Letter regarding publication of the summary of the Risk Management Plan

10.03.2023 6229 views

For the applicant's attention:

a separate summary should be provided for each medicinal product (hereinafter – MP) included in the Risk Management Plan (hereinafter – RMP), but applicants may use one summary if the relevant sections apply to all MPs included in the RMP;
a request for publication of the PSUR summary may be submitted for several medicinal products at once; a separate request for each of the applicant's medicinal products is not required;
the request is submitted as a letter from the applicant/applicant’s representative, together with the material for publication (PDF), to the e-mail address: rmppublic@dec.gov.ua

the letter must contain a completed table, the format and completion template of which are presented below:

Letter on publication of the summary of the Risk Management PlanDOCX · 21 KB

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