Changes to the Medicinal Products Licensing Ordinance (MPLO) – implementation of the Medicrime Convention

The changes to the MPLO (Medicinal Products Licensing Ordinance) arising from the ordinary revision of the TPA (Stage 2) and the revision of the TPA in connection with the approval and implementation of the Medicrime Convention will be addressed in a separate MPLO/Medicrime project. The consultation procedure for the revision of the MPLO in the context of this project is continuing until 25 May 2018. The amendments to the ordinance involve the following topics in particular: 

  • Harmonisation of terms with the TPA;
  • Regulation of broker and agency activities;
  • Further details concerning batch release, the duty of care, the Responsible Person, and the licensing procedure;
  • Removal of the restriction on the period of validity of establishment licences;
  • Simplifications concerning the import of unauthorised medicinal products by medical personnel;
  • Approval of the use of medicinal products intended for clinical trials outside clinical trials 

While the legislative project is ongoing, further information will be successively added to the various processes:

Licensing of medicinal and transplant products

Further links

On the subject

21.05.2019

Report regarding suspected illegal trading in medicinal products

As of 1 January 2019, anyone who produces, sells or distributes medicinal products is required by law to report to Swissmedic any suspicion of illegal trading in such products.

23.11.2018

Ordinance on Licensing in the Medicinal Products Sector: publication of the text

The Federal Council has approved the MPLO

Last modification 21.05.2019

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