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).
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HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
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Term
Term Description as defined by the Health Authority
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Code
Code, if any, associated with the term by the Health Authority
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Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
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Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
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|---|---|---|---|---|
| EU Application Legal Basis | Well-established use application (Article 10a of Directive No 2001/83/EC) |
100000116053
|
EMA | Active |
| EU Application Legal Basis | Unknown human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745) |
200000013168
|
EMA | Active |
| EU Application Legal Basis | Unknown ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745) |
200000013169
|
EMA | Active |
| EU Application Legal Basis | Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) |
100000116056
|
EMA | Active |
| EU Application Legal Basis | Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No 2001/83/EC) |
200000016456
|
EMA | Active |
| EU Application Legal Basis | Similar biological application (Article 10(4) of Directive No 2001/83/EC) |
100000116052
|
EMA | Active |
| EU Application Legal Basis | Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC |
200000023343
|
EMA | Active |
| EU Application Legal Basis | Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC |
200000023342
|
EMA | Active |
| EU Application Legal Basis | New active substance (Article 8(3) of Directive No 2001/83/EC) |
100000116047
|
EMA | Active |
| EU Application Legal Basis | Medicinal product authorised according to Article 126a of Directive No 2001/83/EC |
200000016457
|
EMA | Active |
| EU Application Legal Basis | Medical device composed of a substance or combinations of substances (Article 52 (11) of Regulation (EU) 2017/745) |
200000013171
|
EMA | Active |
| EU Application Legal Basis | Known human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745) |
200000013166
|
EMA | Active |
| EU Application Legal Basis | Known ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745) |
200000013167
|
EMA | Active |
| EU Application Legal Basis | Known active substance (Article 8(3) of Directive No 2001/83/EC) |
100000116048
|
EMA | Active |
| EU Application Legal Basis | Informed consent application (Article 10c of Directive No 2001/83/EC) |
100000116055
|
EMA | Active |
| EU Application Legal Basis | Hybrid application (Article 10(3) of Directive No 2001/83/EC) |
100000116051
|
EMA | Active |
| EU Application Legal Basis | Generic application (Article 10(1) of Directive No 2001/83/EC) |
100000116050
|
EMA | Active |
| EU Application Legal Basis | Fixed combination application (Article 10b of Directive No 2001/83/EC) |
100000116054
|
EMA | Active |
| EU Application Legal Basis | Companion Diagnostics (Article 48 (3), (4), (7), (8) of Regulation (EU) 2017/746) |
200000013170
|
EMA | Active |
| EU Application Legal Basis | Available under Article 83(2) of Regulation (EC) No 726/2004 |
200000023344
|
EMA | Active |
| EU Application Legal Basis | Authorisation according to Article 5(2) of Directive 2001/83/EC |
200000023341
|
EMA | Active |
| EU Application Legal Basis | Authorisation according to Article 5(1) of Directive 2001/83/EC |
200000023331
|
EMA | Active |
| EU Application Legal Basis | Article 58 of Regulation (EC) No 726/2004 |
100000116081
|
EMA | Active |
| EU Application Legal Basis | Ancillary medicinal substance/blood derivative substance (Article 1(4) of both Directives No 93/42/EEC and 90/385/EEC) |
100000116068
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EMA | Active |
Showing 1–24 of 24 terms . Data sourced from public health authority publications and updated periodically.