Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use (Text with EEA relevance) (revoked)
EU Regulation No 1252/2014 · Adopted 28 May 2014 · Extends to United Kingdom
Commission Delegated Regulation (EU) No 1252/2014
of 28 May 2014
supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use
(Text with EEA relevance) (revoked)
F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annotations to the whole text
Textual amendments
- F1
Regulation revoked (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(ee) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)
Contents
- 1Scope Repealed
- 2Definitions Repealed
- 3Quality management Repealed
- 4Personnel Repealed
- 5Buildings and facilities Repealed
- 6Equipment Repealed
- 7Documentation and records Repealed
- 8Material management Repealed
- 9Production and in-process control Repealed
- 10Packaging and labelling Repealed
- 11Placing on the market Repealed
- 12Laboratory controls Repealed
- 13Validation Repealed
- 14Change control Repealed
- 15Rejection and returns Repealed
- 16Complaints and recalls Repealed
- 17Contract manufacturing Repealed
- 18Repackaging Repealed
- 19Entry into force Repealed
- Signature
1ScopeF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2DefinitionsF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3Quality managementF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4PersonnelF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5Buildings and facilitiesF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6EquipmentF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7Documentation and recordsF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8Material managementF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9Production and in-process controlF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10Packaging and labellingF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
11Placing on the marketF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12Laboratory controlsF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13ValidationF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14Change controlF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15Rejection and returnsF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16Complaints and recallsF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
17Contract manufacturingF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18RepackagingF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19Entry into forceF1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Signature
F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .