Guidance Document Authorisation of the human medicinal product with known Active Pharmaceutical Substance
Medicinal products with known APIs are those containing an active pharmaceutical ingredient that is or was contained in a medicinal product already authorised by Swissmedic (Article 12, para. 1, TPLO).
This guidance document describes the requirements regarding the documentation to be submitted for the authorisation of human medicines with known active pharmaceutical ingredients (known APIs). The guidance document comprises guidelines intended for administrative bodies, and thus does not directly address the rights and duties of individuals.
The publication of this guidance document is intended to provide transparency regarding the requirements to be fulfilled in accordance with Swissmedic's practices.The guidance document is intended to contribute towards clearly formulating the conditions and requirements for the submission of the application and for the authorisation of human medicines with known APIs in Switzerland.
Click on this LINK to see Guidance on Authorisation on known Active Pharmaceutical Substance.
Guidance document Time limits for Authorisation Applications
Applicant time is the total time available to the applicant during the ongoing process of handling the application (e.g. for responding to the List of Questions). This time will be debited to the applicant.
This document describes the timetable for authorisation procedures and defines the time limits observed by Swissmedic in connection with submitted authorisation applications. Legal provisions are in existence for certain time limits (e.g. appeal deadlines).
This guidance document pursues three primary objectives:
(1) Make all parties aware of the time limits to be respected by Swissmedic and by the applicant.
(2) Explain the procedure to be followed for applications that are incomplete in terms of formal requirements and content.
(3) By specifying procedure periods, help the applicant with its planning and enable key data to be recorded on the duration of procedures overall and on individual procedure sections.
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