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. 44 Import of individual batches of immunological medicinal products that are authorised or not subject to authorisation or of blood and blood products
1 Any person who imports the following medicinal products that are authorised or not subject to authorisation or blood and blood products into Switzerland requires a licence for each shipment: a. immunological medicinal products; b. blood and blood products. 2 A licence is not required for the import of individual batches of: a. allergens; b. blood that is authorised or not subject to authorisation and blood products of this kind if these medicinal products: 1. are imported in medical emergencies or for autologous transfusion, 2. are not intended for use in humans, or 3. have an official batch release from one of the control authorities belonging to the Official Control Authority Batch Release Network (OCABR Network); c. immunological medicinal products that are authorised or not subject to authorisation provided an official batch release from one of the control authorities belonging to the OCABR Network is available for the batch to be imported. 3 In the interest of protecting health,
Art. 45 Conditions for granting a licence
Any person applying for a licence in accordance with Article 44 paragraph 1 must prove that: a. they have a licence to import medicinal products; b. if these are ready-to-use medicinal products destined for the Swiss market, they have the corresponding authorisation; c. they ensure the safe and lawful import of the medicinal products and accept responsibility for this; d. the manufacturing and import of the medicinal products and wholesale trading in medicinal products are in conformity with the GMP rules described in Annex 1 and the GDP rules described in Annex 4; e. in the case of blood and blood products for use in humans, in addition to letters a–d: 1. no pathogens or indication of the presence of pathogens can be detected, 2. each individual blood donation is analysed using tests that correspond to state-of-the-art scientific and technical knowledge, 3. blood and plasma are only imported unmixed, unless Swissmedic has exceptionally granted a licence to import mixed products, 4. th
Art. 46 Procedure
1 The application for a licence to import individual batches must be submitted to Swissmedic together with the necessary documentation. 2 The licence is valid for one month. 3 The applicant must ensure that the licence is presented to the customs office at the time when the medicinal products are imported. 4 On customs clearance, the customs office shall discharge the licence and forward it to Swissmedic. 5 In the absence of a licence to import individual batches in accordance with Article 44 paragraph 1, medicinal products are refused entry at the border and reported to Swissmedic.
Art. 47
Repealed by Annex No 1 of the O of 23 Nov. 2022, with effect from 1 Jan. 2023 (AS 2022 723).
Art. 48 Import of non-authorised ready-to-use medicinal products by individuals
Individuals may import ready-to-use medicinal products that are not authorised in Switzerland in quantities needed for their personal use. This does not apply to: a. medicinal products which contain genetically modified organisms, b. immunological medicinal products for use in livestock; c. vaccines, toxins and sera for veterinary usage; d. transplant products within the meaning of the Transplantation Ordinance of 16 March 2007 which have been genetically modified.
let. d — SR 810.211
Art. 49 Import of non-authorised ready-to-use medicinal products by professionals
1 A medical professional who has a cantonal dispensing licence may import small quantities of a ready-to-use human medicinal product that is not authorised in Switzerland provided: a. the medicinal product is intended for a specific patient or for emergencies; b. the medicinal product has been authorised by a country with a comparable regulatory system; and c. for the medicinal product concerned: 1. no alternatively usable medicinal product is authorised in Switzerland, 2. an alternatively usable medicinal product is authorised in Switzerland, but is not available on the Swiss market, or 3. it is not appropriate to switch the medication to a medicinal product authorised and available in Switzerland. 2 Treating physicians with a cantonal professional licence may import small quantities of ready-to-use human medicinal products that are not authorised in Switzerland if: a. they have performed a risk analysis to confirm the appropriateness of the usage and notified the competent cantonal a
Para. 7 — SR 812.212.27 Para. 7 — Amended by No III 2 of the O of 3 June 2022, in force since 1 July 2022 (AS 2022 349).
Art. 49a Import of non-authorised ready-to-use medicinal products by intergovernmental organisations and international institutions
Insofar as intergovernmental organisations and international institutions are entitled under an agreement with Switzerland concerning privileges, immunities and facilities, to import items for their official use, they may import a ready-to-use human medicinal product that is not authorised in Switzerland in the quantities required to for official activities and to maintain operations, provided that the medicinal product: a. is imported under the supervision of a physician in the medical service of the organisation or institution; b. is intended exclusively for official use within the organisation or institution and c. is authorised in a country with comparable regulatory system or has been authorised by the World Health Organization under its emergency procedure.
Art. 49a — Inserted by No I of the O of 12 Feb. 2025, in force since 15 March 2025 (AS 2025 109).
Art. 50 Medicinal products that can be used for capital punishment
1 Any person who exports medicinal products that can be used for capital punishment requires a licence from Swissmedic for each transaction. 2 Any person who trades abroad in such medicinal products requires a licence from Swissmedic for each transaction. 3 A licence as described in paragraphs 1 and 2 may be granted provided the applicant: a. confirms to Swissmedic that, following investigations, there is no evidence that the medicinal products in question will be used for capital punishment; and b. submits a declaration by the customer stating that the medicinal products will not be used by the customer or by third parties for capital punishment. 4 Swissmedic publishes a list of medicinal products that can be used for capital punishment It takes into account valid EU law, in particular the delegated acts and implementing acts adopted by the European Commission on the basis of Council Regulation (EC) No 1236/2005.
Para. 4 — Council Regulation (EC) No 1236/2005 of 27 June 2005 concerning trade in certain goods which could be used for capital punishment, torture or other cruel, inhuman or degrading treatment or punishment; OJ L 200 of 30.07.2005 p. 1.
Art. 51 Transit
The transit of medicinal products which are dangerous to health is not permitted.