Special authorisation

Procurement of medicinal products that are not authorised or not available in Switzerland / Special authorisation

1. Introduction

The situation repeatedly arises in which certain patients or domestic or farm animals require medicines that are not authorised in Switzerland or that temporarily cannot be supplied by the authorisation holder (supply shortage due to an interruption in supply).

In such cases, healthcare professionals with dispensing authority (e.g. community pharmacists, hospital pharmacists, physicians licensed to dispense medicinal products, veterinarians) may obtain medicinal products from abroad that are not authorised in Switzerland.

The specific preconditions relating to licence-free import are set out in Article 49 of the Medicinal Products Licensing Ordinance (MPLO; SR 812.212.1) for human medicines and in Article 7 of the Veterinary Medicinal Products Ordinance (VMPO, 812.212.27) for veterinary medicines. The guidance document on special authorisations contains explanations regarding Art. 7 VMPO and helps to clarify whether special authorisation is required or whether licence-free imports are permitted. When these medicinal products are dispensed or used, the cantonal regulations on registering imports of medicinal products must be observed.

To locate suitable sources of supply in other countries, please refer to the official medicine directories and the corresponding authorisation holders – whether based in Switzerland or abroad – in order to ensure that the medicines originate from legal, officially controlled channels. Ordering from unknown sources, particularly online, is strongly discouraged.

Professionals with any queries can contact the relevant cantonal authorities (e.g. cantonal pharmacies).

Contact

Swissmedic
Section Certificates and Licences
Hallerstrasse 7
3012 Bern
Switzerland

Phone: +41 58 462 04 55 (office
hours)

Fax: +41 58 464 04 60
sobe@swissmedic.ch

2. Forms and guidance documents

Guidance document on special authorisations [not available in English]:


Gesuchformular Sonderbewilligung Tierarzneimittel:

3. Information on special authorisations and related topics

We have compiled frequently asked questions connected with the use of medicines that are not authorised or not available in Switzerland with corresponding information in the form of keywords below. 

Prolonged supply shortages / supply interruption
If a therapeutically important medicinal product that is authorised in Switzerland is not available due to a stock-out situation for a temporary period (less than 1 year; longer interruptions must be notified, see "Stock-out" Information sheet), the authorisation holder can, on the one hand, apply for the temporary placing on the market of a foreign medicinal product in accordance with Art. 1 para. 2 let. c. The application for the temporary placing on the market can be approved by Swissmedic provided the foreign medicinal product does not differ essentially from the stock-out product in terms of composition and quality, does not pose any increased risk in terms of drug safety and if no equivalent alternative to this medicinal product is available in Switzerland (e.g. generic, co-marketing medicinal product). The form for submitting a corresponding application and associated explanatory notes can be found under Market surveillance, Out-of-stock https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/marktueberwachung/out-of-stock.html

Licence-free import of human medicinal products not authorised in Switzerland by a healthcare professional

A healthcare professional with a retail trade permit (see introduction) may obtain human medicinal products that are not authorised in Switzerland from another country. Art. 49 paras. 1 to 6 MPLO stipulate the relevant preconditions:

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. 

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; and

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.
  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.
  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.
  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.
  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. 

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[1] 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. 

Licence-free import of veterinary medicinal products not authorised in Switzerland by a healthcare professional
A healthcare professional with a retail trade permit (see introduction) may obtain veterinary medicinal products that are not authorised in Switzerland from another country. Art. 7 para. 2 VMPO stipulates the relevant preconditions:

A healthcare professional with a retail trade permit issued by the competent canton may import small quantities of veterinary medicinal products that have been authorised by a country with a comparable regulatory system for the treatment of a particular pet or group of pets without authorisation, provided no alternative usable medicinal product is authorised in Switzerland. The importing healthcare professional must keep a record of such imports.
If the preconditions are not met, a special authorisation can be requested. Information on the correct procedure employed when a special authorisation is required can be found in the guidance document (see above). According to Art. 7 VMPO, only healthcare professionals can import medicinal products, whereas others, whether they be authorisation holders or other distributors, are not allowed to import medicinal products according to this article.

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. 

https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/clinical-trials/befristete_bewilligungzuranwendungvonarzneimitteln.html

 

[1]  SR 810.211