+Artikolu 32 1
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Artikolu 32 1
1. Mhux aktar tard mit-2 ta’ Jannar 2032, il-Kummissjoni għandha tivvaluta u tadotta rapport dwar l-adegwatezza u l-proporzjon tal-kostijiet u l-benefiċċji li, fil-pjattaforma komuni tad-data, tiġi inkluża d-data dwar sustanzi kimiċi li ġejja relatata mal-prodotti mediċinali skont l-Artikolu 3(3):
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(a)
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kategoriji ġodda ta’ tipi ta’ data;
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(b)
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data dwar sustanzi kimiċi dwar sustanzi għajr sustanzi attivi;
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(c)
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data dwar sustanzi kimiċi dwar sustanzi attivi li ma jissodisfawx il-kriterji msemmija fl-Artikolu 3(3), il-punt (b);
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(d)
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data dwar sustanzi kimiċi miġbura u sottomessa skont atti legali tal-Unjoni elenkati fl-Anness I, il-Parti 2, u miżmuma mill-awtoritajiet kompetenti tal-Istati Membri u mhux mill-Aġenziji.
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1. Ħarsa ġenerali
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Regolamentazzjoni |
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1.1 Referenzi
1.2 Rekwiżiti identifikati
1.3 Standards relatati
2. Rekwiżiti identifikati
3. Standards relatati
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