Medicinal products with new active substances are authorised in an ordinary procedure in accordance with Art. 11 TPA. A new active substance (NAS) is understood to be a chemical, herbal, biological, biotechnological or radiopharmaceutical active substance that to date has not been included in any medicinal product that is or was authorised by Swissmedic in an ordinary procedure in accordance with Art. 11 TPA (Art. 4 para. 1 let. h TPA).
Herbal and complementary medicinal products with new active substances or new aspects not previously approved by Swissmedic, such as new indications, routes of administration, dosage forms or dosages, can be authorised in an ordinary procedure if documentation that fulfils the requirements of Art. 11 TPA is available.
More information can be found in the Guidance document Authorisation of human medicinal product with new active substance HMV4 and in the Guidance document Authorisation of herbal medicinal products HMV4.
If an applicant requests the authorisation, extension or a variation of an authorisation for a medicinal product or procedure for which authorisation has already been granted in a country with a comparable control system for medicinal products, Swissmedic will take into consideration the results of the assessments carried out by the foreign regulatory agency provided that certain requirements are fulfilled. It is vital, in particular, for the current assessment report by the reference authority and their decision based on this assessment to be available.
The guidance document relevant for authorisation of a medicinal product in accordance with Art. 13 TPA and the associated documents can be found below:
The simplified authorisation procedures described below may be used for medicinal products:
Art. 14 para. 1 let. abis TPA Medicinal products whose active substances are used in a medicinal product which has been authorised for at least 10 years in at least one EU or EFTA country.
According to Art. 14 para. 1 let. abis and Art. 14a para. 1 let. a TPA, in conjunction with Art. 17a and 17b TPLO, a medicinal product can be authorised in a simplified procedure if its active substances have been used in an authorised medicinal product for at least 10 years in an EU or EFTA country and if it is comparable to a medicinal product authorised in a foreign country with respect to indication, dosage (dosage strength and dosage recommendation) and route of administration.
Art. 14 para. 1 let. ater TPA Medicinal products with many years of medical use
In accordance with Art. 14 para. 1 let. ater and Art. 14a para. 1 let. b TPA, in conjunction with Art. 17c TPLO, a medicinal product can be authorised in a simplified procedure if it is a non-prescription medicinal product with a stated indication and has been used medically for at least 30 years, including at least 15 years in EU and EFTA countries.
Art. 14 para. 1 let. a quater TPA Medicinal products with cantonal authorisation
In accordance with Art. 14 para. 1 let. aquater and Art. 14a para. 1 let. c TPA, in conjunction with Art. 17d TPLO, a medicinal product can be authorised in a simplified procedure if it has been authorised as a medicinal product for at least 15 years in a canton.
Further simplified authorisation procedures are available for herbal medicinal products and complementary medicinal products as described in Art. 14 para. 1 let. cbis TPA and Art. 14 para. 1 let. b TPA. Compared with the procedures specific to herbal and complementary medicinal products, in the simplified procedures in accordance with Art. 14 para. 1 let. abis-quater a medicinal product remains directly dependent on the foreign or cantonal comparator product throughout the period during which the former is authorised.
The guidance document relevant for authorisation of a medicinal product in a simplified procedure in accordance with Art. 14 para. 1 let. a bis – quater and the associated documents can be found below:
A co-marketing medicinal product is a medicinal product which, on the basis of written authorisation of the holder of authorisation for an existing authorised medicinal product (basic product), can be substantiated by the authorisation documentation of that product. A co-marketing medicinal product can be authorised by Swissmedic simply on the basis of notification, see Article 34ff of the Ordinance of the Swiss Agency for Therapeutic Products of 22 June 2006 on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (TPLO).
The guidance document relevant for authorisation of a co-marketing medicinal product and the associated documents can be found below:
