Reference Member State definition

Reference Member State means the Member State which, for a given medicinal product, has produced the assess- ment report which served as the basis for the procedures referred to in Article 1 or alternatively the Member State chosen in this respect by the marketing authorisation holder with a view to application of this Regulation.
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Reference Member State means a Member State which is responsible for drawing up an assessment report on the safety, efficacy, and quality of a medicinal product based on the outcome of assessment of the medicinal product as laid down in these Rules;
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Reference Member State means a Member State chosen by the applicant whose authorized authority (expert organization) carries out marketing authorization and expert examination;
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Examples of Reference Member State in a sentence

  • The rapporteur shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use or the Reference Member State for the medicinal products concerned.

  • The rapporteur shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use and the Reference Member State for the medicinal products concerned.

  • It follows that, if the period of protection in the Reference Member State and in three Concerned Member States is six years, a decentralised procedure to obtain a marketing authorisation in accordance with Article 10 of Directive 2001/83/EC is only possible regarding these four Member States.

  • A rapporteur appointed for this purpose by the Pharmacovigilance Risk Assessment Committee shall closely collaborate with the rapporteur appointed by the Committee for Medicinal Products for Human Use or the Reference Member State for the medicinal product for human use concerned.

  • In the mentioned decentralised procedure, Germany has acted as Reference Member State (RMS).

  • In MRP, the applicant should provide a response document to Reference Member State (RMS) and Concerned Member States (CMS) not later than ten days following the deadline for the Member States’ comments (i.e., at Day 40).

  • Title and Registration Bureau employees will NCIC all out-of-state lien sales.

  • MHRA fee income changes and costs to business would depend on which proportion of firms selected the UK as a Reference Member State (whereby the MHRA lead the assessment) and how many selected the UK as a Concerned Member State (CMS) (whereby the MHRA decide whether to accept the decision of the RMS), and also on the level of the CMS and RMS fees in other countries.

  • Guidance is given on the role of the Reference Member State (RMS) as co-ordinator of the notification process, and to reflect good practice of the Concerned Member States (CMS) in ensuring a consistent approach is maintained.

  • If the sponsor asks for a deferral and this deferral is agreed by the Member States Concerned and/or Reference Member State, when issuing a decision, they can define the timing for the deferral of the publication of the assessment report for the part of their concern.


More Definitions of Reference Member State

Reference Member State means the UK.
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Reference Member State means the state which in the frames of the MRP or DCP compiles reports on the medicinal product dossiers, based on which the Member States concerned decide on acceptability of risk-benefit balance, i.e. about the assessment of the medicinal product quality, safety and efficacy, pursuant to the provisions of Directive 2001/83/EC,
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Reference Member State means a Member State of the EEA Agreement which has prepared an assessment of a specific medicinal product and issued a marketing authorisation which forms the basis for its recognition in another Member State of the EEA Agreement.
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Related to Reference Member State

  • Non-member state means: a state that has not enacted this compact.

  • Member State means a member state of the European Union.

  • Participating Member State means any member state of the European Community that adopts or has adopted the Euro as its lawful currency in accordance with the legislation of the European Union relating to the European Monetary Union.

  • Member States means the Kingdom of Belgium, the Republic of Bulgaria, the Czech Republic, the Kingdom of Denmark, the Federal Republic of Germany, the Republic of Estonia, Ireland, the Hellenic Republic, the Kingdom of Spain, the French Republic, the Republic of Croatia, the Italian Republic, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Grand Duchy of Luxembourg, Hungary, the Republic of Malta, the Kingdom of the Netherlands, the Republic of Austria, the Republic of Poland, the Portuguese Republic, Romania, the Republic of Slovenia, the Slovak Republic, the Republic of Finland and the Kingdom of Sweden;

  • Participating Member States means the member states of the European Union that have the euro as their lawful currency in accordance with the legislation of the European Union relating to Economic and Monetary Union.

  • host Member State means the Member State other than the home Member State in which a payment service provider has an agent or a branch or provides payment services;

  • Nonmember state means a state that has not enacted this compact.

  • home Member State means either of the following:

  • Relevant Member State means each Member State of the European Economic Area which has implemented the Prospectus Directive, except Luxembourg; and

  • parent institution in a Member State means an institution which has a institution or a financial institution as a subsidiary or which holds a participation in such an institution, and which is not itself a subsidiary of another institution authorised in the same Member State, or of a financial holding company or mixed financial holding company set up in the same Member State.

  • Treaty on European Union means the Treaty of Rome of March 25, 1957, as amended by the Single Xxxxxxxx Xxx 0000 and the Maastricht Treaty (which was signed at Maastricht on February 1, 1992 and came into force on November 1, 1993), as amended from time to time.

  • European Union means the member nations of the European Union established by the Treaty of European Union, signed at Maastricht on February 2, 1992, which amended the Treaty of Rome establishing the European Community.

  • parent mixed financial holding company in a Member State means a mixed financial holding company which is not itself a subsidiary of an institution authorised in the same Member State, or of a financial holding company or mixed financial holding company set up in that same Member State;

  • parent financial holding company in a Member State means a financial holding company which is not itself a subsidiary of an institution authorised in the same Member State, or of a financial holding company or mixed financial holding company set up in the same Member State;

  • EU means the European Union.

  • European Community means the territory comprised by the Member States of the European Community as constituted from time to time;

  • Member Country means the member of the Association in whose territory the Project is carried out or any such member’s political or administrative subdivisions. If such activity is carried out in the territory of more than one such member, “Member Country” refers separately to each such member.”

  • Treaty State means a jurisdiction having a double taxation agreement (a “Treaty”) with the United Kingdom which makes provision for full exemption from tax imposed by the United Kingdom on interest.

  • EMU means economic and monetary union as contemplated in the Treaty on European Union.

  • Principal Financial Centre means, in relation to any currency, the principal financial centre for that currency provided, however, that:

  • Principal Financial Center means, in the case of any Currency, the principal financial center where such Currency is cleared and settled, as determined by the Administrative Agent.

  • Major European Country means the United Kingdom, Italy, Germany, France or Spain.

  • Euro-zone means the region comprised of member states of the European Union that adopt the single currency in accordance with the Treaty establishing the European Community, as amended.