Notes on amending and/or submitting the product information texts
In which language should the dossier and the product information texts in MR-/DC variations and renewals be submitted if only German-speaking member countries (DE/AT or only DE) are involved?
Date: 2021.03.09
All CMDh guidance documents refer to the use of English language dossiers and English language product information texts. At the end of the procedures, the RMS should provide the final English texts for SmPC, PL and labelling. This is also required for providing the texts and, if applicable, the public assessment report in the MRI-PI. Therefore, English texts shall be submitted in a clean version as well as in a version with changes highlighted and evaluated in procedures that include only German-speaking countries as well as in procedures that continue with German-speaking MS alone due to the expiry of marketing authorisations in other CMSs. For type IA and type IB variations the national translations have to be submitted together with the English texts in the application; they are evaluated in parallel with the English texts during the procedure.
Variations submitted after 01.05.2021 without the English texts on SmPC, PL and Labelling will therefore not be accepted.
In cases where the variation results in changes to the SmPC/PL/labelling - how to submit the final agreed changes to the common texts (English) for type II variations / worksharing procedures (DE=RMS)?
Date: 2023.03.24
According to the CMDh Best Practice Guidances for Variations
the MAH should provide the RMS with the final agreed common texts (english) via e-mail before the "end of procedure".
With "EoP Notification", the RMS circulates the texts to the CMS and to the MAH.
In parallel, the clean documents are uploaded to CTS for transfer to the MRI index of the HMA.
Recommended approach in detail:
- The final agreed SmPC/PL/labelling texts should be sent as "tracked" and "clean version" (docx file) via e-mail to the responsible BfArM contact immediately after the last deadline for CMS comments (approx. on procedure Day 81 - in case of reduced/extended timetable on Day 26/111).
- For procedures that can already be approved on Day 60 (30/90) (= positive PVAR + no CMS comments), the submission should take place on approx. Day 56 (20/86).
- A separate file should be submitted per strength/dosage form and type (SmPC/PIL). If the adopted texts for different strengths/dosage forms and type (PI/SmPC/PIL) are in a common file, this can be submitted as a common file. In a worksharing procedure, separate texts should be submitted for each integrated MRP/DCP procedure.
The naming of the files should preferably be as follows:
Procedure number_active substance_FINAL_type(SmPC/PIL)_cv/hv
Example:DE_1234_1_II_2_Diclofenac_FINAL_SmPC_cv
DE_1234_1-2_WS_0815_Ibuprofen_FINAL_PI_hv
How should an adaptation of texts in line with QRD templates be submitted in the context of Type 1B or Type II variations?
Date: 2013.12.11
If an update of the texts in line with the QRD templates (labelling, PIL and SmPC) is submitted in addition to a Type IB or Type II variation, this should be stated clearly in the cover letter and under “Precise scope and background for change” in the application form. In this constellation no fees will be charged. No further variation submission is required, nor is reference to a variation code necessary. No fees will be charged if this change is made in the context of a renewal. Further information is available on the website of the CMDh under variations, Question 3.16.
How should the implementation of the explanatory statements on additional monitoring and adverse drug reaction (ADR) reporting be submitted in Type IB or Type II variations?
Date: 2013.12.11
If the implementation of the explanatory statements on additional monitoring and ADR reporting is submitted in addition to a Type IB or Type II variation of change category C, this should be stated clearly in the cover letter and under “Precise scope and background for change” in the application form. In this constellation no fees will be charged. No further variation submission is required, nor is reference to a variation code necessary. No fees will be charged if this change is made in the context of a renewal. Further information is available on the website of the CMDh under variations, Question 2.11.a.
How should an update of the texts in line with the current QRD templates be submitted in the absence of any further changes to the product information?
Date: 2013.12.11
If only the adaption of the texts in order to be in line with the current QRD template without any further changes (a single variation) is submitted, this is considered to be a Type IB variation with a change category C.I.z. for which fees will be charged.
How should the implementation of the explanatory statements on additional monitoring and ADR reporting be submitted in the absence of any further changes to the product information?
Date: 2013.12.11
If only the implementation of the explanatory statements on additional monitoring and ADR reporting without any further changes (a single variation) is submitted, this is considered to be a Type IAIN with variation a change category C.I.z. in accordance with Article 5 recommendations. In this case fees will be charged. For further information please click here for the CMDh recommendations.
Can an adaptation of the texts to be in line with the current QRD templates be submitted together with Type 1A or Type IAIN variations?
Date: 2013.12.11
It is possible to submit an adaption of the texts together with Type IA or Type IAIN variations. This change is classified as a Type IB variation with the change category C.I.z. which is subject to fees. This classification is a grouping of a variation Type IB with a variation Type IA/ IAIN. and the general regulations for groupings of national variations have to be followed. Further information can be found in the announcement Bekanntmachung vom 12. Juli 2013.
Can an implementation of the explanatory statements on additional monitoring and ADR reporting be submitted together with Type 1A or Type IAIN variations?
Date: 2013.12.11
It is possible to submit the implementation of the explanatory statements on additional monitoring and ADR reporting together with Type IA or Type IAIN variations. This change is classified as a Type IAIN variation with the change category C.I.z. in accordance with the Article 5 recommendation. This classification is a grouping of a variation Type IAIN with a variation Type IA/ IAIN and the general regulations for groupings of national variations have to be followed. Further information can be found in the announcement Bekanntmachung vom 12. Juli 2013.
Can the package leaflet refer to a digital package leaflet?
Yes, according to the CMDh position papier on the use of mobile scanning of package leaflets and labelling, the following options are available:
- A website of the national regulatory authority
- Dedicated pages set up by the marketing authorisation holder for the mobile devices in the Member States, which do not require the mobile devices to be linked to the website of their national competent authorities
- A linked, stand-alone PDF document
If the pharmaceutical company is taking responsibility for publishing the digital package leaflet, e.g. via the platform https://www.gebrauchsinformation4-0.de, the higher federal authorities would not object to the inclusion of the following text under the heading "Further sources of information".
„Die vorliegende gedruckte Gebrauchsinformation enthält die für die Sicherheit des Arzneimittels relevanten Informationen. Gebrauchsinformationen von Arzneimitteln werden fortlaufend überarbeitet und an den aktuellen wissenschaftlichen Erkenntnisstand angepasst. Daher wird im Auftrag und in eigener Verantwortung unseres Unternehmens zusätzlich eine aktuelle digitale Version dieser Gebrauchsinformation unter https://www.gebrauchsinformation4-0.de von der Roten Liste Service GmbH <andere werbefreie Homepage> bereitgestellt und kann auch mit einem geeigneten mobilen Endgerät/Smartphone durch einen Scan <des linearen Barcodes> <des Matrix-2D-Codes/QR-Codes> <über Near Field Communication (NFC)> <auf der Arzneimittel-Packung> <in dieser Gebrauchsinformation> mit der App [Namen angeben, z. B. „Gebrauchsinformation 4.0 (GI 4.0)]“, abgerufen werden.“
Can the reference to the digital package leaflet for national marketing authorisations be included as part of a type IA variation or must it be submitted with a type IB variation?
The submission can either be made via a so-called "P-Procedure", as only the package leaflet is affected, or as an additional change ("editorial change") in the context of a type IB or type II variation concerning the product information.
How is the reference to the digital package leaflet implemented for centrally authorised medicinal products?
In the BfArM's view, the information can be included at the national level at the end of the package leaflet under the heading „Weitere Informationsquellen“ without a reference in the English text. The BfArM does not consider a change notification to be necessary in this context.