Agreement in the form of an Exchange of Diplomatic Notes with Japan in accordance with Article 15(3)(b) of the Agreement on Mutual Recognition (MRA) in order to amend Part B of the Sectoral Annex on Good Manufacturing Practice (GMP) for medicinal products

in forceEuropean Union· EUR-Lex· EN

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22 April 2016

Last action

22 April 2016 · Entry into force

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In force

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22 official languages

Bulgarian
Споразумение под формата на размяна на дипломатически ноти с Япония в съответствие с член 15, параграф 3, буква б) от Споразумението за взаимно признаване с цел да се измени Част Б на Секторното приложение относно добрите производствени практики (ДПП) по отношение на лекарствените продукти
Czech
Dohoda ve formě výměny diplomatických nót s Japonskem v souladu s čl. 15 odst. 3 písm. b) Dohody o vzájemném uznávání za účelem změny části B Odvětvové přílohy o správné výrobní praxi (SVP) pro léčivé přípravky
Danish
Aftale i form af en udveksling af diplomatiske noter med Japan i overensstemmelse med artikel 15, stk. 3, litra b), i aftalen om gensidig anerkendelse (MRA) med henblik på at ændre del B i det sektorspecifikke bilag om god fremstillingspraksis (GMP) for lægemidler
German
Vereinbarung in Form eines diplomatischen Notenwechsels mit Japan nach Artikel 15 Absatz 3 Buchstabe b des Abkommens über die gegenseitige Anerkennung zwecks Änderung von Teil B des Sektoralen Anhangs über gute Herstellungspraxis (GMP) für Arzneimittel
Greek
Συμφωνία με τη μορφή ανταλλαγής διπλωματικών σημειωμάτων με την Ιαπωνία σύμφωνα με το άρθρο 15 παράγραφος 3 σημείο β) της συμφωνίας αμοιβαίας αναγνώρισης (ΣΑΑ) για την τροποποίηση του μέρους Β του τομεακού παραρτήματος για τις ορθές παρασκευαστικές πρακτικές (ΟΠΠ) φαρμακευτικών προϊόντων
Spanish
Acuerdo en forma de canje de notas diplomáticas con Japón de conformidad con el artículo 15, apartado 3, letra b), del Acuerdo sobre reconocimiento mutuo con objeto de modificar la parte B del anexo sectorial sobre normas correctas de fabricación para los medicamentos
Estonian
Leping diplomaatiliste nootide vahetamise teel Jaapaniga vastavalt vastastikuse tunnustamise lepingu artikli 15 lõike 3 punktile b eesmärgiga muuta ravimite häid tootmistavasid käsitleva valdkonnalisa B osa
Finnish
Sopimus Japanin kanssa vaihdettavien diplomaattisten noottien muodossa vastavuoroisesta tunnustamisesta tehdyn sopimuksen 15 artiklan 3 kohdan b alakohdan mukaisesti lääkkeiden hyviä tuotantotapoja koskevan alakohtaisen liitteen B osan muuttamiseksi
French
Accord sous forme d'échange de notes diplomatiques avec le Japon conformément à l'article 15, paragraphe 3, point b), de l'accord de reconnaissance mutuelle (ARM) afin de modifier la partie B de l'annexe sectorielle sur les bonnes pratiques de fabrication (BPF) des médicaments
Croatian
Sporazum u obliku razmjene diplomatskih nota s Japanom u skladu s člankom 15. stavkom 3. točkom (b) Sporazuma o uzajamnom priznavanju u cilju izmjene dijela B Sektorskog priloga o dobroj proizvođačkoj praksi za lijekove
Hungarian
Megállapodás diplomáciai jegyzékek cseréje útján a kölcsönös elismerésről szóló megállapodás 15. cikke (3) bekezdésének b) pontjával összhangban a gyógyszerekre vonatkozó helyes gyártási gyakorlatot tartalmazó ágazati melléklet B. részének módosításáról
Italian
Accordo in forma di scambio di note diplomatiche con il Giappone conformemente all'articolo 15, paragrafo 3, lettera b), dell'accordo sul reciproco riconoscimento (ARR) al fine di modificare la parte B dell'allegato settoriale sulle buone pratiche di fabbricazione (BPF) dei medicinali
Lithuanian
Susitarimas pasikeičiant diplomatinėmis notomis su Japonija pagal Susitarimo dėl abipusio pripažinimo 15 straipsnio 3 dalies b punktą, siekiant iš dalies pakeisti Sektoriaus priedo dėl geros gamybos praktikos (GMP) vaistams B dalį
Latvian
Vienošanās ar Japānu (diplomātisko notu apmaiņas formā saskaņā ar Savstarpējās atzīšanas nolīguma 15. panta 3. punkta b) apakšpunktu) par nozaru pielikuma par zāļu labu ražošanas praksi B daļas grozījumu
Maltese
Ftehim fil-forma ta' Skambju ta' Noti Diplomatiċi mal-Ġappun skont l-Artikolu 15(3)(b) tal-Ftehim ta' Rikonoxximent Reċiproku (MRA) sabiex tiġi emendata l-Parti B tal-Anness Settorjali dwar il-Prassi Tajba ta' Manifattura (GMP) għal prodotti mediċinali
Dutch
Overeenkomst in de vorm van een uitwisseling van diplomatieke nota's met Japan overeenkomstig artikel 15, lid 3, onder b), van de Overeenkomst inzake wederzijdse erkenning houdende wijziging van deel B van de sectorbijlage betreffende goede praktijken bij het vervaardigen (GMP) van geneesmiddelen
Polish
Umowa w formie wymiany not dyplomatycznych z Japonią, zgodnie z art. 15 ust. 3 lit. b) umowy w sprawie wzajemnego uznawania, w celu zmiany części B Załącznika sektorowego w sprawie dobrej praktyki wytwarzania (GMP) w zakresie produktów leczniczych
Portuguese
Acordo sob a forma de Troca de Notas Diplomáticas com o Japão, em conformidade com o artigo 15.°, n.° 3, alínea b), do Acordo sobre Reconhecimento Mútuo (ARM), a fim de alterar a Parte B do Anexo Setorial sobre Boas Práticas de Fabrico (BPF) de Medicamentos
Romanian
Acord sub forma unui schimb de note diplomatice cu Japonia în conformitate cu articolul 15 alineatul (3) litera (b) din Acordul de recunoaștere reciprocă dintre Comunitatea Europeană și Japonia (MRA), în vederea modificării părții B din anexa sectorială referitoare la bunele practici de fabricație (BPF) pentru medicamente
Slovak
Dohoda vo forme výmeny diplomatických nót s Japonskom v súlade s článkom 15 ods. 3 pododsekom b) dohody o vzájomnom uznávaní s cieľom zmeniť časť B sektorovej prílohy o správnej výrobnej praxi (SVP) pre lieky
Slovenian
Sporazum v obliki izmenjave diplomatskih not z Japonsko v skladu s členom 15(3)(b) Sporazuma o vzajemnem priznavanju za spremembo dela B Sektorske priloge o dobri proizvodni praksi (DPP) za zdravila
Swedish
Avtal i form av utväxling av diplomatiska noter med Japan i enlighet med artikel 15.3 b i avtalet om ömsesidigt erkännande i syfte att ändra del B i den sektoriella bilagan om god tillverkningssed för läkemedel

Records

Official treaty CELEX 22016A0520(02) from European Union at EUR-Lex. Dated 22 April 2016. Status: In force.

Timeline

22 April 2016
Signed
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22 April 2016
Entry into force
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24 official files

Dohoda vo forme výmeny diplomatických nót s Japonskom v súlade s článkom 15 ods. 3 pododsekom b) dohody o vzájomnom uznávaní s cieľom zmeniť časť B sektorovej prílohy o správnej výrobnej praxi (SVP) pre lieky

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Dohoda vo forme výmeny diplomatických nót s Japonskom v súlade s článkom 15 ods. 3 pododsekom b) dohody o vzájomnom uznávaní s cieľom zmeniť časť B sektorovej prílohy o správnej výrobnej praxi (SVP) pre lieky
official_journal · SK · 22 April 2016
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Ftehim fil-forma ta' Skambju ta' Noti Diplomatiċi mal-Ġappun skont l-Artikolu 15(3)(b) tal-Ftehim ta' Rikonoxximent Reċiproku (MRA) sabiex tiġi emendata l-Parti B tal-Anness Settorjali dwar il-Prassi Tajba ta' Manifattura (GMP) għal prodotti mediċinali
official_journal · MT · 22 April 2016
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Споразумение под формата на размяна на дипломатически ноти с Япония в съответствие с член 15, параграф 3, буква б) от Споразумението за взаимно признаване с цел да се измени Част Б на Секторното приложение относно добрите производствени практики (ДПП) по отношение на лекарствените продукти
official_journal · BG · 22 April 2016
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Avtal i form av utväxling av diplomatiska noter med Japan i enlighet med artikel 15.3 b i avtalet om ömsesidigt erkännande i syfte att ändra del B i den sektoriella bilagan om god tillverkningssed för läkemedel
official_journal · SV · 22 April 2016
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Συμφωνία με τη μορφή ανταλλαγής διπλωματικών σημειωμάτων με την Ιαπωνία σύμφωνα με το άρθρο 15 παράγραφος 3 σημείο β) της συμφωνίας αμοιβαίας αναγνώρισης (ΣΑΑ) για την τροποποίηση του μέρους Β του τομεακού παραρτήματος για τις ορθές παρασκευαστικές πρακτικές (ΟΠΠ) φαρμακευτικών προϊόντων
official_journal · EL · 22 April 2016
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Sporazum v obliki izmenjave diplomatskih not z Japonsko v skladu s členom 15(3)(b) Sporazuma o vzajemnem priznavanju za spremembo dela B Sektorske priloge o dobri proizvodni praksi (DPP) za zdravila
official_journal · SL · 22 April 2016
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Susitarimas pasikeičiant diplomatinėmis notomis su Japonija pagal Susitarimo dėl abipusio pripažinimo 15 straipsnio 3 dalies b punktą, siekiant iš dalies pakeisti Sektoriaus priedo dėl geros gamybos praktikos (GMP) vaistams B dalį
official_journal · LT · 22 April 2016
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Megállapodás diplomáciai jegyzékek cseréje útján a kölcsönös elismerésről szóló megállapodás 15. cikke (3) bekezdésének b) pontjával összhangban a gyógyszerekre vonatkozó helyes gyártási gyakorlatot tartalmazó ágazati melléklet B. részének módosításáról
official_journal · HU · 22 April 2016
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Acordo sob a forma de Troca de Notas Diplomáticas com o Japão, em conformidade com o artigo 15.°, n.° 3, alínea b), do Acordo sobre Reconhecimento Mútuo (ARM), a fim de alterar a Parte B do Anexo Setorial sobre Boas Práticas de Fabrico (BPF) de Medicamentos
official_journal · PT · 22 April 2016
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Sopimus Japanin kanssa vaihdettavien diplomaattisten noottien muodossa vastavuoroisesta tunnustamisesta tehdyn sopimuksen 15 artiklan 3 kohdan b alakohdan mukaisesti lääkkeiden hyviä tuotantotapoja koskevan alakohtaisen liitteen B osan muuttamiseksi
official_journal · FI · 22 April 2016
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Vereinbarung in Form eines diplomatischen Notenwechsels mit Japan nach Artikel 15 Absatz 3 Buchstabe b des Abkommens über die gegenseitige Anerkennung zwecks Änderung von Teil B des Sektoralen Anhangs über gute Herstellungspraxis (GMP) für Arzneimittel
official_journal · DE · 22 April 2016
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Sporazum u obliku razmjene diplomatskih nota s Japanom u skladu s člankom 15. stavkom 3. točkom (b) Sporazuma o uzajamnom priznavanju u cilju izmjene dijela B Sektorskog priloga o dobroj proizvođačkoj praksi za lijekove
official_journal · HR · 22 April 2016
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Accordo in forma di scambio di note diplomatiche con il Giappone conformemente all'articolo 15, paragrafo 3, lettera b), dell'accordo sul reciproco riconoscimento (ARR) al fine di modificare la parte B dell'allegato settoriale sulle buone pratiche di fabbricazione (BPF) dei medicinali
official_journal · IT · 22 April 2016
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Accord sous forme d'échange de notes diplomatiques avec le Japon conformément à l'article 15, paragraphe 3, point b), de l'accord de reconnaissance mutuelle (ARM) afin de modifier la partie B de l'annexe sectorielle sur les bonnes pratiques de fabrication (BPF) des médicaments
official_journal · FR · 22 April 2016
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Dohoda ve formě výměny diplomatických nót s Japonskem v souladu s čl. 15 odst. 3 písm. b) Dohody o vzájemném uznávání za účelem změny části B Odvětvové přílohy o správné výrobní praxi (SVP) pro léčivé přípravky
official_journal · CS · 22 April 2016
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Umowa w formie wymiany not dyplomatycznych z Japonią, zgodnie z art. 15 ust. 3 lit. b) umowy w sprawie wzajemnego uznawania, w celu zmiany części B Załącznika sektorowego w sprawie dobrej praktyki wytwarzania (GMP) w zakresie produktów leczniczych
official_journal · PL · 22 April 2016
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Leping diplomaatiliste nootide vahetamise teel Jaapaniga vastavalt vastastikuse tunnustamise lepingu artikli 15 lõike 3 punktile b eesmärgiga muuta ravimite häid tootmistavasid käsitleva valdkonnalisa B osa
official_journal · ET · 22 April 2016
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Acuerdo en forma de canje de notas diplomáticas con Japón de conformidad con el artículo 15, apartado 3, letra b), del Acuerdo sobre reconocimiento mutuo con objeto de modificar la parte B del anexo sectorial sobre normas correctas de fabricación para los medicamentos
official_journal · ES · 22 April 2016
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Aftale i form af en udveksling af diplomatiske noter med Japan i overensstemmelse med artikel 15, stk. 3, litra b), i aftalen om gensidig anerkendelse (MRA) med henblik på at ændre del B i det sektorspecifikke bilag om god fremstillingspraksis (GMP) for lægemidler
official_journal · DA · 22 April 2016
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Acord sub forma unui schimb de note diplomatice cu Japonia în conformitate cu articolul 15 alineatul (3) litera (b) din Acordul de recunoaștere reciprocă dintre Comunitatea Europeană și Japonia (MRA), în vederea modificării părții B din anexa sectorială referitoare la bunele practici de fabricație (BPF) pentru medicamente
official_journal · RO · 22 April 2016
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Overeenkomst in de vorm van een uitwisseling van diplomatieke nota's met Japan overeenkomstig artikel 15, lid 3, onder b), van de Overeenkomst inzake wederzijdse erkenning houdende wijziging van deel B van de sectorbijlage betreffende goede praktijken bij het vervaardigen (GMP) van geneesmiddelen
official_journal · NL · 22 April 2016
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Vienošanās ar Japānu (diplomātisko notu apmaiņas formā saskaņā ar Savstarpējās atzīšanas nolīguma 15. panta 3. punkta b) apakšpunktu) par nozaru pielikuma par zāļu labu ražošanas praksi B daļas grozījumu
official_journal · LV · 22 April 2016
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Agreement in the form of an Exchange of Diplomatic Notes with Japan in accordance with Article 15(3)(b) of the Agreement on Mutual Recognition (MRA) in order to amend Part B of the Sectoral Annex on Good Manufacturing Practice (GMP) for medicinal products
official_journal · EN · 22 April 2016
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Official source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:22016A0520(02)
Open data entity: http://publications.europa.eu/resource/cellar/38150879-1e53-11e6-ba9a-01aa75ed71a1
eurlex · 22016A0520(02) · source updated 22 April 2016