Medicinal Products Licensing Ordinance (MPLO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 1 Object and definition of terms
1 This Ordinance regulates: a. the manufacture of medicinal products; b. wholesale trading in medicinal products; c. the import, export and transit trade in medicinal products; d. trading in medicinal products in foreign countries from Switzerland; e. the extracting of blood for transfusions or for the manufacture of medicinal products together with other essential elements of transfusion safety in handling blood and labile blood products; f. brokerage or agency activities in connection with medicinal products; g. temporary licences to use medicinal products in accordance with Article 9b paragraph 1 TPA. 2 With the exception of Articles 27, 28 and 47, this Ordinance applies by analogy to the handling of transplant products as described in Article 2 paragraph 1 letter c of the Transplantation Ordinance of 16 March 2007. 3 Articles 29–38 do not apply to transplant products described in Article 2 paragraph 1 letter c number 2 of the Transplantation Ordinance of 16 March 2007.
Para. 2 — SR 810.211
Art. 2 Definitions
In this Ordinance: a. active pharmaceutical ingredients means substances or mixtures to which the effect of a ready-to-use medicinal product is attributed and which are used in ready-to-use medicinal products; b. immunological medicinal products means medicinal products administered to create active or passive immunity or help diagnose immunity status, in particular vaccines, toxins and sera, and medicinal products intended to identify or cause a particular acquired modification of the immune response to an allergising substance, such as allergens; c. ready-to-use medicinal product means a medicinal product that has been released technically on the basis of the entire manufacturing process and is available in a form and presentation enabling it to be used as intended; d. blood means human blood; e. labile blood products means products that are extracted from donated blood, either directly or in one or a small number of manufacturing steps, and which quickly change without any external
let. o — Footnote not relevant to the English text.