On the 3rd of August 2017, the Committee of the Eurasian Economic Union (EAEU) released the standards for EAEU electronic submissions.
The Board of the EAEU has published decisions on the electronic submission of drug applications. These include decisions 78 and 79 of the Board:
- Decision 78 gives details and clarifications on content & structure of the submissions. For existing applicants, this will involve changes in regulatory requirements. Due to the change of the modules / sections structure, existing applications will have to be re-structured to adapt the new structure and to comply with the current requirements. In general, the whole application procedure will change. From the 31st of December 2020, applicants will no longer be able to submit new applications as a national procedure, it will be replaced by either Decentralized Procedure (DCP) / Mutual Recognition Procedure (MRP).
- Decision 79 gives details on technical compliance of the electronic submissions. Additional XML files need to be provided alongside with the PDF documents for a drug application. The XML for the application form is known as “R.017” which contains information on the applicant company, the product, and the substance. A second XML “R.022” contains information on the documents submitted, together with specific identifiers for each document type.
What does it mean for the applicant? What is the to-do list?
For all your existing applications already approved in one of the EAEU member states, you should start getting prepared for the transition to the electronic format by:
- updating the content and structure of your application to be compliant with decision 78.
- making documents electronic by scanning / OCR processing or creating new ones.
Additionally, it is advised that you submit a baseline submission of your existing dossier in electronic form.
If you don’t have an existing and approved application within one of the EAEU member states, you are now able to start your application directly in the electronic format.