In the first version of the Administrative Ordinance (Instructions relating to the application of Art. 13, TPA) of 11 November 2008, Chapter 6.1.1, it was stated that following a first authorisation or a modification requiring approval in application of Art. 13, TPA, all subsequent modifications proved or prescribed by the reference authority must also be submitted and approved for Switzerland. In the new Administrative Ordinance relating to the authorisation of medicinal products already authorised in foreign countries (Art. 13, TPA) of 23 June 2010, this statement is no longer included.
a) Does this mean, therefore, that now that the new version is in force, it is no longer necessary to inform Swissmedic of modifications approved or prescribed by the reference authorities?
Yes. When Swissmedic issues the official authorisation, the authorisation procedure in application of Arts. 5a - 5d of the Ordinance on Medicinal Products (VAM) is concluded. Conditions imposed by the reference authority that have not yet been fulfilled at the point when the Agency issues a decision regarding authorisation are usually also imposed by Swissmedic. After the granting of the authorisation in Switzerland, decisions on the part of the reference authority regarding the fulfilment of such conditions must be submitted to the Agency within a reasonable time.
b) Does this also apply automatically to medicinal products that were authorised in application of the former Administrative Ordinance of 11 November 2008 relating to the application of Art. 13, TPA, and which include such conditions?
Yes. Under administrative law, the general rule is that a subsequent modification that is made with regard to the legal situation (in this case, the entry into force of Art. 5a et seq., VAM), is applied for decisions whose legal consequences have an effect for a specified or unspecified duration in the future.
Last updated on: 13.04.2011