Leave this field blank. 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. The EMA will check at the beginning of the procedure whether the submission of an RMP has been correctly performed in accordance to the above criteria. The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission. If the date is after the submission deadline specified in the EURD list , submission is mandatory irrespective of whether the date is before or after the start date of the procedure. 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.
Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. 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. 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 can result in having to submit a large number of sets of tracked change product information with the additional burden of providing translations. The submission should include a cover letter containing the following formatted table template to facilitate the registration of the submission. 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. Guideline on good pharmacovigilance practices GVP:
For the submission of responses to the PSUR Repository, the xml delivery file is filled in the same way as the original PSUR submission apart from the selection of ‘response’ as a regulatory activity submission unit. Following receipt of the final compiled translations, the Commission will start the day Standing Committee consultation, addressing only legal and public health matters which means in principle dma further linguistic review.
The list will then be amended accordingly when appropriate and published on the European medicines website. CMDh best practic guide 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.
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. However as the reference product information might be different for the various EU product informationit 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.
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. PSURs and any related submissions using the existing file naming conventions are no longer possible.
Disagreements should be solved directly with the concerned MS. This portal replaces the following mailboxes gatewaysupport ema. The PSUR should focus on summary information, scientific assessment and integrated benefit-risk evaluation.
Periodic safety update reports (PSURs)
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. These should take into account all EU authorised indications for products containing that active substance or combination of active substances.
Day 1 — 14 1 to 14 days after position: Please refer to the guideline on the processing of renewals in the centralised procedure. The data presented in the submissions should be intended exclusively for the purposes of the concerned procedure.
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.
PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. 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: For more details on how to submit amendments to the list, please refer to the EURD list cover note sections 2 and 5.
Guideline on good pharmacovigilance practices GVP: Please note that late submissions can no longer be accepted once the procedure has started. In case of CMDh position by consensus, Member States may perform a voluntary linguistic review in the translation process, therefore the following timelines apply:.
– Cambridge Regulatory Services
Reference SME declaration Data submission for authorised medicines. In case of incomplete or incorrect data in the web form, the request may not be processed.
There may be some delay before EMA is able to respond due to the high volume of requests and necessary processing time. Annex I scientific conclusions and grounds for variation to the terms of the marketing authorisations Annex II amendments to the product information of the nationally authorised medicinal products Annex III conditions to the marketing authorisationsas applicable Procedures that contain nationally authorised products NAP s Annex C: Procedures that contain centrally authorised products CAP s.
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.
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. The list overrules the ‘standard’ PSUR submission cycle and any conditions related to the frequency of PSUR submission included in a marketing authorisation.
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 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.
The EMA has published further guidance on how the fees are calculated and collected. The EURD list 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. However, the parallel importer will not become party to the PSUR procedure and will not receive a copy of the assessment report and outcome documentation as a MAH would.