Reporting requirements of ICSR
Obsah
In accordance with the transitional provisions set out in Article 2(4) and Article 2(5) of Directive 2010/84/EU, the reporting requirements as detailed in the table below shall apply to valid ICSRs reported by healthcare professionals or non-healthcare professionals. This is independent of the condition of use of the suspected medicinal product and of the expectedness of the adverse reaction.
Directive 2010/84/EU has been implemented into the Slovak Act No.-362/2011 Coll. by its amendment which enters into force by 1st September 2012.
|
Marketing authorisation procedure |
Origin of report |
Adverse reaction type |
Reporting |
Time frame
|
|
• Centralised • Mutual recognition (MRP), • decentralised (DCP) • Subject to referral • Purely national
|
Slovakia |
All serious |
Yes, Electronically* to SIDC
|
15 days
|
|
All non-serious |
No |
- |
||
|
Non EU |
All non-serious |
No |
- |
|
|
Serious |
No, Electronically* directlyto Eudravigilance
|
15 days |
* Electronic reporting means reporting via gateway. Sending by email is not considered electronic reporting.
State Institute for Drug Control
Slovak Republic
6 August 2012 (actualisation)