eCTD format on Portugal

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Infarmed, I.P., the Portuguese National Authority of Medicines and Health Products, published on the 12/07/2010 the “Deliberação n.º 102/CD/2010, de 1 de Julho”, regarding the rules for presenting documents in electronic format (national, Mutual Recognition and decentralized procedures).

Currently, Infarmed accepts:

  • CTD (Common Technical Document) dossiers having different electronic structures if a minimal organisation is adopted (as the one available at Infarmed’s web site or the NeeS structure organisation) ; Download Infarmed’s dossier structure: EXE or ZIP
  •  eCTD (Electronic Common Technical Document) format.

Since 12/07/2010, paper submission of Module 1 is no longer mandatory. The paper copy is only mandatory for documents requiring a signature (submission letter and Module 1.2).

Transitory period :

– Dossiers with the above mentioned format will be accepted until 12/12/2010.

– From the 13/12/2010 on only the following formats will be accepted:

  • eCTD (Electronic Common Technical Document);
  • NeeS (Non eCTD Electronic Submission).

Once submitted under the eCTD or the NeeS format, subsequent dossier’s submissions must be done under these formats.

The SPC (Summary of Product Characteristics), the leaflet and labelling information are to be submitted in Word format.

From the 01/01/2012 on:

  • Only eCTD format dossiers will be accepted.

The eCTD is the result of the ICH M2 group and is common to Europe, USA and Japan. eCTD aims are to diminish the cost of management evaluation and dossier archiving and to optimize the evaluation process. eCTD allows all players to visualize and to manage the medicinal product life cycle.