Decision of the Chairman of the Board of Directors of the Emirates Medicines Agency No. 57 of 2025 Regarding the language used in the package leaflet for a medicinal product

Chairman of the Board of Directors of the Emirates Medicines Authority:

Having reviewed:

Federal Decree-Law No. 28 of 2023 establishing the Emirates Medicines Agency, And pursuant to Federal Decree-Law No. 38 of 2024 concerning medical products, the profession of pharmacy and pharmaceutical establishments,

In the public interest,

Has decided:

Article 1:

The words and terms used in this Decision shall have the meanings set out in Federal Decree-Law No. (38) of (2024), referred to above.

Article (2):

The use of at least Arabic and English is required in the printed or electronic package leaflet for a medicinal product; however, an exemption from the use of both or of either of these languages may be granted in any of the following cases:

1. Compassionate use of a medicinal product that has not been granted marketing authorisation in the State.
2. The use of a medicinal product intended for research, development and clinical trials prior to obtaining marketing authorisation.
3. Emergency use of a medical product.
4. Use of a...