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Commission Delegated Regulation (EU) 2016/161 ANNEX I

Commission Delegated Regulation (EU) 2016/161 ANNEX I

ANNEX ISupplementary provisions

ANNEX I List of medicinal products or product categories subject to prescription that shall not bear the safety features, referred to in Article 45(1) Name of active substance or product category Pharmaceutical form Strength Remarks Homeopathic medicinal products Any Any   Radionuclide generators Any Any   Kits Any Any   Radionuclide precursors Any Any   Advanced therapy medicinal products which contain or consist of tissues or cells Any Any   Medicinal gases Medicinal gas Any   Solutions for parenteral nutrition having an anatomical therapeutical chemical (‘ATC’) code beginning with B05BA Solution for infusion Any   Solutions affecting the electrolyte balance having an ATC code beginning with B05BB Solution for infusion Any   Solutions producing osmotic diuresis having an ATC code beginning with B05BC Solution for infusion Any   Intravenous solution additives having an ATC code beginning with B05X Any Any   Solvents and diluting agents, including irrigating solutions, having an ATC code beginning with V07AB Any Any   Contrast media having an ATC code beginning with V08 Any Any   Tests for allergic diseases having an ATC code beginning with V04CL Any Any   Allergen extracts having an ATC code beginning with V01AA Any Any

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Other provisions in Commission Delegated Regulation (EU) 2016/161

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

CitationANNEX I of Commission Delegated Regulation (EU) 2016/161 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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