Executive Decree No.95 of 14 May 2019 has been issued and published in Official Gazette No.28776-B of 17 May 2019 as a new amended and restated regulation on medicinal and health products.
The 2001 regulations have been superseded by Executive Decree No.95, mainly due to advancements in scientific and technological fields. The regulation also includes new fees for registration of health products before the Pharmacy and Drugs National Directorate.
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