Art. 4 – Definitions

Medicinal productsmeans products of chemical or biological origin which are intended or claimed to have a medicinal effect on the human or animal organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and handicaps; blood and blood products are also considered to be medicinal products;

Medicinal products with indicationsmeans medicinal products with an officially authorised indication in a specific field of application which are intended for use in accordance with the rules of the medical and pharmaceutical sciences;

Complementary medicines with indicationsmeans medicinal products with an officially authorised indication in a specific field of application which are manufactured according to the manufacturing regulations for complementary therapies such as homeopathy, anthroposophic medicine or traditional Asian medicine and whose field of application is determined according to the principles of the corresponding therapy approach;

a^quater.¹¹ Complementary medicines without indications means complementary medicines without an officially authorised indication in a specific field of application which are intended for use in individual therapies;

a^quinquies.¹² Herbal medicines means medicinal products with an authorised indication which exclusively contain one or more herbal substances or herbal preparations and which are not classified as complementary medicines;

a^sexies.¹³ Original preparation means a medicinal product that is authorised by the Swiss Agency for Therapeutic Products (Agency) as the first with a specific active substance, including all dosage forms authorised at the same time or later;

a^septies.¹⁴ Generic medicinal productmeans a medicinal product authorised by the Agency which is essentially the same as an original preparation and which is interchangeable with the original preparation due to its identical active substances and its dosage form and dosage;

a^octies.¹⁵ Reference preparationmeans a biological medicinal product that is used in the authorisation documentation for a biosimilar product as a reference for the comparability of its pharmaceutical quality, efficacy and safety;

a^novies.¹⁶ Biosimilar productmeans a biological medicinal product sufficiently similar to a reference preparation authorised by the Agency and that refers to its documentation;

Medical devices means products, including instruments, apparatus, equipment, in vitro diagnostics, software, implants, reagents, materials and other goods or substances which are intended or claimed to have a medical use and whose principal effect is not obtained with a medicinal product;

Manufacture means all stages in the manufacture of a therapeutic product, from the acquisition of the precursors and the processing to the packaging, storage and delivery of the end products, and including the quality controls and batch release;

Placing on the market means the distribution and dispensing of therapeutic products;

Distribution means the transfer or release, either free of charge or in return for payment, but not the dispensing, of a therapeutic product and includes the activities of brokers and agents;

Dispensing means the transfer or release, either free of charge or in return for payment, of a ready-to-use therapeutic product destined for use by the purchaser or for use on a third party or on animals;

Prescriptionmeans the recorded decision of a qualified medical professional issued in accordance with Article 26 paragraph 2 to a specific person, granting that person a right of access to medical services such as care services, medication, analyses or medical devices;

Pharmacopoeia (Pharmacopoeia Europaea and Pharmacopoeia Helvetica) means a collection of regulations on the quality of medicinal products, excipients and certain medical devices;

New active substance means an active substance which is authorised for the first time in Switzerland pursuant to an ordinary procedure under Article 11. Active substances previously only authorised in medicinal products for human use shall be considered new active substances if they are used in products for veterinary use, and vice versa;

Public pharmacy means a pharmacy licensed by the canton, run by a pharmacist, which guarantees regular opening hours and offers direct access to the public;

Hospital pharmacymeans a pharmacy in a hospital establishment which is run by a pharmacist and offers, in particular, pharmaceutical services to the customers of the hospital; for the preparation of radiopharmaceuticals in accordance with Article 9 paragraph 2 letter a and paragraph 2^bis, an internal radiopharmaceutical establishment is also deemed to be a hospital pharmacy;

Pro-pharmacymeans the cantonally approved dispensing of medicinal products in a doctor’s practice or an outpatient healthcare service whose pharmacy is under the professional responsibility of a doctor with a professional licence.