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

  • The applicant should indicate the reference Member State, details of the marketing authorisation (date and number), procedure number, and for each “wave” of mutual recognition procedure concerned Member State(s) and the proposed (or agreed) common renewal date.The procedure number is the Mutual Recognition Procedure number allocated by the RMS.

  • Doris has not only incorporated multimedia meaningfully into her teaching but has managed to link online activity directly to the face-to-face lecture adding relevance and purpose to both.

  • In the Netherlands Copaxone 20 mg/ml (NL License RVG 30086) has been registered since 29 March 2004 through Mutual Recognition Procedure UK/H/0453/002.Since both authorisations for Copaxone are considered to belong to the same global marketing authorisation this approach is acceptable.

  • The product was approved through a Mutual Recognition Procedure (FR/H/0100/001).The Dutch amlodipine innovator product Norvasc 5 mg and 10 tablets (NL RVG 13348-13349) has been registered by Pfizer since June 1990 for the indications hypertension, chronic stable angina pectoris and vasospastic (Prinzmetal’s) angina.

  • Where a product has already been authorized for marketing in a Member State of the EEA, this National MA can be recognized in another Member States through the Mutual Recognition Procedure.

  • The amount of work involved should therefore be similar to that when UK is CMS in an Incoming Mutual Recognition Procedure.

  • As in all EU countries, pharmaceuticals can either be approved EU-wide by the EMA in the Centralized Procedure, or locally in the Decentralized Procedure, Mutual Recognition Procedure, or National Procedure.

  • HSA’s reference drug regulatory agencies are: • Australia Therapeutic Goods Administration (TGA);• Health Canada;• US Food and Drug Administration (FDA);• European Medicines Agency (EMA) via the Centralised Procedure; and• UK Medicines and Healthcare Products Regulatory Agency (UK MHRA) via- the national procedure; or- as the Reference Member State (RMS) via the Mutual Recognition Procedure or Decentralised Procedure on or prior to 31 January 2020 when the UK has formally left the European Union.

  • The innovator product was registered throughout the EU using one Mutual Recognition Procedure for both strengths, therefore, the innovator product marketed in the EU is expected to be identical.

  • This marketing authorization was for Copaxone powder for solution in vials containing 20 mg glatiramer acetate.In the Netherlands Copaxone 20 mg/ml (NL License RVG 30086) has been registered since 29 March 2004 through Mutual Recognition Procedure UK/H/0453/002.


More Definitions of Mutual Recognition Procedure

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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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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Related to Mutual Recognition Procedure

  • Dispute Resolution Procedure means the procedure for resolving disputes as set out in Clause 17 (Dispute Resolution);

  • 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 set out in Clause 22.1 (Variation Procedure);

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

  • Reconciliation Procedures means those procedures set forth in Section 7.09 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.

  • Operation Procedures means the procedures contained in Annexure A hereto which the Contractor is obliged to follow when performing work on behalf of the company

  • 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 the municipality, in terms of section 53(l) (c) (ii) of the MFMA, for implementing the municipality's delivery of municipal services and which 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;

  • Settlement Procedures Timetable For offers to purchase Certificated Notes accepted by the Company, Settlement Procedures A through F set forth above shall be completed as soon as possible following the trade but not later than the respective times (New York City time) set forth below: Settlement Procedure 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 Project Implementation Plan referred to in paragraph 3 (a) of Schedule 4 to this Agreement, as same may be amended from time to time in agreement with the Association, and such term includes any schedules to the Project Implementation Plan;