Guidance to manufacturers outside the EU/EEA area

Applications for authorisation of medicinal products according to particular procedures must enclose specific documents. The particular application procedures are as follows:

• National procedure
• MRP
• Variation applications concerning adding a new manufacturing site, where the manufacturer is located outside the EU/EEA area, where the country in question does not have an agreement with the EU about mutual recognition of good manufacturing practice and where EEA authorities have not carried out an inspection with a satisfactory result within the last two years.

Besides the documents marked in Module 1, Administrative Information Application Form, the following specific documents should be enclosed:

• Manufacturing authorisation from the local national authorities
• Site master file(s) for the current manufacturing location(s)
• Audit report from audit carried out of/for the applicant at the manufacturing location
• Statement of the manufacturer saying that the manufacturer is ready for the authorities’ inspection

Manufacturing of medicinal products outside the EU/EEA has to meet the EU GMP requirements.