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

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.

Operational scope of medicinal products or drugs

Article 1

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: (a) at the end of the entry for point (f), the word ‘and’ shall be removed; (b) at the end of the entry for point (g), the full stop shall be replaced by ‘; and’; and, (c) after the entry for point (g), the following entry shall be added: ‘(h) active pharmaceutical ingredients.’.

Article 2

This Decision shall enter into force on the date of its adoption.

Legal status of the amendment

Article 2

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.

Authentic texts

Article 3

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.

Entry into force

Article 4

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.