EU marketing authorisation definition

EU marketing authorisation means a marketing authorisation granted or renewed by the European Commission under Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, as last amended on 7 January 2019;9
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EU marketing authorisation means the Marketing Authorisation for the Product granted by the EMA covering the European Union.
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EU marketing authorisation the approval under the relevant provisions of Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervisions of medicinal products for human and veterinary use and establishing a European Medicines Agency, by the European Commission necessary for the placing on the market of the Product for vaccination in the territory of the European Union, including conditional marketing authorisation in accordance with Article 14-a of Regulation 726/2004 and Commission Regulation 507/2006/EC. ‘Final specification’: the final specification of the Product as to be determined by contractor in accordance with in Article I.6.2. ‘Force majeure’: any unforeseeable, exceptional situation or event beyond the control of the Parties that prevents either of them from fulfilling any of their obligations under the APA. The situation or event must not be attributable to error or negligence on the part of the Parties or on the part of the subcontractors and must prove to be inevitable despite their exercising due diligence. Defaults of service, defects in equipment or material or delays in making them available, labour disputes, strikes and financial difficulties may not be invoked as force majeure, unless they are caused by a relevant case of force majeure. ‘Formal notification’ (or ‘formally notify’): form of communication between the Parties made in writing by mail or e-mail in English, which provides the sender with compelling evidence that the message was delivered to the specified recipient. ‘Fraud’: an act or omission committed in order to make an unlawful gain for the perpetrator or another by causing a loss to the Union's financial interests, and relating to: i) the use or presentation of false, incorrect or incomplete statements or documents, which has as its effect the misappropriation or wrongful retention of funds or assets from the Union budget, ii) the non-disclosure of information in violation of a specific obligation, with the same effect or iii) the misapplication of such funds or assets for purposes other than those for which they were originally granted, which damages the Union's financial interests. ‘GDP’: good distribution practices in accordance with standards currently required by EU legislation, regulation and guidance, in particular those set out in its Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use published by the Euro...
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Examples of EU marketing authorisation in a sentence

  • Pack sizes‌When presenting a range of pack sizes for a medicinal product it is important that the principles of rational use of medicinal products are taken into consideration.As a EU marketing authorisation is valid throughout the EU, every pack size covered by the authorisation may be available in any Member State.

  • Figure 3 illustrates HTA timelines for pharmaceuticals in different EU Member States compared with the EU marketing authorisation timeline (EMA process)48.

  • However, the Parties acknowledge that there is a risk that (i) a conditional EU marketing authorisation may not be granted and that the placing of the Product on the market may instead require a full EU marketing authorisation and that (ii) an EU marketing authorisation may not be granted at all.

  • The contractor currently anticipates that the rolling submission of the dossier to the EMA for EU marketing authorisation of the Product will begin in and that conditional EU marketing authorisation may be granted within one or two months after submission, based on anticipated accelerated EMA timelines.

  • However, as section 5.2.3.1.2 explained, this is not a boundless power.

  • It was possible that over one million patients suffering from these orphan diseases in the EU had benefited from the availability of these new treatments.By 2017, 142 unique orphan medicines had received an EU marketing authorisation for 107 orphan indications.

  • In April 2021, AstraZeneca exercised its option to acquire the remaining 45% of shares in Acerta, following the final condition for exercising the option being satisfied in November 2020 when Calquence received EU marketing authorisation.

  • Northern Ireland, either— (aa) the UK marketing authorisation holder, or (bb) where applicable, the EU marketing authorisation holder,”.

  • However, there remains a potential for measurement bias, since exposure was self-reported, and the psychiatric symptoms investigated are for an association with pesticide-related illness, not specifically acute exposure to OPs. Furthermore, the questionnaire used in the study was developed by the study authors and is not a validated instrument.

  • It is worthy of note that the first EU marketing authorisation for Bovilis BVD was granted in 1998, and the vaccine is currently authorised in 14 EU Member States.


More Definitions of EU marketing authorisation

EU marketing authorisation means a marketing authorisation for a veterinary medicinal product granted by the European Commission in accordance with Title 3 of Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency(23).
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EU marketing authorisation means a marketing authorisation granted or renewed by the European Commission under Regulation(EC) No 726/2004;
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EU marketing authorisation means the approval to market a medicinal product in one, several or all member states of the European Union, including, but not limited to, a marketing authorisation granted by the European Commission in accordance with Article 3(1) of Regulation (EC) 726/2004 or by a national competent authority of a member state of the European Union in accordance with Article 6 of Directive 2001/83/EC (as implemented into national medicines legislation);
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Related to EU marketing authorisation

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • Marketing Authorization Application or “MAA” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Regulatory Approval means, with respect to a country, the grant of all approvals (including all applicable pricing and governmental reimbursement approvals) required from the relevant regulatory authority(ies), required to market and sell a CAR Product labeled for the prevention or treatment of a human disease, state or condition in such country.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Regulatory Authorities means, collectively, the Federal Trade Commission, the United States Department of Justice, the Board of the Governors of the Federal Reserve System, the Office of Thrift Supervision (including its predecessor, the Federal Home Loan Bank Board), the Office of the Comptroller of the Currency, the Federal Deposit Insurance Corporation, all state regulatory agencies having jurisdiction over the Parties and their respective Subsidiaries, the NASD and the SEC.

  • FDA means the United States Food and Drug Administration.

  • Drug Approval Application means a New Drug Application as defined in the FFDCA or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval.

  • Authorisations means authorisations, orders, grants, recognitions, determinations, certificates, confirmations, consents, licences, clearances, provisions and approvals, in each case, of a Third Party.

  • Authorisation means an authorisation, consent, approval, resolution, licence, exemption, filing, notarisation or registration.

  • Required Authorisation means any authorisation, consent, declaration, licence, permit, exemption, approval or other document, whether imposed by or arising in connection with any law, regulation, custom, contract, security or otherwise howsoever which must be obtained at any time from any person, Government Entity, central bank or other self-regulating or supra-national authority in order to enable the Borrowers lawfully to borrow the loan or draw any Advance and/or to enable any Security Party lawfully and continuously to continue its corporate existence and/or perform all its obligations whatsoever whensoever arising and/or grant security under the relevant Security Documents and/or to ensure the continuous validity and enforceability thereof;

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • contracting authorities means the State, regional or local authorities, bodies governed by public law or associations formed by one or more such authorities or one or more such bodies governed by public law;

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.