WebJan 1, 2013 · Harmonised Birth Date(HBD) Virtual date of first marketing authorisation in a EC member state (“birth date”) aimed to harmonise the Periodic Safety Update Report(PSUR) submission schedules of medicinal products containing the same active substance; see also data lock point, european union reference date, international birth … WebApr 20, 2013 · A European harmonised birth date has been allocated and subsequently the first data lock point for. desmopressin is 31 December 2011, after which the PSUR submission cycle is 3 years. A renewal application should be submitted at the same time as the first PSUR. The following post-approval commitments have been made during the …
Public Assessment Report Scientific discussion Omeprazol
WebEU Harmonised Birth Dates, Data Lock-in Points & Allocated RMS xlsx Current list adopted 22 October 2024. Other documents. Best Practice Guide on handling PSURs in EU … WebHarmonised application form Application for Schengen Visa This application form is free 1 ... Surname at birth (Former family name(s)): 3. First name(s) (Given name(s)): 1 No logo is required for Norway, Iceland, Liechtenstein and Switzerland. 2 Date of birth (day-month-year): 5. Place of birth: 6. Country of birth: 7.Current nationality: clear vite cache
Public Assessment Report Scientific discussion Desmopressin …
Web5 This is analogous to the International Birth Date (IBD) for a PSU R, defined as the date of first marketing approval worldwide. 6 For the purposes of this document, we use the term “authorisation/ authorised” to refer to approvals of clinical trials, and “approved/ marketing approval” to refer to marketing authorizations. WebMedication HBD abbreviation meaning defined here. What does HBD stand for in Medication? Get the top HBD abbreviation related to Medication. WebTelephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail [email protected] Website clear visual studio credentials cache