The FAMHP  Vigilance department has found several encoding errors in the Article 57 database of the EMA. Some medicines licensed in Belgium appear two or three times in the database, in two or three national languages. As a result, they are registered multiple times for the same marketing authorization (MA). Every medicine may only be coded once based on the MA number (BE #).

As MA holders are encouraged by EMA to carefully check and correct the registered entries of their different medicines in the database if necessary, FAMHP is asking marketing authorization holders to check whether their registered data are correct.


More information can be found here.

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