cuatro. What’s the Range of European union source times (EURD record) and you will regularity of entry away from PSURs?
The menu of Relationship reference dates and you will frequency of distribution regarding PSURs (so-called the EURD listing) includes productive ingredients and combos from effective ingredients, whereby PSURs is going to be recorded according to the European union source times and you will frequencies dependent on new Committee for Healing Things to possess Peoples Explore (CHMP) while the Coordination Classification for Shared Identification and you can Decentralised Strategies – Individual (CMDh) adopting the appointment with the Pharmacovigilance and you can Risk Investigations Panel (PRAC).
Europe resource time (EURD) corresponds to brand new day of your own basic or the earliest acknowledged date of your profit authorisation regarding the Eu of a healing device that features the latest active substance or blend of effective ingredients.
Plus the Eu resource schedules and you can frequencies away from PSURs, this new EURD record has the benefit of the knowledge Secure Point (DLP) of one’s 2nd PSUR articles.
The new EURD listing encourages the new harmonisation off DLPs and frequency off submitting out-of PSURs to own medicinal products that features an equivalent effective substance or the exact same blend of productive substances susceptible to various other marketing authorisations, authorised in more than simply one User State. Celý příspěvek →