European Medicines Agency definition

European Medicines Agency means the European Union agency for the evaluation of medicinal products, or any successor entity thereto.
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European Medicines Agency means the Agency established according to the Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
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Examples of European Medicines Agency in a sentence

  • The Paediatric Committee of the European Medicines Agency has given an opinion on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver.

  • The measures and timelines of the agreed paediatric investigation plan and the subset(s) of the paediatric population and condition(s) covered by the waiver are set out in the Annex I.This opinion is forwarded to the applicant and the Executive Director of the European Medicines Agency, together with its annex and appendix.

  • Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

  • The Paediatric Committee of the European Medicines Agency has given an opinion on the agreement of a paediatric investigation plan and on the granting of a deferral.

  • The measures and timelines of the agreed paediatric investigation plan are set out in the Annex I.This opinion is forwarded to the applicant and the Executive Director of the European Medicines Agency, together with its annex and appendix.

  • The Paediatric Committee of the European Medicines Agency has given an opinion on the agreement of a paediatric investigation plan and on the granting of a waiver.

  • The measures and timelines of the agreed paediatric investigation plan and the subset(s) of the paediatric population and condition(s) covered by the waiver are set out in the Annex I.This opinion is forwarded to the applicant and the Executive Director of the European Medicines Agency, together with its annexes and appendix.

  • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p.

  • The European Medicines Agency (EMA) European Public Assessment Report.

  • Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.

Related to European Medicines Agency

  • Website of the European Central Bank means the website of the European Central Bank currently at http://www.ecb.europa.eu or any successor website officially designated by the European Central Bank.

  • international application means an application filed under this Treaty;

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

  • Health Agency means the California Department of Health Services, or the local health officer with respect to a small water system.

  • European Commission means the authority within the European Union that has the legal authority to grant Regulatory Approvals in the European Union based on input received from the EMA or other competent Regulatory Authorities.

  • Central Agency means the agency operating the National Load Despatch Centre or such other agency as the Central Commission may designate from time to time;

  • State educational agency means any state or local educational licensing body that provides a license, permit, authorization or other approval necessary for an educational institution or other entity to operate or to provide educational programs or courses in that state.

  • European Communities means the European Economic Community, the European Coal and Steel Community and the European Atomic Energy Community.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • European Monetary System means the European Monetary System established by the Resolution of December 5, 1978 of the Council of the European Communities.

  • Nodal Agency means the Madhya Pradesh Urja Vikas Nigam Limited, (MPUVNL) Bhopal;

  • Regulatory Agency means any federal or state agency charged with the supervision or regulation of depository institutions or holding companies of depository institutions, or engaged in the insurance of depository institution deposits, or any court, administrative agency or commission or other authority, body or agency having supervisory or regulatory authority with respect to the Company, the Bank or any of their Subsidiaries.

  • Educational Agency means a school district, board of cooperative educational services (BOCES), school, or the New York State Education Department (NYSED).

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • permitted supranational agency means any of the following:

  • Public safety agency means a functional division of a public agency, county, or the state that provides fire fighting, law enforcement, ambulance, medical, or other emergency services.

  • 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.

  • Local educational agency except as otherwise provided, means

  • Health Authority means the regional health board designated under the Health Authority Act, RSBC 1996, c.180, or the Provincial Health Services Authority, to which the Participant is designated under Section 5.4 of this Contract, unless designated otherwise by the Province;

  • Federal agency means any department, agency, or other instrumentality of the Federal Government, any independent agency or establishment of the Federal Government including any Government corporation, and the Government Printing Office.

  • international carriage means any carriage in which, according to the contract of carriage, the place of departure and the place of destination are situated in two different States, or in a single State if, according to the contract of carriage or the scheduled itinerary, there is an intermediate port of call in another State;

  • ug/l means micrograms per liter.

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

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

  • statutory authority means Central or State Government, quasi-Government, administrative, judicial, public or statutory body, department, instrumentality, agency, authority, board entrusted with and carrying any statutory functions, as required from time to time in connection with performance by the Preferred Bidder of its obligations hereunder;

  • Environmental Protection Agency or “EPA” means the United States Environmental Protection Agency.