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Art. 95

812.21TPAFederal ActJan 1, 2002Original source
  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.1The foregoing is without prejudice to:
    1. the revocation of an authorisation by the canton;
    2. 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 diagnostics may be placed on the market in accordance with the former Act until 7 December 2003. Licences and registrations of in vitro diagnostics established in accordance with the former Act shall be valid until the expiration of their validity period or for a maximum of three years from the commencement of this Act.
  5. Authorisations issued by the Confederation and by the cantons in accordance with the former Act are valid until the expiry of their validity period or for a maximum of five years from the commencement date of this Act.
  6. Persons who do not satisfy the provisions relating to the dispensing of medicinal products (Articles 24 and 25) must cease to dispense them within seven years from the commencement of this Act. The Federal Council may, however, issue exemptions for persons who can prove that they have sufficient education and training.
  7. The administrative measures taken by the Agency and referred to in Article 66 are reserved.

Footnotes

  1. Amended by No I of the FA of 21 June 2013, in force since 1 Jan. 2014 (AS 2013 4137;BBl 2013 32813289). ↩

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