Update of information sheet on non-standardised medicinal products and on the list of non-standardised medicinal products and medicinal product groups with a manufacturing process subject to mandatory authorisation according to Annex 3 TPLO


With regard to the conditions for exemption from the requirement for a licence and mandatory authorisation for non-standardised medicinal products, the following changes have been made in section 3.3 of the information sheet:

  • Further details on the requirement for a closed system.
  • Rewording of description of situations which are not permitted without a licence for better comprehensibility.

The revised information sheet is valid with effect from 18 May 2022.

Last modification 01.07.2022

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