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Version 4 of the Commission Q&A; on the importation of APIs from outside of the EU

On 5 April 2025 the Commission published version 4 of their Q&A regarding the importation of APIs from outside of the EU. This version contained 3 new questions and answers:

• Question 2a asks “Does the written confirmation apply to blood plasma?” The answer is “no”. However, substances isolated from blood plasma are considered active substances and in this case written confirmation is required.

• Question 10a asks “Do starting materials that undergoes additional purification or chemical synthesis in the production of an active substance require written confirmation if imported into the EU?”. The answer is “no”, starting materials such as those that undergo additional purification or chemical synthesis do not meet the definition of materials that require a written confirmation.

• Question11b addresses the manufacture of finished dosage forms that are intended for export only. The answer is “yes”, the API that is incorporated into a finished dosage form, manufactured in the EU but intended for export only, does still require written confirmation.

Download from API Import Q&A Version 4