Chapter I: Pharmaceutical products

I of Article L. 5134-1 is applicable in New Caledonia and French Polynesia. The first paragraph of Article L. 5134-1 is applicable in French Polynesia as amended by Law No. 2016-41 of 26 January 2016 and in New Caledonia as amended by Law No. 2001-588 of 4 July 2001. For its application in French Polynesia, in the third paragraph of I of Article L. 5134-1, the words: “by decree” are…

The provisions of Title I of Book III of this Part relating to the National Agency for the Safety of Medicines and Health Products established in Title II of Book III of the same Part shall apply within the limits of the provisions extended to New Caledonia and French Polynesia and subject to the adaptations provided for in this Chapter. In other cases, the Agency may enter into agreements with…

For the application of Article L. 5311-1 in New Caledonia and French Polynesia, paragraphs 1 to 21 are replaced by the following paragraphs 1 to 14: 1° Medicinal products, including magistral, hospital and officinal preparations, narcotic, psychotropic or other poisonous substances used in medicine, insecticides, acaricides and antiparasiticides for human use, essential oils and medicinal plants, raw materials for pharmaceutical use ; 2° Contraceptives and contraceptive products; 3° Medical devices…

For the purposes of Chapter I-I of Title IV of Book V of Part One, the following definitions shall apply: Gene therapy preparation, any medicinal product other than proprietary medicinal products and industrially manufactured medicinal products mentioned in Article L. 5121-8, used to transfer genetic material and not consisting of cells of human or animal origin. These preparations are prepared in advance and dispensed on medical prescription to one or…

Articles L. 5127-2 first paragraph, L. 5411-1, L. 5411-2, L. 5411-3, L. 5412-1, L. 5413-1 and L. 5425-1 are applicable in French Polynesia and New Caledonia, subject to the following amendments: a) In Articles L. 5411-11, L. 5412-1 and L. 5413-1 the reference: “L. 5311-1” is replaced by the reference: “L. 5541-3” ; b) The following sentence is added to the first paragraph of Article L. 5127-2: “The consignment measure…