Where a marketing authorisation is withdrawn, revoked or not renewed, the former marketing authorisation holder is encouraged to continue to collect spontaneous reports of suspected adverse reactions occurring in the EU see GVP Module VI to, for example, facilitate review of delayed onset adverse reactions or of retrospectively notified cases of adverse reactions. 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. For more information, see: The changes proposed to the labelling can be based on the reference product information. Reference SME declaration Data submission for authorised medicines. If a translation is considered not to be of an acceptable quality, the Member State concerned will inform the MAH and the Agency within 3 days of receipt of the translation. Before submitting a request, EMA encourages stakeholders to carefully consult the Introductory cover note.
The procedural start dates is published in the PSUR assessment timetable. For more information, see: How useful was this page? 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. For CMDh position by majority vote: They shall be submitted by marketing authorisation holders at defined time points during the post-authorisation phase. If the contact details you provide are incomplete or inaccurate this may prevent the Agency from communicating with you.
The timelines for assessment are for up to days followed by 67 days of Commission decision making process if applicable.
To further facilitate the check and assessment, the Xover should present clean and tracked changes Word versions of the RMP in the submission. This portal improves the efficiency of the technical support by allowing users to report issues, track progress of their queries and obtain answers to frequently asked questions.
Periodic safety update reports (PSURs)
It should be noted that the responsibility for the quality of the submitted documentation lies renswal the MAH s and is crucial to the overall assessment. Before submitting a request, EMA encourages stakeholders to carefully consult the Introductory cover note. After the translation renewla Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented. The share payable by each marketing authorisation will be calculated by the EMA.
Good quality of the translations and compliance with the Member States’ comments is required to facilitate the process. Skip to main content. For more information on how to use the PSUR repository, see: Where a renewap authorisation is withdrawn, revoked or not renewed, the former marketing authorisation holder is encouraged rwnewal continue to collect spontaneous reports of suspected adverse reactions occurring in the EU see GVP Module VI to, for example, facilitate review of delayed onset adverse reactions or of retrospectively notified cases of adverse reactions.
For CMDh position by majority vote: The total of chargeable units in the procedure will be identified from the Art.
Any amendment to the EURD list becomes effective six months after its publication. 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.
In such case, only the amended parts of the SmPC and package leaflet should be provided in track changes and in English language under the EU regional appendix. At start of the procedure, the invoice will leyter sent to each MAH with the relevant chargeable units calculation. The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product.
The European Union reference date EURD corresponds to the date of the first or the earliest known date of the marketing authorisation in the EU of a medicinal product containing the active substance or combination of active substances. This affects all PSURs irrespective whether they are for centrally or nationally authorised medicinal products and whether they follow the EU single assessment or purely national PSUR procedure. Of note, MAHs cannot use the information and data contained in the submissions for any other purposes than those related to the concerned procedure.
It addresses specific challenges in the EU single assessment procedure for nationally authorised productsbut the issues may also apply to centrally authorised products: Human ocver Overview Research and development Marketing authorisation Post-authorisation Herbal products.
Periodic safety update reports (PSURs) | European Medicines Agency
Day 1 — 14 1 to 14 days after position: It should be noted that the PSUSA cut-off date continues genewal apply to procedures containing nationally authorised medicinal productsand indicates the next upcoming start date for relevant submission deadlines in the EURD list. A revised timetable will then be prepared. The submission requirements for responses to requests for supplementary information are the same as those for the submission of the PSURs. The PSUR is not the appropriate procedure for submitting final or interim study reports to the EU regulatory authorities.
Use of the PSUR repository is mandatory for both centrally and nationally authorised medicines, whether they follow the EU single assessment or a purely national assessment procedure. This portal replaces the following mailboxes gatewaysupport ema.
The outcome of the PSUR assessment results in a legally binding decision or CMDh position letrer any action to vary, suspend or revoke the marketing authorisations must be implemented in a harmonised and timely manner for all products within the scope of the procedure across the EU.
An advice note will be generated at the data lock point DLP date and sent accordingly to the relevant QPPVs in order ldtter ensure the accurate identification of the chargeable units for the ckdh involved in the procedure. Additionally, product information should be kept up-to-date by the MAH by submitting the appropriate variations taking account of the latest scientific knowledge or conclusions of assessments and recommendations made public by means of the EMA and national competent authority websites.
For centrally authorised products interim results not impacting on the product information or on the condition as stated in the Annex II of the marketing authorisation can be submitted as a post-authorisation measure PAM as described in question How and to whom shall I submit my PAM data see Post-authorisation measures: Based on the evaluation of the cumulative safety data ccover 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 leter PSUR.
For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5.