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The Portuguese Drug Regulatory Agency INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P) has recently released the national eSubmission roadmap for Portugal. The corresponding document is currently available in Portuguese language only. Please find below a professional translation.
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Professional Translation from Portuguese by
beo Gesellschaft für Sprachen und Technologie mbH
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Start of translation
Deliberation No. 102/CD/2010
Within the framework of the modernisation strategy of INFARMED, I.P., and in accordance with the commitments undertaken at the level of the group of Heads of Medicines Agencies of the European Union, it is ordered that the rules be defined regarding the submission of documents to INFARMED-Autoridade Nacional de Medicamentos e Produtos de Saúde, I.P. (INFARMED, I.P.) in electronic format.
INFARMED, I.P. currently accepts different CTD (Common Technical Document) electronic formats, providing minimum organisation is adopted, such as the structure of folders available on INFARMED, I.P.'s web page and NeeS (Non eCTD Electronic Submission).
Similarly, all applicants who wish to do, may currently submit applications in eCTD (Electronic Common Technical Document) format.
It is now important to begin the format standardisation process until the eCTD is fully adopted, recognising that the pharmaceutical industry is at different stages of preparation for the eCTD and that the success of the transition to a new stage in submissions in electronic format should not cause disorder in the applicant companies' operations.
Therefore:
Under the terms of sub-heading h) of No. 1 of article 202 of Decree-Law 176/2006, of 30th August, INFARMED, I.P.'s, Board of Directors deliberates that:
1. Until 12th December 2010 electronic formats of the CTD (Common Technical Document) continue to be accepted, providing minimum organisation is adopted, such as the structure of folders available on INFARMED, I.P'.s web page and NeeS (Non eCTD Electronic Submission).
2. After the transition period mentioned in the previous heading has ended and taking point 8 below into consideration, only the following document submission formats are permitted:
a) eCTD (Electronic Common Technical Document);
b) NeeS (Non eCTD Electronic Submission).
3. The rules adopted relating to eCTD and NeeS, are defined within the framework of the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and the European Medicines Agency, through the Telematics Implementation Group for electronic submission and ICH Implementation (TIGes).
4. All documentation submitted must comply with the rules in force for the formats defined, namely regarding the type of files that may be used.
5. Additionally, the summary of the product's characteristics, information leaflet and labelling are submitted in "Word" format.
6. From the publishing date of this Deliberation, it ceases to be mandatory to submit module 1 in paper format, with only documents requiring signature having to be submitted, namely:
a) Application;
b) Module 1.2 (excluding annexes);
7. From 1st January 2012, Market Introduction Authorisation (MIA) application submissions shall only be accepted in eCTD format.
8. The above mentioned provisions are applicable to new Market Introduction Authorisations, submitted through national procedures, mutual recognition and decentralised, it is also being recommended that they be considered for submissions performed after the MIA.
9. Once the eCTD and NeeS formats have been adopted (the latter during the transition period) for the submission of the application for Market Introduction Authorisation, all subsequent submissions relating to the same application must adopt these formats.
Lisbon, 1st July 2010
The Board of Directors
Jorge Torgal, Chairman
Hélder Mota Filipe, Vice Chairman
Miguel Vigeant Gomes, Vice Chairman
Cristina Furtado, Member of the Board
António Neves, Member of the Board
End of translation
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[Source: INFARMED website]
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