Authorization of medicines with proven quality has been simplified

A greater number of medicines with proven quality will become more available in Moldova, as the Ministry of Health has simplified the procedure of authorizing them.

The simplified rules will apply to the drugs registered by the EU's European Medicines Agency, or at least in any European Economic Area country, or in Switzerland, the United States, Canada, Japan and Australia. Manufacturers from these countries will no longer be required to provide samples to get authorized in Moldova.

The applicants however will have to submit a statement certifying that the application submitted in Moldova is identical to the one sumbitted to EMA or to the relevant authorities of the named countries.

Also, the period of examining applications has been reduced to 60 days from 210 days before.

Earlier, Healh Minister Ruxanda Glavan said that many medicines were not available in our country and vowed to remove bureaucratic procedures. 

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