Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (Text with EEA relevance)
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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 |
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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 | |
ANNEX II List of medicinal products or product categories not subject to prescription that shall bear the safety features, referred to in Article 45(2)
Name of active substance or product category | Pharmaceutical form | Strength | Remarks |
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omeprazole | gastro-resistant capsule, hard | 20 mg | |
omeprazole | gastro-resistant capsule, hard | 40 mg | |
ANNEX III
Note: The number of entries is not binding.
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Notification to the European Commission of medicinal products not subject to prescription judged to be at risk of falsification, pursuant to article 54a(4) of Directive 2001/83/EC |
Member State: | Name of competent authority: |
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Entry No | Active substance (Common Name) | Pharmaceutical form | Strength | Anatomical Therapeutical Chemical (ATC) Code | Supporting Evidence(please provide evidence of one or more incidents of falsification in the legal supply chain and specify the source of the information). |
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ANNEX IV
Note: The number of entries is not binding.
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Notification to the European Commission of medicinal products judged not to be at risk of falsification, pursuant to article 54a(4) of Directive 2001/83/EC |
Member State: | Name of competent authority: |
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Entry No | Active substance (Common Name) | Pharmaceutical form | Strength | Anatomical Therapeutical Chemical (ATC) Code | Comments/Complementary information |
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