Therapeutic Products Act (TPA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Introductory and Transitional Provisions
Art. 91 Take-over of the Intercantonal Office for the Control of Medicinal Products by the Agency
1 The Federal Council may require authorities which before the commencement of this Act were responsible for registering therapeutic products or for supervising the market to hand over their files to the Agency. 2 Furthermore, the Federal Council shall conclude an agreement with the Intercantonal Union for the Control of Medicinal Products on the take-over of the Intercantonal Office for the Control of Medicinal Products by the Agency.
Art. 92 Transitional rules for staff
1 The Federal Council shall appoint the first executive director of the Agency on the proposal of the Federal Department of Home Affairs. 2 The Federal Department of Home Affairs shall carry out the first appointment of the other members of the management. Their appointment shall be ratified by the Agency Council in accordance with Article 72 paragraph 1 letter h within 18 months of the Agency commencing its activity. 3 The contract service conditions of the staff transferred to the Agency from the FOPH and the Intercantonal Office for the Control of Medicinal Products shall be subject to the conditions of employment of the Agency from the time it commences its activity.
Para. 3 — Name in accordance with No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). The change has been made throughout the text.
Art. 93 Deficit of the Federal Pension Fund
At the time the Agency is set up, the Confederation shall take over the deficit of the Federal Pension Fund for the policyholders who are transferred from the FOPH.
Art. 94 Pending procedures
1 Procedures which on the commencement of this Act are pending before the FOPH, the FSVO, the Intercantonal Office for the Control of Medicinal Products, the organs of the Intercantonal Union for the Control of Medicinal Products as well as before the cantonal authorities of first instance shall be completed in accordance with the provisions of this Act and by the competent authorities designated by it. 2 Procedural acts carried out by authorities deemed competent before the commencement of this Act shall remain valid unless they contradict the material provisions of this Act.
Para. 1 — Name in accordance with No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). The change has been made throughout the text.
Art. 95 Transitional provisions
1 Registrations of medicinal products carried out by the FOPH, the FSVO and by the Intercantonal Office for the Control of Medicinal Products remain valid for up to five years after the commencement of this Act. 2 Cantonal authorisations for medicinal products are valid until 31 December 2017; medicinal products may be authorised by the Agency within two years of the expiry of the transitional period. The foregoing is without prejudice to: a. the revocation of an authorisation by the canton; b. the replacement, on request, of a cantonal authorisation by a marketing authorisation issued by the Agency. 3 Requests for a marketing authorisation for medicinal products for which no authorisation was previously required either under cantonal or federal legislation, but which must be authorised under this Act must be submitted within one year of the commencement of this Act. Medicinal products may continue to be placed on the market until the Agency has reached a decision. 4 In vitro diagnosti
Para. 2 — Amended by No I of the FA of 21 June 2013, in force since 1 Jan. 2014 (AS 2013 4137; BBl 2013 3281 3289).
Art. 95a Transitional provisions to the amendment of 13 June 2008
For medicinal products which are authorised when the amendment of 13 June 2008 comes into force, the periods mentioned under Article 16a paragraph 1 start from the date on which this amendment comes into force.
Art. 95a — Inserted by No 1 of the FA of 13 June 2008, in force since 1 Oct. 2010 (AS 2008 4873, 2010 4027; BBl 2007 2393).
Art. 95b Transitional provisions to the amendment of 18 March 2016
As long as there is no full list in accordance with Article 67 paragraphs 3 and 4, the Agency shall publish the information on medicinal products in the form of an electronic directory at the expense of the marketing authorisation holders. It may delegate the establishment and operation of the directory to third parties.
Art. 95b — Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Section 2 Referendum and Commencement
Art. 96
1 This Act is subject to an optional referendum. 2 The Federal Council shall determine the commencement date. Commencement date: 1 January 2002Art. 71 and 72: 1 October 2001
Para. 2 — FCD of 28 Sept. 2001.