Other Notifications

 

The submission of notifications to INFARMED and CEIC should be done through RNEC if these regards to clinical trials that were submitted through this portal. Otherwise, it should be done independently to these two entities, through the usual pathways.

 

INFARMED, I.P.

For submission of notifications to INFARMED, see:

• Law n.º 21/2014, of 16th April, modified by Law n.º 73/2015, of 27th July.
• Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial (CT-1)

 

Protocol deviations:

All protocol or GCP deviations shall be documented by the sponsor in order for the appropriate corrective and preventative actions to be taken and reported according to GCP. Serious deviations (serious breaches) from clinical trial protocols and GCP that are deemed by the sponsor as likely to significantly impact the scientific value of the reported results of the trial shall be notified to INFARMED trough the RNEC portal. It is the responsibility of the Sponsor to assess the impact of all deviations and to proceed with its notification to the competent authorities.

 

CEIC

This section is under constrution. Any question please conctact ceic@ceic.pt

 

Notification of Safety Information

 

INFARMED, I.P.

INFARMED monitors the safety of investigational medicinal products use, in order to allow a constant benefit-risk assessment on which it relied the authorization of ongoing clinical trials and, if necessary, the suspension or revocation of the authorization.

This supervision is done by INFARMED through the management and assessment of notifications of Suspected Unexpected Serious Adverse Reactions (SUSAR's), Safety Annual Reports and other safety information, in order to detect and assess safety signals.

The responsibilities and guidance on this matter are defined in the Law no. 21/2014 of 16 April (transposing the Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001) and in the guideline " Communication from the Commission - Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use («CT-3»)".

For SUSAR reporting to INFARMED and additional guidance please consult the clinical trials pharmacovigilance area at INFARMED website.

 

CEIC

This section is under constrution. Any question please conctact ceic@ceic.pt