It provides an overview of periodic table detailed explanation pdf European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked ‘New’ or ‘Rev. These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text. Periodic safety update reports are pharmacovigilance documents intended to provide a safety update resulting in an evaluation of the impact of the reports on the risk-benefit balance of a medicinal product. They shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase.

What is the scope of PSUR assessment under the EU single assessment? PSUR assessment for a single centrally authorised product and of the EU PSUR single assessment. Please note that, for nationally authorised medicinal products which are marketed in only one Member State and whose active substance or combination of active substances is included in the EURD list, the MAH should submit a PSUR as part of PSUSA procedure. Note that a PSUSA is foreseen for each active substance or combination of active substances registered in the EURD list. For purely nationally authorised medicinal products, containing substances or combination of actives substances not included in the EURD list, for which no PSUSA procedure has been established, the assessment of the PSURs will remain at national level.

Purely nationally authorised medicinal products are considered those which contain substances or a combination of actives substances which are only authorised in one Member State. How shall I present my PSUR and in which format? To keep the terminology consistent with the one used in the EU legislation, the new PBRER continues to be described as PSUR. Unless otherwise requested by competent authorities, the marketing authorisation holder shall prepare a single PSUR for all its medicinal products containing the same active substance with information covering all the authorised indications, route of administration, dosage forms and dosing regiments, irrespective of whether authorised under different names and through separate procedures. Even if a single PSUR is prepared for several products, please note that for medicinal products with documentation previously submitted in eCTD format, PSURs should be presented in a new eCTD sequence in the respective eCTD lifecycle of the concerned product. Where relevant, data relating to a particular indication, dosage form, and route of administration or dosing regimen, shall be presented in a separate section of the PSUR and any safety concerns shall be addressed accordingly.

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Within the PSUR, the marketing authorisation holder is required to consider the impact of the data and evaluations presented within the report, on the marketing authorisation. Based on the evaluation of the cumulative safety data and the risk-benefit analysis, the marketing authorisation holder shall draw conclusions in the PSUR as to the need for changes to the product information of the products covered by the PSUR. These should take into account all EU authorised indications for products containing that active substance or combination of active substances. It is important that changes proposed to the product information which are based on the submitted PSUR data are not submitted in parallel via a separate variation procedure. Additional clarification on the content of the PSUR can be found in the explanatory note to GVP Module VIIĀ  and should be used by MAHs for the preparation of PSURs subject to single assessment. As it complements GVP Module VII, both documents should be consulted in conjunction.