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Applications for Changes of the Labelling or PIL Not Associated with SmPC (Type P Variations)

SÚKL informs marketing authorisation holders (MAH) about the aspects of submitting applications for changes of the labelling or PIL not associated with the SmPC (Notification under Article 61(3) of Directive 2001/83/EC and under Section 35(5) of the Act on Pharmaceuticals; so called Type P variations), incl. procedural differences between national and MRP variations and how to distinguish between them in specific cases.  

National Type P variations

 

Cases where applications for national Type P variations are to be submitted

Applications for national Type P variations shall be submitted for medicinal products authorised nationally and for medicinal products authorised via MRP/DCP with the Czech Republic as the Reference Member State (RMS) or Concerned Member State (CMS), where national requirements are concerned, e.g., changes to the design of Czech mock-ups or changes only to the Czech texts of the labelling or PIL not associated with the SmPC (i.e., if other states involved in the procedure do not require the submission of an application for changes to common English mock-ups or the common English texts of the labelling or PIL not associated with the SmPC).

Specifically, the changes most frequently submitted as applications for national Type P variations are the following ones:

-  Change to the design of Czech mock-ups (e.g., change of colour, addition/deletion of symbols and pictograms; for more information, please refer to the effective version of guideline REG-96);

- Corrections of the Czech texts of the labelling or PIL;

- Addition/change to the texts of the labelling or PIL of a nationally authorised medicinal product for which there is no classification specified by the Regulation on variations;

-  Change to the text of the labelling as per the QRD product-information template of a nationally authorised medicinal product – only in case the QRD product-information template has already been implemented to the SmPC and PIL within another procedure;

-  Introduction of a multilanguage labelling, change to the number of languages on the labelling, introduction of a foreign-language text of the labelling:

  • The content of the texts of the labelling and PIL in multiple languages has to be identical; compared to previous version, the submitted texts may only contain formal amendments (e.g., expiry date changed to “EXP”) – in the application, it is necessary to declare that the content of the Czech and foreign-language texts of the labelling is identical and that no content amendment has been made to the submitted texts since the last approval;
  • The submitted dossier must always include mock-ups;
  • Where the only change is that of a language on a previously approved multilanguage labelling, it is not necessary to submit a national Type P variation; it shall suffice to send this information to the following e-mail address: mock-upy@sukl_cz;

- Change to the box size (secondary packaging), if affecting the readability, i.e., requiring a font size change or change to the design;

- Change for addition of a QR code or another scanning technology for a nationally authorised medicinal product (requirements are defined by document CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product, which is available from here, and by the effective version of guideline REG-96).

 

Procedural aspects of applications for national Type P variations

For national Type P variations governed by Section 35(5) of the Act on Pharmaceuticals, the following shall be submitted:

-  Cover letter specifying the type of an application;

-   Application for national Type P variation, which is to be submitted only for one marketing authorisation of a medicinal product (for each MA number separately; grouping cannot be applied to Type P variations), on a completely filled-in effective version of form REG-90, which is available from here;

-   In the application form for national Type P variation, it is always necessary to:

  • Specify the MAH and, if applicable, his representative authorised by a Power of Attorney (information on Powers of Attorney and their specimens are available from here);
  • Select the type of change (several types may be selected); in case of a change type not mentioned herein, it is necessary to provide an additional specification of this change;
  • Provide information on any pending or parallelly submitted applications for the same medicinal product;
  • Provide a detailed description and background for all of the proposed changes;
  • Specify the respective section of the present and proposed text of the labelling or PIL – changed words have to be underlined or highlighted;
  • Tick or specify any submitted documents;
  • Complete the full applicant's declaration, incl. implementation of the submitted variation (detailed information on the implementation is available from here);

-  Prior to the submission of the application, it is mandatory to pay an administrative fee in the amount of 2,000 CZK (code S-001) and covering expenditures in the amount of 6,000 CZK (code R-008); the documents to be submitted are the payment orders of the administrative fee and covering expenditures specifying the variable symbols necessary for the payments thereof, which should be generated from here for the administrative fee and from here for covering expenditures;  

-  In case of changes to the texts of the labelling or PIL, it is necessary to submit updated texts of the labelling or PIL in the MS Word format (track version with all of the revisions from the approved version highlighted, and clean version);

- In case of changes to the mock-ups, it is necessary to submit the currently approved version of the mock-ups (if available) and the newly proposed graphic design thereof (for more information, please refer to the effective version of guideline REG-96);

- It is strongly recommended to submit the application in the eCTD format, nevertheless, the NeeS format complied with the effective validation criteria is also acceptable; for more information on the format of dossier for national Type P variations to medicinal products authorised via MRP/DCP, please refer to sections 4.6 and 4.8 of document CMDh Best Practice Guide on the use of eCTD in the MRP/DCP;

-  The application must be sent officially, i.e., via CESP, data mailbox (in these cases, a scan of a signature of the MAH or his authorised representative shall be sufficient on the cover letter and on the application form) or via e-mail with a certified electronic signature of the MAH or his authorised representative sent to posta@sukl_cz.

 

Following validation of the application for national Type P variation, SÚKL shall send an e-mail confirmation of the payments made; no notification of application completeness shall be issued.

If the submitted application for national Type P variation meets all of the particulars and it is complete, it shall be approved within 90 days of the delivery and a notification of approval along with the relevant texts of the labelling or PIL shall be issued. If the change does not require amendments to the texts of the labelling or PIL (e.g., where mock-ups only are changed), SÚKL shall issue only a notification of approval.

If the submitted application does not contain the required particulars, a request for supplementary information within the timeline of 30 days shall be issued; in compliance with Section 35(5) of the Act on Pharmaceuticals, amendment of the application may only be made once. In case not all of the deficiencies have been eliminated within the established timeline, a decision on rejection of the application shall be issued within the timeline of further 30 days. Where all of the deficiencies have been eliminated within the established timeline, the procedure shall be resumed as of the date of delivery of amendment and, within the timeline of further 30 days, a notification of approval shall be issued along with the relevant texts of the labelling or PIL (if the change requires amendment thereof).

The date of revision specified in the issued PIL shall be the date as of which the notification of approval is issued.  

 

 

MRP Type P Variations

 

Cases where applications for MRP Type P variations are to be submitted

Applications for MRP Type P variations shall be submitted for medicinal products authorised via MRP/DCP with the Czech Republic as the RMS or CMS, where changes to the design of common English mock-ups or changes to the common English texts of the labelling or PIL not associated with the SmPC are concerned (i.e., changes that have to be made to the common texts and thereafter to the Czech texts). Specifically, the changes most frequently submitted as applications for MRP Type P variations are the following ones:

-  Change to the design of common mock-ups, unless Czech mock-ups have been submitted for approval, and common mock-ups hence apply also to the Czech market;

-  Corrections of common (and subsequently Czech) texts of the labelling or PIL;

-  Addition/change to the common (and subsequently Czech) texts of the labelling or PIL of a MRP/DCP authorised medicinal product for which there is no classification specified by the Regulation on variations;

-  Change to the common (and subsequently Czech) text of the labelling as per the QRD product-information template of a MRP/DCP authorised medicinal product – only in case the QRD product-information template has already been implemented to the SmPC and PIL within another procedure;

-  Introduction of a multilanguage labelling in compliance with document CMDh Best Practice Guide on Multilingual Packaging, which is available from here;

-  Change for addition of a QR code or another scanning technology for a MRP/DCP authorised medicinal product (requirements are defined by document CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product, which is available from here, and by the effective version of guideline REG-96).

 

Procedural aspects of applications for MRP Type P variations

For MRP Type P variations governed by Art. 61(3) of Directive 2001/83/EC, the following shall be submitted:

-  Cover letter specifying the type of an application;

-   Application for MRP Type P variation, which is to be submitted only for one marketing authorisation of a medicinal product (for each MA number separately; grouping cannot be applied to Type P variations), on a completely filled-in Notification Form, which is available from here;

-   A joint application for medicinal products of the same MRP number (i.e. for a medicinal product with several strengths) may be submitted only in case such application submission is permitted by the RMS;

-   In the application form for MRP Type P variation, it is always necessary to:

  • Specify the MAH and, if applicable, his representative authorised by a Power of Attorney (information on Powers of Attorney and their specimens are available from here);
  • Provide a detailed description and background for all of the proposed changes;
  • Tick any submitted documents;
  • Complete the full applicant's declaration, incl. implementation of the submitted variation (detailed information on the implementation is available from here);

-  Prior to the submission of the application, it is mandatory to pay an administrative fee in the amount of 2,000 CZK (code S-001) and covering expenditures in the amount of 12,000 CZK (code R-025) for a medicinal product with the Czech Republic acting as the RMS, or in the amount of 4,000 CZK (code R-034) for a medicinal product with the Czech Republic acting as the CMS (if the RMS permits a joint application for several medicinal products, covering expenditures shall be paid for each additional product in the amount of 50% of the aforementioned amounts); the documents to be submitted are the payment orders of the administrative fee and covering expenditures specifying the variable symbols necessary for the payments thereof, which should be generated from here for the administrative fee and from here for covering expenditures (in case of a joint application for several products, the number of additional products shall be specified in the “Number of additional medicinal products involved into application” field of the web form for the payment of covering expenditures; thereafter, the payment order stating the total amount of covering expenditures will be generated);    

-  In case of changes to the texts of the labelling or PIL, it is necessary to submit updated common and Czech texts of the labelling or PIL in the MS Word format (track version with all of the revisions from the approved version highlighted, and clean version);

-   In case of changes to the mock-ups, it is necessary to submit the currently approved version of the mock-ups (if available) and the newly proposed graphic design thereof (for more information, please refer to the effective version of guideline REG-96);

-  The application must be submitted in the eCTD format;

-  The application must be sent officially, i.e., via CESP (a scan of a signature of the MAH or his authorised representative shall be sufficient on the cover letter and on the application form).

 

MRP Type P variations have their own series of sequential numbers and are separate to other procedures, and their form is CC/H/nnnn/sss/P/001, with next Type P variation (regardless of the number of Type IA, IB, II variations to MA submitted in the meantime) bearing an identifier in the form CC/H/nnnn/sss/P/002, etc.

The MRP Type P variation flowchart is available from document CMDh Flowchart for Article 61(3) Procedure here. In case the change is approved by the RMS, a notification of approval shall be issued along with the relevant texts of the labelling or PIL. If the change does not require amendments to the texts of the labelling or PIL (e.g., where mock-ups only are changed), SÚKL does not issue anything. If the RMS rejects the change, a decision on rejection of the application shall be issued.

The date of revision specified in the issued PIL shall be the date of change approval by the RMS (so called End of Procedure).

 

 

Detailed information on the placement on the market of the medicinal product complying with dossier prior to the implementation of the change, so called final sale, which is identical both for the national and MRP Type P variations, is available from here.

 

 

Marketing Authorisation Section

29 August 2022

 

 

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