Generated Narrative: CodeSystem 100000116045 version: 5.0.0; Last updated: 2023-08-03 11:35:00+0000 This case-sensitive code system http://spor.ema.europa.eu/v1/lists/100000116045 defines the following codes: Code Display 100000116046 Full application (Article 8(3) of Directive No 2001/83/EC) 100000116047 New active substance (Article 8(3) of Directive No 2001/83/EC) 100000116048 Known active substance (Article 8(3) of Directive No 2001/83/EC) 100000116049 Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC) 100000116050 Generic application (Article 10(1) of Directive No 2001/83/EC) 100000116051 Hybrid application (Article 10(3) of Directive No 2001/83/EC) 100000116052 Similar biological application (Article 10(4) of Directive No 2001/83/EC) 100000116053 Well-established use application (Article 10a of Directive No 2001/83/EC) 100000116054 Fixed combination application (Article 10b of Directive No 2001/83/EC) 100000116055 Informed consent application (Article 10c of Directive No 2001/83/EC) 100000116056 Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC) 100000116057 Full application (Article 12(3) of Directive No 2001/82/EC) 100000116058 Full application - New active substance (Article 12(3) of Directive No 2001/82/EC) 100000116059 Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC) 100000116060 Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC) 100000116061 Generic application (Article 13(1) of Directive No 2001/82/EC) 100000116062 Hybrid application (Article 13(3) of Directive No 2001/82/EC) 100000116063 Similar biological application (Article 13(4) of Directive No 2001/82/EC) 100000116064 Well-established use application (Article 13a of Directive No 2001/82/EC) 100000116065 Fixed combination application (Article 13b of Directive No 2001/82/EC) 100000116066 Informed consent application (Article 13c of Directive No 2001/82/EC) 100000116067 Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC) 100000116068 Ancillary medicinal substance/blood derivative substance (Article 1(4) of both Directives No 93/42/EEC and 90/385/EEC) 100000116069 Bibliographical application (stand-alone) 100000116070 Informed consent (abridged application) - Council Directive 81/851/EEC 100000116071 Fixed combination 100000116072 Complete application (stand-alone) 100000116073 Complete mixed application 100000116074 Generic (abridged application) - art 10(1) 100000116075 Last paragraph (abridged application) 100000116076 Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93 100000116077 Complete application (stand-alone) - Directive No 2001/82/EC 100000116078 Generic (abridged application) - art 13(1) 100000116079 Informed consent (abridged application) - art 10c 100000116080 Complete application (stand-alone) - Council Directive 81/851/EEC 100000116081 Article 58 of Regulation (EC) No 726/2004 100000116082 Informed consent (abridged application) - Council Regulation 2001/82/EC 200000013166 Known human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745) 200000013167 Known ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745) 200000013168 Unknown human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745) 200000013169 Unknown ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745) 200000013170 Companion Diagnostics (Article 48 (3), (4), (7), (8) of Regulation (EU) 2017/746) 200000013171 Medical device composed of a substance or combinations of substances (Article 52 (11) of Regulation (EU) 2017/745) 200000013173 Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC) 200000013174 Homeopathic medicinal products (Article 19 of Directive No 2001/82/EC) 200000013175 Legal basis not covered by Directive 2001/82/EC 200000013176 Authorisations for temporary use (article 8 of Directive No 2001/82/EC) 200000013177 Legal basis reviewed according to Acquis communautaire 200000013178 Full application - new active substance (Article 8 of Regulation (EU) 2019/6) 200000013179 Full application - known active substance (Article 8 of Regulation (EU) 2019/6) 200000013180 Generic application (Article 18 of Regulation (EU) 2019/6) 200000013181 Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6) 200000013182 Combination veterinary medicinal products (Article 20 of Regulation (EU) 2019/6) 200000013183 Informed Consent application (Article 21 of Regulation (EU) 2019/6) 200000013184 Bibliographic application (Article 22 of Regulation (EU) 2019/6) 200000013185 Applications for limited markets (Article 23 of Regulation (EU) 2019/6) 200000013186 Applications in exceptional circumstances (Article 25 of Regulation (EU) 2019/6) 200000013187 Registered homeopathic veterinary medicinal products (Article 86 of Regulation (EU) 2019/6) 200000013188 Permission for national use due to health situation (Article 116 of Regulation (EU) 2019/6) 200000013189 Authorised homeopathic medicinal products (Article 85(2) of Regulation (EU) 2019/6) 200000013906 Veterinary medicinal products intended for animals exclusively kept as pets (article 5(6) of Reg 2019/6) 200000013907 Parallel traded products as referred to in article 102 of Regulation 2019/6 200000016435 Hybrid application - change in therapeutic indication(s) (Article 19(1)(a) of Regulation (EU) 2019/6) 200000016436 Hybrid application - change in strength (Article 19(1)(a) of Regulation (EU) 2019/6) 200000016437 Hybrid application - change in route of administration (Article 19(1)(a) of Regulation (EU) 2019/6) 200000016438 Hybrid application - change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6) 200000016439 Hybrid application - bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6) 200000016440 Hybrid application - differences in raw materials or in manufacturing processes of biological VMPs (Article 19(1)(c) of Regulation (EU) 2019/6) 200000016456 Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No 2001/83/EC) 200000016457 Medicinal product authorised according to Article 126a of Directive No 2001/83/EC 200000022794 Simplified registration application for a homeopathic veterinary medicinal product (Article 17 of Directive No 2001/82/EC) 200000023331 Authorisation according to Article 5(1) of Directive 2001/83/EC 200000023341 Authorisation according to Article 5(2) of Directive 2001/83/EC 200000023342 Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC 200000023343 Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC 200000023344 Available under Article 83(2) of Regulation (EC) No 726/2004 200000029645 Hybrid application (Article 19(1) of Regulation (EU) 2019/6) 200000029646 Hybrid application - change in target species (Article 19(1)(a) of Regulation (EU) 2019/6) 200000029648 Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6) 200000029650 Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6) 200000029651 Full application (Article 8 of Regulation (EU) 2019/6) 200000043394 New active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6) 200000043395 Known active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6) 200000043396 New active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6) 200000043397 Known active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)
Marketing Authorisation Application Legal Basis
Full application (Article 8(3) of Directive No 2001/83/EC)
New active substance (Article 8(3) of Directive No 2001/83/EC)
Known active substance (Article 8(3) of Directive No 2001/83/EC)
Generic, hybrid or similar biological application (Article 10 of Directive No 2001/83/EC)
Generic application (Article 10(1) of Directive No 2001/83/EC)
Hybrid application (Article 10(3) of Directive No 2001/83/EC)
Similar biological application (Article 10(4) of Directive No 2001/83/EC)
Well-established use application (Article 10a of Directive No 2001/83/EC)
Fixed combination application (Article 10b of Directive No 2001/83/EC)
Informed consent application (Article 10c of Directive No 2001/83/EC)
Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)
Full application (Article 12(3) of Directive No 2001/82/EC)
Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Generic, hybrid or similar biological application (Article 13 of Directive No 2001/82/EC)
Generic application (Article 13(1) of Directive No 2001/82/EC)
Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Well-established use application (Article 13a of Directive No 2001/82/EC)
Fixed combination application (Article 13b of Directive No 2001/82/EC)
Informed consent application (Article 13c of Directive No 2001/82/EC)
Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Ancillary medicinal substance/blood derivative substance (Article 1(4) of both Directives No 93/42/EEC and 90/385/EEC)
Bibliographical application (stand-alone)
Informed consent (abridged application) - Council Directive 81/851/EEC
Generic (abridged application) - art 10(1)
Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93
Complete application (stand-alone) - Directive No 2001/82/EC
Generic (abridged application) - art 13(1)
Informed consent (abridged application) - art 10c
Complete application (stand-alone) - Council Directive 81/851/EEC
Article 58 of Regulation (EC) No 726/2004
Informed consent (abridged application) - Council Regulation 2001/82/EC
Known human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)
Known ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)
Unknown human blood/plasma derived ancillary medicinal substance (Article 52 (9) of Regulation (EU) 2017/745)
Unknown ancillary medicinal substance (not human blood/plasma derived) (Article 52 (9) of Regulation (EU) 2017/745)
Companion Diagnostics (Article 48 (3), (4), (7), (8) of Regulation (EU) 2017/746)
Medical device composed of a substance or combinations of substances (Article 52 (11) of Regulation (EU) 2017/745)
Registered homeopathic medicinal products (Article 17 of Directive No 2001/82/EC)
Homeopathic medicinal products (Article 19 of Directive No 2001/82/EC)
Legal basis not covered by Directive 2001/82/EC
Authorisations for temporary use (article 8 of Directive No 2001/82/EC)
Legal basis reviewed according to Acquis communautaire
Full application - new active substance (Article 8 of Regulation (EU) 2019/6)
Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Generic application (Article 18 of Regulation (EU) 2019/6)
Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)
Combination veterinary medicinal products (Article 20 of Regulation (EU) 2019/6)
Informed Consent application (Article 21 of Regulation (EU) 2019/6)
Bibliographic application (Article 22 of Regulation (EU) 2019/6)
Applications for limited markets (Article 23 of Regulation (EU) 2019/6)
Applications in exceptional circumstances (Article 25 of Regulation (EU) 2019/6)
Registered homeopathic veterinary medicinal products (Article 86 of Regulation (EU) 2019/6)
Permission for national use due to health situation (Article 116 of Regulation (EU) 2019/6)
Authorised homeopathic medicinal products (Article 85(2) of Regulation (EU) 2019/6)
Veterinary medicinal products intended for animals exclusively kept as pets (article 5(6) of Reg 2019/6)
Parallel traded products as referred to in article 102 of Regulation 2019/6
Hybrid application - change in therapeutic indication(s) (Article 19(1)(a) of Regulation (EU) 2019/6)
Hybrid application - change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)
Hybrid application - change in route of administration (Article 19(1)(a) of Regulation (EU) 2019/6)
Hybrid application - change in pharmaceutical form (Article 19(1)(a) of Regulation (EU) 2019/6)
Hybrid application - bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Hybrid application - differences in raw materials or in manufacturing processes of biological VMPs (Article 19(1)(c) of Regulation (EU) 2019/6)
Simplified registration application for a homeopathic medicinal product (Article 14 of Directive No 2001/83/EC)
Medicinal product authorised according to Article 126a of Directive No 2001/83/EC
Simplified registration application for a homeopathic veterinary medicinal product (Article 17 of Directive No 2001/82/EC)
Authorisation according to Article 5(1) of Directive 2001/83/EC
Authorisation according to Article 5(2) of Directive 2001/83/EC
Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC
Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC
Available under Article 83(2) of Regulation (EC) No 726/2004
Hybrid application (Article 19(1) of Regulation (EU) 2019/6)
Hybrid application - change in target species (Article 19(1)(a) of Regulation (EU) 2019/6)
Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6)
Hybrid application - other (Article 19(1)(a) of Regulation (EU) 2019/6)
Full application (Article 8 of Regulation (EU) 2019/6)
New active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)
Known active substance - Limited Markets (Article 23 of Regulation (EU) 2019/6)
New active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)
Known active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)