Code identifying the type/legal basis of a regulatory application (e.g. NDA, MAA, full vs abridged). ICH "Application" concept; regionally defined (EU implements as Application Legal Basis).
| Term | Code | Agency | Status |
|---|---|---|---|
| New active substance (Article 8(3) of Directive No 2001/83/EC) | 100000116047 | EMA | Active |
| Known active substance (Article 8(3) of Directive No 2001/83/EC) | 100000116048 | EMA | Active |
| Generic application (Article 10(1) of Directive No 2001/83/EC) | 100000116050 | EMA | Active |
| Hybrid application (Article 10(3) of Directive No 2001/83/EC) | 100000116051 | EMA | Active |
| Similar biological application (Article 10(4) of Directive No 2001/83/EC) | 100000116052 | EMA | Active |
| Well-established use application (Article 10a of Directive No 2001/83/EC) | 100000116053 | EMA | Active |
| Fixed combination application (Article 10b of Directive No 2001/83/EC) | 100000116054 | EMA | Active |
| Informed consent application (Article 10c of Directive No 2001/83/EC) | 100000116055 | EMA | Active |
| Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) | 100000116056 | EMA | Active |
| Ancillary medicinal substance/blood derivative substance (Article 1(4) of both Directives No 93/42/EEC and 90/385/EEC) | 100000116068 | EMA | Active |
| Article 58 of Regulation (EC) No 726/2004 | 100000116081 | EMA | Active |
| Known human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745) | 200000013166 | EMA | Active |
| Known ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745) | 200000013167 | EMA | Active |
| Unknown human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745) | 200000013168 | EMA | Active |
| Unknown ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745) | 200000013169 | EMA | Active |
| Companion Diagnostics (Article 48 (3), (4), (7), (8) of Regulation (EU) 2017/746) | 200000013170 | EMA | Active |
| Medical device composed of a substance or combinations of substances (Article 52 (11) of Regulation (EU) 2017/745) | 200000013171 | EMA | Active |
| Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No 2001/83/EC) | 200000016456 | EMA | Active |
| Medicinal product authorised according to Article 126a of Directive No 2001/83/EC | 200000016457 | EMA | Active |
| Authorisation according to Article 5(1) of Directive 2001/83/EC | 200000023331 | EMA | Active |
| Authorisation according to Article 5(2) of Directive 2001/83/EC | 200000023341 | EMA | Active |
| Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC | 200000023342 | EMA | Active |
| Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC | 200000023343 | EMA | Active |
| Available under Article 83(2) of Regulation (EC) No 726/2004 | 200000023344 | EMA | Active |
24 terms shown for EMA. Data sourced from public health authority publications and updated periodically.