Commission Decision (EU) 2021/1125 of 8 July 2021 refusing to include the medicinal product subject to prescription Zinc-D-gluconate in the list of medicinal products that shall not bear the safety features referred to in Article 54, point (o), of Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance)

• CELEX: Decision (EU) 2021/1125
• Articles: 2

Article 1

The medicinal product subject to prescription Zinc-D-gluconate shall not be included in Annex I to Delegated Regulation (EU) 2016/161 and shall not be exempted from the requirement to bear the safety features referred to in Article 54, point (o), of Directive 2001/83/EC.

Article 2

This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .