Submission instructions to Infarmed
A - PASS studies to be carried out exclusively in Portugal in fulfillment of an obligation
Must be submitted to Infarmed, I.P. for evaluation studies conducted in compliance with an obligation imposed in accordance with paragraph 5 of Article 24 or of paragraphs 1 to 5 Article 26a of Decree-Law No. 128/2013, of September 5 to be realized exclusively in Portugal.
Before performing a study the marketing authorization holder (MAH) has to submit to INFARMED, IP, a protocol design.
Within 60 days of the submission of the draft protocol, INFARMED, IP, adopt and notify the MAH of its decision.
The study may begin only after the approval of INFARMED, IP.
1 - After the start of a study, any substantial amendments
the protocol must be submitted by the MAH to INFARMED, IP, before to implementation.
2 - INFARMED, IP, assess the amendments and inform the MAH of its endorsement or objection.
Conclusion of study
After conclusion of the study, ie after the end of data collection, the MAH has within 12 months, to submit the final report and the summary of the final report.
If available, progress reports should be submitted in accordance with GVP Module VIII Addendum 1.
All relevant documentation should be submitted through RNEC, as provided in the document 'Technical requirements and functional specifications' according to Article 10 of Decree No. 65/2015, of March 5.
B - PASS Studies to be carried out in more than one EU Member State
In order to facilitate the exchange of pharmacovigilance information and increase transparency between the EMA, the Members states and the MAH or the sponsor shall perform the registration of all studies that intends to carry on European Network Centers for Pharmacoepidemiology and Pharmacovigilance (http://www.encepp.eu/encepp_studies/indexRegister.shtml).
Whenever one of these studies take place in Portugal, in fulfillment of an obligation or on its own initiative, the marketing authorization holder or the sponsor must submit to Infarmed the identification of the submitted study ENCePP E-Register of Studies (EU PASS register number), the protocol (protocol model - Annex I) and related substantial changes, progress repots and within 12 months the final report (final report model - Annex II).