A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release {Name and address} [In cases where more than 1 manufacturer responsible for batch release is designated, list all and add the following statement:] • C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION Periodic safety update reports (PSURs) [For medicinal products authorised as conditional marketing authorisation (CMA), please use the below statement.] [For all medicinal products, including CMA in addition to the above paragraph, please use the below statement.] The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. [In addition, for initial MAA for which the 1 st PSUR has a data lock point within 6 months after the Commission Decision, please select the below statement as well.] • B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
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