Implementation of Art. 64a revTPA brought forward
29.09.2017 - In accordance with the Federal Council’s decision of 5 April 2017, the entry into force of the new Article 64a of the revised Therapeutic Products Act1 (revTPA), decreed by the Federal Assembly on 18 March 2016, has been brought forward to 1 January 2018. The new article governs cross-border inspections, and entails changes affecting inspections carried out in Switzerland by foreign authorities, as well as inspections by the Swiss authorities abroad.
Art. 64a revTPA:
The new Article is worded as follows:
1 After notifying the Agency, competent foreign authorities will be entitled to inspect Swiss establishments operating in the therapeutic products sector provided that:
a. the inspection is solely intended to review compliance with therapeutic products legislation;
b. the results of the inspection will be used solely in administrative proceedings associated with the enforcement of therapeutic products legislation;
c. the establishment to be inspected gives its consent; and
d. the foreign authority informs the Agency of the results of its inspection by providing a copy of its inspection report in one of Switzerland’s official languages or in English.
2 The Agency may accompany the foreign authority during its inspection.
3 By arrangement with the competent authorities, the Agency can inspect establishments abroad that operate in the therapeutic products sector if this is necessary to guarantee health protection.
What is changing?
A foreign authority is entitled to carry out its inspection if the establishment to be inspected gives its consent (letter c). Authorisation by SECO is no longer required. In all cases, foreign authorities must notify the Agency in advance of their intention to perform an inspection and provide the Agency with a copy of the inspection report after they have performed their inspection. Swiss companies and foreign authorities will therefore have to make arrangements for inspections with each other. Swissmedic will notify establishments in good time if it intends to accompany the inspection. The Agency will notify all foreign authorities that have carried out inspections in Switzerland over the last four years of the change. The new procedure applies to all inspections that will be taking place in Switzerland from 1 January 2018.
Paragraph 3 provides a legal framework for carrying out inspections abroad. For example, GCP inspections can be carried out abroad even if there is no link to a trial being carried out in Switzerland; i.e. they do not have to be triggered by a preceding inspection. Accordingly, an inspection abroad may be triggered by an application for authorisation. In all cases, Swissmedic must notify the foreign authority of the inspection in advance.
The information sheet “General procedure for foreign governmental inspections in Switzerland related to therapeutic products” will be updated to reflect the new situation by the end of 2017.
1Federal Gazette 2016 p. 1953ff. (https://www.admin.ch/opc/de/federal-gazette/2016/1953.pdf)