COVER LETTER PSUR EMA

However, they shall provide case narratives in the relevant risk evaluation section of the PSUR where integral to the scientific analysis of a signal or safety concern in the relevant risk evaluation section. This can result in having to submit a large number of sets of tracked change product information with the additional burden of providing translations. 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. Regarding centrally authorised products , the marketing status should also be provided as a stand-alone report through the relevant mailbox and using the dedicated template as indicated in the EMA Post-authorisation Guidance on ‘marketing and cessation notification’ — What is the reporting format to the agency and to whom to report. 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 accurate identification of the chargeable units for the products involved in the procedure. It should be noted that the responsibility for the quality of the submitted documentation lies with the MAH s and is crucial to the overall assessment.

The Agency uses this information to support the analysis of data, regulatory activities and communication. Any information included in this section, will be discussed by the CMDh for nationally authorised products with the aim of agreeing on any necessary action, which will then be transmitted to MAHs either in the CMDh minutes or as a press release dependent on the issue. You will be able to contact the RMS throughout the procedure. MAHs should contact the relevant Risk Management Specialist in case of such requests if there is a need for initial clarification on the process. This is a legally binding requirement from the EU pharmaceutical legislation. In the absence of a reply within two days, the EMA will assume that no oral explanation is requested The MAH of centrally authorised medicinal products should submit a clean and a tracked version of the agreed amended product information prior to the adoption of the PRAC recommendation.

Periodic safety update reports (PSURs)

Please note that late submissions can no longer be accepted once the procedure has started. At start of the procedure, the invoice will be sent to each MAH with the relevant chargeable units calculation.

In the absence of a reply within two days, the EMA will assume that no oral explanation is requested. For more information, see the questions-and-answers below and Periodic safety update report single assessments. Timeframe for submission of variation.

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The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product. The explanatory note highlights and addresses challenges specific to the EU single assessment for nationally authorised products. The outcome of the PSUR assessment results in a legally binding decision or CMDh position and 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.

By analogy to the implementation of referral procedures, the respective variations for the NAPs have to be submitted to the relevant NCA within 10 days after publication of the Commission Decision on the EC website. Depending on the date of the EC decision on the revocation or withdrawal, or the date of expiry of the marketing authorization in case of non- renewalmarketing authorisation holders may still be required to submit a PSUR:.

cover letter psur ema

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: The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation. 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.

Variations

The information and data contained in the individual submissions will be assessed and reflected in the single assessment report. The PSUR frequency as published on the EURD list for a given active substance or combination of pzur substances overrules the standard submission cycle i. Expand section Collapse section. The share payable by each marketing authorisation will be calculated by the EMA. If a parallel importer receives a notification of an adverse drug reaction from a patient, a doctor or any other source, the parallel importer should inform this person that the adverse drug reactions should be reported directly to the MAH of the medicinal product concerned.

A PSUR assessment can determine ea further investigations on a specific issue are needed, or if an action is necessary to protect public health e. The regulatory activity ‘PSUR’ can only be lwtter for the ‘initial’ PSUR submission due to the built-in business rules linking to the submission deadline.

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cover letter psur ema

Annex I – Definitions. For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5. The official contact person for the PSUR procedure is the one provided in the xml delivery file. For more details on PSUR submissions for generics, products containing well-established substances, homeopathic or herbal medicinal productsplease refer to the question 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?

In case of incomplete or incorrect data in the web form, the request may not be processed.

Periodic safety update reports (PSURs) | European Medicines Agency

You will be able to contact the RMS throughout the procedure. The EMA has published further guidance on how the fees are calculated and collected. They, however, remain part of the Commission Decision in the Community Psuf on the Commission’s webpage. The data presented in the submissions should be intended exclusively for the purposes of the concerned procedure.

cover letter psur ema

The explanatory note will form the basis of the upcoming revision of GPV VII; this update, once finalised, will therefore supersede this guidance document. For more information, see: The contact information provided in the xml delivery file will always override any information provided in the cover letter.

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. Where relevant, peur relating to a particular indicationdosage 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.

It addresses specific challenges in the EU single assessment procedure for nationally authorised productsbut the issues may also apply to centrally authorised products: