Nr.	Titel
582	Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
583	Q6B Specifications: Test-Procedures and Acceptance Criteria for Biotechnological/Biological Products
584	Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
649	EC-USA MRA, Sectoral Annex on Good Manufacturing Practices (GMP)
706	Eudralex Volume 2B - Medicinal products for human use - Presentation and content of the dossier - Common Technical Document (CTD)
711	Compilation of Community Procedures on Inspections and Exchange of Information
712	Annex VI to Guidance for the conduct of GCP inspections - Record keeping and archiving of documents
753	Chapter 1 - Marketing Authorisation (updated version - November 2005)
754	Chapter 2 - Mutual Recognition (updated version - February 2007)
755	Chapter 3 - Community Referral (updated version - September 2007)
756	Chapter 4 - Centralised Procedure (updated version - April 2006)
757	Chapter 5 - Guideline on the operation of the procedures laid down in Chapters II, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 as well as on the documentation to be submitted pursuant to these procedures. - (February 2010)
758	Chapter 6 - Community Marketing Authorisation (updated version - November 2005)
759	Chapter 7 - General Information (revision July 2008)
778	Guideline on the categorisation of New Applications (NA) versus Variations Applications (V) (October 2003)
779	Guideline on the processing of renewals in the centralised procedure (October 2005)
780	Application form for renewal of a marketing authorisation and guidance for the completion of the application form (February 2007)
781	Guidance concerning consultation with target patient groups for the package leaflet
782	Guideline on fast track procedure for human influenza vaccines
783	Guideline on Summary of Product Characteristics (September 2009)
784	Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
785	Application form for variation to a marketing authorisation for medicinal products (human and veterinary) to be used in the mutual recognition and the centralised procedure
787	Guideline on the packaging information of medicinal products for human use authorised by the Community (February 2008)
788	Guideline on changing the classification for the supply of a medicinal product for human use
789	Guideline on the readability of the label and package leaflet of medicinal product for human use, revision 1 (12 January 2009)
795	Q10 Pharmaceutical Quality System
832	91/412/EEC - Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products
835	Chapter 1: Quality Management (Revision 2008)
836	Chapter 2: Personnel
837	Chapter 3: Premises and Equipment
839	Chapter 5: Production
840	Chapter 6: Quality Control
841	Chapter 7: Contract Manufacture and Analysis
842	Chapter 8: Complaints and Product Recall
843	Chapter 9: Self Inspection
857	Annex 13: Investigational Medicinal Products
859	Annex 14: Manufacture of Medicinal Products derived from Human Blood or Plasma
864	Glossary
875	Q1B Stability Testing: Photostability Testing of New Drug Substances and Products
876	Q1C Stability Testing: Requirements for New Dosage Forms
879	Q2(R1) Validation of Analytical Procedures: Text and Methodology
885	Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
886	Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
887	Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
888	Q5D Derivation and Characterisation of Cell Substrates Used For Production of Biotechnological/Biological Products
892	M4Q(R1) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality - Quality Overall Summary of Module 2 - Module 3: Quality
893	M4(R3) Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
900	Verordnung zum Medizinproduktegesetz
902	Verordnung über die Verschreibungspflicht von Medizinprodukten
918	Mutual Recognition Agreement Between the European Community and the United States of America Mai 1998
919	Joint Procedure for the Information Exchange of Serious or Life-Threatening Human / Animal Pharmaceutical Product Quality Defects and Recalls May 2001
926	Validation-Master Plan, IQ, OQ, non-sterile Process Validation, Cleaning Validation (PI 006-3) Sept 2007
929	PIC/S GMP Guide for Blood Establishments (PE 005-3) Sept 2007
931	Recommendations on Quality System Requirements for Pharmaceutical Inspectorates (PI 002-3)Sept 2007
932	Isolators used for Aseptic Processing and Sterility Testing (PI 014-3) Sept 2007
1090	The IPEC Excipient Composition Guide
1100	Process Simulation Testing for Aseptically Filled Products
1101	GAMP Good Practice Guide: a Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5
1162	A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry
1167	GAMP-Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacturing, Version 5.0
1202	Aide-Memoire - Inspection of Utilities (PI 009-3) Sept 2007
1203	SOP - Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects (PI 010-4) Jan 2011
1204	Standard Operating Procedure - PIC/S Inspection Report Format (PI 013-3) Sept 2007
1217	Bundesgesetz vom 15. Dezember 2000 über Arzneimittel und Medizinprodukte (Heilmittelgesetz, HMG)
1218	Organisationsverordnung vom 28. September 2001 für das Schweizerische Heilmittelinstitut
1219	Verordnung vom 28. September 2001 über das Personal des Schweizerischen Heilmittelinstituts
1220	Verordnung vom 17. Oktober 2001 über die Bewilligungen im Arzneimittelbereich (Arzneimittel-Bewilligungsverordnung, AMBV)
1221	Verordnung vom 17. Oktober 2001 über die Arzneimittel (Arzneimittelverordnung, VAM)
1222	Verordnung vom 17. Oktober 2001 über die Arzneimittelwerbung (Arzneimittel-Werbeverordnung, AWV)
1224	Verordnung vom 17. Oktober 2001 über klinische Versuche mit Heilmitteln (VKlin)
1227	Verordnung vom 25. Mai 2011 über die Betäubungsmittelkontrolle (BetmKV)
1228	Bundesgesetz über die Betäubungsmittel und die psychotropen Stoffe
1235	Guidance for Industry - Cybersecurity for Networked Medical Devices Containing off-the-Shelf (OTS) Software
1238	Changes to an Approved NDA or ANDA, Questions and Answers
1241	EC-Swiss, Explanatory Notes to Chapter 15 (Medicinal Products GMP inspection and batch certification) of Annex 1 of the EU-Swiss MRA October 2002
1244	EC-Canada MRA, SECTORAL ANNEX ON GOOD MANUFACTURING PRACTICES (GMP)
1245	EC-Australia MRA, Sectoral Annex: Medicinal Products GMP Inspection and Batch Certification
1246	EC-New Zealand MRA, Sectoral Annex: Medicinal Products GMP Inspection and Batch Certification
1255	Verordnung des Schweizerischen Heilmittelinstituts vom 9. November 2001 über die Anforderungen an die Zulassung von Arzneimitteln (Arzneimittel-Zulassungsverordnung, AMZV) 2006
1256	Verordnung des Schweizerischen Heilmittelinstituts vom 12. Dezember 1996 über die Betäubungsmittel und psychotropen Stoffe (Betäubungsmittelverordnung Swissmedic, BetmV-Swissmedic) Dezember 2001
1257	Verordnung vom 22. Juni 2006 über die Gebühren des Schweizerischen Heilmittelinstituts (Heilmittel-Gebührenverordnung, HGebV)
1259	Verordnung vom 22. Juni des Schweizerischen Heilmittelinstituts über die vereinfachte Zulassung und die Meldepflicht von Arzneimitteln (VAZV)
1260	Bundesgesetz über die Transplantation von Organen, Geweben und Zellen
1263	Reflection Paper: Chemical, pharmaceutical and biological information to be included in dossiers when Process Analytical Technology (PAT) is employed
1264	Q1E Evaluation of Stability Data
1266	Q1D Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products
1267	Q3A(R2) Impurities in New Drug Substances
1268	Q3C(R4) Impurities: Guideline for residual solvents
1270	Q6A Attachments: Decision Trees #1 Through #8
1271	Verordnung über Vertriebswege für Medizinprodukte
1272	Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Lot Release Protocols
1273	Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - (AMG)
1274	Verordnung über die Anwendung der Guten Herstellungspraxis bei der Herstellung von Arzneimitteln und Wirkstoffen und über die Anwendung der Guten fachlichen Praxis bei der Herstellung von Produkten menschlicher Herkunft(Arzneimittel- und Wirkstoffherstellungsverordnung – AMWHV)
1275	Guide to Inspections of Quality Systems
1276	Medical Device Tracking
1277	Guideline for the Manufacture of In Vitro Diagnostic Products
1278	Guideline for the Monitoring of Clinical Investigations
1279	Quality System Information for Certain Premarket Application Reviews, Guidance for Industry
1282	Labelling - Regulatory Requirments for Medical Devices
1283	Medical Glove Guidance Manual
1284	GUIDANCE ON PARAMETRIC RELEASE (PI 005-2) July 2004
1285	EK-Med-Empfehlung Validierung von Prozessen der Produktion und der Dienstleistungserbringung (einschließlich Software)
1286	89/105/EEC - Council Directive 89/105/EEC of 21 December 1988, relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems - English Version
1288	EC/297/95 - Council Regulation (EC) No 297/95, of 10 February 1995, on fees payable to the European Agency for the Evaluation of Medicinal Products. Amended by Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products. Amendments
1289	EC/540/95 - Commission Regulation (EC) No 540/95, of 10 March 1995, laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93.
1292	EC/1662/95 - Commission Regulation (EC) No 1662/95, of 7 July 1995, laying down certain detailed arrangements for implementing the Community decision-making procedures in respect of marketing authorizations for products for human or veterinary use.
1293	EC/2141/96 - Commission Regulation (EC) No 2141/96, of 7 November 1996, concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EEC) No 2309/93.
1294	EC/141/2000 - Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products.
1295	EC/847/2000 Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and‘clinical superiority’
1297	Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
1298	90/219/EEC - Council Directive 90/219/EEC, of 23 April 1990, on the contained use of genetically modified micro-organisms.
1301	EEC/1768/92 - Council Regulation No (EEC) 1768/92, of 18 June 1992, concerning the creation of a supplementary protection certificate for medicinal products.
1302	6/5/1982 Commission Communication on parallel imports of proprietary medicinal products for which marketing authorizations have already been granted.
1303	94/C 82/04 Commission Communication on the implementation of the new marketing authorization procedures for medicinal products for human and veterinary use in accordance with Council Regulation (EEC) No 2309/93 of 22 July 1993 and Council Directives 93/39/EEC, 93/40/EEC and 93/41/EEC, adopted on 14 June 1993.
1304	98/C 229/03 Commission communication on the Community marketing authorisation procedures for medicinal products
1305	75/320/EEC - Council Decision 75/320/EEC, of 20 May 1975, setting up a Pharmaceutical Committee.
1306	78/25/EEC - Council Directive 78/25/EEC, of 12 December 1977, on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products.
1312	COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS
1314	Comparison Chart GMP/ISO 9000:1994
1315	Guidance on IDE Policies and Procedures
1317	Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
1318	Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1)
1320	Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
1321	Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
1323	Essential Principles Of Safety & Performance of Medical Devices
1324	Labelling For Medical Devices
1325	Role of Standards in the Assessment of Medical Devices
1326	Q1C Stability Testing for New Dosage Forms
1327	Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
1331	Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices
1332	Charge & Mission Statement
1336	Process Validation Guidance
1337	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7)
1338	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers –Part 1: General Requirements
1339	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies
1343	21 CFR Part 314.420 Drug Master Files
1344	21 CFR Part 26 Mutual recognition of pharmaceutical good manufacturing practice reports, and certain medical device product evaluation reports: US and the EC
1345	21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
1346	21 CFR Part 206 Imprinting of Solid Oral Dosage Form Drug Products for Human Use
1360	Reflection Paper on Markers Used for Quantitative and Qualitative Anaysis of Herbal Medicinal Products and Traditional Herbal Medicinal Products
1382	About the Global Harmonization Task Force (GHTF)
1386	2001/18/EC - Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
1387	Current Practices in the Validation of Aseptic Processing - 2001
1388	2003/94/EC - Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use; Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products
1389	Introduction
1396	Applications for Parenteral Products in Plastic Immediate Containers
1437	PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
1438	Good Practices for Computerised Systems in Regulated "GXP" Environments (PI 011-3) Sept 2007
1441	Part 11, Electronic Records, Electronic Signatures: Scope and Application
1449	GAMP Good Practice Guide Validation of Process Controls Systems
1450	Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
1451	Drug Approval Application Process
1462	Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
1463	Guide to Good Manufacturing Practice for Medicinal Products (PE 009-9) Introduction (Sept 2009)
1464	PIC/S Guide to Inspections of Source Plasma Establishment and Plasma Warehouses (PI 008-3) Sept 2007
1465	Site Master File for Source Plasma Establishments (PI 019-3) Sept 2007
1466	Site Master File for Plasma Warehouses (PI 020-3) Sept 2007
1470	Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
1472	Verordnung über die Anwendung der Guten Klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Arzneimitteln zur Anwendung am Menschen
1475	Acceptability of Standards from Alternative Compendia (BP/EP/JP)
1476	Draft Guidance for Industry; Blood Establishment Computer Systems Validation in the User's Facility
1477	EC/1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Note: shall apply from 30 December 2008)(Official Journal L 324, 10/12/2007 p. 121 - 137).
1478	EC/658/2007 of 14 June 2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 155, 15/6/2007 p. 10 - 19).
1502	The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP)
1503	GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS
1504	Section 1
1505	Section 2
1506	Section 3
1508	INDs for Phase 2 and Phase 3 Studies; Chemistry, Manufacturing, and Controls Information
1513	Eudralex Volume 10 - Clinical Trials
1533	Position Paper on Specifications for Class 1 and Class 2 Residual Solvents in Active Substances
1535	Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products
1536	Note for Guidance on Parametric Release
1537	Note for Guidance on Quality of Modified Release Products: A. Oral Dosage Forms; B. and Transdermal Dosage Forms; Section I (Quality)
1568	Explanatory Note ot the Operation of Two-Year Transition Period for Application of Note for Guidance on Residual Solvents to Marketed Products
1570	Note for Guidance on Manufacture of the Finished Dosage Form
1576	WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principle
1577	Active pharmaceutical ingredients (bulk drug substances)
1578	Pharmaceutical excipients
1579	WHO Good Manufacturing paractices for Sterile pharmaceutical products
1580	Biological products
1581	Investigational pharmaceutical products for clinical trials in humans
1582	Herbal medicinal products
1597	Guideline on Plastic Immediate Packaging Materials
1627	Aide memoire Inspektion von Qualifizierung und Validierung in pharmazeutischer Herstellung und Qualitätskontrolle
1629	Einleitung zum EG-GMP Leitfaden
1630	Ausstellung von Bescheinigungen nach § 73 Abs. 6 AMG (Zollbescheinigungen)
1631	Organisatorische Aspekte der Vorbereitung, Durchführung und Nachbereitung von GMP-Drittlandinspektionen
1633	Kapitel 1 Teil I des EG-GMP Leitfadens
1634	Erstellung und Format von Inspektionsberichten
1635	Amtliche Entnahme von Proben nach § 65 AMG
1636	Vorgehensweise bei Arzneimittelrisiken, Verbraucherbeschwerden und sonstigen Beanstandungen
1637	Bewertung von Abweichungen, Fehlern und Mängeln
1638	Arzneimittelüberwachung in Deutschland - Jahresbericht der Länder - 2010
1639	Entscheidung über die Erteilung einer Herstellungserlaubnis gemäß § 13 AMG oder Einfuhrerlaubnis gemäß § 72 Absatz 1 AMG
1641	Ausstellung von Zertifikaten gemäß § 73a Abs. 2 AMG (WHO-Zertifikate)
1642	Information der Länder durch die ZLG-Website
1643	Austausch von Zertifikaten im Rahmen von Drittstaatenabkommen (MRA)
1645	Umgang mit Ergebnissen: Bewertung und Bericht sowie Ergebnisse außerhalb der Spezifikation [OOS-(Out-of-Specification) Results]
1647	Guideline on Control of Impurities of Pharmacopoeial Substances: Compliance with the European Pharmacopoeial General Monograph "Substances for Pharmaceutical Use" and General Chapter" Control of Impurities in Substances for Pharmaceutical Use"