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.