Mutual Recognition Procedure definition

Mutual Recognition Procedure means the mutual recognition procedure for human medicinal products provided for in Directive 2001/83/EC;
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Mutual Recognition Procedure means the mutual recognition procedure for marketing authorization in accordance with Directive No. 2003/83/EC of November 6, 2001 or any successor regulations and/or directives.
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Mutual Recognition Procedure means the decentralized procedure to obtain a marketing authorisation for prescription drugs in EU countries;
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Examples of Mutual Recognition Procedure in a sentence

  • In addition, we are not aware of any lawsuit or regulatory proceeding, pending or threatened, brought by or before the European Medicines Agency, the European Commission’s Enterprise Directorate General and the regulatory agencies within each Member State of the EEA granting Marketing Authorization through the Mutual Recognition Procedure or any other regulatory body with jurisdiction over the Company or any of its subsidiaries.

  • This Amendment No. 1 to Terms and Conditions of Purchase (the “Amendment”), effective as of the date of full execution (“Amendment Effective Date”), is entered into by and between: Berkeley Lights, Inc., a Delaware corporation (“BLI”) with a principal place of business at 0000 Xxxxxx Xxxxxx, Suite 320, Emeryville, California 94608, on the one hand, and Korvis, LLC, a Limited Liability Company (“Korvis”) with a principal place of business at 0000 XX Xxxx Xxxxxx St., Corvallis, OR 97330, USA.

  • Auxilium shall, at its cost, use commercially reasonable efforts to continue filing Marketing Authorization Applications in a timely manner in any country governed by the Mutual Recognition Procedure in the EU and shall keep Ipsen informed thereon as appropriate.

  • In 2003, following the successful completion of the European Union Mutual Recognition Procedure, Ezetrol has been launched in five European countries - Germany, the United Kingdom, Switzerland, Sweden and the Netherlands.

  • A successful Scientific Advice Meeting held with the Danish Health and Medicines Authority (DKMA) regarding the planned submission of RHB-101(cardio) for a Marketing Authorization Application (MAA) in Europe, with Denmark as the reference member state for the European Mutual Recognition Procedure (MRP).

  • Buyer shall use Commercially Reasonable Efforts to obtain Regulatory Approval for Plenaxisâ Product in each of the Regulatory Target Countries, including, in the Initial Regulatory Target Countries only, using Commercially Reasonable Efforts to commence, as soon as practicable and no later than one hundred eighty (180) days after the Closing Date, the Mutual Recognition Procedure for Plenaxisâ Product.

  • On July 11, 2006 Shire received confirmation that FOSRENOL had been recommended for approval through the Mutual Recognition Procedure in 11 markets in Europe (the UK, Germany, Spain, Norway, Hungary, Estonia, Lithuania, Malta, Latvia, Slovenia and Slovakia).

  • Eloxatin® successfully completed a Mutual Recognition Procedure in Europe in December 2003, which allowed the product to be marketed for the treatment of metastatic colorectal cancer in combination with 5-fluorouracil and folinic acid (i.e., in first- and second-line treatment).

  • In March, a filing was made by Janssen to the Reference Member State in the EU Mutual Recognition Procedure, to gain marketing approval in Europe.

  • In 2003, following the successful completion of the European Union Mutual Recognition Procedure, Ezetrol (the brand name for Zetia outside of the United States) had been launched in five European countries–Germany, the United Kingdom, Switzerland, Sweden and the Netherlands.


More Definitions of Mutual Recognition Procedure

Mutual Recognition Procedure means procedure in the course whereof the EEA State(es) in cooperation examine the application(identical applications) to recognise the granted another medicinal preparation by an EEA State.
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Mutual Recognition Procedure means the procedure whereby a Regulatory Target Country may recognize the German Marketing Authorization in accordance with Article 28(4) of Directive 2001/83/EC. Such terms also include any analogous or successor procedure under any successor legislation.
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Related to Mutual Recognition Procedure

  • Dispute Resolution Procedure means the procedure for resolution of Disputes set forth in Article 26;

  • Dispute Resolution Procedures means the procedures outlined in Annexure A of the MSA Determination.

  • Dispute Resolution Process means the process described in clause 9

  • Mutual aid agreement means an agreement between the City and a town or other city for the City’s fire department to provide assistance to the fire department of a town or other city.

  • dispute resolution proceeding ’ means any process in which an alternative means of dispute resolution is used to resolve an issue in controversy in which a neutral is appointed and specified parties participate;

  • Dispute Resolution Scheme means the Electricity and Gas Complaints Commission or such other dispute resolution scheme approved or provided for in accordance with section 95 of the Act;

  • Alternative dispute resolution means mediation, arbitration, conciliation, or other nonjudicial procedure that involves a neutral party in the decisionmaking process. The form of alternative dispute resolution chosen pursuant to this article may be binding or nonbinding, with the voluntary consent of the parties.

  • Dispute Resolution means the procedure set forth in this LGIP for resolution of a dispute between the Parties.

  • Variation Procedure means the procedure for carrying out a Variation as set out in Clause 16.1 (Variation Procedure);

  • Conciliation agreement means a written agreement setting forth the resolution of the issues in conciliation.

  • Reconciliation Procedures has the meaning set forth in Section 2.3(a) of this Agreement.

  • Procedure Document means Ministry Procedure titled "Procedure for Preparing an Emission Summary and Dispersion Modelling Report" dated July 2005, as amended.

  • Mediation agreement means a written agreement between the parties to a mediation meeting.

  • Staff Vetting Procedure means the Authority’s procedures for the vetting of personnel and as advised to the Contractor by the Authority.

  • Implementation Plan means the schedule included in the Statement of Work setting forth the sequence of events for the performance of Services under the Statement of Work, including the Milestones and Milestone Dates.

  • service delivery and budget implementation plan means a detailed plan approved by the executive mayor of a municipality in terms of section 53(l)(c)(ii) of the MFMA for implementing the municipality's delivery of municipal services and its annual budget, and which must indicate

  • Implementation Letter means the letter of even date herewith from the Borrower to the Bank setting forth the Project monitoring indicators;

  • Assignment of Recognition Agreement With respect to a Cooperative Loan, an assignment of the Recognition Agreement sufficient under the laws of the jurisdiction wherein the related Cooperative Unit is located to reflect the assignment of such Recognition Agreement.

  • Implementation Agreement means the Implementation Agreement dated ……… by and between the GOB, PGCB and the Company in connection with the Project, and also includes any amendment of it made from time to time;

  • Data Use Agreement means the agreement incorporated into the Contract to facilitate creation, receipt, maintenance, use, disclosure or access to Confidential Information.

  • Framework Agreement means the Clauses of this Framework Agreement together with the Framework Schedules and annexes to it;

  • Transparency Reports means a report in accordance with Schedule 7 Part 1 (Transparency Reports) containing the contract information as set out in the table for that Part for publication by the Authority in the interests of transparency.

  • Recognition Agreement With respect to any Cooperative Loan, an agreement between the Cooperative Corporation and the originator of such Mortgage Loan which establishes the rights of such originator in the Cooperative Property.

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.

  • Further Competition Procedure means the further competition procedure described in paragraph 3 of Framework Schedule 5 (Call Off Procedure);