Part One: General health protection

For their application in New Caledonia and French Polynesia: 1° In Article L. 1231-1, V does not apply ; 2° In the first paragraph of Article L. 1231-3, the words “Minister of Health” are replaced by the words “Representative of the State in New Caledonia or French Polynesia, taken after consultation with the health authorities of New Caledonia and French Polynesia”; 3° Article L. 1231-4 reads as follows: Art. L….

Title IV of Book II of this Part is applicable in New Caledonia and French Polynesia, with the exception of Articles L. 1242-3, L. 1243-1, L. 1243-2-1, L. 1243-5 to L. 1243-9, L. 1244-1-1, L. 1244-1-2, L. 1244-5, L. 1245-6 and subject to the adaptations provided for in this chapter. Article L. 1241-1 is applicable there in the version resulting from Order no. 2022-1086 of 29 July 2022. Articles L….

For their application in New Caledonia and French Polynesia: 1° In Article L. 1241-1, the words: “by the Agence nationale de sécurité du médicament et des produits de santé pursuant to 1° of Article L. 5311-2” are replaced by the words: “in accordance with the conditions laid down by local regulations having the same purpose” ; 2° In the last paragraph of Article L. 1241-3, the words: “in particular with…

For their application in New Caledonia and French Polynesia : 1° The first three paragraphs of Article L. 1243-2 are replaced by the following paragraph: In order to be authorised to ensure the preparation, conservation, distribution and transfer, for autologous or allogeneic therapeutic purposes, of tissues and their derivatives and cell therapy preparations, health establishments must operate in accordance with the principles set out in Title I of this book….

For their application in New Caledonia and French Polynesia : a) In Article L. 1245-1, the last two paragraphs do not apply ; b) Article L. 1245-5 is replaced by the following provisions: Art.L. 1245-5.- Only persons whose activity involves medical biology examinations, anatomical cytopathology examinations, legal expertise or quality control or assessment, in particular of in vitro diagnostic medical devices, may import or export biological samples. Only organisations authorised…

Titles V and VI of Book II of this Part are applicable in New Caledonia and French Polynesia, subject to the following adaptations: a) The following sentence is added to article L. 1251-1 : “An agreement between the Agence de la biomédecine and the competent authorities of New Caledonia and French Polynesia sets out the procedures for registering patients and allocating transplants, taking particular account of the specific requirements for…

The Biomedicine Agency set up under Chapter VIII of Title I of Book IV of this Part shall exercise in New Caledonia and French Polynesia the powers conferred upon it under Title IV of Book V of Part I and Title IV of Book IV of Part II. In other cases, the agency may enter into agreements with the authorities of New Caledonia and French Polynesia, in particular for :…