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.
Sample 1Sample 2Sample 3
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;
Sample 1Sample 2Sample 3
Reference Member State means a Member State chosen by the applicant whose authorized authority (expert organization) carries out marketing authorization and expert examination;
Sample 1Sample 2

Examples of Reference Member State in a sentence

  • 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.

  • 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.

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

  • For mutual recognition and decentralised procedures, all package sizes authorised in the Reference Member State and in the Concerned Members States should be listed.For each container the proposed container, closure and administration device should be indicated.

  • To provide Member States a chance to resolve issues among themselves, procedures have been set up through which Member States that are in conflict can meet with the Reference Member State to attempt to settle the unresolved issues.

  • 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.

  • In exceptional circumstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS).

  • Under the Decentralized Procedure an identical dossier is submitted to the competent authorities of each of the Member States in which the MA is sought, one of which is selected by the applicant as the Reference Member State, or RMS.

  • It aims to provide guidance on the role of the Reference Member State (RMS) as co-ordinator of the procedure, and to reflect good practice of the Concerned Member States (CMS) in handling of type II variations.

  • It aims to provide guidance on the role of the Reference Member State (RMS) as co-ordinator of the procedure, and to reflect good practice of the Concerned Member States (CMS) in handling of type II variations.The Regulation and the “Commission guideline on the details of the various categories of variations”, referred to in Article 4 of the Regulation, set out a list of changes to be considered as Type II variations.


More Definitions of Reference Member State

Reference Member State means the UK.
Sample 1Sample 2
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 EU 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,
Sample 1
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.
Sample 1

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.

  • EU Member State means a member state of the EU;

  • Participating Member State means any member state of the European Union that has the Euro as its lawful currency in accordance with legislation of the European Union relating to Economic and 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 Communities that adopt or have adopted the euro as their lawful currency in accordance with the legislation of the European Union relating to European 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 in a Member State 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.

  • Member School means a full or associate member school of the DIAA.

  • 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.”

  • Central Bank Rate Adjustment has the meaning given to that term in the Reference Rate Terms.

  • 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.

  • Reference Gilt means the Treasury Stock specified as such in the relevant Final Terms for so long as such stock is in issue, and thereafter such issue of index-linked Treasury Stock determined to be appropriate by a gilt-edged market maker or other adviser selected by the Issuer and approved by the Bond Trustee (an “Indexation Adviser”).

  • Reference mass means the mass of the vehicle in running order less the uniform mass of the driver of 75 kg and increased by a uniform mass of 100 kg.

  • Euro Unit means the currency unit of the Euro.

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

  • Reference man means a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.