CRED SMPC 2024

ANNEX II

A.

MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR >

B.

C.

D.

[Annex II reflects the CHMP opinion on conditions and specific obligations, if/as applicable, to be imposed on the marketing authorisation. To facilitate the review, applicants should complete this Annex and present a draft together with the SmPC, labelling and package leaflet when submitting their product information as part of the marketing authorisation application. The final content of Annex II will be determined by the CHMP as a result of the assessment of the application.]

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