MIA format updated according to EMA's community procedures

11 February 2015

We have updated our IT systems and are now able to transfer Manufacturing and Importation Authorisations (MIA) to EudraGMDP via EMA's latest XML form. This implies some changes to how we will issue MIAs in future.

Changes to MIAs

Firstly, the technical update means that we can now transfer MIAs according to the new version of the EU harmonised format. Read more about the applicable format for MIAs in EMA's Compilation of Community Procedures on Inspections and Exchange of Information on pages 148-163.

Secondly, we have corrected some errors that we have not been able to correct previously due to technical issues. We have made the following changes:

  • The formats for human and veterinary use have been joined, and in future only one authorisation will be issued. The application forms have been combined into one form, in which the applicant can indicate whether the application concerns medicinal products for human use, veterinary use or both. The indication of human and/or veterinary use is made on an overall level.
  • It is possible to transfer the comment fields for Annexes 1 and 2, parts 1 and 2.
  • It is possible to transfer special products. Note that the list of special products has been updated/changed to 6 new types according to the EU guidelines.
  • New validation rules have become effective, which means that all activities carried out can be covered by the authorisation. The updated guidance will contain more information about this.
  • Item 1.4.1.3 (manufacture of biological APIs) has been removed. The manufacture of biological APIs now forms part of the manufacture of biological medicinal products under 1.3.
  • An extra biological product has been added; Tissue engineered products under items 1.3.1.7, 1.3.2.7 and 2.2.3.7. Consequently, the item covering other biological medicinal products has moved to items 1.3.1.8, 1.3.2.8 and 2.2.3.8.
  • The importation part (part 2) has been changed, as other importation activities have been changed from 2.2.4 to 2.3. The number of activities under 2.3 has been reduced and changed relative to 2.2.4.
  • Only one of each activity can be transferred per site. This means that we had to remove the national sub-items under 1.4.1.4 and 2.2.4.6. Instead, use the comment fields to indicate any sub-items.
  • It is possible to transfer comments to the activities allowing such transfer; 1.1.1.6, 1.1.2.5, 1.2.1.8, 1.2.1.15/17, 1.3.1.8, 1.3.2.8, 1.4.1.4, 1.4.3, 1.5.1.8, 1.5.1.15/17, 2.2.3.8 and 2.3.4.

You can find the updated application form for MIAs on our website under Applications for authorisation to manufacture and import medicines and intermediates

Practical implications

Brief overview of the practical implications of our updated IT systems:

  • We have updated the application form so that only one form is available in future for both human and veterinary use. In the form, please tick whether the application concerns human use, veterinary use or both.
  • We will update our authorisation templates and use them when we issue MIAs in future.
  • We will update our guidelines so that they reflect the many changes.

Impact on GMP certificates

We will continue to issue GMP certificates of the activities inspected. Moreover, we will issue one certificate per domain inspected. We will distinguish between the following domains: 1) human medicinal products, 2) veterinary medicinal products, 3) investigational medicinal products, 4) active substances for human use and 5) active substances for veterinary use.

EudraGMDP

EudraGMDP is a Community database in the EU administered by EMA. The database contains information about manufacturers and wholesale dealers in the EU/EEA, both authorisations and certificates. Moreover, the database contains information about non-compliance as well as companies registered as API manufacturers, distributors or importers. Access to EudraGMDP via http://eudragmp.ema.europa.eu/

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