Human and veterinary medicines

Authorisations

Medicinal products may only be placed on the Swiss market if they are authorised by Swissmedic.

Medicinal products that require authorisation include:

 

  • human synthetic drugs
  • human medicines manufactured using biotechnology
  • complementary and herbal medicines
  • vaccines for humans
  • blood products
  • veterinary medicines.

When authorising new medicinal products, Swissmedic bases its decisions on internationally acknowledged criteria. The products may only be placed on the market if their quality, safety and effectiveness are sufficiently evaluated and proved.

The required evaluation of medicinal products calls for significant resources, and can often take several months. Swissmedic makes every effort to keep the processing time as short as possible, while maintaining the same high quality of the assessment in order that new, important medicines are made available to patients as rapidly as possible.

Market monitoring of medicines

The medicinal products are also subject to official controls once they are placed on the market. Despite in-depth examination prior to being authorised and the stringent authorisation criteria, rare risks from medicines can at times only be identified after they are placed on the market, within the framework of extremely widespread application and everyday use. Swissmedic collects and evaluates reports of adverse drug reactions from healthcare professionals (doctors, pharmacists, druggists), from pharmaceutical companies and from patients. It is also compulsory for these professionals to report quality problems. The Agency examines the incoming reports carefully and, in the case of new risks, takes the appropriate measures. These include precautions regarding use, restricting the distribution channels, or the recall of a product from the market.

Obtaining medicines via the Internet constitutes a considerable health risk. The World Wide Web makes it possible to have medicines from all over the world delivered to Switzerland. Many of the products in question, however, are not of sufficiently high quality, wrongly labelled or knowingly falsified. In Switzerland, mail order trade for medicinal products is only permitted subject to legally defined conditions: the corresponding licences are issued by the Cantons.

Taking medicines – even in moderation - that do not correspond to their intended use can be harmful to health. For this reason, restrictive regulations apply to advertising them, and particularly on radio, television, or in cinemas or on the Internet. Prescription-only medicines may not be advertised directly to the public, but only to healthcare professionals.

In order to monitor all these activities, Swissmedic works with the customs authorities and the Cantonal health and penal authorities. In addition to Swissmedic, it is notably the Cantonal pharmacists who are mandated to carry out important activities in the therapeutic products sector. Networked co-operation is also used to control national and international commerce in narcotics, psychotropic substances and precursor chemicals. The objective is to guarantee that these substances are used appropriately and safely, for medical purposes.