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Document 32026D1070
Council Decision (EU) 2026/1070 of 5 May 2026 on the position to be taken on behalf of the European Union within the CETA Joint Committee established under the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part, as regards the inclusion of active pharmaceutical ingredients as medicinal products or drugs listed in paragraph 2 of Annex 1 to the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products
Council Decision (EU) 2026/1070 of 5 May 2026 on the position to be taken on behalf of the European Union within the CETA Joint Committee established under the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part, as regards the inclusion of active pharmaceutical ingredients as medicinal products or drugs listed in paragraph 2 of Annex 1 to the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products
Council Decision (EU) 2026/1070 of 5 May 2026 on the position to be taken on behalf of the European Union within the CETA Joint Committee established under the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part, as regards the inclusion of active pharmaceutical ingredients as medicinal products or drugs listed in paragraph 2 of Annex 1 to the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products
ST/8148/2026/INIT
OJ L, 2026/1070, 12.5.2026, ELI: http://data.europa.eu/eli/dec/2026/1070/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
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Official Journal |
EN L series |
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2026/1070 |
12.5.2026 |
COUNCIL DECISION (EU) 2026/1070
of 5 May 2026
on the position to be taken on behalf of the European Union within the CETA Joint Committee established under the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part, as regards the inclusion of active pharmaceutical ingredients as medicinal products or drugs listed in paragraph 2 of Annex 1 to the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular the Article 207(4), first subparagraph, in conjunction with Article 218(9), thereof,
Having regard to the proposal from the European Commission,
Whereas:
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(1) |
Council Decision (EU) 2017/37 (1) provides for the signing on behalf of the European Union of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part (2) (the ‘Agreement’). The Agreement was signed on 30 October 2016. |
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(2) |
Council Decision (EU) 2017/38 (3) provides for the provisional application of parts of the Agreement, including the establishment of the CETA Joint Committee. Parts of the Agreement have been provisionally applied since 21 September 2017. |
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(3) |
In accordance with Article 26.1(5)(c) of the Agreement, the CETA Joint Committee may consider or agree on amendments to the Agreement. |
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(4) |
Article 30.2 of the Agreement provides that the CETA Joint Committee may decide to amend the protocols and annexes of the Agreement. Pursuant to Article 26.3(3) of the Agreement, such decision is to be made by mutual consent of the Parties. |
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(5) |
Pursuant to Article 15(5) of the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products to CETA (the ‘GMP Protocol’), the Joint Sectoral Group is to review the Annexes the GMP Protocol at the request of the Parties to the Agreement and develop recommendations for their amendment for consideration by the CETA Joint Committee. |
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(6) |
Pursuant to Article 15(6), on 15 December 2022 the Joint Sectoral Group reviewed the operational scope of the GMP Protocol and recommended that active pharmaceutical ingredients which are currently listed in paragraph 1 of Annex 1 to the GMP Protocol, and for which the GMP requirements and compliance programmes of both Parties are equivalent, also be included in the list of medicinal products or drugs listed in paragraph 2 of Annex 1 to the GMP Protocol. |
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(7) |
The CETA Joint Committee is to adopt a decision on the inclusion of the active pharmaceutical ingredients in the operational scope of medicinal products or drugs listed in Annex 1 to the GMP Protocol. |
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(8) |
It is therefore appropriate to establish the position to be taken on behalf of the Union within the CETA Joint Committee on the basis of the attached draft decision of the CETA Joint Committee as regards the inclusion of active pharmaceutical ingredients as medicinal products or drugs listed in paragraph 2 of Annex 1 to the GMP Protocol, |
HAS ADOPTED THIS DECISION:
Article 1
The position to be taken on behalf of the Union within the CETA Joint Committee as regards the inclusion of active pharmaceutical ingredients as medicinal products or drugs listed in paragraph 2 of Annex 1 to the GMP Protocol to the Agreement shall be based on the draft decision of the CETA Joint Committee attached to this Decision.
Article 2
This Decision shall enter into force on the date of its adoption.
Done at Brussels, 5 May 2026.
For the Council
The President
M. KERAVNOS
(1) Council Decision (EU) 2017/37 of 28 October 2016 on the signing on behalf of the European Union of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part (OJ L 11, 14.1.2017, p. 1, ELI: http://data.europa.eu/eli/dec/2017/37/oj).
(2) OJ L 11, 14.1.2017, p. 23, ELI: http://data.europa.eu/eli/agree_internation/2017/37/oj.
(3) Council Decision (EU) 2017/38 of 28 October 2016 on the provisional application of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part (OJ L 11, 14.1.2017, p. 1080, ELI: http://data.europa.eu/eli/dec/2017/38/oj).
DRAFT
DECISION No …/2026 OF THE CETA JOINT COMMITTEE
of …
as regards the inclusion of active pharmaceutical ingredients as the medicinal products or drugs listed in paragraph 2 of the Annex 1 to the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products
THE CETA JOINT COMMITTEE,
Having regard to Article 26.1 of the Comprehensive Economic and Trade Agreement (CETA) between Canada, on the one part, and the European Union and its Member States, on the other part, done at Brussels on 30 October 2016 (the ‘Agreement’),
Whereas:
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(1) |
Under the provisions of Article 30.7.3(a) of the Agreement, the Agreement has been provisionally applied since September 21, 2017. |
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(2) |
Article 26.1.5(c) of the Agreement provides that the CETA Joint Committee may consider or agree on amendments as provided in the Agreement. |
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(3) |
Article 30.2.2 of the Agreement provides that the CETA Joint Committee may decide to amend the protocols and annexes of the Agreement. |
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(4) |
Article 15 paragraphs 5 and 6 of the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products (the ‘Protocol’) provides that the Joint Sectoral Group is to review the operational scope of medicinal products or drugs under paragraph 2 of Annex 1, with a view to including those medicinal products or drugs listed in paragraph 1 of Annex 1. |
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(5) |
The European Commission and Health Canada have conducted evaluations of the applicable Canadian and EU Good Manufacturing Practices programs for active pharmaceutical ingredients and have concluded that their respective regulatory and enforcement frameworks in this area are equivalent. |
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(6) |
The Protocol, on the recommendation of the Joint Sectoral Group to the CETA Joint Committee, should therefore be amended by including active pharmaceutical ingredients as medicinal products or drugs listed in paragraph 2 of Annex 1 to the Protocol. |
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(7) |
The entry into force of this Decision does not require any further procedure under the European Union legal order, |
HAS ADOPTED THIS DECISION:
Article 1
Operational scope of medicinal products or drugs
Paragraph 2 of Annex 1 to the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products shall be amended as follows:
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(a) |
at the end of the entry for point (f), the word ‘and’ shall be removed; |
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(b) |
at the end of the entry for point (g), the full stop shall be replaced by ‘; and’; and, |
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(c) |
after the entry for point (g), the following entry shall be added: ‘(h) active pharmaceutical ingredients.’. |
Article 2
Legal status of the amendment
Upon entry into force of this Decision, the amendment set out in Article 1 will become part of the Protocol. The Parties recognize that since the Agreement, including the Protocol, is provisionally applied, the amendment will also be provisionally applied until the Agreement enters into force.
Article 3
Authentic texts
This Decision is drawn up in duplicate in the Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish languages, each version being equally authentic.
Article 4
Entry into force
This Decision shall enter into force on the first day of the second month following the date Canada has provided to the European Union a written notification certifying that it has completed its internal requirements and procedures necessary for entry into force.
Done at …, …
For the Joint Committee
The Co-chairs
ELI: http://data.europa.eu/eli/dec/2026/1070/oj
ISSN 1977-0677 (electronic edition)