The AEMPS publishes new features in the treatment of drug registration dossiers
Source: actasanitaria.com
The Spanish Agency for Medicines and Health Products (AEMPS) has published the news regarding the submission of requests for regulatory activities of medicines for human use, being mandatory from January 1, 2019 the use of the eCTD format in all applications for authorization, variation and revalidation, both under national (NP) and European (MRP / CP / DCP) procedures, establishing a series of exceptions, in purely national procedures, included in Raefar II.
Once the mandatory use of the eCTD format has been established for all types of applications for the registration of medicines for human use as of January 1, 2019, and considering that the eCTD format, the aforementioned regulatory body indicates that it will always be recommended for all type of shipments and a series of exceptions are established, for which the NeeS format can still be used.
Regarding the exceptions, the AEMPS indicates that they apply to purely national requests, related to medicines approved by the National Procedure or by MRP / DCP. The activities to which this exception applies are, among others, transfer of ownership, request for request of national codes, advanced therapy, application of a centralized national code, modification of centralized and temporary suspensions.
For all the procedures included in this list, said Agency emphasizes that it will be mandatory to register in the corresponding application in Raefar. In addition, he adds that the procedures are included, as well as the values ??of the fields, Regulatory Activity and Subactivity, to be filled out in the CESP platform, in case of sending the support documentation for said platform.
From Distefar we eco the news presented by the AEMPS regarding the treatment of medication registration dossiers.
