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. Expand section Collapse section. Amendments to the SmPC, labelling and package leaflet as a result of the PSUR assessment are implemented without subsequent variation submission for centrally authorised products and through the appropriate variation at national level for nationally authorised products including those authorised through the mutual recognition and decentralised procedures. For CMDh position by majority vote: Day 15 15 days after the position:
The total of chargeable units in the procedure will be identified from the Art. 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. PSUR repository mandatory use: For CMDh position by consensus: In case of incomplete or incorrect data in the web form, the request may not be processed.
It addresses specific challenges in the EU single assessment procedure for nationally authorised productsbut the issues may also apply to centrally authorised products: This portal replaces the following mailboxes gatewaysupport ema. No specific template needs to be followed for the responses to the request for supplementary information RSI.
Heads of Medicines Agencies: Renewals
The total of chargeable units in the procedure will be identified from the Art. For more information, see the questions-and-answers below and Periodic safety update report single assessments. Day days after position The MAH s will implement the required changes. It should be presented as a tracked change version of each EU SmPCs and package leaflets of the products concerned and each product information should be translated into English language including the tracked changes proposed, in order to enable the EU single assessment.
Human regulatory Overview Ldtter and development Marketing authorisation Post-authorisation Herbal products. Standards of translation of Annexes The structure of the English Annexes has to be strictly followed and should be exactly translated as per the adopted English version i.
If the above does not apply, the updated RMP should be submitted as a stand-alone variation. PSURs of renedal authorised product s ; PSURs of any mix of centrally authorised products and nationally authorised products including through the mutual recognition and decentralised procedures ; PSURs of nationally authorised products.
MAHs should translate all relevant Annexes for each procedure. Implementing variation needed, type and classification. PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its coer. Start of the procedure according to the published timetable.
In case no changes to the product information are being proposed as part of the PSUR, the MAH should not include any product information within the EU covver appendix. 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.
The share payable by each marketing authorisation will be calculated by the EMA. For nationally authorised products NAPsplease submit your query using the following web form. Guideline on good pharmacovigilance practices GVP: The explanatory note will form the basis of the upcoming revision of GPV VII; this update, once finalised, will therefore supersede this guidance document.
The MAH rdnewal centrally authorised renesal products should submit a clean and a tracked version of the agreed amended product information prior to the adoption of the PRAC recommendation.
Applications for Marketing Authorisation
For more information, see: For CMDh position by majority vote: Procedures that contain nationally authorised products NAP s. 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. This will, where appropriate, allow one single assessment of PSURs for products containing the same active substance. View all ratings. The inclusion as an appendix does not discharge the MAH from their obligation to ckver procedure in line with the above mentioned guidelines on the details of the various categories of variations.
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 authorisationsauthorised in more than one Member State.
Periodic safety update reports (PSURs)
Purely nationally authorised medicinal products are considered rendwal which contain substances or a combination of actives substances which are only authorised in one Member State. Periodic safety update reports PSURs. For purely nationally authorised medicinal productscontaining substances or combination of actives substances not included in the EURD listfor which no PSUSA procedure has been established, the assessment of the PSURs will remain at national level.
A PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect public health e.
Day 1 — 14 1 to 14 days after position: