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

EU marketing authorisation means the Marketing Authorisation for the Product granted by the EMA covering the European Union.

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...

Examples of EU marketing authorisation in a sentence

• 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 Business Process Co-ordination section processes all national and EU marketing authorisation applications for medicinal products for human use, as well as applications for scientific advice on medicinal products, applications for clinical trials using medicinal products and marketing status notifications.

• Subject to the grant of an EU marketing authorisation, the contractor agrees to supply to the participating Member States a total of 225 million doses of the Product (the “Initial European Doses”) in accordance with the estimated delivery schedule set out in Article I.11 below (as adjusted pursuant to Article I.12, as the case may be).

• 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.

• The Parties acknowledge that there is a risk that (i) the time-line for the EU marketing authorisation or (ii) the time-line for scaling up the production of the Product may be delayed or that (iii) an EU marketing authorisation may not be granted at all or (iv) the production of the Product may not be feasible.

• The "final specification" of the Product will be determined by the contractors documentation of the Product as approved in the EU marketing authorisation.

• If a participating Member State should request delivery of the Product prior to the grant of the EU marketing authorisation and if contractor accepts such request (where the withholding of such acceptance is at the contractors discretion pursuant to Article I.7.1), the relevant specification of the Product will be determined by the documentation submitted by the contractor as approved in the temporary national authorisation granted by that participating Member State.

• 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.

• The second up-front payment (plus value-added taxes, if any) shall be paid by the participating Member State within [*****] calendar days after notification by the contractor that the interim data package has been submitted to the EMA for the purpose of obtaining EU marketing authorisation for the Product, but no sooner than [*****] calendar days after receipt of a corresponding payment request from the contractor in accordance with Article II.15 below.

• Grounds for automatic termination of the APA The APA will be automatically terminated if and when the contractor notifies the Commission of its inability to provide the Product because of, and only because of, the following reasons: (i) the clinical trial results not being satisfactory, (ii) the clinical trial results not meeting their end point in terms of efficacy or safety or (iii) the EU marketing authorisation not being granted.

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).

EU marketing authorisation means a marketing authorisation granted or renewed by the European Commission under Regulation(EC) No 726/2004;

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);