The Process of Submitting National Translations

The Marketing Authorizing Holder (MAH) should submit the national translation of the Product Information (PI) text as Word documents to the agency to grant national Marketing Authorization after completing MRP, DCP, and Variations impacting PI text. The national translations and applications outside the eCTD or NeeS structure (working documents) shall be submitted.

Management of the national phase of marketing authorization application in the European Union post-MRP/DCP involves planning and proper execution. This anticipation would help to manage the national phase in a shorter time frame. The first step would be to evaluate the blue box and region-specific requirements well in advance. This is key in reimbursement status checks and prescription box requirements. To be more efficient, parallel region-specific translations can be arranged well before the estimated approval date; however, the MAH should ensure that there won’t be any open concerns for standard PI text during the last phase of the application assessment. What happens if there are open concerns about PI text? The MAH should refer to the PI text received and the End of Procedure letter for translation.


Regional considerations for translated PI

The regional requirement should be implemented in the translated PI file in line with region-specific guidance. A few criteria to be taken into account for the linguistic update or review of the PI would be:

  • Compliance of the translation with the final agreed English PI,
  • Use of the QRD template,
  • Country-specific national language version,
  • Compliance with specific national requirements regarding specific style sheets of the texts,
  • Use of the appropriate scientific terminology,
  • Consistency of terminology with other medicinal products (innovator, generic, or class-similar medicinal products) already approved by the NCA,
  • User-friendly terms and National Blue Box requirements.

Moreover, the submission format of national phase documents, for example, Z-form (Germany- BfArM), SPC fragments (United Kingdom – MHRA), and AMM forms (ANSM – France) can be considered critical documents, as accurate and timely submission of these documents ensures the smooth processing of national phase.


What about Mockups during the phase of MRP/DCP process?

In addition, submission of the mockups during the national phase of the MRP/DCP process is critical to ensure patient safety; therefore, adhering to the regional requirements and guidelines during mockup preparation is essential. Further, the MAH must consider the requirement of multilingual mockups at the beginning of the MA application to accomplish shared packaging promptly and effectively.

In conclusion, during the submission of national phase documents to the agency, careful attention to regulatory requirements and close coordination with health authorities are the most significant aspects of accomplishing the national phase within a shorter timeframe.


Consider PLG to support your National Phase Management

At ProductLife Group, we specialize in managing the national phase in a shorter timespan with regional experts located across different geographies to help you reduce time to market.

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Best practices for National Phase Management in EU post-MRP/DCP