![]() The marketing authorisation holder (MAH) shall provide the competent authority with a consolidated version of the file in respect of quality, safety and efficacy including an evaluation of data contained in suspected adverse reaction reports, Periodic Safety Update Report (PSUR) data (if applicable) and any relevant new information affecting the benefit/risk of the product together with a list of all variations introduced since the MA was granted. Examples of Periodic Safety Update Report in a sentenceĪs per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |