2. 1 Human medicinal products
1. Licence-free import of human medicinal products not authorised in Switzerland
Art. 49 paras. 1 to 6 MPLO stipulate the relevant preconditions:
Paras. 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 alternative usable medicinal product is authorised in Switzerland,
2. an alternative 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.
Paras. 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 authorities of their conclusions before the medicinal products are imported;
b the medicinal product:
1. fulfils the conditions described in paragraph 1 letters a and c, and
2. has been authorised by a country with a comparable regulatory system for use in a clinical trial.
Paras. 3: Pharmacists with pharmaceutical responsibility in a hospital pharmacy may import small quantities of ready-to-use human medicinal products to supply their own customers if the conditions in paragraph 1 letters b and c or the conditions in paragraph 1 letter c and paragraph 2 letters a and b are fulfilled.
Paras. 4: Medical professionals as described in Article 25 paragraph 1 letters b and c TPA who have a cantonal professional licence may import small quantities of non-prescription ready-to-use human medicinal products that are not authorised in Switzerland under the terms of their dispensing licence provided the conditions in paragraph 1 are fulfilled.
Paras.5: Prior to import, importing persons must check in each case whether the relevant requirements in paragraphs 1-4 are met and ensure that the medicinal products are transported in conformity with the GDP rules described in Annex 4.
Paras. 6: They must keep a record of the check described in paragraph 5 and of the time when the check was carried out and the import took place, and the nature, number and intended use of the imported human medicinal products.
2. Licence-free import of human medicinal products not authorised in Switzerland for personal use
According to Art. 48 MPLO, individuals may import medicinal products that are not authorised in Switzerland for their own use, i.e. one month's supply or the smallest package exceeding a one-month supply, without authorisation. This article states:
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.
Ordering from unknown sources, particularly online, is strongly discouraged. Passing on medicinal products imported for personal use to third parties is a punishable offence.
3. Temporary authorisation for the use of medicinal products according to Article 9b paragraph 1 TPA ("compassionate use")
Patients who are to be treated with a product that has so far been successfully tested in Switzerland in clinical trials but that is not yet authorised, can be treated outside a clinical trial. To this end, the sponsor of the clinical trial must apply for a temporary authorisation to use medicinal products in accordance with Article 9b paragraph 1 TPA. This authorisation is subject to several preconditions, which are set out in Chapter 5 of the revised MPLO. The authorisation is issued by Swissmedic and allows the sponsor to make this medicinal product available for use in Switzerland. The treating physicians do not need to submit an application to Swissmedic for this purpose.