Category: Medicines for human use

Medicines for human use

The EMA has published the document ‘Eudravigilance registration documents’ as a summary of the registration procedures that TACs, among others, must follow with the EMA.

T1, T2, T3

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May 15, 2024

Medical devices

Revision 2 of the ‘Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD’ has been published.

T1, T2, T3

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May 2, 2024

Medicines for human use

The EMA has published a new update (v. 137) of the ‘ List of European Union reference dates and frequency of submission of periodic safety update reports’.

T2,T3

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April 30, 2024

Medicines for human use

The minutes of the meeting of the CMDh subgroup dedicated to the publication of the list of safety concerns and prospectuses have been published with proposals for the current failure to update the list of safety concerns (T3).

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April 3, 2024

Medicines for human use

As of 01 Apr 2024, the EMA MLM service has extended its coverage also to MEDLINE (T1, T2, T3).

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March 27, 2024

Medicines for human use

The EMA has published a new update (v. 136) of the ‘List of European Union reference dates and frequency of submission of periodic safety update reports’ (T2,T3).

Read more "

March 27, 2024

Medicines for human use

A new version (1.3) of the ‘Guidance on the electronic submission of information on investigational medicinal products in the XEVMPD) has been published. (T1, T2, T3).

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March 20, 2024

Medicines for human use

A new version of the EV Registration Manual (Rev. 14) has been published (T1, T2, T3).

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March 13, 2024

Medicines for human use

A new version (13 Mar 2024) of the ‘Eudravigilance registration documents’ (T1, T2, T3) has been published.

Read more "

March 7, 2024

Medicines for human use

New version (29 Feb 2024) of the ‘EV user declaration for qualified person for pharmacovigilance/responsible perrson of EV’, ‘Connecting to the Agency ESTRI Gateway (29 Feb 2024) and ‘EV Human Sponsor Registration form'(29 Feb 2024) (T1, T2, T3) have been published.

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March 7, 2024

Medicines for human use

A new version ( 29 FEB 2024) of the ‘Eudravigilance support guide’ (T1, T2, T3) has been published.

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March 7, 2024

Medicines for human use

A new version (1.7) of the ‘Eudravigilance-EVWEB User Manual’ (T1, T2, T3) has been published.

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March 7, 2024

Category: Medicines for human use

The EMA has published the document ‘Eudravigilance registration documents’ as a summary of the registration procedures that TACs, among others, must follow with the EMA.

Revision 2 of the ‘Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD’ has been published.

The EMA has published a new update (v. 137) of the ‘ List of European Union reference dates and frequency of submission of periodic safety update reports’.

The minutes of the meeting of the CMDh subgroup dedicated to the publication of the list of safety concerns and prospectuses have been published with proposals for the current failure to update the list of safety concerns (T3).

As of 01 Apr 2024, the EMA MLM service has extended its coverage also to MEDLINE (T1, T2, T3).

The EMA has published a new update (v. 136) of the ‘List of European Union reference dates and frequency of submission of periodic safety update reports’ (T2,T3).

A new version (1.3) of the ‘Guidance on the electronic submission of information on investigational medicinal products in the XEVMPD) has been published. (T1, T2, T3).

A new version of the EV Registration Manual (Rev. 14) has been published (T1, T2, T3).

A new version (13 Mar 2024) of the ‘Eudravigilance registration documents’ (T1, T2, T3) has been published.

New version (29 Feb 2024) of the ‘EV user declaration for qualified person for pharmacovigilance/responsible perrson of EV’, ‘Connecting to the Agency ESTRI Gateway (29 Feb 2024) and ‘EV Human Sponsor Registration form'(29 Feb 2024) (T1, T2, T3) have been published.

A new version ( 29 FEB 2024) of the ‘Eudravigilance support guide’ (T1, T2, T3) has been published.

A new version (1.7) of the ‘Eudravigilance-EVWEB User Manual’ (T1, T2, T3) has been published.

Zaragoza

Pamplona