EU: Updated additional data requirements for MRP/DCP published by CMD(h)
The CMD(h) published an updated table (revision 5) for
"Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document(CTD) and/or in the EEA approved Guidelines/Recommendation papers". The last update (revision 4) was published in early April this year (see our related News Article).
The recent update includes additional requirements for Hungary. The Hungarian National Institute for Pharmacy (NIP) now also requests
Annex 5.4 Letter of authorisation for communication on behalf of the applicant/MAH (the signatures must be officially authenticated by a notary or Administrative official)
Application form, Annex 5.22 with original signature
The revised table is available for download from the CMD(h) website (see link below).