Please note that late submissions can no longer be accepted once the procedure has started. The PSUR is not the appropriate procedure for submitting final or interim study reports to the EU regulatory authorities. 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. View all ratings. The regulatory activity ‘PSUR’ can only be used for the ‘initial’ PSUR submission due to the built-in business rules linking to the submission deadline. 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. 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.
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. The total of chargeable units in the procedure will be identified from the Art. The inclusion as an appendix does not discharge the MAH from their obligation to submit procedure in line with the above mentioned guidelines on the details of the various categories of variations. For these active substances , the frequency of submission is established at national level. 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.
The share payable by each marketing authorisation will be calculated by the EMA. 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.
The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product.
Points highlighted covver 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.
PSURs of centrally 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.
Applications for Marketing Authorisation
Where the proposed changes are not based on the data submitted within the PSUR, these will not be considered and a variation will have to be submitted as appropriate to the relevant national competent authority. This is a legally binding requirement from the EU lettee legislation.
This should be clearly discussed in both the conclusions and cmfh section of the body of the PSUR as well as in the Eltter regional appendix. A revised timetable will then be prepared. An advice note will be generated at the data lock point DLP date and sent accordingly to the relevant QPPVs in order to ensure the lettef identification of the chargeable units for the products involved in the procedure. Use renewla 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.
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 regional appendix. In case of a CMDh position by consensusthe Agency will compile the Annexes in all languages, send the final copies to the Member States and, where applicable, the full set of Annexes will be published on the EMA website.
If the above does not apply, the updated RMP should be submitted as a stand-alone variation. The MAH s will implement the required changes. For these active substancesthe frequency of submission is established at national level. However, the parallel importer will not cmxh party to the PSUR procedure and will not receive a copy of the assessment report and outcome documentation as a MAH would.
The fee will be due to the EMA within 30 calendar days from the date of the invoice.
Heads of Medicines Agencies: Applications for MA
National competent authorities can also request PSUR for generic medicinal products at any time on the grounds detailed in Article c 2 of the Directive. Please note that late submissions can no longer be accepted once the procedure has started. PSURs and any renswal submissions using the existing file naming conventions are no longer possible. 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 rejewal active substances subject to different marketing authorisationsauthorised in more than one Member State.
The EURD cndh is a living document, meaning that it can be amended whenever considered necessary by the PRACCHMP or CMDh in response to the emergence of relevant new safety information, newly authorised substances or requests from the marketing authorisation holders. Any amendment to the EURD list becomes effective six months after its publication.
In case of incomplete or incorrect data in the web form, the request may not be processed. Once the translations are received from the MAH, the Agency will check if all Member States’ comments have been implemented.
The inclusion as an appendix does not discharge the MAH from their obligation to submit procedure in line with the above mentioned guidelines on the lettrr of the various categories of variations. MAHs should contact the relevant Cmdg Management Specialist in case of such requests if there is a need for initial clarification on the process. At start of the procedure, the invoice will be sent to each MAH with the relevant chargeable units calculation.
No specific template needs to be followed for the responses to the request for supplementary information RSI. 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 reneaal the need for changes to the product information of the products covered by the PSUR.
Day 1 — 14 1 to 14 days after position: For translations of Annexes QRD templates for each language should be used Make sure that cmch title pages are adjusted and all brackets i. Please refer to the guideline on the processing of renewals in the centralised procedure. 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 lettr English language including the tracked changes proposed, in order to enable the EU single assessment.
The list overrules the ‘standard’ PSUR submission cycle and any conditions related to the frequency of PSUR submission included in a marketing authorisation.
Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.