European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines. Revised topics are marked...

European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines. Revised topics are marked ‘New’ or ‘Rev. Provisions that extend to Iceland, Liechtenstein and Norway by virtue periodic table questions and answers pdf 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. The data presented in the submissions should be intended exclusively for the purposes of the concerned procedure. The information and data contained in the individual submissions will be assessed and reflected in the single assessment report. Such information and data will not be redacted from the single assessment report with respect to individual products prior to sharing them with all concerned MAHs. Of note, MAHs cannot use the information and data contained in the submissions for any other purposes than those related to the concerned procedure.

PSURs of nationally authorised products. 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. Worldwide marketing authorisation status” applies irrespectively to centrally authorised products and nationally authorised products. 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.

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. The changes proposed to the labelling can be based on the reference product information. However as the reference product information might be different for the various EU product information, it is essential that the MAH considers the proposed changes for the reference product information in the context of the different EU product information for the products covered by the submitted PSUR. This should be clearly discussed in both the conclusions and actions section of the body of the PSUR as well as in the EU regional appendix. These should take into account all EU authorised indications for products containing that active substance or combination of active substances. How can I propose changes to the product information within the PSUR for NAPs which are part of an EU single assessment?

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. MAHs for the preparation of PSURs subject to single assessment. As it complements GVP Module VII, both documents should be consulted in conjunction. The explanatory note highlights and addresses challenges specific to the EU single assessment for nationally authorised products. Points highlighted in this document may nevertheless also apply to the assessment of centrally authorised products and hence it is recommended that all MAHs consult the document prior to finalisation of their PSUR.

2010 all holders of marketing authorisations for medicines in the European Union and the European Economic Area must submit information to the European Medicines Agency on authorised medicines and keep this information up-to-date. This is a legally binding requirement from the EU pharmaceutical legislation. The Agency uses this information to support the analysis of data, regulatory activities and communication. In relation to the submission of PSURs, this facilitates the processing of the submissions in the PSUR Repository. To whom should I submit my PSUR? EU of a medicinal product containing the active substance or combination of active substances. The EURD list facilitates the harmonisation of DLPs and frequency of submission of PSURs for medicinal products containing the same active substance or the same combination of active substances subject to different marketing authorisations, authorised in more than one Member State.

This will, where appropriate, allow one single assessment of PSURs for products containing the same active substance. PSURs included in the Marketing Authorisation. PSUR at any given time. The EURD list is a living document, meaning that it can be amended whenever considered necessary by the PRAC, CHMP or CMDh in response to the emergence of relevant new safety information, newly authorised substances or requests from the marketing authorisation holders. Periodic safety update report and the introductory cover note to the EURD list.

When do changes to the EURD list become legally binding? EC come into force 6 months after its publication. This publication occurs after adoption of the EURD list by the CHMP and CMDh following consultation of the PRAC. Whilst changes become binding 6 months after publication, there might exceptionally be situations where PSUR submissions are necessary prior to the new frequency taking effect and this will be indicated in the EURD list as well.

It is the responsibility of the marketing authorisation holder to check regularly the list of EU reference dates and frequency of submission published in the European medicines web-portal to ensure compliance with the PSUR reporting requirements for their medicinal products. How can I request to amend the list of EU reference dates? The request and its grounds should be considered by the PRAC and the CHMP if it concerns at least one marketing authorisation granted in accordance with the centralised procedure or the CMDh otherwise, which will either approve or deny the request. The list will then be amended accordingly when appropriate and published on the European medicines website. EC, a homeopathic simplified registration or a traditional-use registration are not required to submit PSURs, unless there are specific requirements in the MA for the product. PSURs shall also be submitted upon request of NCA. Do I have to submit a PSUR my medicinal product if it is a generic, a product containing a well-established substance, a homeopathic or herbal medicinal product?

Do I have to submit a PSUR if the combination of active substances of my product is not in the EURD list but one or more individual components are listed? If the specific fixed dose combination is not listed in the EURD list, PSURs should not be submitted according to the EURD list entry of one or more individual components. MAHs or national competent authorities can request the inclusion of the fixed combination in the EURD list for reasons related to public health, in order to avoid duplication of assessment or in order to achieve international harmonisation. Do I have to submit a PSUR if my medicinal product is not marketed?