SmPC and PL

1. For which proprietary medicinal products do the readability, clarity, and user-friendliness have to be assessed in a readability test? When do the results of the readability test have to be submitted?

A readability test (user test) is required for all proprietary medicinal products which are granted marketing authorisation after 2-Jan-2006, regardless of when the application for marketing authorisation was originally submitted. The results of the readability test should be available at the time the dossier is submitted and should be included in Module 1.3.4 of the CTD. In decentralised procedures, the results of the readability test can be submitted later, i.e., at the time of the clock stop; in this case, an explanation should be given in Module 1.3.4.


For previously submitted applications which are currently in the assessment phase or whose assessment has already been concluded, the administrative decision may include a request for a readability test to be submitted within 6 months after the date the marketing authorisation enters into effect.


Legal basis: Austrian Medicinal Products Act (Arzneimittelgesetz, AMG), Federal Gazette I No. 185/1983, Art 16c para 2: ‘The Patient Information Leaflet (Gebrauchsinformation) has to reflect the results of the cooperation with patient target groups. The Federal Minister of Health can issue by ordinance more detailed provisions regarding the readability, clarity, and user-friendliness of the Patient Information Leaflet.’ *

2. Are there exceptions to the requirement to submit a readability test?

Yes, under certain conditions. However, each dossier will be assessed for whether such an exception applies to the proprietary medicinal product for which approval is sought. Applicants not submitting a readability test are obliged to include a justification in their application for marketing authorisation.


However, the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG)/AGES Austrian Medicines and Medical Devices Agency (AGES Medizinmarktaufsicht) reserves the right to request a readability test if there is doubt that the submitted Package Leaflet fulfils the prescribed requirements.


Examples of possible exceptions:

2.1. Are the QRD templates also binding for Package Leaflets that have already undergone a readability test?

The order of the headings as presented in the QRD template must be adhered to. Both the headings and the running text as given in the templates have to be implemented into the Package Leaflet (PL) without any changes. If, however, the readability test proves that changing the wording of the template substantially improves the comprehensibility and readability for the patients, the PL may deviate from the template; any such improvement must be documented in the results report.

2.2. Does a readability test have to be performed when a Package Leaflet is adapted to the new QRD template?

No, if a readability test has been performed previously and the Package Leaflet is merely adapted to the new QRD template, the readability tests does not have to be repeated.

3. Does the Package Leaflet (PL) of a new application for marketing authorisation for a generic medicinal product have to undergo readability testing even if the PL directly corresponds to the PL of the reference medicinal product?

Yes, the Package Leaflet of a generic medicinal product also has to undergo readability testing. See also Question 5.2.

4. Does a readability test also have to be submitted for already approved proprietary medicinal products?

There is no general requirement for readability tests to be submitted for already approved proprietary medicinal products. However, if substantial changes to the text of the Package Leaflet (PL) of a given product are submitted for approval, a readability test is required. If the PL is merely adapted to the current QRD template, an additional readability test does not have to be performed.

5. In what form and where in the dossier should the readability test results be presented?

The results of the readability test should be presented in Module 1.3.4 of the application for marketing authorisation. See also ‘Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use, Revision 1, 12 January 2009’


In EU procedures, the summary report should be submitted in English. In purely national procedures, the report may be submitted in German.


If the Package Leaflet deviates from the QRD template because of the results of the readability test, a justification should also be given in Module 1.3.4.

5.1. Does the Package Leaflet of a medicinal product approved in an MRP or DCP whose text is harmonized between several EU member states have to undergo readability testing?

For the new, jointly used Package Leaflet, the results of a readability test have to be submitted; the main assessment is carried out by the RMS.

5.2. Under which conditions can a bridging report rather than a readability test report be submitted?

Bridging means that, if certain preconditions are met, the results of a successfully completed readability test performed on a medicinal product similar to the newly submitted product can also be used for this new product. One of these preconditions is that both the previous and the current product are very closely related. See the CMD(h) document ‘Recommendations for Bridging.’

5.3. How should medical terms be translated in the Package Leaflet?

All medical terms should be transferred into language that is easily understandable by patients. The document provided below (both medical terms and layterms provided only in German) provides a number of examples of possible translations for the german version of the PL In addition to the lay terms, the medical terms may also be given in the text.

Recommended translations

6. Does a certain type of readability test have to be performed?

No, but the application dossier must contain a description of the test and a justification why a particular type of test procedures was chosen. The ‘Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use, Revision 1, 12 January 2009’ contains an example of a readability test. The provision of mock-ups/samples of the Package Leaflet used in the readability test in the application dossier is recommended.


It is sufficient for the test to be performed in one official EU language.

7. Do text parts subject to the provisions of patent law have to be included in the SmPC and PL?

Pursuant to Art 15 para 5 AMG, text covered by patent law does not have to be included in the SmPC and PL.


Art 15 para 5 AMG: ‘For marketing authorisations in accordance with Art 10, those sections of the Summary of Product Characteristics (Fachinformation) of the reference medicinal product which refer to therapeutic indications, dosage forms, or other patent aspects which were still covered by patent law at the time the generic medicinal product was placed on the market need not be included.’*
After finalisation of a European procedure, but before national approval, applicants of generic medicinal products can apply for text parts covered by patent law to be not included.


In the case of already approved generics, applicants wishing text passages subject to patent protection not to be included have to sending the information to the appropriate mailbox (rms@ages.at, basg-cms@ages.at or nat@ages.at) respectively. Please note that only contents protected by patent law may be not included in sections 4.1 and 4.2 of the SmPC and the corresponding sections in the PL.


Should the SmPC and PL have to be changed after the patent protection has expired, this will again have to be sending the information to the appropriate mailbox (rms@ages.at, basg-cms@ages.at or nat@ages.at) respectively.

8. Which file formats should be used when submitting SmPCs, PLs, and Labelling?

For updated information on the submission of the product information to the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG)/AGES Austrian Medicines and Medical Devices Agency (AGES Medizinmarktaufsicht) please refer to the FAQ eServices "Marketing Authorisation & Lifecycle Management of Medicines".

9. Are there any stylistic recommendations?

The stylistic recommendations have been agreed upon between the departments of the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG)/AGES Austrian Medicines and Medical Devices Agency (AGES Medizinmarktaufsicht) and are summarised in the document Empfohlene Vorgehensweise für stilistische Belange (‘Stylistic recommendations,’ available in German only). The document is a work in progress. Therefore, if you would like to see additional items included in the list, please send an email to qrd@ages.at.

    10. When do the Blue Box requirements for Austria apply?

    The Blue Box requirements for Austria have to be applied to translations of the product information submitted in the national phase.

    CMDh/258/2012/Rev.9 March 2016

     

    Reference to Blue Box requirements applied for centralised procedures:

    Notice to Applicants, Guideline on the Packinging Information of Medicinal Products for human use authorised by the Union Revision 14.3 July 2015

    11. When were the updated versions of the QRD templates published? Which timelines apply for adapting the product information to the new template?

    The 2010 Pharmacovigilance legislation (Regulation EU No 1235/2010; Directive 2010/84/EU) also affects the product information.


    The Working Group on Quality Review of Documents (QRD) of the European Medicines Agency (EMA) published the revised version of the QRD template in March 2013 for centralised and decentralised procedures.


    For all products a standardised statement asking healthcare professionals and patients to report any suspected adverse reactions (ADRs) has to be added in section 4.8 of the SmPC and section 4 of the PL. In addition, the details regarding national reporting systems have to be provided (see FAQ 11.1). According to Art 94h para 4 AMG this standardised statement had to be implemented until 01-July-2014.


    Marketing authorisation holders should have implemented the revised template in the course of the next text-relevant regulatory activity (type II variation, type IB variation, renewal, or line extension) until 01-July-2014.

     

    In case Austria is CMS, the time-limits of the RMS can be accepted if necessary.

     

    If no text-relevant regulatory procedure is foreseen, a type IAin (C.I.z) variation should be submitted. The corresponding classification can be found on the website of the CMD(h): http://www.hma.eu/293.html (CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 (July 2013)).


    For products subject to additional monitoring a black triangle (size proportional to the font size of the subsequent standardised text and each side of the triangle shall have a minimum length of 5 mm) and a standardised explanatory sentence have to be implemented in SmPC and PL.

     

    A publicly available list according to Art 23 Regulation (EC) 726/2004, kept up to date by the EMA, is the basis for this.

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000366.jsp&mid=WC0b01ac058067c852

     

     

    Implementation of the black triangle and the standardised explanatory sentence have to follow the Commission Implementing Regulation (EU) No 198/2013 and for products subject to additional monitoring authorised before 01-Sep-2013 compliance with the revised QRD template must have been achieved no later than 31-Dec-2013. Marketing authorisation holders may request a longer period of time to be granted by the competent authorities, where they can demonstrate that compliance with this date may unduly affect the appropriate and continued supply of the medicinal product. In addition, stocks of human medicinal products produced, packaged and labelled before 01-Jan-2014, which do not include the black triangle in the package leaflet may continue to be placed on the market, distributed, dispensed, sold, and used until stocks are exhausted.


    An “Implementation plan for centrally approved medicinal products” is available at the EMA website.

    11.1. What do I have to consider regarding the inclusion of the details of the national reporting systems in SmPC and PL?

    The list of details of the national reporting systems to communicate adverse reactions is published on the EMA website in a special document, Appendix V.


    Attention should be paid to the difference between the electronic version of SmPC and PL (i.e. regarding MR/DC procedures the final English texts which are published on the HMA website) referring to Appendix V with an according hyperlink, and the German version for the printed materials where no reference to Appendix V should be included, but the actual details of the national reporting system (as listed within this Appendix V) of the concerned Member State(s) shall be displayed instead.


    Further information can be found in the guidance document below and in the “annotated template” published on the EMA website.

    12. Do we have to use all headings and standard sentences from the QRD template?

    Yes, the standard sentences and headings in the QRD template have to be used. Standard sentences and headings that do not apply to a particular medicinal product because of the nature of the product can be omitted. Please be sure to adhere to the bracketing conventions as explained in the annotated QRD template: {Text in curly brackets} is to be replaced with product-specific information (e.g., {name of the medicinal product}). Depending on the medicinal product, <text in angle brackets> is to be selected or deleted as appropriate (e.g., <The tablet can be divided into equal doses.>).


    If you have further questions regarding the use of QRD templates, please write an email to qrd@ages.at. Any deviations from the standard sentences or headings given in the templates should be explained and justified in Module 1.3.4.

    12.1 Do we have to include a reference to healthcare professionals in the package leaflet?

    In the Austrian Package Leaflet a reference to healthcare professionals (German term: “medizinisches Fachpersonal”) in terms of medical advice, advice regarding administration of medicinal products or administration of medicinal products is - in accordance with Austrian law – not always applicable.


    The bracketing convention according to the QRD template allows the omittance of any such reference in the Austrian PL. The decision whether such a reference is appropriate regarding the respective medicinal product is at the applicant’s discretion.

    13. Placement of a QR-Code (Quick Response-Code) in Summary of Product Characteristics, Package Leaflet or Labelling – what do I have to consider and what is the procedure?

    QR Codes are two-dimensional (2D-) barcodes, consisting of black and white square dots, providing information that can be accessed via smartphones. Usually they link via internet to the encoded information.

     

    The “CMD(h) position paper on the use of QR Codes to provide information about the medicinal product” was published in April 2014.
    According to this document a QR code can be submitted via
    - a marketing authorisation application (not later than D106) or
    - an art 61(3) notification (P-notification) or
    - may be included in another Type IB, Type II, ‘C’ category only variation affecting the product information or Renewal.

     

    Details regarding submission can be found in this document and have to be followed for national and MR-/DC-procedures and the “Template for the Applicant declaration” (Annex 2) has to be used.
    For submissions via variation procedures the request for a QR Code should be included in the application form (“Scope of variation”).

    13.1. Placement of a Speech Code in Summary of product characteristics, Package leaflet or Labelling – what do I have to consider and what is the procedure?

    Speech Codes are two-dimensional (2D-) barcodes, consisting of colored dots, which contain the provided information within the code. Amongst other things they have been designed to work as “Speaking Package Leaflet”.
    The Placement of a Speech Code in the Labelling or Package Leaflet is acceptable in Austria for all medicinal products.
    Preferably, the Speech Code should be placed in the package leaflet under the heading “other sources of information” according to the QRD template.
    With this application a complete account of the contents of the Speech Code has to be submitted.

    If you have further questions, please write an email to the corresponding email-address according to our assignment of procedures.

    * This partial English translation of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) is provided for convenience only. The original German-language version of the Austrian AMG is the only legally binding and authoritative version.
    For the original German-language version of the Austrian AMG as amended, please go to RIS.

    14. Which date shall be used as date of (last) revision in the product information?

    Variations:

     

    Please refer to: End of procedure date in the SPC and PIL

     

     

    MRP/DCP Renewal:

     

    9. Date of first authorisation/renewal of the authorisation:

    Date of first authorisation: Date of the national authorisation

    Date of latest renewal: Common Renewal Date

     

    10. Date of revision of the text:

    Approval date of the renewal procedure

     

    The national implementation date of the renewal is not reflected in the SmPC.

    15. How does the Delegated Regulation (EU) 2016/161 for the Safety features impact the product information? Which timelines apply for the implementation?

    In accordance with the Delegated Regulation (EU) 2016/161 a revised QRD template has been published on 09.02.2016 to enable the implementation of the unique identifier in the labelling.

    The QRD template for the labelling has been supplemented with two sections:

    Section 17: Unique Identifier – 2D Barcode

    Section 18: Unique Identifier – human readable data

     

    Links:

    CMD(h) annotated QRD template

    QRD Templates (EMA Website)

     

    According to the CMD(h) Implementation plan for new marketing authorisation applications (national/MR/DC procedures) submitted from 1st April 2016 the revised QRD template should be used, but the revised QRD template and ATD are not conditions of validation of the application but should be submitted at the earliest opportunity during the evaluation of the application.

     

    For existing approved marketing authorisations the safety features – if applicable - have to be implemented until 09th February 2019, from this date the Delegated Regulation will apply.

    Details can be found in the Implementation plan on the CMD(h) Website.

    16. At what time do mock ups have to be submitted?

    Mock ups of the labelling (primary packaging and secondary packaging) have to be submitted within marketing authorisation procedure.
    Mock ups of different strengths and dosage forms have to be distinguishable from each other (e.g. different colours).

    Created: 15.04.2009 | Page last modified: 10.03.2016

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