The guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4 describes the particular requirements to be fulfilled by applications under the simplified authorisation procedures according to Art. 14 para. 1 abis-quater of the Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA; SR 812.21). These procedures entered into force on 1 January 2019 at the same time as the revised Therapeutic Products Act. Drawing on the experience gained with the new process during the 2019 business year, Swissmedic is now able to clarify certain points in the guidance document.
Precondition for the application of the procedure according to Art. 14 para. 1 let. abis TPA
Art. 14 para. 1 let. abis TPA is worded in such a way that the active substances contained in the chosen foreign reference medicinal product – rather than the product itself – have to have been authorised in a medicinal product in the EU/EFTA for at least ten years at the time the application is submitted. As a result, the chosen foreign reference medicinal product may possibly not have been authorised in the EU/EFTA for ten years. In this case, the relevant precondition for applying the procedure is that the foreign reference product must be indicated for the same medical indication as that of the medicinal product that has been authorised in an EU/EFTA country for at least ten years.
Preparing Information for healthcare professionals for medicinal products under the authorisation procedure according to Art. 14 para. 1 let. ater TPA
In accordance with Art. 17c para. 1 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; SR 812.212.23), Information for healthcare professionals can be omitted from the simplified authorisation procedure according to Art. 14 para. 1 let. ater TPA.
A clarifying statement has been added to the guidance document, explaining that the company may use its own discretion to decide whether or not to issue Information for healthcare professionals.
Special notes in medicinal product information
According to Art. 17b para. 5, Art. 17c para. 3 or Art. 17d para. 3 TPLO, medicinal product information must include notes for the user explaining the special features of the simplified authorisation procedure. In the light of the experience gained, Swissmedic has specified the wording of these notes in the guidance document Authorisation according to Art. 14 para. 1 abis-quater TPA HMV4.
In particular, the notes for medicinal products in the authorisation procedure according to Art. 14 para. 1 let. abis TPA (and in special cases according to Art. 14 para. 1 let. ater TPA) must now also include information on the date on which the text for the chosen foreign comparator medicinal product was last revised.
Date of revision in medicinal product information
The “Date of revision” section in Information for healthcare professionals and Patient Information or the "This package leaflet was last revised by the medicines agency (Swissmedic) in … (month/year)” statement indicates when Swissmedic last reviewed the medicinal product information. Under the procedure according to Art. 14 para. 1 let. abis-quater TPA, Swissmedic either carries out only a summary review of the safety and efficacy of the medicinal product submitted for authorisation (let. abis) or does not review safety and efficacy at all (let. ater and aquater). The above-mentioned sections of the medicinal product information will now take account of this fact by providing transparency and a clearer distinction as to who last revised the texts and in what form. The corresponding text requirements for human and veterinary medicinal products can be found in the guidance document Authorisation according to Art. 14 para. 1 let. abis-quater TPA HMV4.
The new version of the guidance document Authorisation according to Art. 14 para. 1 let. abis-quater TPA HMV4 enters into force on 1 February 2020. The associated Q&A document has been updated accordingly.