Chapter I: Health protection.

I.-Subject to the adaptations mentioned in II, the provisions of Title II of Book I of this Part shall apply to the Wallis and Futuna Islands, in the wording indicated in the right-hand column of the table in I:

II.-For the application to the Wallis and Futuna Islands of the provisions mentioned in I:

1° In article L. 1121-1 :

a) After the words: "This person or their legal representative must be established in the European Union", the following words are added: ", or in the Wallis and Futuna Islands or in French Polynesia or in New Caledonia";

b) For its application, references to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014, references to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and references to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 are replaced by references to the rules applicable in mainland France under Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 ;

2° In Article L. 1121-6, the words: "in a health or social establishment" are replaced by the words: "at the Wallis and Futuna Islands Health Agency";

3° In Article L. 1121-11, the last paragraph does not apply;

4° In Article L. 1121-13, the words: "the Director General of the Regional Health Agency" are replaced by the words: "the High Administrator of the Wallis and Futuna Islands on a proposal from the Director of the Health Agency" and the words: "in an establishment mentioned in Article L. 5126-1" are replaced by the words: "in an establishment with a pharmacy authorised by the competent authorities of the Wallis and Futuna Islands";

5° In Article L. 1122-1, after the words: "Where non-interventional research relates to compliance with a treatment and is carried out in response to a request from the Agence nationale de sécurité du médicament et des produits de santé, the Haute Autorité de santé or the European Medicines Agency," the words: "or the competent authority of the Wallis and Futuna Islands" are added;

6° In Article L. 1123-1, a second paragraph is inserted as follows:

"The competence of these committees is extended to the Wallis and Futuna Islands";

7° In Article L. 1124-1, the words "that in health establishments, at the Etablissement français du sang, in army hospitals or other elements of the army health service mentioned in Article L. 6147-7 or at the Institution nationale des invalides" are replaced by the words: "than at the health agency of the Wallis and Futuna Islands" and for the application of this article, the references to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 are replaced by references to the rules applicable in mainland France under Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014;

8° For the application of Articles L. 1125-1, L. 1125-2, L. 1125-4, L. 1125-5, L. 1125-7, L. 1125-16, L. 1125-17, L. 1125-20, L. 1125-21, L. 1125-28, L. 1125-31, the references to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are replaced by references to the rules applicable in mainland France under Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017;

9° In Article L. 1125-10, the last paragraph is not applicable;

10° In Article L. 1125-12, the words: "the Director General of the Regional Health Agency" are replaced by the words: "the Chief Executive of the Wallis and Futuna Islands on a proposal from the Director of the Health Agency";

11° In Article L. 1125-27, the words: "the national invalids' institution or in a health establishment or armed forces hospital with a pharmacy for internal use" are replaced by the words: "the Wallis and Futuna Health Agency";

12° In Article L. 1126-9, the last paragraph is not applicable;

13° In article L. 1126-26, the words: "l'institution nationale des invalides ou dans un établissement de santé ou un hôpital des armées disposant d'une pharmacie à usage intérieur" are replaced by the words: "l'agence de santé de Wallis-et-Futuna";

14° For the application of articles L. 1126-1, L. 1126-2, L. 1126-4, L. 1126-6, L. 1126-15, L. 1126-16, L. 1126-19, L. 1126-20, L. 1126-27, L. 1126-29, the references to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 are replaced by references to the rules applicable in mainland France under Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017;

15° For the application of Article L. 1127-3, references to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are replaced by references to the rules applicable in mainland France under Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017;

16° For the purposes of Articles L. 1128-1, L. 1128-3 and L. 1128-12, references to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 are replaced by references to the rules applicable in mainland France under Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014.