I-SMI.TI.22e 根据 MPLO 第 41 条的通知
I-SMI.TI.22e Notifications according to Article 41, MPLO
Swissmedic 发布 I-SMI.TI.22e《根据 MPLO 第 41 条的通知》，属 GMP/GDP 检查员技术解释文件。因新治疗产品法（TPA, SR 812.21）及第四批治疗产品条例于 2019 年 1 月 1 日生效，部分 GMP/GDP 文件中的法律引用尚待更新，更新工作正在进行，但其内容仍然有效且未作改动。
Inspectorates
GMP/GDP documents
Certain legal references within GMP/GDP documents have yet to be updated following the entry into force of the new Therapeutic Products Act (TPA, SR 812.21) and the fourth package of ordinances on therapeutic products on 1 January 2019. The process of updating them is in progress. Despite this, their content remains valid and unaltered.
Directives
Directives are basic terms of reference for inspectorates in accordance with Article 63 MPLO (SR 818.212.1). They guarantee uniform inspection procedures throughout Switzerland and are terms of reference for any standard operating procedures for the inspectorates.
16.07.2026
Guidelines
The inspectorates are bound by guidelines. The guidelines often relate to procedures, are administrative in nature, occasionally supplement directives issued in accordance with Article 63 MPLO (SR 818.212.1) or may prescribe local working instructions for the inspectorates.
Technical Interpretations (TI)
These documents describe the requirements on individual GMP/GDP topics taking account of the specific legal provisions of therapeutic products legislation. The technical interpretations (TI) are intended primarily for administrative bodies and ensure the harmonisation of inspections practice among GMP/GDP inspectorates in Switzerland as well as the uniform and equitable application of the legal provisions. The publication of the TI provides clear information to licence holders concerning the requirements that they must fulfil in order to conduct their activities in compliance with GMP/GDP.
来源：Swissmedic 药品质量与 GMP 更新 · swissmedic.ch