Si 2010/504 Medicines/prods for Human Use PDF Download
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Author:
Publisher:
ISBN: 9780111520697
Category :
Languages : en
Pages :
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Author:
Publisher:
ISBN: 9780111520697
Category :
Languages : en
Pages :
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Author: Northern Ireland
Publisher:
ISBN: 9780337987472
Category :
Languages : en
Pages : 78
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Author: Great Britain
Publisher:
ISBN: 9780111529171
Category :
Languages : en
Pages : 4
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Enabling power: Medicines Act 1971, s. 1 (1) & European Communities Act 1972, s. 2 (2) & Finance Act 1973, s. 56 (1) (2). Issued: 10.10.2012. Made: 04.10.2012. Laid: 10.10.2012. Coming into force: 02.11.2012. Effect: S.I. 2012/504 amended. Territorial extent & classification: E/W/S/NI. General
Author: Great Britain
Publisher:
ISBN: 9780111536506
Category :
Languages : en
Pages : 82
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Enabling power: Medicines Act 1971, s. 1 (1) (2) & European Communities Act 1972, s. 2 (2) & Finance Act 1973, s. 56 (1) (2). Issued: 12.03.2013. Made: 07.03.2013. Laid: 11.03.2013. Coming into force: In accord. with reg. 1. Effect: S.I. 2004/1031 amended & S.I. 1998/574; 1999/566; 2000/592; 2003/625; 2006/2125; 2009/3222 revoked (01.04.2013) & S.I. 2012/504, 2546 revoked with saving (01.04.2013). Territorial extent & classification: E/W/S/NI. General
Author: Great Britain
Publisher:
ISBN: 9780111143902
Category :
Languages : en
Pages : 84
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Book Description
Enabling power: Medicines Act 1971, ss. 1 (1) (2) & European Communities Act 1972, s. 2(2) & Finance Act 1973, ss. 56 (1), (2). Issued: 25.02.2016. Made: 11.02.2016. Laid: 24.02.2016. Coming into force: 01.04.2016. Effect: S.I. 1995/449; 2004/1031; 2012/1916 amended & S.I. 2013/532 revoked with saving. Territorial extent & classification: E/W/S/NI. General
Author: Great Britain
Publisher:
ISBN: 9780111494547
Category : Law
Languages : en
Pages : 76
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Book Description
Enabling power: Medicines Act 1971, s. 1 (1) (2) & European Communities Act 1972, s. 2 (2) & Finance Act 1973, s. 56 (1) (2). Issued: 04.03.2010. Made: 26.02.2010. Laid: 04.03.2010. Coming into force: 01.04.2010. Effect: S.I. 1994/105; 2004/1031 amended & S.I. 2009/389 revoked with savings. Territorial extent & classification: E/W/S/NI. General
Author: Great Britain
Publisher:
ISBN: 9780111527603
Category :
Languages : en
Pages : 318
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Enabling power: European Communities Act 1972, s. 2 (2) (5) & Medicines Act 1968, ss. 87 (1), 88 (1) (2), 91 (2), 129 (1) (2) (5). Issued: 24.07.2012. Made: 19.07.2012. Laid: 24.07.2012. Coming into force: 14.08.2012. Effect: 1968 c.29, c.67; 1971 c.69; 1975 c.25; 1987 c.43; 1990 c.43; 1994 c.23; 1999 c.8; 2003 c.21; 2007 asp 113 & S.I. 1972/1265 (NI. 14); 1976/1213 (N.I. 22), 1214 (N.I. 23); 1978/1006; 1980/14; 1981/1115 (N.I. 22); 1986/1700, 1761; 1989/684; 1995/449; 1997/1830, 1997/2778 (N.I. 19), 2779 (N.I. 20); 2000/620; 2001/880, 1841, 3998; 2002/3170; 2003/1076, 1374, 1376, 1571, 1680; 2004/291, 478, 627, 1022, 1031, 1975; 2005/1478; 2007/121, 1523, 3544; 2008/548, 944, 1270, 3258 & S.S.I. 2004/115, 116; 2009/45, 183, 669; 2010/2880 & S.R. 1987/414; 1995/8; 1996/81; 1997/381; 1998/28, 45; 1999/433; 2001/422, 2002/1; 2003/34, 493; 2004/140; 2005/160, 161, 176; 2006/478; 2007/68, 234, 236 amended & S.I. 1973/367; 1976/968; 1978/40; 1983/1724; 1999/1129; 1992/605; 1993/834; 1994/105, 899, 1932, 1933, 3144; 1995/2321; 1996/482; 1997/1830; 1998/3105; 1999/267, 784; 2002/236; 2003/1618, 2317; 2004/480; 2005/765, 768, 1094, 1520, 1710, 2750, 2754, 2787, 2589; 2006/395, 1952; 2008/1692, 3097; 2009/1164, 3062; 2010/1882 revoked. Territorial extent & classification: E/W/S/NI. General. With correction slip dated November 2012. Revoked by SI 2013/1855 (ISBN 9780111102251)
Author: GREAT BRITAIN.
Publisher:
ISBN: 9780111178782
Category :
Languages : en
Pages : 12
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Enabling power: European Communities Act 1972, ss. 2 (2) (5). Issued: 24.01.2019. Sifted: -. Made: 14.01.2019. Laid: 18.01.2019. Coming into force: 09.02.2019. Effect: S.I. 2012/1916 amended. Territorial extent & classification: E/W/S/NI. General. EC note: These Regulations amend the Human Medicines Regulations 2012 in order to implement: points 8, 9, 11 and 12 of Article 1 of Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (Directive 2011/62/EU); Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (the Delegated Regulation).
Author: Great Britain. Medicines and Healthcare products Regulatory Agency
Publisher:
ISBN: 9780857112859
Category : Drugs
Languages : en
Pages : 0
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Book Description
Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK drug regulatory body, MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation. Changes in this new edition: Revised Annex 15. The revision of Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology. Revised Annex 16. The GMP Guide Annex 16 has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable. Also, some areas, where the interpretation by Member States has not been consistent, have been clarified. This revised Annex came into operation 15 April 2016. The introduction of guidelines on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. The introduction of guidelines on the formalised risk assessment for ascertaining the appropriate GMP for excipients. The addition of the Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01). These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for manufacturers, importers and distributors of active substances for medicinal products for human use. These guidelines should be followed as of 21 September 2015. The addition of the principles and guidelines of Good Manufacturing Practice (GMP) for active substances for medicinal products for human use, including active substances intended for export. Revisions to the UK Human Medicines Regulations 2012. MHRA GMP Data Integrity Definitions and Guidance for Industry is now included which sets out MHRA expectations for data integrity in good manufacturing practice (GMP). The Guidance complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume.
Author: Adrian Kilcoyne
Publisher: OUP Oxford
ISBN: 0191510394
Category : Medical
Languages : en
Pages : 473
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Book Description
The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
