EU Q&A on Importation of APIs

The Falsified Medicines Directive came into force in Europe in January 2013. Among the Directive’s requirements is the stipulation that APIs imported into the European Union meet equivalent GMPs to those applied in the EU. To implement this requirement, manufacturers must obtain certification from the competent authority in the country where the API is manufactured that they were made in compliance with GMPs equivalent to those of the EU.  Alternatively, countries of origin may apply for exemption from this rule for APIs manufactured within their borders.  

To assist manufacturers, the European Commission published version 5.0 Questions and Answers regarding Importation of Active Substances for Medicinal Products for Human Use on 13 November 2013 which adds two new questions and answers — 33 and 34:

33. QUESTION:WHAT HAPPENS WHEN AN ACTIVE SUBSTANCE MANUFACTURING SITE COVERED BY A WRITTEN CONFIRMATION IS FOUND GMP NON-COMPLIANT FOLLOWING AN INSPECTION BY A EU MEMBER STATE?

Answer: A statement of GMP non-compliance issued by a EU Member State for a specific site and API supersedes the corresponding written confirmation until the noncompliance is resolved.

34. QUESTION: WHERE CAN I FIND A LIST OF ACTIVE SUBSTANCE MANUFACTURING SITES THAT RECEIVED STATEMENTS OF GMP NON-COMPLIANCE?

Answer: Statements of GMP non-compliance are stored in the EudraGMDP database (https://eudragmdp.eudra.org/inspections/displayWelcome.do). They are currently accessible only by EU national competent authorities, but are expected to become publicly available by end of 2013. Until then, a list of active manufacturing sites that received a statement of GMP noncompliance can be found here: https://ec.europa.eu/health/humanuse/quality/index_en.htm#ias.

The EudraGMDP database referenced above now includes summary reports and reasons for non-compliance status identified during inspections. It may be found at: https://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do