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27 results in 7 documents

  1. #1911886

    comhlíontacht le GMP a dheimhniú.

    confirmation of GMP compliance.

    Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)

  2. #1951997

    Cigireachtaí a aithint agus glacadh le doiciméid oifigiúla GMP

    Recognition of inspections and acceptance of official GMP documents

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  3. #1952005

    Malartú doiciméad oifigiúil GMP

    Exchange of official GMP documents

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  4. #2165420

    5’-guanaláit déshóidiam (GMP).

    Disodium 5'-guanylate (GMP).

    Commission Implementing Regulation (EU) 2021/2093 of 29 November 2021 concerning the authorisation of disodium 5'-guanylate as a feed additive for all animal species (Text with EEA relevance)

  5. #2165430

    Maidir le 5’-guanaláit déshóidiam (GMP) sa bhreiseán beathaithe a shainaithint:

    For the identification of disodium 5'-guanylate (GMP) in the feed additive:

    Commission Implementing Regulation (EU) 2021/2093 of 29 November 2021 concerning the authorisation of disodium 5'-guanylate as a feed additive for all animal species (Text with EEA relevance)

  6. #1951989

    ciallaíonn ‘doiciméad oifigiúil GMP’ doiciméad arna eisiúint ag údarás de chuid Páirtí tar éis cigireacht a dhéanamh ar shaoráid mhonaraíochta, lena n-áirítear, mar shampla, tuarascálacha cigireachta, deimhnithe lena bhfianaítear go bhfuil saoráid mhonaraíochta comhlíontach le dea-chleachtas monaraíochta, nó ráiteas maidir le neamhchomhlíonadh GMP.

    "official GMP document" means a document issued by an authority of a Party following the inspection of a manufacturing facility, including, for example, inspection reports, certificates attesting the compliance of a manufacturing facility with GMP, or a GMP non-compliance statement.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  7. #1952025

    I gcás ina ndéanfar aithint cigireachtaí agus glacadh le doiciméid oifigiúla GMP de bhun Airteagal 5(1) a chur ar fionraí, ar iarraidh ó Pháirtí, pléifidh na Páirtithe an t-ábhar laistigh den Mheitheal um Tháirgí Íocshláinte agus déanfaidh siad gach iarracht breithniú a dhéanamh ar bhearta féideartha lena bhféadfaí aitheantas a thabhairt d’iniúchtaí agus chun glacadh le doiciméid oifigiúla GMP a thabhairt ar ais.

    Where recognition of inspections and acceptance of official GMP documents pursuant to Article 5(1) is suspended, at the request of a Party, the Parties shall discuss the matter within the Working Group on Medicinal Products and they shall make every effort to consider possible measures that would enable the recognition of inspections and acceptance of official GMP documents to be restored.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  8. #1952003

    Féadfaidh Páirtí glacadh le doiciméid oifigiúla GMP arna n-eisiúint ag údarás de chuid an Pháirtí eile le haghaidh saoráidí monaraíochta atá suite lasmuigh de chríoch an údaráis eisiúna.

    A Party may accept official GMP documents issued by an authority of the other Party for manufacturing facilities located outside the territory of the issuing authority.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  9. #1952004

    Féadfaidh gach Páirtí na téarmaí agus na coinníollacha a chinneadh faoina nglacfaidh sé le doiciméid oifigiúla GMP arna n-eisiúint faoi mhír 3.

    Each Party may determine the terms and conditions under which it accepts official GMP documents issued under paragraph 3.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  10. #1952024

    Le linn na tréimhse 60 lá sin, leanfaidh an dá Pháirtí d’iniúchtaí a aithint agus glacfaidh siad le doiciméid oifigiúla GMP arna n-eisiúint ag údarás de chuid an Pháirtí eile.

    During that 60-day period, both Parties shall continue to recognise inspections and accept official GMP documents issued by an authority of the other Party.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  11. #2165432

    Maidir le 5’-guanaláit déshóidiam (GMP) sa bhreiseán beathaithe, i réamh-mheascáin bhlaistithe agus in uisce a chinneadh:

    For the determination of disodium 5'-guanylate (GMP) in the feed additive, flavouring premixtures and water:

    Commission Implementing Regulation (EU) 2021/2093 of 29 November 2021 concerning the authorisation of disodium 5'-guanylate as a feed additive for all animal species (Text with EEA relevance)

  12. #1735479

    Leis an bpróiseas monaraíochta, comhlíonfar ceanglais Threoir 91/412/CEE ón gCoimisiún lena leagtar síos na prionsabail agus na treoirlínte le haghaidh táirgí íocshláinte tréidliachta agus comhlíonfar na prionsabail agus na treoirlínte maidir le Dea-chleachtas Monaraíochta (GMP), a d’fhoilsigh an Coimisiún sna Rialacha lena rialaítear táirgí tréidliachta san Aontas Eorpach, Imleabhar 4.

    The manufacturing process shall comply with the requirements of Commission Directive 91/412/EEC laying down the principles and guidelines for veterinary medicinal products and with the principles and guidelines on Good Manufacturing Practice (GMP), published by the Commission in The rules governing medicinal products in the European Union, Volume 4.

    Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)

  13. #1879811

    aon socruithe cur chun feidhme is gá a ghlacadh chun doiciméid oifigiúla Dea-Chleachtais Mhonaraíochta a mhalartú le húdarás de chuid na Ríochta Aontaithe faoi Airteagal 6 [Doiciméid oifigiúla GMP a mhalartú] d’Iarscríbhinn TBT-2 [Táirgí Íocshláinte] a ghabhann leis an gComhaontú Trádála agus Comhair agus chun faisnéis a mhalartú le húdarás de chuid na Ríochta Aontaithe i ndáil le cigireachtaí ar shaoráidí monaraíochta faoi Airteagal 7 [Coimircí] den Iarscríbhinn sin;

    adopt any necessary implementing arrangements for the exchange of official Good Manufacturing Practice documents with an authority of the United Kingdom under Article 6 [Exchange of official GMP documents] of Annex TBT-2 [Medicinal Products] to the Trade and Cooperation Agreement and for the exchange of information with an authority of the United Kingdom regarding inspections of manufacturing facilities under Article 7 [Safeguards] of that Annex;

    Council Decision (EU) 2020/2252 of 29 December 2020 on the signing, on behalf of the Union, and on provisional application of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and of the Agreement between the European Union and the United Kingdom of Great Britain and Northern Ireland concerning security procedures for exchanging and protecting classified information

  14. #1951987

    ciallaíonn ‘Dea-Chleachtas Monaraíochta’ nó ‘GMP’ an chuid sin de dhearbhú cáilíochta lena n-áirithítear go ndéantar táirgí a tháirgeadh agus a rialú go comhsheasmhach i gcomhréir leis na caighdeáin cháilíochta is iomchuí don úsáid atá beartaithe dóibh agus de réir mar a cheanglaítear leis an údarú margaíochta nó leis na sonraíochtaí táirge is infheidhme, mar a liostaítear i bhFoscríbhinn 12-B;

    "Good Manufacturing Practice" or "GMP" means that part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use and as required by the applicable marketing authorisation or product specifications, as listed in Appendix 12-B;

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  15. #1951999

    Féadfaidh údarás de chuid Páirtí, in imthosca sonracha, a roghnú gan glacadh le doiciméad oifigiúil GMP arna eisiúint ag údarás de chuid an Pháirtí eile le haghaidh saoráidí monaraíochta atá suite i gcríoch an údaráis eisiúna.

    An authority of a Party may in specific circumstances opt not to accept an official GMP document issued by an authority of the other Party for manufacturing facilities located in the territory of the issuing authority.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  16. #1952001

    Áiritheoidh gach Páirtí, i gcás ina roghnaíonn údarás de chuid Páirtí gan glacadh le doiciméad oifigiúil GMP arna eisiúint ag údarás de chuid an Pháirtí eile, go gcuirfidh an t-údarás sin in iúl d’údarás ábhartha an Pháirtí eile na cúiseanna nár glacadh leis an doiciméad agus go bhféadfaidh sé soiléiriú a iarraidh ar údarás an Pháirtí eile.

    Each Party shall ensure that where an authority of a Party opts not to accept an official GMP document issued by an authority of the other Party, that authority notifies the relevant authority of the other Party of the reasons for not accepting the document and may request clarification from the authority of the other Party.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  17. #1952006

    Áiritheoidh gach Páirtí, má iarrann údarás de chuid Páirtí doiciméad oifigiúil GMP ar údarás an Pháirtí eile, go ndéanfaidh údarás an Pháirtí eile iarracht an doiciméad a tharchur laistigh de 30 lá féilire ó dháta na hiarrata.

    Each Party shall ensure that if an authority of a Party requests an official GMP document from the authority of the other Party, the authority of the other Party shall endeavour to transmit the document within 30 calendar days of the date of the request.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  18. #1952015

    Déanfaidh na Páirtithe an fhaisnéis uile is gá a mhalartú, lena n-áirítear athruithe ar a ndlíthe, ar a rialacháin, ar a dtreoirlínte teicniúla nó ar a nósanna imeachta cigireachta faoi seach a bhaineann le Dea-Chleachtas Monaraíochta ionas gur féidir le gach Páirtí breithniú a dhéanamh i dtaobh na gcoinníollacha chun cigireachtaí a aithint agus chun glacadh le doiciméid oifigiúla GMP de bhun Airteagal 5(1).

    The Parties shall exchange all the necessary information, including changes to their respective laws, regulations, technical guidelines or inspection procedures relating to Good Manufacturing Practice so that each Party can consider whether the conditions for the recognition of inspections and acceptance of official GMP documents pursuant to Article 5(1) continue to exist.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  19. #1952016

    Más rud é, mar thoradh ar aon cheann de na bearta nua nó de na hathruithe dá dtagraítear i mír 1 den Airteagal seo, go measann Páirtí nach féidir leis cigireachtaí a aithint a thuilleadh nó doiciméid oifigiúla GMP arna n-eisiúint ag an bPáirtí eile a ghlacadh, cuirfidh sé in iúl don Pháirtí eile go bhfuil sé ar intinn aige Airteagal 9 a chur i bhfeidhm agus rachaidh na Páirtithe i mbun comhairliúcháin laistigh den Mheitheal um Tháirgí Íocshláinte.

    If as a result of any of the new measures or changes referred to in paragraph 1 of this Article, a Party considers that it can no longer recognise inspections or accept official GMP documents issued by the other Party, it shall notify the other Party of its intention to apply Article 9 and the Parties shall enter into consultations within the Working Group on Medicinal Products.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  20. #1952019

    Gan dochar d’Airteagal 5(2), tá sé de cheart ag gach Páirtí aitheantas cigireachtaí agus glacadh le doiciméid oifigiúla GMP de chuid an Pháirtí eile a chur ar fionraí go hiomlán nó go páirteach de bhun Airteagal 5(1) do na táirgí uile nó do chuid de na táirgí a liostaítear i bhFoscríbhinn 12-C.

    Without prejudice to Article 5(2), each Party has the right to suspend totally or partially the recognition of inspections and acceptance of official GMP documents of the other Party pursuant to Article 5(1) for all or some of the products listed in Appendix 12-C.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  21. #1952022

    Leanfaidh Páirtí ar aghaidh ag glacadh le doiciméid oifigiúla GMP de chuid an Pháirtí eile a eisíodh roimh fhionraí den sórt sin, mura gcinnfidh an Páirtí a mhalairt ar bhonn cúinsí sláinte nó sábháilteachta.

    A Party shall continue to accept official GMP documents of the other Party issued prior to such suspension, unless the Party decides otherwise on the basis of health or safety considerations.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  22. #1952023

    Más rud é, tar éis comhairliúcháin dá dtagraítear in Airteagal 8(3), go gcuireann Páirtí, mar sin féin, aitheantas cigireachtaí agus glacadh le doiciméid oifigiúla GMP ar fionraí de bhun Airteagal 5(1), féadfaidh sé déanamh amhlaidh i gcomhréir le mír 1 den Airteagal seo tráth nach luaithe ná 60 lá tar éis tús a chur leis na comhairliúcháin.

    Where, following consultations referred to in Article 8(3), a Party nevertheless suspends the recognition of inspections and acceptance of official GMP documents pursuant to Article 5(1), it may do so in accordance with paragraph 1 of this Article not earlier than 60 days after the commencement of the consultations.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  23. #1955320

    Chun críoch na hIarscríbhinne seo, agus gan dochar do dheighilt inmheánach na hinniúlachta sa Ghearmáin maidir le hábhair a thagann faoi raon feidhme na hIarscríbhinne seo, tuigfear go gcumhdaítear le ZLG na húdaráis inniúla Länder a eisíonn doiciméid GMP agus a dhéanann cigireachtaí cógaisíochta.

    For the purpose of this Annex, and without prejudice to the internal division of competence in Germany on matters falling within the scope of this Annex, ZLG shall be understood as covering all the competent Länder authorities issuing GMP documents and conducting pharmaceutical inspections.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  24. #1955321

    Chun críoch na hIarscríbhinne seo, agus gan dochar do roinnt inmheánach na hinniúlachta sa Spáinn maidir le hábhair a thagann faoi raon feidhme na hIarscríbhinne seo, tuigfear go gcumhdaítear le Agencia Española de Medicamentos y Productos Sanitarios na húdaráis inniúla réigiúnacha go léir a eisíonn doiciméid oifigiúla GMP agus a dhéanann cigireachtaí cógaisíochta.

    For the purpose of this Annex, and without prejudice to the internal division of competence in Spain on matters falling within the scope of this Annex, Agencia Española de Medicamentos y Productos Sanitarios shall be understood as covering all the competent regional authorities issuing official GMP documents and conducting pharmaceutical inspections.

    Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part

  25. #2703514

    Go háirithe, an t-aigéad sailleach a éilíonn an tionscal cosmaidí, an tionscal cógaisíochta, an tionscal ceimiceach nó an tionscal bia, deartar é chun ceanglais éagsúla deimhniúcháin a chomhlíonadh (amhail Kosher, Halal, GMP+, FSSC 22000, deimhniú RSPO, ISO 9001, ISO 14001, ISO 45001), fad nach gceanglaítear ar tháirgeoirí bithdhíosail ach deimhniú chun an Treoir maidir le Fuinneamh In-athnuaite (AE) 2018/2001 ó Pharlaimint na hEorpa agus ón gComhairle (“RED II”) a chomhlíonadh (scéim dheonach a aithníonn an Coimisiún Eorpach de bhun RED II, amhail ISCC AE nó 2BSVS, nó scéim deimhniúcháin náisiúnta arna bhunú de bhun RED II).

    In particular, the fatty acid required by the cosmetic, pharmaceutical, chemical or food industries are designed to meet various certification requirements (such as Kosher, Halal, GMP+, FSSC 22000, RSPO certification, ISO 9001, ISO 14001, ISO 45001), while biodiesel producers only require a certification to comply with the Renewable Energy Directive (EU) 2018/2001 (RED II) (a voluntary scheme recognised by the European Commission pursuant to the RED II, such as ISCC EU or 2BSVS, or a national certification scheme established pursuant to the RED II).

    Commission Implementing Regulation (EU) 2023/111 of 18 January 2023 imposing a definitive anti-dumping duty on imports of fatty acid originating in Indonesia

  26. #2777015

    Chun críoch na hIarscríbhinne seo, agus gan dochar do roinnt inmheánach na hinniúlachta sa Ghearmáin maidir le hábhair a thagann faoi raon feidhme na hIarscríbhinne seo, tuigfear go gcumhdaítear le ZLG údaráis inniúla uile na státrialtas (Länder) a eisíonn doiciméid GMP agus a dhéanann cigireachtaí cógaisíochta.

    For the purpose of this Annex, and without prejudice to the internal division of competence in Germany on matters falling within the scope of this Annex, ZLG shall be understood as coordinating authority for all competent Laender authorities issuing GMP documents and conducting pharmaceutical inspections.

    Decision No 2536/2023 of the Joint Sectoral Committee established under Article 14 of the United States – European Union amended Sectoral Annex for pharmaceutical good manufacturing practices (GMPs) (the ‘Annex’) on including veterinary products within the product coverage of the Annex of 11 May 2023 [2023/1044]

  27. #2777016

    Chun críoch na hIarscríbhinne seo, agus gan dochar do roinnt inmheánach na hinniúlachta sa Ghearmáin maidir le hábhair a thagann faoi raon feidhme na hIarscríbhinne seo, tuigfear go gcumhdaítear le ZLG údaráis inniúla uile na státrialtas (Länder) a eisíonn doiciméid GMP agus a dhéanann cigireachtaí cógaisíochta.

    For the purpose of this Annex, and without prejudice to the internal division of competence in Spain on matters falling within the scope of this Annex, Agencia Española de Medicamentos y Productos Sanitarios shall be understood as covering all the competent regional authorities issuing GMP documents and conducting pharmaceutical inspections.

    Decision No 2536/2023 of the Joint Sectoral Committee established under Article 14 of the United States – European Union amended Sectoral Annex for pharmaceutical good manufacturing practices (GMPs) (the ‘Annex’) on including veterinary products within the product coverage of the Annex of 11 May 2023 [2023/1044]