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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)

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)

Decision (EU) 2021/1125 · Decision · 2 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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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

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

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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