In brief
The Spanish Agency for Medicines and Health Products has streamlined the procedure for applying for the national code (NC) of centrally authorized medicinal products. In order to have more efficient management, this change has been included in a guide containing information on the documents required for the assignment of the NC. From now on it will be possible to send the NC application as soon as the final texts have been adopted by the applicant and the regulatory agencies. Finally, it will also be possible to present the European Commission’s decision in English.
In more detail
The Spanish Agency for Medicines and Health Products (AEMPS) has recently streamlined the processing of the application for the national code (NC) of those medicines that have been authorized through the centralized procedure. In addition, the AEMPS has published a guide on its own website in which it has updated and compiled all the information on the documents required to assign an NC, as well as any future modifications that may be made. These changes are included in the “AEMPS’ Annual Work Plan 2022”, whose objectives include the optimization of its organizational management.
Currently, the new “Guidance on the submission of the national code and blue box application for centrally authorized medicinal products and subsequent amendments to the registration” details that pharmaceutical companies have the option to submit the NC application from the moment their final texts and translations are agreed between the applicant company and the regulatory agencies. This date is equivalent to the 237th day of the calendar that is usually followed for the authorization of centralized medicines. It should be noted that this will give companies and the AEMPS more time to review the information, which will make it easier to remedy any errors that may arise prior to the authorization of the medicinal product by the European Commission.
Another aspect that should not go unnoticed is that, as a novelty, the AEMPS will also allow English and Spanish to be used in the process of sending the European Commission’s decision, facilitating the completion of the application by reducing this requirement. In this regard, it will also no longer be necessary to send the European administrative data as an attachment to the relevant NC application.
With regard to this procedure, the list of modifications that involve the issuing of an official letter signed by the AEMPS to endorse the change has also been added. The figure of the batch releaser has also undergone changes with regard to the procedure for its update. Now it will only be necessary to attach an official document to endorse the identification of this figure without the need to add a NeeS sequence to carry out the update.
Detailed information on the new “Guidance on the submission of the national code and blue box application for centrally authorized medicinal products and subsequent amendments to the registration” can be found by clicking on this link.
