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Commission Delegated Regulation (EU) 2016/161Dangos y teitl llawn

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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This legislation may since have been updated - see the latest available (revised) version

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 categoryPharmaceutical formStrengthRemarks
Homeopathic medicinal productsAnyAny
Radionuclide generatorsAnyAny
KitsAnyAny
Radionuclide precursorsAnyAny
Advanced therapy medicinal products which contain or consist of tissues or cellsAnyAny
Medicinal gasesMedicinal gasAny
Solutions for parenteral nutrition having an anatomical therapeutical chemical (‘ATC’) code beginning with B05BASolution for infusionAny
Solutions affecting the electrolyte balance having an ATC code beginning with B05BBSolution for infusionAny
Solutions producing osmotic diuresis having an ATC code beginning with B05BCSolution for infusionAny
Intravenous solution additives having an ATC code beginning with B05XAnyAny
Solvents and diluting agents, including irrigating solutions, having an ATC code beginning with V07ABAnyAny
Contrast media having an ATC code beginning with V08AnyAny
Tests for allergic diseases having an ATC code beginning with V04CLAnyAny
Allergen extracts having an ATC code beginning with V01AAAnyAny

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 categoryPharmaceutical formStrengthRemarks
omeprazolegastro-resistant capsule, hard20 mg
omeprazolegastro-resistant capsule, hard40 mg

ANNEX III

Note: The number of entries is not binding.

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:
Entry NoActive substance (Common Name)Pharmaceutical formStrengthAnatomical Therapeutical Chemical (ATC) CodeSupporting 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.

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:
Entry NoActive substance (Common Name)Pharmaceutical formStrengthAnatomical Therapeutical Chemical (ATC) CodeComments/Complementary information
1
2
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