http://www.legislation.gov.uk/eur/2016/161/signature/adoptedCommission 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)Commission Delegated Regulation (EU) 2016/161Commission 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)2021-02-16King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32016R0161texttext/xmlen This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 2 October 2015. For the Commission The President Jean-Claude Juncker
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<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-6" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/6">reg. 6</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect RequiresApplied="false" AffectingEffectsExtent="E+W+S+N.I." AffectedProvisions="Art. 12" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)" AffectedClass="EuropeanUnionRegulation" Type="modified by S.I. 2012/1916, reg. 36(4)(5) (as inserted)" AffectingYear="2019" Row="13" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" AffectedNumber="161" AffectingNumber="62" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedYear="2016" AffectingProvisions="reg. 4" URI="http://www.legislation.gov.uk/id/effect/key-4786526a0f0c83db167328f97c761dbd" EffectId="key-4786526a0f0c83db167328f97c761dbd" Modified="2024-08-20T18:30:38Z">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-12" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/12">Art. 12</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/4">reg. 4</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedNumber="161" AffectedYear="2016" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" Row="14" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" Type="modified by S.I. 2012/1916, reg. 42(4)(5) (as inserted)" AffectedProvisions="Art. 12" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingProvisions="reg. 6" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)" EffectId="key-214434d1c3c8790dfdadca9d732c9dfd" URI="http://www.legislation.gov.uk/id/effect/key-214434d1c3c8790dfdadca9d732c9dfd" AffectingYear="2019" AffectingEffectsExtent="E+W+S+N.I." AffectedClass="EuropeanUnionRegulation" AffectingNumber="62" Modified="2024-08-20T18:30:38Z" RequiresApplied="false">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-12" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/12">Art. 12</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-6" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/6">reg. 6</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingClass="UnitedKingdomStatutoryInstrument" EffectId="key-70eed2fea9e77cf14c702b689f318610" AffectingYear="2019" AffectingNumber="62" Row="15" Type="modified by S.I. 2012/1916, reg. 36(4)(5) (as inserted)" AffectingProvisions="reg. 4" AffectedProvisions="Art. 13" URI="http://www.legislation.gov.uk/id/effect/key-70eed2fea9e77cf14c702b689f318610" AffectingEffectsExtent="E+W+S+N.I." AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" AffectedNumber="161" RequiresApplied="false" AffectedClass="EuropeanUnionRegulation" AffectedYear="2016" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" Modified="2024-08-20T18:30:38Z">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-13" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/13">Art. 13</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/4">reg. 4</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" AffectedNumber="161" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedProvisions="Art. 13" AffectingEffectsExtent="E+W+S+N.I." AffectingNumber="62" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)" AffectingYear="2019" AffectingProvisions="reg. 6" AffectedYear="2016" AffectedClass="EuropeanUnionRegulation" Modified="2024-08-20T18:30:38Z" Type="modified by S.I. 2012/1916, reg. 42(4)(5) (as inserted)" URI="http://www.legislation.gov.uk/id/effect/key-b0c9c8fbf25f3e1159bc38f798df545f" Row="16" RequiresApplied="false" EffectId="key-b0c9c8fbf25f3e1159bc38f798df545f" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-13" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/13">Art. 13</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-6" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/6">reg. 6</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect EffectId="key-cadc5a5e6625d1ccb070af935946d5ef" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingProvisions="reg. 4" AffectedNumber="161" AffectingEffectsExtent="E+W+S+N.I." AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" URI="http://www.legislation.gov.uk/id/effect/key-cadc5a5e6625d1ccb070af935946d5ef" AffectedProvisions="Art. 14" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" AffectedYear="2016" RequiresApplied="false" Row="17" AffectedClass="EuropeanUnionRegulation" Modified="2024-08-20T18:30:38Z" AffectingNumber="62" AffectingYear="2019" Type="modified by S.I. 2012/1916, reg. 36(4)(5) (as inserted)" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-14" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/14">Art. 14</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/4">reg. 4</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingClass="UnitedKingdomStatutoryInstrument" AffectedNumber="161" Modified="2024-08-20T18:30:38Z" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)" Row="18" AffectingEffectsExtent="E+W+S+N.I." AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" URI="http://www.legislation.gov.uk/id/effect/key-ffd4a8c5946d8be9c5724c2d30346aa1" AffectingProvisions="reg. 4" RequiresApplied="false" AffectedProvisions="Art. 15" EffectId="key-ffd4a8c5946d8be9c5724c2d30346aa1" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" AffectingYear="2019" AffectingNumber="62" AffectedClass="EuropeanUnionRegulation" Type="modified by S.I. 2012/1916, reg. 36(4)(5) (as inserted)" AffectedYear="2016">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-15" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/15">Art. 15</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/4">reg. 4</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedYear="2016" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" AffectingYear="2019" AffectingEffectsExtent="E+W+S+N.I." RequiresApplied="false" AffectedClass="EuropeanUnionRegulation" AffectingProvisions="reg. 4" Row="19" Type="modified by S.I. 2012/1916, reg. 36(4)(5) (as inserted)" URI="http://www.legislation.gov.uk/id/effect/key-d45c4d9606996a61e5d2f0cbb69da8f0" AffectedProvisions="Art. 16" AffectedNumber="161" Modified="2024-08-20T18:30:38Z" AffectingNumber="62" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" EffectId="key-d45c4d9606996a61e5d2f0cbb69da8f0" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-16" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/16">Art. 16</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/4">reg. 4</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect Type="modified by S.I. 2012/1916, reg. 36(4)(5) (as inserted)" AffectedProvisions="Art. 17" URI="http://www.legislation.gov.uk/id/effect/key-19c89933c602e59ddccc83aca7c41992" AffectedClass="EuropeanUnionRegulation" AffectedNumber="161" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" Modified="2024-08-20T18:30:38Z" AffectingClass="UnitedKingdomStatutoryInstrument" AffectingProvisions="reg. 4" AffectingEffectsExtent="E+W+S+N.I." AffectingYear="2019" EffectId="key-19c89933c602e59ddccc83aca7c41992" RequiresApplied="false" Row="20" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" AffectingNumber="62" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)" AffectedYear="2016">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-17" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/17">Art. 17</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/4">reg. 4</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect URI="http://www.legislation.gov.uk/id/effect/key-ceef93d3cd157b52f6abf396bdf9caa5" Modified="2024-08-20T18:30:38Z" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" AffectingYear="2019" Row="21" AffectingClass="UnitedKingdomStatutoryInstrument" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" AffectedProvisions="Art. 18" AffectingEffectsExtent="E+W+S+N.I." AffectedClass="EuropeanUnionRegulation" AffectingProvisions="reg. 4" RequiresApplied="false" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)" AffectedNumber="161" AffectedYear="2016" Type="modified by S.I. 2012/1916, reg. 36(4)(5) (as inserted)" EffectId="key-ceef93d3cd157b52f6abf396bdf9caa5" AffectingNumber="62">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-18" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/18">Art. 18</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/4">reg. 4</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectingEffectsExtent="E+W+S+N.I." URI="http://www.legislation.gov.uk/id/effect/key-97c40bf652cc7f438e7eb4bda4bf18a6" AffectingNumber="62" Row="22" AffectedProvisions="Art. 20" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" AffectedNumber="161" Modified="2024-08-20T18:30:38Z" Type="applied (with modifications) by S.I. 2012/1916, reg. 36(6)(7) (as inserted)" RequiresApplied="false" AffectedYear="2016" EffectId="key-97c40bf652cc7f438e7eb4bda4bf18a6" AffectingProvisions="reg. 4" AffectedClass="EuropeanUnionRegulation" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" AffectingYear="2019" AffectingClass="UnitedKingdomStatutoryInstrument" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-20" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/20">Art. 20</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-4" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/4">reg. 4</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
<ukm:UnappliedEffect AffectedClass="EuropeanUnionRegulation" AffectedYear="2016" URI="http://www.legislation.gov.uk/id/effect/key-4f206d00e4136e71520960ae26612a52" AffectedURI="http://www.legislation.gov.uk/id/eur/2016/161" AffectedNumber="161" RequiresApplied="false" AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/62" EffectId="key-4f206d00e4136e71520960ae26612a52" Modified="2024-08-20T18:30:38Z" AffectingYear="2019" AffectedProvisions="Art. 20" Row="23" AffectingEffectsExtent="E+W+S+N.I." AffectingNumber="62" AffectingClass="UnitedKingdomStatutoryInstrument" Notes="This amendment not applied to legislation.gov.uk. Regulation (EU) 2016/161 revoked on IP completion day by S.I. 2019/755, reg. 1, Sch. 9 para. 1(hh)" Type="modified by S.I. 2012/1916, reg. 42(4)(5) (as inserted)" AffectingProvisions="reg. 6">
<ukm:AffectedTitle>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)</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="article-20" URI="http://www.legislation.gov.uk/id/eur/2016/161/article/20">Art. 20</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Human Medicines (Amendment) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-6" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/6">reg. 6</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/62/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2019-02-09" Qualification="wholly in force"/>
</ukm:InForceDates>
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<Para>
<Text>This Regulation shall be binding in its entirety and directly applicable in all Member States.</Text>
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<Signatory>
<Para>
<Text>Done at Brussels, 2 October 2015.</Text>
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<Signee>
<Para>
<Text>
<Emphasis>For the Commission</Emphasis>
</Text>
</Para>
<Para>
<Text>
<Emphasis>The President</Emphasis>
</Text>
</Para>
<Para>
<Text>
Jean-Claude
<Uppercase>Juncker</Uppercase>
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