cuatro. What is the Variety of European union resource dates (EURD listing) and you can regularity out-of distribution from PSURs?
The list of Union resource dates and volume away from distribution regarding PSURs (so-called the EURD checklist) consists of productive compounds and you will combos off effective substances, which PSURs might be filed according to the Eu source schedules and you can frequencies determined by the latest Committee for Medicinal Items getting People Explore (CHMP) and Coordination Classification to have Mutual Identification and you may Decentralised Methods – Peoples (CMDh) following appointment towards the Pharmacovigilance and you will Chance Testing Committee (PRAC).
Europe source date (EURD) corresponds to the latest day of your earliest or perhaps the earliest known day of the business authorisation regarding the European union away from a therapeutic device which includes the effective compound or mix of active ingredients.