbitration at step D(4) of this article.