Periodic safety update reports: questions and answers

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This page lists questions that marketing-authorisation holders (MAHs) may have on periodic safety update reports (PSURs). It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.

A PDF version of the entire post-authorisation guidance is available:

These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

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1. What is a PSUR? Rev. March 2013

PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product. They are submitted by marketing-authorisation holders at defined time points during the post-authorisation phase.

The legal requirements for submission of PSURs are established in Regulation (EU) No 1235/2010, Directive 2010/84/EU and in Commission Implementing Regulation (EU) No 520/2012.

The format of PSURs follows the structure described in the Commission Implementing Regulation (EU) No 520/2012. Refer to 'in which format should I submit my PSUR?'

Further details and guidance for the submission of PSURs in the EU, including the list of Union reference dates and frequency of submission are provided in the questions and answers below.

References

2. What is the European Union (EU) single assessment? Rev. March 2013

The EU single assessment is the assessment of PSURs for medicinal products subject to different marketing authorisations containing the same active substance or the same combination of active substances whether or not held by the same marketing-authorisation holder and for which the frequency and dates of submission of PSUR have been harmonised in the list of EU reference dates. This could include a mixture of centrally authorised products, products authorised through the mutual-recognition and decentralised procedures, and purely nationally authorised products.

The single-assessment procedure including a mixture of centrally authorised products started in July 2012.

The single-assessment procedure including a mixture of centrally authorised products and products authorised nationally and through the mutual-recognition and decentralised procedures started for data lock points as of 1 April 2013.

The single-assessment procedure involving only nationally authorised medicinal products did not start in 2012 and will not start until further notice. The start date will be communicated on this website. See 'what procedure will be followed for the assessment of my PSUR?'

References

3. What is the list of EU reference dates (EURD list) and frequency of submission of PSURs? Rev. March 2013

The EU reference date (EURD) corresponds to the date of the first or the earliest known date of the marketing authorisation in the Union of a medicinal product containing the active substance or combination of active substances.

The list of Union reference dates and frequency of submission of PSURs (referred to as the 'EU reference-date list in GVP module VII) consists of a list of active substances and combinations of active substances sorted in alphabetical order, for which PSURs should be submitted in accordance with the EU reference dates and frequencies determined by the Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) following consultation with the Pharmacovigilance Risk Assessment Committee (PRAC).

The EU reference-date list has been compiled in order to facilitate the harmonisation of data lock points 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 authorisations, authorised in more than one Member State. This will, where appropriate, allow the single assessment of related PSURs as set out in the new EU pharmacovigilance legislation.

The data lock point is the date designated as the cut-off for data to be included in a PSUR.

The list is a living document, i.e. it can be amended whenever considered necessary by the PRAC, CHMP or CMDh in response to the emergence of relevant new safety information, newly authorised substances and requests received from marketing-authorisation holders as defined in the legislative provisions 107c(6) of Directive 2010/84/EU.

The principles of the EU reference dates list are included in the GVP module VII – PSURs (VII.C.3).

The PSUR frequency as published in the EU reference-date list for a given active substance or combination of active substances overrules the submission schedule described in the legislative provisions 107c(2) of Directive 2010/84/EU and any conditions related to the frequency of submission of PSURs included in the marketing authorisation. This approach is without prejudice to the right of a national competent authority (NCA) to request the submission of PSURs at any time.

As a result of the publication of the EU reference-date list, any changes to the PSUR submission frequency and data lock point will trigger the obligation of the marketing-authorisation holders (MAHs) to submit, where applicable, a variation for the products where contradictory requirements are specified in the marketing authorisation. Refer to 'which variation classification should I apply to align the PSUR frequency in my marketing authorisation with the EURD list?'

For guidance on submission of requests for amendment of the EU reference-date list, refer to 'how can I request to amend the list of EU reference dates?'

References

4. When does the EURD list come into force? Rev. February 2014

The EURD list will come into force 6 months after its publication as final i.e. after adoption by the CHMP and CMDh following consultation of the PRAC. The list was first published on 1st October 2012 and is binding from DLPs as of 1st April 2013. It is a living document which is updated on a regular basis (currently every month). However there is a limit until which the list can be updated, in particular if the frequency should be increased to 6 months or reduced to at least 1 year. As laid down in Art 107c(7) of the Directive 2001/83/EC as amended, “any change to the dates of submission and frequency of periodic safety update reports specified in the marketing authorisation (…) shall take effect 6 months after the date of such publication”. Therefore, the EURD list can only include DLP of PSUR for which the submission deadlines fall after the date when the change published in the list becomes legally binding. As a consequence, if PRAC recommends a change in the PSUR frequency from 1 year or more to 6 months, an “ad hoc” PSUR should be requested to the concerned MAHs, while the DLP of the subsequent PSUR will be reflected in the list. A note on this ad hoc PSUR will also be included in the EURD list.

By analogy, any changes to the PSUR cycles from 6 months to 1 year or more will only take effect after the DLP published in the list at the time of the PRAC recommendation.

5. Do I have to submit a PSUR if my medicinal product is not on the EURD list? Rev. March 2013

If the active substance contained in the medicinal product is not listed in the EURD list, the MAH should continue to submit PSURs according to the conditions in the marketing authorisation (MA), if any. Otherwise, they should be submitted according to the standard submission cycle (i.e. six-monthly, yearly and thereafter three-yearly) unless the medicinal product is a generic, well established, authorised under of Directive 2001/83/EC, homeopathic simplified registration and traditional-use registration without conditions in the MA. In addition, PSURs shall also be submitted upon request of national competent authorities or the European Commission or European Medicines Agency.

6. How can I request to amend the list of EU reference dates? Rev. March 2013

Marketing-authorisation holders are allowed to submit requests to the CHMP or the CMDh, as appropriate, to determine the Union reference dates or to change the frequency of submission of PSURs on one of the following grounds:

  • for reasons relating to public health;
  • in order to avoid a duplication of the assessment;
  • in order to achieve international harmonisation.

The request and its grounds will be considered by the PRAC and the CHMP if they concern at least one marketing authorisation granted in accordance with the centralised procedure or the CMDh otherwise, which will either approve or deny the request.

The list will then be amended accordingly when appropriate and published.

For more details on how to submit amendments to the list, please refer to the introductory cover note to the list of EU reference dates and frequency of submission of PSURs (sections 2 and 5).

Reference

7. What procedure will be followed for the assessment of my PSUR? Rev. July 2013

The procedure involving the PRAC for PSUR assessment for centrally authorised medicinal products (CAPs) started in July 2012.

However, the single-assessment procedure involving only nationally authorised medicinal products did not start in 2012 and will not start until further notice. The start date will be communicated on this website.

The procedure for the different types of products is summarised below:

  • For a single CAP (i.e. for a substance or combination of active substances contained in only one medicinal product which is centrally authorised), any PSUR submitted as of 2 July 2012 will follow the new procedure involving the PRAC as detailed in GVP Module VII.
  • For several CAPs containing the same active substance or combination of active substances and where the submission dates are harmonised, the single-assessment procedure involving the PRAC will be followed.
  • As of 1 April 2013 when the EURD list became binding, where centrally and nationally authorised medicinal products contain the same active substance or combination of active substances, the single assessment procedure involving the PRAC is being followed for the PSURs submitted according to the data lock points stated in the EURD list. For more details, refer to EU reference dates and submission of PSURs.
  • Where nationally authorised medicinal products containing the same active substance or combination of active substances are authorised in more than one Member State and follow already the current worksharing (WS) scheme, refer to CMDh: PSUR WS and synchronisation project, where arrangements for the assessment of these PSURs is provided until the single-assessment procedure involving the PRAC is implemented.
  • For nationally authorised medicinal products containing the same active substance or combination of active substances, which are authorised in more than one Member State but which are not covered by the current WS scheme, the assessment of the PSUR remains at an individual national level until the single assessment procedure involving the PRAC is implemented.

Note that for purely nationally authorised medicinal products identified by the MAH as not authorised in more than one Member State, the assessment of the PSUR remains at an individual national level as it is outside the scope of the single-assessment procedure defined in the legislation.

8. In which format should I submit my PSUR? Rev. July 2013

As set out in the Commission Implementing Regulation, the new format and content of PSUR has applied since 10 January 2013. The format and content of the PSUR is outlined in the guideline on GVP module VII – PSURs.

PSURs that are submitted to the European Medicines Agency (EMA) in relation to CAPs have to follow the mandatory Electronic Common Technical Document (eCTD) format. Submissions of nationally authorised products that are sent to the EMA as part of a single-assessment procedure (mixture of centrally and nationally authorised medicinal products) should be sent electronically only, preferably in eCTD format but non-eCTD-electronic-submission (NeeS) format is also accepted as a temporary measure. See 'how and to whom should I submit my PSUR?'

The submission should include an explanatory cover letter. The cover letter should contain the published EMA updated formatted template table to facilitate the registration of the submission.

References

9. Do I need to include line listings in my PSUR? Rev. March 2013

PSURs prepared under the new format and content will not contain line listings. However, the MAH may have to provide them upon request of the EMA or the national competent authorities.

10. Can I submit a RMP update within my PSUR/PSUSA procedure? Rev. February 2014
  • PSUR for single centrally authorised medicinal product

A RMP update of a single centrally authorised medicinal product can be submitted together with a PSUR only when the changes to the RMP are a direct result of data presented in the PSUR. In this case no stand-alone RMP variation is necessary.

Should only the timing for submission of both documents coincide, but not be related to each other, the RMP submission should be handled as a stand-alone variation.

  • PSUR EU single assessment (in reference to the EURD list)

As an interim measure, submission of RMP updates cannot be accepted together with the PSURs of medicinal products (centrally and/or nationally authorised) subject to a PSUR EU single assessment (PSUSA). MAHs should update their RMP through another upcoming procedure affecting the RMP. Alternatively MAHs should submit a separate variation to update their RMP, after finalisation of the PSUR single assessment procedure.

For nationally authorised medicinal products, RMP updates should be submitted to the National Competent Authority for assessment.

11. What are the timelines for the submission of PSURs? Rev. July 2013

MAHs should submit PSURs to the Agency within 70 or 90 days from the data lock point as established in GVP module VII, as follows:

  • within 70 calendar days of the data lock point (day 0) for PSURs covering intervals up to 12 months (including intervals of exactly 12 months);
  • within 90 calendar days of the data lock point (day 0) for PSURs covering intervals in excess of 12 months;
  • the timeline for the submission of ad hoc PSURs requested by competent authorities will be normally specified in the request, otherwise the ad hoc PSURs should be submitted within 90 days of the data lock point.

The deadline date for the submission of PSURs is day 70 or day 90 following the DLP as published in the EURD list.

The timetables for the PSUR single assessment procedure involving CAPs and mixture of CAPs and nationally authorised products are available. The column 'submission date' referred to in this timetable corresponds to a cut-off date defining all the PSUR procedures that will be enrolled in each PRAC and CHMP meeting in order to facilitate planning the agendas of the committees appropriately.

References

12. How and to whom should I submit my PSUR? Rev. July 2013

Until the EMA delivers the new PSUR repository, the following should be considered with regards to PSUR submission involving CAPs and nationally authorised medicinal Products (NAPs):

PSURs for CAPs:

Submission to the European Medicines Agency

The EMA strongly recommends using the eSubmission Gateway or eSubmission web client as the preferred submission method for all eCTD submissions. Detailed information on the required naming conventions and file formats can be found in EMA eSubmission Gateway: questions and answers relating to practical and technical aspects of the implementation and in eSubmission Gateway web client: guidance for applicants. Applicants must not send duplicate submissions electronically or via CD-ROM or DVD as this might lead to delays in the handling of applications.

MAHs not yet using the eSubmission Gateway or the web-client solution should send their PSURs as CD-ROM or DVD to the attention of the Product and Application Business Support (PA-BUS) at the following address:

European Medicines Agency
Loading Dock
Ontario Way
Canary Wharf
London
E14 4HB
United Kingdom

Only one CD-ROM or DVD (in eCTD format) containing the relevant eCTD sequence for each product should be submitted to the Agency, together with an original, signed cover letter when using this format of submission (refer to question 'iIn which format should I submit my PSUR?'). The coordinating product team leader should be indicated in copy (cc) on the cover letter (no additional copy needed).

One electronic copy of the PSUR (in eCTD format) should be submitted to the (co-)rapporteurs, after the eSubmission Gateway / web client confirmation of a technically valid submission. When submitted as CD-ROM or DVD the applicant should dispatch an electronic copy to the (co-)rapporteur at the same time as dispatching to the EMA.

The EMA will only check whether the content of an application is correct and complete, when an eCTD submission is technically valid. Any additional information or documentation requested by the Agency prior to the start of the procedure should be also provided to the (co-)rapporteurs.

Once a favourable eCTD technical validation is received from the EMA (in the case of eSubmission Gateway or web client), one electronic copy of the PSUR should be provided for each of the other committee members.

It is essential that identical eCTD sequences are circulated to committee members. Any minor changes that affect the md5 checksum will lead to inconsistencies and could possibly result in future technical invalidity.

Where applications are amended during the Agency’s review, such as responses to a request for supplementary information or comments sent by the MAH during the procedure, a new or consolidated eCTD sequence should be provided in order to maintain the eCTD lifecycle.

For a full overview of dossier requirements for national competent authorities of (co-)rapporteur and committee members, including delivery addresses, refer to dossier requirements for CAPs.

Note that the EMA only accepts submissions made in the mandatory eCTD format.

PSURs for single-assessment procedure involving CAPs and NAPs

Article 2 of Directive 2001/83/EC lays down transitional provisions regarding PSUR submission requirements. Until the EMA can ensure the functionalities agreed for the PSUR repository, MAHs should submit PSURs to all Member States in which the medicinal product has been authorised.

The centralised submission of PSURs is a key element for the optimisation of the functioning of the EU PSUR single-assessment procedure for substances contained in both CAPs and NAPs. As a consequence, MAHs concerned are requested to submit their PSURs to all the PRAC and CHMP members representing the national competent authorities (NCAs) of the countries where the medicinal products have been authorised, to the PRAC independent scientific experts and CHMP co-opted members, to the PRAC rapporteur for the procedure and to the EMA.

MAHs that are required to submit PSURs for EU single assessment should include the updated formatted table template in their submissions (refer to question 'in which format should I submit my PSUR?'). This table should be filled in in accordance with the published EURD list, where the procedure number is the combination of a unique ID and the applicable data lock point in YYYYMM format. PSURs for CAPs that are submitted as part of a single-assessment procedure must be submitted in eCTD format only preferably via the eSubmission Gateway or web client (refer to 'PSURs for CAPs' of this section).

PSURs for NAPs that are subject to a single-assessment procedure procedure must be submitted via the eSubmission Gateway or web client in eCTD or non-eCTD-electronic-submission (NeeS) format. It is essential to follow the published file-naming conventions in section 5 of the Introductory cover note to the list of EU reference dates and frequency of submission of PSURs. Failing to do so might result in non-acknowledgement of your submission. Concerned MAHs should submit their PSURs to all PRAC and CHMP members representing the national competent authorities of the countries where the medicinal products have been authorised. Consult the dossier requirements for CAPs. For submission requirements for NAPs, follow the national submission guidelines of each Member State.

References

13. Do I have to submit a PSUR for my generic medicinal product? Rev. March 2013

For medicinal products referred to in Article 107 b (3) of Directive 2001/83/EC, the requirement to submit PSUR is waived, unless otherwise specified in the marketing authorisation or required through the EURD list (see column 'are PSURs required for products referred to in Articles 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended? Yes / No' of the EURD list). National competent authorities can also request PSURs for generic medicinal products at any time on the grounds detailed in Article 107c (2) of the Directive.

Therefore, if the substance contained in the medicinal product is not included in the EURD list and no specific condition providing for the submission of PSURs is included in the marketing authorisation of the product concerned, no PSUR is required. However please note that for substances contained in NAPs (including generics) with data lock points up to 31 August 2014, PSURs should be submitted as requested by the EU regulatory network in line with the list of substances under PSUR worksharing scheme and other substances contained in NAPs with data lock point synchronised, until the single assessment of these substances starts. For more details, please refer to CMDh: PSUR worksharing and synchronisation project.

14. Do I have to submit a PSUR for my hybrid medicinal product? Rev. March 2013

Medicinal products authorised in accordance with Article 10(3) of Directive 2001/83/EC (hybrid application) irrespective of the change applied for (e.g. new strength, new route of administration, etc.) are not exempt from the obligation to submit PSURs. Therefore, PSUR submissions are required for hybrid medicinal products.

15. For my product authorised as a generic or hybrid, whom should I contact to establish the corresponding PSUR requirements? Rev. March 2013

For centrally authorised medicinal products, please liaise with the Agency through the product team leader for your product to clarify.

16. Do I have to submit a PSUR for my medicinal product containing a well established substance? Rev. March 2013

For medicinal products containing a well established substance, the requirement to submit a PSUR is only waived for those authorised in accordance with Article 10a of Directive 2001/83/EC. Medicinal products containing a known substance authorised through another legal basis are required to submit PSURs.

17. Is PSUR worksharing still applicable? Rev. March 2013

Until single assessment starts for nationally authorised medicinal products, the current PSUR worksharing scheme continues. See CMDh: PSUR worksharing and synchronisation project for information on current arrangements and updates on the process.

18. If the PSUR cycle of my medicinal product is changed as per the EURD list, can I submit my PSUR according to the new data lock point (DLP) without submitting a variation? Rev. March 2013

MAHs should follow the new PSUR cycle as defined in the EURD list, independently of a higher or lower frequency than the current one. However, if the PSUR cycle is stated in the marketing authorisation of a medicinal product, a variation will have to be submitted to align the marketing authorisation in line with EURD list. For centrally authorised products, refer to the implementation plan for the update to annex II of the Quality Review of Documents template. For nationally authorised products please refer to the national competent authorities' websites.

19. Which variation classification should apply to align the PSUR frequency in my marketing authorisation with the EURD list? Rev. March 2013

As set out in the legislation, the MAH has to vary its marketing authorisation where the PSUR cycle is specified in the marketing authorisation and needs to be brought in line with the EURD list. Instead of specifying the PSUR frequency, PSUR statements cross-referring to the EURD list will be mentioned (in annex II for CAPs) in order to avoid the need to submit variations when there will be changes to the EURD list. For CAPs, refer to the product-information templates.

In order to facilitate the implementation pending the publication of the final revised variation classification guideline, the CMDh issued a recommendation on classification of an unforeseen variation for change in the PSUR frequency or date of submission in accordance with Article 5 of Regulation (EC) No 1234/2008. It is classified as a type-IAIN variation.

For centrally authorised products, the  implementation plan for the update to annex II of the Quality Review of Documents template provides further details.

20. How will my PSUR submission be handled? Rev. February 2014

In accordance with the new legislative framework, the procedure for the PSUR assessment for a single PSUR or several PSURs for the same active substance involves the PRAC and if applicable either the CHMP or the CMDh.

The timelines for assessment are for up to 134 days followed by 67 days of Commission decision making process (if applicable).

The submission deadlines and full procedural detailed timetables are now published as a generic calendar.

Upon technical validation by the EMA of the submitted PSUR, the following timetable shall apply to the PSUR evaluation:

 

Day

Action

Day 0

Start of the procedure according to the published timetable

Day 60

PRAC Rapporteur’s preliminary assessment report

Day 90

MAH and PRAC members’ comments

Day 105

PRAC Rapporteur’s updated assessment report (if necessary)

Day 120

PRAC recommendation adoption with the final PRAC assessment report

Day 134

CHMP opinion / CMDh position

 

The MAH’s comments, which are expected by Day 90, should be submitted in a new eCTD sequence to EMA, the PRAC Rapporteur and to all the PRAC members, as per the PSUR dossier submission requirements published at the EMA’s external website.

Information regarding PSUR submissions can also be found in the eSubmissions website and in the “Introductory cover note to the List of European Union reference dates and frequency of submission of Periodic Safety Update Reports”

The MAH is expected to provide (as applicable), e.g:  

  • responses to the “request for supplementary information” as outlined in the relevant section of the PRAC Rapporteur PSUR preliminary assessment report,
  • comment on the proposed wording (in case the recommendation is a variation),
  • propose a wording in case the recommendation is a variation but no exact wording is proposed by the PRAC Rapporteur,
  • provide a justification in case the MAH does not agree with the PRAC Rapporteur recommendation to vary, suspend or revoke the MA; and/or
  • include additional comments or clarification deemed necessary by the MAH.

In case the PRAC adopts a recommendation on the maintenance of the marketing authorisation, there is no requirement to transmit such recommendation to the CHMP or CMDh and the procedure ends with the adoption of the PRAC recommendation.

In case of the PRAC recommends any regulatory action i.e. variation, suspension or revocation of the marketing authorisation, the PRAC recommendation adopted in accordance with the new procedure for a single CAP or the single PSUR assessment procedure will be transmitted to the CHMP if it includes at least one CAP or to the CMDh if it includes only NAPs. At its next meeting following the PRAC recommendation, the CHMP or the CMDh, as applicable, will adopt an opinion or a position, respectively. Subsequently, competent authorities in Member States, or the European Commission for centrally authorised products, shall take the necessary measures to vary, suspend or revoke the marketing authorisation(s), in accordance with the outcome of the assessment.

The outcome of the PSUR assessment results in a legally binding decision or position in case of any action to vary, suspend, revoke the marketing authorisations of the medicinal products containing the concerned active substance or combination of active substances, on the basis of the position of the CMDh or the opinion of the CHMP following the recommendations from the PRAC. Furthermore, marketing authorisation holders are reminded of their obligation to keep their marketing authorisation up to date in accordance with the current legislative framework [REG Art 16(3)] and [DIR Art 23(3)]. The recommendations are therefore implemented in a harmonised and timely manner for all products within the scope of the procedure across the EU.

Amendments to the SmPC, package leaflet and labelling as a result of the PSUR assessment should be implemented without subsequent variation submission for centrally authorised products and through the appropriate variation for nationally authorised products, including those authorised through the mutual recognition and decentralised procedures.

Reference:

Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report, Rev 1 (EMA/816292/2011, 09 December 2013)

21. Does every PSUR assessed by PRAC need to go to CHMP or CMDh? Rev. March 2013

In cases with any regulatory action i.e. variation, suspension or revocation of the marketing authorisation, the PRAC recommendation adopted in accordance with the new procedure for a single CAP or the single PSUR assessment procedure will be transmitted to the CHMP if it includes at least one CAP or to the CMDh if it includes only NAPs.

If the PRAC adopts a recommendation on the maintenance of the marketing authorisation, there is no requirement to transmit this recommendation to the CHMP or CMDh and the procedure ends with the adoption of the PRAC recommendation.

22. In the PSUR worksharing scheme, should I still submit a core safety profile (CSP) at the time of PSUR submission? Rev. March 2013

For new-format PSURs, CSPs are no longer required. See GVP module VII B.4 for the reference documentation to include under the new format.

23. Will existing CSPs be updated? Rev. March 2013

As the new format for PSUR benefit-risk evaluation is introduced, existing CSPs will not be updated.

24. Why are some data lock points included in the EURD list so far in the future? Rev. March 2013

The PSUR frequencies and data lock points included in the EURD list have been defined by national competent authorities following a risk-based approach. These have subsequently been adopted by the CHMP and CMDh following consultation with the PRAC.

Data lock points in the far future are likely to be amended on a monthly basis to take into account any need to re-evaluate the risk-benefit profile of a substance or product earlier or, in particular, in case of the emergence of any pharmacovigilance concerns.

Products containing the same active substance may currently follow different data lock points and PSUR frequencies. Therefore, the reporting period for the related PSURs submitted according to the first data lock point in the EURD list will vary. The frequency in the EURD list corresponds to estimation on when the subsequent (i.e. second) PSUR will have to be submitted according to the EURD list.

25. Do I have to submit a PSUR if my combination product is not on the EURD list but one or more standalone components are listed? Rev. March 2013

If the specific fixed-combination medicinal product is not listed in the EURD list and if the medicinal product does not fall within the categories of medicinal products exempted by the legislation of the obligation to submit PSURs, the MAH should continue to submit PSURs according to the condition in the marketing authorisation, if any. Otherwise, they should be submitted according to the standard submission cycle (i.e. six-monthly, yearly and thereafter three-yearly).

Stakeholders can request the inclusion of the fixed combination in the EURD list for reasons related to public health, in order to avoid duplication of assessment or in order to achieve international harmonisation. Instructions on how to submit comments and requests to amend the EURD list can be found on EU reference dates and submission of PSURs.

26. As a MAH of products referred to in Articles 10(1), 10a, 14 and 16a of Directive 2001/83/EC, how should I communicate any safety information to national competent authorities and the Agency? Rev. March 2013

Products referred to in Articles 10(1), 10a, 14 and 16a of Directive 2001/83/EC are exempted from routine submission of PSURs. Therefore, alternative mechanisms such as signal-management and emerging-safety-issue channels should be used to communicate relevant new safety informationto regulatory authorities (see GVP modules VI and IX). Additionally, product information should be kept up-to-date in line with Article 16(3) of Regulation (EC) No 726/2004 and Article 23(3) of Directive 2001/83/EC by submitting the appropriate variations taking account of the current scientific knowledge, which includes the conclusions of the assessment and recommendations made public by means of the EMA and national-competent-authority websites.

27. Do I have to submit a PSUR for my medicinal product authorised under the older Directive? Rev. March 2013

Medicinal products authorised through the equivalent legal basis as the current Articles 10(1) and 10a legal basis before the recodification of the Directive 2001/83/EC i.e. respectively Article 4.8 a(iii), first paragraph (essential similarity) of Directive 65/65/EEC / 10 a(iii), first paragraph of Directive 2001/83/EC and Art 4.8 a(ii) (well established use) of Directive 65/65/EEC / 10.1 a(ii) of Directive 2001/83/EC are, by analogy, not required to submit PSURs unless there is a specific condition in the authorisation or there is an indication in the EURD list that PSUR submission is required, or in response to a specific request.

28. If the medicinal product is not marketed, is the MAH required to submit a PSUR? Rev. March 2013

The MAH is required to submit PSURs once a medicinal product is authorised in the EU, even if it is not marketed.

Reference

29. In view of my upcoming renewal application, how shouldl I manage my PSUR submission? Rev. March 2013

PSURs, PSUR addenda, summary bridging reports and line listings should no longer be submitted as part of renewal applications. The clinical overview submitted in the renewal application should include relevant information to support the benefit-risk re-evaluation of the medicinal product. Refer to the guideline on the processing of renewals in the centralised procedure.

References

30. Who should I contact if I have a question when preparing my application? New April 2014

If you cannot find the answer to your question in the Q&A when preparing your application, please contact us using the following email address: PSURquery@ema.europa.eu

The Agency aims to respond to your query within 5 working days. To help us deal with your enquiry, please provide as much information as possible including the name of the product in your correspondence.

The above email address is only applicable when you have a pre-submission query. A dedicated Procedure Manager (PM) will be assigned to the procedure once your application has been validated. You will be able to contact this PM throughout the procedure.