Expanding the submission of opinions reflecting permission

as a result of the reexamination

Add a pre-announcement procedure for 14 days to classify the Adverse effect analysis results

Opportunities for submitting opinions from industries will be expanded when reflecting permits based on the results of the reexamination.

 

A pre-announcement procedure is added to the previous opinion inquiry.

 

The MFDS announced that since the 27th of last month, the procedure for reflecting permits based on the results of the reexamination has been improved and applied.

 

There was a 14-day period of submitting opinions through "Inquiry on Opinions on Permit Change" before reflecting the results of the retrial in the permission.

 

An opportunity to submit opinions will be given one more time.

 

An official from the MFDS said, "It is expected that opportunities for the industry to submit opinions will expand through a pre-announcement period." A total of 28 days of opinion submission period will be given.

 

At the end of the pre-announcement period, a change order will be issued as before.

 

After the change order, the changes in permission matters within three months must be reflected in the product insert.

 

In this improvement plan, in order to distinguish between PMS survey results and general post-marketing adverse effect analysis evaluation, it will be divided into domestic post-marketing adverse effect analysis results and domestic post-marketing adverse effect analysis evaluation results.

 

The results of the analysis and evaluation of the adverse effect after domestic marketing are the same as the existing re-examination method.

 

An official from the MFDS explained, "We distinguish between the results of the adverse effect analysis collected in the post-market survey and the results of the adverse effect analysis reported after the market and reflect them in the permit, but we revised the phrase to clarify the analysis results." The improvement of the method of writing the improvement plan will be applied from the change of permission after the 27th of last month, and the pre-announcement period will be given from the items for re-examination received after the same day.