European Medicines Agency. ‘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 ...
European Medicines Agency. Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. 2018. xxxxx://xxx.xxx.xxxxxx.xx/en/documents/scientific-guideline/draft-guideline-quality-non- clinical-clinical-aspects-medicinal-products-containing-genetically_en.pdf. Accessed 01.Dec.2019.
European Medicines Agency. Annex III: Summary of product characteristics, labelling and package leaflet - Targocid. https://xxx.xxx.xxxxxx.xx/en/medicines/human/referrals/targocid-associated- names (2014).
European Medicines Agency. CHMP post-authorisation summary of positive opinion for Keytruda. 2018; Available from: xxxxx://xxx.xxx.xxxxxx.xx/en/documents/smop/chmp- post-authorisation-summary-positive-opinion-keytruda-ii-47_en.pdf.
European Medicines Agency. CHMP post-authorisation summary of positive opinion for Opdivo. 2018; Available from: xxxxx://xxx.xxx.xxxxxx.xx/en/documents/smop/chmp-post- authorisation-summary-positive-opinion-opdivo_en-1.pdf.
European Medicines Agency. CHMP post-authorisation summary of positive opinion for Mekinist. 2018; Available from: xxxxx://xxx.xxx.xxxxxx.xx/en/documents/smop/chmp- post-authorisation-summary-positive-opinion-mekinist-ws/1274_en.pdf.
European Medicines Agency. CHMP post-authorisation summary of positive opinion for Tafinlar. 2018; Available from: xxxxx://xxx.xxx.xxxxxx.xx/en/documents/smop/chmp-post- authorisation-summary-positive-opinion-tafinlar-ws-1274_en.pdf.
European Medicines Agency. European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. 2015;2(April):1-144.
European Medicines Agency. Guideline on the scientific application and the practical arrangements necessary to implement commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC. Eur Med Agency. 2006;44(December):1-10. xxx.xxx.xxxxxx.xx/xxxx/xx_XX/...xxxxxxxxx/.../XX000000000.xxx.
European Medicines Agency. Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004. 2016;44(February):1-8. xxxx://xxx.xxx.xxxxxx.xx/docs/en_GB/document_library/Scientific_guideline/2016/03/WC50020277 4.pdf.
