The menu of Commitment reference dates and volume regarding submission regarding PSURs (so-called the EURD list) contains effective compounds and you will combos out of energetic substances, by which PSURs is submitted according to the European union resource schedules and you may wavelengths influenced by the new Panel getting Medicinal Factors to own Peoples Play with (CHMP) therefore the Coordination Group having Mutual Identification and you will Decentralised Strategies — Individual (CMDh) after the visit towards Pharmacovigilance and you will Risk Assessment Panel (PRAC).
The european union reference go out (EURD) corresponds to the newest date of first or the earliest known time of one’s product sales authorisation on the Eu of a therapeutic unit with the newest effective material otherwise mix of energetic substances.
In addition to the Eu resource dates and you may wavelengths of PSURs, brand new EURD record also offers the information Secure Point (DLP) of the second PSUR articles.
The latest EURD list facilitates the new harmonisation away from DLPs and you will volume out-of submission regarding PSURs getting medicinal things with which has an equivalent energetic compound and/or same mix of effective compounds at the mercy of other marketing authorisations, authorised in more than just one to Representative County. This can, in which compatible, make it one single testing of PSURs for points containing an equivalent energetic substance.
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