|
4.
|
Notice to Applicants - Rechtliche Anmerkungen zum
Entwurf vom Dezember 1994, Doc. III/5944/94 der
Kommission der Europäischen Gemeinschaften
|
|
|
in: pharmind 1995, 289
|
|
5.
|
Die Änderung von Zulassungen für Humanarzneimittel
nach den Durchführungsverordnungen der Kommission/
Teil I: Darstellung der Verfahren,
|
|
|
in: pharmind 1995, 547
|
|
6.
|
Die Änderung von Zulassungen für Humanarzneimittel nach
den Durchführungsverordnungen der Kommission/ Teil II:
Rechtliche Anmerkungen zu den Verfahren
|
|
|
in: pharmind 1995, 635
|
|
7.
|
Der Anspruch auf rechtliches Gehör und das
Akteneinsichtsrecht des Betroffenen im Rahmen der
europäischen Zulassungsverfahren für Arzneimittel/ Teil
I: Gewährung des Anhörungsrechts |
|
|
in: pharmind 1996, 118
|
|
8.
|
Der Anspruch auf rechtliches Gehör und das
Akteneinsichtsrecht des Betroffenen im Rahmen der
europäischen Zulassungsverfahren für Arzneimittel/ Teil
II: Akteneinsichtsrecht
|
|
|
in: pharmind 1996, 205
|
|
9.
|
Die Verschreibungspflicht nach § 49 AMG als
Voraussetzung des Unterlagenschutzes nach § 24a AMG -
Ordnungsgemäße Umsetzung des Art. 4 Abs. 2 Nr. 8a) iii)
der Richtlinie 65/65/EWG |
|
|
in: Pharma Recht 1997, 2 und pharmind 1997, 305
|
|
10.
|
Automatische Durchführung des gegenseitigen
Anerkennungsverfahrens - Zur Vorgehensweise nach dem
1. Januar 1998 |
|
|
in:
pharmind 1998, 15
|
|
11.
|
Rechtsschutz gegen versagende Zulassungsbescheide,
Festbeträge und Positivliste – Sind die planten
Einschränkungen verfassungsgemäß? Verstoß gegen
EU-Recht?
|
|
|
in: Pharma
Recht 2000, 106
|
|
12. |
Kollision zwischen nationaler Zulassung und Orphan
Drug-Status - Kommissionslösung contra Rechtsfolgen nach
der Orphan Drug-Verordnung
|
|
|
in: pharmind 2002, 943 |
|
13. |
Neue Verordnungen der EU-Kommission zu Variations |
|
|
in: pharmind 2003, 1213 |
|
14. |
Essential Similarity of Biological Products - New
Provisions contained in Commission Directive 2003/63/EC |
|
|
in: pharmind 2004, 60 |
|
15. |
New Commission Directive 2003/94/EC "Good Manufacturing
Practice" |
|
|
in: pharmind 2004, 161 |
|
16. |
Parallel import of medicinal products: New Commission
Communication about parallel import of proprietary
medicinal products for which marketing authorisations
have already been granted (COM (2003) 839 final) and
Specific Mechanism for certain accessing countries |
|
|
in: pharmind 2004, 292 |
|
17. |
Draft of the 2nd Revision of the “Guideline on the
format and content of applications for designation as
orphan medicinal products and on the transfer of
designations from one sponsor to another” |
|
|
in: pharmind 2004, 537 |
|
18. |
Review of European Pharmaceutical Legislation -
Essential Amendments to General Provisions, System of
Marketing Authorisation Procedures, Structure of the
Agency and Centralised Procedure; Part I: Essential
Changes in General Provisions |
|
|
in: pharmind 2004, 728 |
|
19. |
Review of European Pharmaceutical Legislation -
Essential Amendments to General Provisions, System of
Marketing Authorisation Procedures, Structure of the
Agency and Centralised Procedure; Part II: Essential
Changes in the Mutual Recognition and Introduction of a
Decentralised Procedure |
|
|
in: pharmind 2004, 853 |
|
20. |
Review of European Pharmaceutical Legislation -
Essential Amendments to General Provisions, System of
Marketing Authorisation Procedures, Structure of the
Agency and Centralised Procedure; Part III: Essential
Changes relating to the Agency and in the Centralised
Procedure |
|
|
in: pharmind 2004, 970 |
|
21. |
A new Proposal on a Council Regulation on the Fees
payable to the European Medicines Agency |
|
|
in: pharmind 2004, 1090 |
|
22. |
Draft of a "Commission Directive regarding the
principles and detailed guidelines for good clinical
practice as regards investigational medicinal products
and in relation to the manufacture and importation of
such products" |
|
|
in: pharmind 2004, 1202 |
|
23. |
Orphan Medicinal Products: Draft Guideline on Elements
required to support Medical Plausibility and the
Assumption of Significant Benefit |
|
|
in: pharmind 2004, 1310 |
|
24. |
Draft on the Commission Regulation on the conditional
marketing authorisation for medicinal products falling
within the scope of Regulation (EC) No. 726/2004 of the
European Parliament and the Council of 31 March 2004 |
|
|
in: pharmind 2004, 1489 |
|
25. |
Draft for the "Procedure for the European Union
Guidelines and related documents within the
pharmaceutical legislative framework |
|
|
in: pharmind 2005, 52 |
|
26. |
Orphan Medicinal Products: Draft Guideline on the
Assessment of similarity and/or clinical superiority of
orphan medicinal products when assessing marketing
authorisation applications and variations |
|
|
in: pharmind 2005, 159 |
|
27. |
Proposal for a guideline on the definition of a
potential serious risk to public health |
|
|
in: pharmind 2005, 282 |
|
28. |
Proposal for a Commission Regulation laying down the
maximum amounts and the conditions and methods for the
collection of penalties under Regulation (EC) No.
726/2004 |
|
|
in: pharmind 2005, 402 |
|
29. |
Draft Guideline “Guidance on the occasions when it is
appropriate for Competent Authorities to conduct
inspections at the premises of Manufacturers of Active
Substances used as starting materials |
|
|
in: pharmind 2005, 527 |
|
30. |
Advanced Therapies: Proposal for a Community Regulation
on Advanced Therapies and amending Regulation (EC) No.
726/2004 |
|
|
in: pharmind 2005, 648 |
|
31. |
Draft Guidelines on similar biological medicinal
products containing biotechnology-derived
proteins as active substance: quality issues (EMEA/CHMP/BWP/49348/2005)
and non-clinical and clinical issues (EMEA/CHMP/42832/2005) |
|
|
in: pharmind 2005, 886 |
|
32. |
Draft Guidance concerning “consultation with target
patient groups” for the package leaflet |
|
|
in: pharmind 2005, 1031 |
|
33. |
Einfuhr von Bulkware aus Drittländern - Umstrittene
Einfuhrerlaubnis gemäß § 72 Abs. 1 AMG |
|
|
in: pharmind 2005, 1298 |
|
34. |
Revision of SPC-Guideline and draft proposal for the
revision of the Switch-Guideline |
|
|
in: pharmind 2005, 1430 |
|
35. |
Data protection after Review: Part I: Draft Guideline on
a new Therapeutic Indication for a well-established
Substance |
|
|
in: pharmind 2006, 59 |
|
36. |
Data protection after Review: Part II: Draft Guideline
regarding documentation required to benefit from
extended 11-year marketing protection |
|
|
in: pharmind 2006, 184 |
|
37. |
Support for Micro, Small and Medium-Sized Enterprises:
Commission Regulation (EC)
No. 2049/2005 of December 15, 2005 lays down Special
Provisions for Support of Micro,
Small and Medium-Sized Companies (SME) |
|
|
in: pharmind 2006, 298 |
|
38. |
Commission Regulation (EC) No. 507/2006 (OJ No. L 92,
30.03.2006, p. 6) on the conditional marketing
authorisation for medicinal products for human use
falling within the scope of Regulation (EC) No. 726/2004
of the European Parliament and the Council |
|
|
in: pharmind 2006, 418 |
|
39. |
Draft of a Commission Directive regarding the principles
and detailed guidelines for good clinical practice as
regards investigational medicinal products and in
relation to the requirements for manufacture and
importation of such products |
|
|
in: pharmind 2006,
|
|
40. |
Revision 2 of the detailed guidance on the collection,
verification and presentation of adverse reaction
reports arising from clinical trials on medicinal
products for human use |
|
|
in: pharmind 2006, 575 |
|
41. |
Draft Guideline on the Handling of Direct Healthcare
Professional Communications on the Safe and Effective
Use of Medicinal Products for Human Use ( “Dear
Doctor-Letters”) |
|
|
in: pharmind 2006, 830 |
|
42. |
Proposal for
a guidance on the “Definition of Investigational
Medicinal Products (IMPs) and definition of Non
Investigational Medicinal Products (NIMPs)” and
Draft “Guidance on ‘specific modalities’ for
non-commercial clinical trials referred to in Commission
Directive 2005/28/EC
laying down the principles and detailed guidelines for
good clinical practice”
|
|
|
in: pharmind 2006, 941 |
|
43. |
Standard Operating Procedure for the Annual
Re-Assessment for Centrally Authorised Medicinal
Products for Human Use |
|
|
in: pharmind 2006, 1057 |
|
44. |
New Texts relating to “Readability of the Label and
Package Leaflet”, the “Legal Status for the Supply to
the Patient of Centrally authorised Medicinal Products”
and “Revised Checking Process of Mock-ups and Specimen” |
|
|
in: pharmind 2006, 1158 |
|
45. |
Reflection Papers regarding Publication of Withdrawals
of Marketing Authorisation Applications and Scientific
Committee’s Negative Opinion and Refusal of Marketing
Authorisation Applications in the Centralised Procedure
for Human Medicinal Products |
|
|
in: pharmind 2006, 1271 |
|
46. |
EMEA Pandemic Influenza Crisis Management Plan and Note
for Sponsors of Orphan Medicinal Products regarding the
Enlargement of the European Union |
|
|
in: pharmind 2006, 1381 |
|
47. |
Regulation (EC) No. 1901/2006 on
Medicinal
Products for
Paediatric
Use has been published in the Official
Journal – Part I |
|
|
in: pharmind 2007, 61 |
|
48. |
Regulation (EC) No. 1901/2006 on
Medicinal
Products for
Paediatric
Use has been published in the Official
Journal – Part II |
|
|
in: pharmind 2007, 173 |
|
49. |
Initiatives for Revision of European Pharmaceutical
Legislation in the European Pharmacovigilance System and
System of Variations |
|
|
in: pharmind 2007, 306 |
|
50. |
Draft for a “Guideline on aspects of the application of
Article 8 (2) of Regulation (EC) No 141/2000: Review of
the period of market exclusivity of orphan medicinal
products |
|
|
in: pharmind 2007, 413 |
|
51. |
Draft for a “Guideline on requirements for first-in-man
clinical trials for potential high-risk medicinal
products” |
|
|
in: pharmind 2007, 546 |
|
52. |
Commission Regulation (EC) No 658/2007 of 14 June 2007
concerning financial penalties for infringement of
certain obligations in connection with marketing
authorisations granted under Regulation (EC) Bi 726/2004
of the European Parliament and of the Council |
|
|
in: pharmind 2007, 796 |
|
53. |
Guideline on Compassionate Use of Medicinal Products,
Pursuant to Article 83 of Regulation (EC) No. 726/2004 |
|
|
in: pharmind 2007, 924 |
|
54. |
Paper on the mandate, objectives and rules of procedure
for the GCP inspectors working group |
|
|
in: pharmind 2007, 1035 |
|
55. |
ECJ: Anthroposophic Medicinal Products are Subject to
Provisions of Directive 2001/83/EC |
|
|
in: pharmind 2007, 1145 |
|
56. |
Regulation of the European Parliament and the Council on
Advanced Therapy Medicinal Products and amending
Directive (EC) 2001/83 and Regulation (EC) No. 726/2004
adopted by the Council – Part I |
|
|
in: pharmind 2007, 1278 |
|
57. |
Regulation of the European Parliament and the Council on
Advanced Therapy Medicinal Products and amending
Directive (EC) 2001/83 and Regulation (EC) No. 726/2004
adopted by the Council – Part II |
|
|
in: pharmind 2007, 1428 |
|
58. |
New Guidances on Data Protection:
- Guidance on a new Therapeutic Indication for a
Well-established Substance and
- Guidance on elements required to support the
significant clinical benefit for benefiting from
extended (11-year) marketing protection |
|
|
in: pharmind 2008, 86 |
|
59. |
Guideline on the Acceptability of Names for Human
Medicinal Products processed through the Centralised
Procedure (CPMP/328/98)– Revision 5 |
|
|
in: pharmind 2008, 219 |
|
60. |
European Commission Policy against Counterfeit Medicines
for Human Use |
|
|
in: pharmind 2008, 481 |
|
61. |
Advanced Therapies Regulation: Public Consultation Paper
on the Draft of a Regulation on the Certification of
Quality and Non-Clinical Data For Small and Medium-Sized
Enterprises |
|
|
in: pharmind 2008, 611 |
|
62. |
New Commission Regulation on Variations replacing the
two Commission Regulations on Variations, Commission
Regulation (EC) No. 1084/2003 and Commission Regulation
(EC) No. 1085/2003 has been adopted by Standing
Committees – Part I |
|
|
in: pharmind 2008, 837 |
|
63. |
New Commission Regulation on Variations replacing the
two Commission Regulations on Variations, Commission
Regulation (EC) No. 1084/2003 and Commission Regulation
(EC) No. 1085/2003 has been adopted by Standing
Committees – Part II |
|
|
in: pharmind 2008, 950 |
|
64. |
2 New Commission Guidelines on the
Interpretation of Conditions for Market Exclusivity of
Orphan Medicinal Products |
|
|
in: pharmind 2008, 1194 |
|
65. |
ECJ: Concerned Member States have only limited
Discretion in Assessment of Generic Applications in
Mutual Recognition Procedures - ECJ considerably
strengthens the Principle of Mutual Recognition |
|
|
in: pharmind 2008, 1345 |
|
66. |
Paediatric Regulation: Guideline on the Format and
Content of Applications for Agreement or Modification on
a Paediatric Investigation Plan |
|
|
in: pharmind 2008, 1464 |
|
67. |
European
Commission
Communication
on
Safe, Innovative and Accessible Medicines: A Renewed
Vision for the Pharmaceutical Sector |
|
|
in: pharmind 2009, 84 |
|
68. |
European
Commission:
Proposal for a Directive and Regulation amending
Provisions regarding Information to the General Public
on Medicinal Products subject to Medical Prescription |
|
|
in: pharmind 2009, 264 |
|
69. |
European
Commission
: Proposal for a Directive amending the Community Code
as regards the Prevention of Entry into the Legal Supply
Chain of Medicinal Products which are falsified in
relation to their Identity, History or Source |
|
|
in: pharmind 2009, 435 |
|
70. |
European
Commission:
Draft Guidelines according to Articles 4 (1) (a) and 4
(1) (b) of the New Variations
Regulation
(EC) No. 1234/2008 |
|
|
in: pharmind 2009, 604 |
|
71. |
European
Commission:
Draft of a Commission
Regulation
implementing the Regulation on Advanced Therapies with
regard to the Evaluation and
Certification
of Quality and Non-clinical Data developed by Micro,
Small and Medium Sized Enterprises |
|
|
in: pharmind 2009, 803 |
|
72. |
Commission
Note regarding the Switch of Classification of Medicinal
Products |
|
|
in: pharmind 2009, 942 |
|
73. |
Draft of EMEA Transparency Policy published for Public
Consultation |
|
|
in: pharmind 2009, 1148 |
|
74. |
ECJ: Concept of "Reference Medicinal Product" in the
Sense of Art. 10 (2) (a) of Directive 2001/83/EC |
|
|
in: pharmind 2009, 1335 |
|
|
|
