The list of Commitment site dates and you may frequency regarding submitting out of PSURs (so-known as EURD listing) contains productive compounds and you can combos off energetic ingredients, by which PSURs would be recorded according to the European union source schedules and you may wavelengths determined by new Committee to possess Healing Factors to own Human Play with (CHMP) and the Control Group getting Mutual Identification and you will Decentralised Methods – Peoples (CMDh) after the visit to the Pharmacovigilance and you will Chance Assessment Committee (PRAC).

Europe site date (EURD) represents the fresh day of your own earliest or the earliest acknowledged day of the purchases authorisation on European union of a medicinal tool who has the new effective material otherwise combination of productive substances.

Also the Eu resource times and you can frequencies off PSURs, the newest EURD record even offers the knowledge Lock Point (DLP) of your own 2nd PSUR distribution.

New EURD list facilitates the harmonisation regarding DLPs and you will frequency out of distribution out-of PSURs getting therapeutic factors who has an equivalent energetic substance or perhaps the same mix of productive substances at the mercy of more purchases authorisations, authorised much more than one to User County. This can, in which suitable, enable it to be a single investigations off PSURs having affairs that features the same active compound.

The newest PSUR regularity while the blogged into the EURD record to have a beneficial given productive material otherwise mixture of energetic compounds overrules the high quality submission cycle (i.e. 6-monthly, annual and you can thereafter 3-yearly) set-out from the guidelines and you may one standing connected with the fresh volume away from entry off PSURs within the Product sales Authorisation. 閱讀更多4. What’s the Directory of Eu site dates (EURD list) and you can volume regarding entry of PSURs?