The wording of the PAM will describe the issue under investigation that has led to the request together with a clear outline of the studies or activities expected to address it and the deadline for its submission. PAMs other than specific obligations can be required for any type of authorisation and will be included in the opinion of an initial marketing authorisation or further to the committees' assessment during post-authorisation. Only certain medicinal products can be subject to specific obligations (see also ' What is a Specific Obligation?'). cumulative review following a request originating from a PSUR or a signal evaluation ,Corrective Action/Preventive Action (CAPA), paediatric submissions, MAH's justification for not submitting a requested variation) interim results of imposed/non-imposed interventional/non-interventional clinical or nonclinical studies)
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |