Fee application form for human products Some change to go here on specified future date. Guide to fees for human products PDF : 255 KB | 02/07/2024 Fees for human medicines and medical devices View tracked changes Calculating your fees Select what category your application relates to - Select - Authorisations of medicines Clinical trial authorisations Manufacturers/Importers Authorisations and wholesale distributor authorisations Blood and tissue establishments and organ authorisations Exempt medicinal products Cosmetics Precursor chemicals Miscellaneous fees Medical devices Clinical trial authorisations Choose which category of Clinical Trials Authorisations relates to your application - Select - Request for Authorisation of a substantial amendment under Regulation 21 of the Clinical Trial Regulations 2004 Request for Authorisation under Reg 536/2014 Clinical Trial Regulations Appeal of a Clinical Trial Decision Amendments to Clinical Trials (applications cannot be made under this legislation after 31/01/2025) Select which category of Amendments to Clinical Trials applies to you - Select - 340: Notice of amendment under Reg 21 of CTR) - €410 346: Amendment to include a new investigational medicinal product dossier - €880 Select with category of Request for Authorisation under Regulation No. 536/2014 Clinical Trial Regulations - Select - Applications with IMPD Applications with no IMPD or with simplified IMPD or a low intervention trial Substantial Modifications (Parts 1& 2 or Part 1 only) - with the addition of a new IMPD Substantial Modifications - other Substantial Modifications - Part II only Select what Applications with IMPD relate to your application - Select - 1001: Mono National - €3.610 1002: IE - Reporting Member State - €9.035 1003: IE - Concerned Member State, initial or additional applications - €3,370 1004: Supplement -where IE subsequently becomes the RepMS - €5,520 1005: Reporting Member State - 2nd & subsequent waves Submit
