This page lists questions that marketing-authorisation holders (MAHs) may have on renewals of marketing authorisations. 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:
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
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.
- 1. How long is my marketing authorisation valid?
In accordance with Article 14 (1-3) of Regulation (EC) No 726/2004, a marketing authorisation (MA) is valid for five years from the date of notification of the Commission Decision to the marketing authorisation holder (MAH), and is renewable upon application by the MAH.
Notification dates of the Commission Decision are published in the Official Journal and can also be found in the EC Pharmaceuticals - Community Register for each product. Once renewed, the MA will be valid for an unlimited period, unless the Competent Authority decides, on justified grounds relating to pharmacovigilance (e.g. exposure of an insufficient number of patients to the medicinal product concerned), to mandate one additional five-year renewal.
MAs under exceptional circumstances granted under Article 14(8) of Regulation (EC) No 726/2004 are also valid for 5 years.
Conditional MAs granted under Article 14(7) of Regulation (EC) No 726/2004 do not fall under the above provisions. They are valid for 1 year and should therefore be renewed annually. For further information on the ‘conditional’ MAs, see Q&A 53 of the pre-submission procedural guidance ‘Could my application qualify for a conditional marketing authorisation?’).
- Article 14 (1-3) of Regulation (EC) No 726/2004
- Article 24 of Directive 2001/83/EC
- Guideline on the processing of renewals in the centralised procedure (EMEA/CHMP/2990/00 Rev.4)
- 2. When shall I submit my renewal application?
In order to remain valid, the renewal of the MA is required within five years of its granting; A renewal application should be submitted to the Agency at the latest 9 months before the expiry date of the MA. A renewal application should also be submitted for suspended MA.If a MAH does not submit the renewal application, the MA will expire on the last day of its validity.
The MA validity period is calculated from the date of notification of the Commission Decision to the MAH.
To ensure that the Commission Decision on the renewal application is issued before expiry of the MA, when planning for their renewal submission, MAHs should take into account the following principles:
- The renewal application must be submitted at least 9 months before the MA expiry date. Any anticipation in the submission of the renewal application by more than 2 months will not be accepted by the Agency.
- The start of the evaluation process will be the nearest possible starting date to the submission of a valid dossier, as published by the EMA in the “Human Medicines – Procedural Timetables / Submission dates”).
- The PRAC/ CHMP assessment process can take up to 120 days of active time.
- The Decision-Making Process (including the Standing Committee consultation) for renewal procedures is 67 days.
In addition, as the quality of the renewal application is key to ensure a timely start and finalisation of the procedure, a dialogue between MAHs and the Agency will be promoted, for a pre-renewal data-check, approximately one year in advance of MA expiry.
- Guideline on the processing of renewals in the centralised procedure (EMEA/CPMP/2990/00 Rev. 4)
- Community Register of medicinal product : website of the European Commission
- 3. How shall I present my renewal application?
Renewal applications should be submitted in eCTD format and have to contain the documents listed in the Annex 2 of the Guideline on the processing of renewals in the centralised procedure (EMEA/CHMP/2990/00 Rev.4) and which are listed below:
1.0 Cover letter.
The cover letter should contain the template table to facilitate submission and registration and should be signed by the person designated as MAH contact with the EMA. (NB: the Renewal application is not an opportunity to notify the Agency of changes in contact person).
1.2 Renewal Application form.
The electronic EU Renewal application form (eAF) should be signed by the person designated as MAH contact with the EMA and completed with the following annexes (the form is available on the EMA public website):
- List of all authorised product presentations for which renewal is sought in tabular format (following the template for Annex A to CHMP Opinion)
The MAH should complete and sign the renewal application form, appending a list of all authorised strengths, pharmaceutical forms and presentations of the product concerned for which renewal is sought. In cases where the MAH does not wish to renew certain product presentations (e.g. a certain pharmaceutical form, strength or pack-size), this should be clearly indicated in the cover letter and the concerned presentations should not be included in the appended list.
- Details of contact persons:
- Qualified person in the EEA for pharmacovigilance
- Contact person in the EEA with the overall responsibility for product defects and recalls
- Contact person for scientific service in the EEA in charge of information about the medicinal product
Note: the Renewal application is not an opportunity to notify the Agency of changes in contact persons. These changes should be notified as per Q.4. undersection ‘Other post-authorisation activities: questions and answers’ of the EMA published guidance: “How do I notify the EMA of changes to my Contact Persons specified in the application form”):
- List of EU Member states/Norway/Iceland where the product is on the market and indicating for each country which presentations are marketed and the launch date
- Chronological list of all post-authorisation submission since granting the MA or since the last renewal: a list of all approved or pending Type IA/IB and Type II variations, Extensions, Art 61(3) Notifications, USR, and PSURs/PBRER, giving the procedure number (where applicable), date of submission, date of approval (if approved) and brief description of the change.
- Chronological list of conditions and Specific Obligations submitted since the granting of marketing authorisation or last renewal indicating scope, status, date of submission and date the condition/ obligation was fulfilled (where applicable)
- Revised list of all remaining conditions and Specific Obligations (where applicable)
- A statement, or when available, a certificate of GMP compliance, not more than three years old, for the manufacturer(s) of the medicinal product listed in the application issued by an EEA competent authority or MRA partner authority. A reference to the Community EudraGMP database, if available will suffice.
- For manufacturing sites of the medicinal product not located in the EEA or in the territory of an MRA partner, a list of the most recent GMP inspections carried out indicating the date, inspection team and outcome
- In accordance with Article 46(f) of Directive 2001/83/EC, manufacturing authorisation holders are required to use as starting materials only active substances which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials as adopted by the Community. The following declarations are required:
- A declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders (i.e. located in the EEA) listed in the application form where the active substance is used as a starting material
- A declaration by the Qualified Person (QP) of the manufacturing authorisation holder(s) listed in the application as responsible for batch release.
- These declarations should state that all the active substance manufacturer(s) referred to in the application form operate in compliance with the detailed guidelines on good manufacturing practice for starting materials.
1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet
- If no changes to the PI (SmPC, Annex II, outer/ inner labelling and Package Leaflet) are proposed by the MAH, a ‘clean’ version of the latest PI in English has to be provided (in Word format).
- If changes to the PI are proposed as part of the Renewal dossier, a version of the PI in English, highlighting the changes proposed by the MAH should be provided in Word format. In addition, a ‘clean’ version of the PI should be provided in the eCDT and Word.
- Note: All other language versions are only to be submitted after adoption of the opinion (See also “When do I have to submit revised product information? In all languages?”).
1.4 Information about the Expert
1.4.1 Information about the Expert – Quality (incl. Signature + CV)
1.4.2 Information about the Expert – Non-Clinical (incl. Signature + CV) – if applicable
1.4.3 Information about the Expert – Clinical (incl. Signature + CV)
1.8.2 Risk Management Plan:
An RMP is not systematically required as part of the renewal application. Three scenarios are possible:
- Where there are no new data in the Renewal dossier justifying changes to the latest approved RMP or no recommended update to the RMP to be implemented, no RMP should be included in section 1.8.2 of the Renewal dossier. In this case, the MAH should specify this in the cover letter and provide a declaration in the clinical overview, confirming that the current approved RMP remains unchanged and applicable.
- If an update of the RMP is proposed by the MAH as a consequence of data submitted with the Renewal application, section 1.8.2 should contain the updated RMP (‘clean’ version). In this case, a version of the RMP, highlighting the changes proposed by the MAH should be provided in Word format.
- Where there is no RMP for the medicinal product, this should be stated in the cover letter.
2.3 Addendum to Quality Overall Summary
The Addendum should include a declaration of compliance with Article 16(1) of Regulation (EC) No 726/2004, which obliges the MAH “…to take account of technical and scientific progress and introduce any changes that may be required to enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods”.
The Addendum to the Quality Overall Summary should also include:
- Confirmation that all changes relating to the quality of the product have been made following applications for variations and that the product conforms to current CHMP Quality guidelines.
- Currently authorised specifications for the active substance and the finished product (with date of latest approval and procedure number)
- Qualitative and quantitative composition in terms of the active substance(s) and the excipient(s) (with date of latest approval and procedure number)
2.4 Addendum to Non-clinical Overview
An Addendum to the non-clinical Overview is not systematically required as part of the renewal application.
When new data are submitted in the non-clinical Addendum, a critical discussion must be submitted as part of the renewal application supporting the benefit/risk balance re-evaluation for the product taking into account any new non-clinical data accumulated since the initial MA or the last renewal, or any relevant new information in the public domain.
In case no new non-clinical data have been gathered since the initial MAA or since the last renewal, this should be stated in the Addendum to the Clinical Overview.
2.5 Addendum to Clinical Overview
A critical discussion should be provided within the Addendum to the Clinical Overview. It should address the benefit/risk balance for the product at the time of the application for the Renewal, on the basis of the Periodic Safety Update Reports (PSUR)/ Periodic Benefit Risk Evaluation Report (PBRER) data and safety/efficacy data accumulated since the granting of the MA or since the last renewal, making reference to relevant new information in the public domain. The discussion should clearly reflect the data previously included in the PSURs/PBRER and the new data that have emerged since the DLP of the last PSUR/PBRER up to the DLP of the renewal.
Note: MAHs are advised to consider the Good Vigilance Practice Module on PSUR/PBRER as guidance for the preparation of the sections of the clinical overview described below.
The Addendum to the Clinical Overview should contain the following information:
- Actions taken for safety reasons during the period covered since the initial MA or since the last renewal until 90 days prior to renewal submission: description of significant actions related to safety that had a potential influence on the benefit/risk balance of the approved medicinal product (e.g. suspension, withdrawal, temporary halt or premature ending of clinical trial for safety reasons, issue requiring communication to healthcare professionals…). Actions taken from the DLP of the last PSUR/PBRER up to the DLP of the renewal should be clearly identified and highlighted.
- Significant changes made to the Reference Information (RI) during the period covered since the initial MA or since the last renewal. In this section, it should be clearly identified the changes included in the PSUR/PBRER and the new changes made from the DLP of the last PSUR/PBRER up to the DLP of the renewal.
- Estimated exposure and used patterns: data on cumulative exposure of subjects in clinical trials as well as of patients from marketing exposure for EU and non EU regions. If the MAH becomes aware of a pattern of use of the medicinal product considered relevant for the implementation of the safety data, a brief description should be provided; such patterns may include in particular off-label use.
- Data in summary tabulations: Summary tabulations of serious adverse events from clinical trials as well as summary tabulations of adverse reactions from post-marketing data sources reported during the period covered since the initial MA or since the last renewal until 90 days prior to the renewal submission.
- Summaries of significant safety and efficacy findings from clinical trials and non-interventional studies during the period covered by the renewal: description of any significant safety findings that had an impact on the conduct of clinical trials or non-interventional studies. It should also address whether milestones from post-authorisation safety studies, post-authorisation efficacy studies, studies from the RMP pharmacovigilance plan and studies conducted as condition and specific obligations of the MA, have been reached in accordance with agreed timeframes. New data since the DLP of the last PSUR/PBRER up to the DLP of the renewal should be highlighted.
- Overview of signals: High level overview of signals for which evaluation was completed during the period covered by the renewal and any action taken or planned; and high level overview of ongoing signals (i.e. that are undergoing evaluation at the DLP of the renewal application) should be provided. The information should be provided in tabular format.
- Signal and risk evaluation: the MAH should summarise signals for which evaluation was completed during the reporting period of the renewal. For signals that became important identified or potential risks or are related to a known risk, a characterisation of the risk should be provided. Evaluation of signals completed from the DLP of the last PSUR/PBRER to the DLP of the renewal should be clearly highlighted. The MAH should discuss whether any changes are considered necessary to the existing safety concerns and whether any additional risk minimisation activities for the product are warranted, considering the data collected during the period covered by the renewal.
- Relevant information on patterns of medication errors and potential medication errors (even when not associated with adverse outcomes) during the period covered by the renewal. Such information may be relevant to the interpretation of safety data or the overall benefit/risk balance evaluation.
- Literature: review of important literature references published during the period covered since the initial MA or since the last renewal until the DLP of the renewal application that had a potential impact on the benefit/risk balance of the medicinal product.
- Benefit evaluation: the MAH should summarise important efficacy and effectiveness information (including information on lack of efficacy) for the period covered since the initial MA or since the last renewal until the DLP of the renewal application.
- Benefit/risk balance: a discussion on the benefit/risk balance for the approved indication should be presented, based on the above information.
- Late-breaking information: The MAH should summarise the potentially important safety, efficacy and effectiveness findings that arise after the data lock point but during the period of preparation of the addendum to the clinical overview.
The Clinical Expert Statement should:
- Confirm that no new clinical data are available which change or result in a new risk/benefit balance evaluation.
- Confirm that the product can be safely renewed at the end of a 5-year period for an unlimited period, or any action recommended or initiated should be specified and justified.
- Confirm that the authorities have been kept informed of any additional data significant for the assessment of the benefit/risk balance of the product concerned.
- Confirm that the product information is up to date with the current scientific knowledge including the conclusions of the assessments and recommendations made publicly available on the European medicines web-portal.
It should be noted that the responsibility for the quality of the submitted documentation lies with the MAH and is crucial to the overall process. For queries relating to the presentation of the application, please contact the EMA at: firstname.lastname@example.org.
- Guideline on the processing of renewals in the centralised procedure (EMEA/CPMP/2990/00 Rev. 4)
- Electronic Renewal application form
- Template for cover letter
- 4. How and to whom shall I submit my renewal application?
How: The requirements for the submission of applications related to the centralised procedure are provided on the EMA website. Please refer to Other post-authorisation activities: questions and answers - How and to whom shall I submit my application? (Question 5).
To whom: To the EMA, CHMP, PRAC and CAT (when involved) members, submissions via the Common Repository only.
- 5. How shall my renewal application be handled (timetable)?
The MAH must apply for a renewal no later than 9 months before the expiry date of the MA. The recommended submission dates published on the EMA website will apply in order to determine the start of the procedure.
The Agency will acknowledge receipt of a valid renewal application and shall start the procedure in accordance with the recommended starting dates published on the EMA website. The MAH will be informed of the adopted timetable at the start of the procedure.
The timetable for the scientific evaluation by the PRAC and the CHMP will be set in order to allow the Commission Decision to be adopted before the expiry date of the MA. Please refer to Annex 1 of the Guideline on the processing of renewals in the centralised procedure (EMEA/CPMP/2990/00 Rev. 4).
Full procedural detailed timetables are published as a generic calendar on the EMA website (see: submission deadlines and full procedural timetables).
The published timetables identify the start and finish dates of the procedures as well as other interim dates/milestones that occur during the procedure.
The renewal procedure will involve the CHMP Rapporteur and the PRAC Rapporteur for the medicinal product.
Start of procedure (see published dates on EMA website)
Receipt of Joint CHMP Rapporteur / PRAC Rapporteur AR
Circulation to EMA, CHMP, PRAC members and MAH, highlighting major issues if any
Deadline for comments from CHMP, PRAC members on the Joint AR and PRAC Advice
When applicable, discussion at PRAC Meeting
Day 76 Endorsement of the Joint Assessment Report (PRAC outcome)
Discussion at the CHMP (if applicable):
- If no outstanding issues: adoption of opinion
- If outstanding issues: adoption of List of Outstanding Issues + decision on possible oral explanation by MAH
MAH provides answers to list of outstanding issues to CHMP /PRAC Rapporteur, CHMP, PRAC members and EMA
Day 96 Revised AR from CHMP and PRAC Rapporteurs. Circulated to CHMP and PRAC members and MAH Day 98 Comments from CHMP and PRAC members on the Joint Assessment Report
When applicable, discussion at PRAC meeting
Adoption of CHMP opinion/possible Oral explanation by MAH
Art. 9(2) of Regulation (EC) No 726/2004 also applies to CHMP Opinions adopted for renewal applications. This means that the MAH may notify the EMA/CHMP of their intention to request a re-examination of the opinion within 15 days of receipt of the opinion (after which, if such a request is not made, the opinion becomes final). The detailed grounds for the request must be forwarded to the EMA within 60 days of receipt of the opinion. If the MAH wishes to appear before the CHMP for an oral explanation, the request should also be sent at this stage.
The CHMP will appoint a different CHMP Rapporteur and where necessary a different CHMP Co-Rapporteur to co-ordinate the re-examination procedure. In case a PRAC Rapporteur is deemed necessary, he/she will be appointed. Within 60 days from the receipt of the detailed grounds for re-examination, the CHMP will re-examine its opinion. If considered necessary, an oral explanation can be held within this 60 days timeframe.
- 6. What fee do I have to pay for a renewal?
For information about fees and fee payment in the Centralised Procedure, please refer to the Explanatory note on fees payable to the European Medicines Agency
In case an inspection is required, please note that in addition to the renewal fee, an inspection fee will be requested (see also Inspections website).
- 7. Can other non-renewal specific changes be included in the renewal application?
None of the changes introduced at renewal should substitute for the MAH's obligation to update the MA throughout the life of the product as data emerge.
Besides, major changes to the product, such as the introduction of a new indication and quality changes such as an extension of shelf life, should not be modified as part of the renewal procedure but have to be submitted and assessed through the appropriate variation procedure.
Where there are adequate and objective reasons not to renew the MA in its existing terms and changes are necessary to the SmPC, labelling and package leaflet arising from the renewal evaluation, the MAH may submit additional information and/or change the product information as part of the renewal process to address the concerns raised. Such changes will not initiate a separate variation procedure.
Other issues arising from assessment and changes due to the revision of the SmPC guideline, other relevant guidelines impacting on the product information, or EMA/QRD Product Information Templates should be considered within the renewal procedure.
The section “present/proposed” in the application form should clearly list any changes introduced to the product information (incl. any minor linguistic amendment introduced for each language). Alternatively, such listing may be provided as a separate document attached to the application form. Any changes not listed, will not be considered as part of the renewal application.
- 8. How to handle other ongoing variation applications during the renewal procedure and what impact may ongoing procedures have on the renewal procedure?
MAHs are advised to plan, when possible, the submission of variation applications outside the period of the submission of the renewal application and the renewal assessment procedure. However, where the need for a variation of the MA has been identified, in particular in the context of safety concerns, the MAH is advised to contact the Agency in advance of the submission of the variation application to agree on the procedural aspects for handling these parallel applications.
In case an ongoing variation (Type IA/IB or Type II) affecting the product information is not yet finalised at the time of the submission of the renewal application, the last product information adopted/accepted by the EC/CHMP/EMA should be used for the submission of the renewal application.
If a variation procedure is finalised before or upon finalisation of the renewal procedure, the accepted/adopted variation changes should be reflected in the product information adopted with the CHMP Renewal opinion.
In cases where any ongoing procedure may affect the product information, the MAH is advised to contact the Agency in advance of the submission or finalisation of the procedure(s) concerned.
- 9. Do I have to submit mock-ups and specimens?
For information concerning submission of mock-ups and specimens in the framework of post-authorisation procedures, please refer to the document ‘Checking process of mock-ups and specimens of outer/immediate labelling and package leaflet of human medicinal products in the centralised procedure.
- 10. When do I have to submit revised product information? In all languages? Rev. April 2016
Where no amendments to the product information are proposed by the MAH, only a copy of the latest approved product information (full set of Annexes, ‘clean’) in English must be submitted to the Agency in Word format.
In case the renewal application includes proposals for changes to the SmPC, Annex II, labelling and/or package leaflet, the product information must be submitted as follows:
English language (only): complete set of Annexes within the eCTD sequence and in Word format (both clean and highlighted showing the changes proposed as part of the Renewal).
If changes are approved as part of the Renewal, the following steps will apply:
After CXMP Opinion (Day +5)
All EU languages (incl. EN, NO and IS): complete set of annexes in Word format (highlighted)
After Linguistic check (Day +25)
All EU languages (incl. EN, NO and IS): complete set of annexes in Word format (highlighted) and in PDF (clean)
Translations of the adopted product information in all EU languages (incl. EN, NO and IS) are to be provided electronically (in one Eudralink package) to the Member States Contact Points for Translations by Day +5 with a copy to the EMA Procedure Assistant and to the EMA Product Shared Mailbox.
The ‘full set of Annexes’ consists of Annex I, II, IIIA, IIIB and, if applicable, IV and 127a as appropriate.
Annexes must be presented sequentially (i.e. Annex I, II, IIIA, IIIB, and if applicable, IV) as one Word document for each official EU language. Annex 127a (when applicable) must be presented as a separate PDF document with “127a” removed from the title page together with the Word files highlighted with tracked changes. All translations should be numbered as ONE document, starting with "1" (bottom, centre) on the title page of Annex I and Annex (127a) when applicable. The ‘QRD Convention’ published on the EMA website defines format and layout of the PI. The PDF user guide should also be followed as it provides guidance on how to correctly prepare the PDF versions. When submitting the full set of Annexes in PDF format, this should be accompanied by the completed Day +25 Checklist. Highlighted changes should be indicated via ‘Tools – Track changes’. Clean versions should have all changes ‘accepted’.
The revised Annex A, where applicable, is to be provided to the Agency as a separate Word document in all EU languages (see point 1.12 below) and in PDF (clean).
The Annexes provided should only reflect the changes introduced by the Renewal. However, in exceptional cases where MAHs take the opportunity to introduce minor linguistic amendments to the texts (e.g. further to a specimen check), this should be clearly mentioned in the cover letter.
In addition, the section “present/proposed” in the application form should clearly list the minor linguistic amendments introduced for each language.
Alternatively, such listing may be provided as a separate document attached to the application form. Any changes not listed will not be considered as part of the renewal application.
- 11. When will the linguistic checking of the product information take place?
During the scientific renewal assessment, a detailed pre-opinion review of the English (EN) version of the product information will be performed by the Agency, the QRD (Quality Review Document) members and representatives of Patients’ and Consumers’ Organisations. Technical Labeling Review comments will be sent to the MAH by day 75. When providing a revised EN version for adoption of the opinion, applicants should inform the Agency if and why certain Technical Labeling Review comments are not taken into account.
Translations of the adopted product information in all other EU languages (including IS and NO) are to be provided electronically (in one Eudralink package) to the Member States Contact Points for Translations by Day +5 with a copy to the EMA Procedure Assistant and to the EMA Product Shared Mailbox.
The following checks post-opinion will apply:
Who When Scope QRD/ ‘Member State’ Day +5 to +19 Detailed review of (highlighted changes in) all translations EMA Day +25 to +27 Review of implementation of Member States comments
Comments will be sent directly by the Member States to the MAH at the latest by Day +19, with a copy to the EMA Product Shared Mailbox.
The MAH will send the final translations with tracked changes, incorporating the Member States’ comments in Word format, as well as in PDF format (clean), electronically (in one Eudralink package) to the EMA Procedure Assistant with a copy to the EMA Product Shared Mailbox by Day +25. The Eudralink package should be presented in compliance with the Day +25 Checklist.
The Agency will check if all Member States’ comments have been implemented before sending the final translations to the Commission. In order to facilitate and accelerate the check of the implementation of the Member States’ comments, the applicant should indicate in QRD Form 2 for each language if all comments have been implemented or not. In the latter case, a justification as why certain comments are not reflected in the final texts should be provided for the appropriate language(s). Such justification(s) and/or alternative proposals should be discussed and agreed with the relevant Member State(s) before submitting final translations to the Agency.
In case the Renewal affects only the Annex II, no or a shorter post-opinion translation timetable may be considered by the Agency on a case-by-case basis.
Following receipt of the final translations from the EMA, the Commission will start the 22-day Standing Committee consultation, addressing only legal and public health matters (which means in principle no further linguistic review).
The Commission Decision on the renewal will be issued after consultation of the Standing Committee, by Day +67.
- The new Linguistic Review Process of Product Information in the Centralised Procedure (EMEA/5542/02 Rev. 5)
- SOP/EMEA/0046: PIQ/QRD Pre-opinion Review of Product Information for Renewal Procedures
- Procedure for review of information on medicinal products by Patient’s/Consumers Organisations (PCOs) (EMA/174255/2010 Rev. 2)
- SOP/EMEA/0048: QRD Post-opinion Review of Product Information for post-authorisation procedures affecting the annexes, excluding Annex II applications
- 12. What do I need to do if I do not want to renew the Marketing authorisation of certain product presentations or the entire product?
MAHs should only complete the renewal application form for those presentations which they would like to renew. In cases where the MAH does not wish to renew certain product presentations (e.g. a certain pharmaceutical form, strength or pack-size) this should be clearly indicated in the cover letter (see also “How shall I present my renewal application”).
In case the MAH does not wish to renew the entire MA (i.e. all authorised presentations) a letter to this effect should be addressed to the Agency and the European Commission, at the latest 9 months prior to the expiry of the concerned MA, clearly stating if the MA is surrendered for any reasons beyond purely commercial ones.
This is without prejudice of the MAH obligation to notify such action to the Agency according to the provisions set out in Article 14 (b) of Regulation (EU) No 726/2004. Please refer to the EMA questions and answers on Withdrawn product notification.
- 13. Will there be any publication on the outcome of my renewal application?
The EPAR (published on the EMA website) will be revised to implement the CHMP conclusions in relation to the renewal procedure.
Besides, the CHMP meeting highlights following each CHMP meeting give information in its Annex on opinions in relation to renewal applications. This information includes the invented name of the product, its INN and the name of the MAH.
In case of an unfavourable opinion, recommending the suspension or the non-renewal of the MA, a Question and Answer (Q&A) document will be published by the Agency. This will include information and reasons for such opinion. The information will be provided in lay language, so that it can be understandable for the general public.
- 14. Who should I contact if I have a question when preparing my application and during the procedure? Rev. June 2016
If you cannot find the answer to your question in the Question and Answer (Q&A) when preparing your application or during the procedure, please contact the Procedure Manager responsible for your product.
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