Röhrig-friesE

Lawfirm

ISERt / ALTENKIRCHEN

Germany

Zum Bongard 1

D - 57612 Isert / Altenkirchen

Tel (+49)-(0) 2681 - 87 976 70

Fax (+49)-(0) 2681 - 87 976 71

Office-Email: Office@Kanzlei-Roehrig.de

 

Publications

Dr. Brigitte Röhrig

   
  Books:
 
1.

Offene Fragen der neuen europäischen Zulassungsverfahren für Arzneimittel  - insbesondere Verfahren und Rechtsschutz des Antragstellers und Zulassungsinhabers bei Zulassungsentscheidungen (published in German/ English translation of the title:

Open Questions of the New European Marketing Authorisation Procedures for Medicinal Products - especially Procedure and Legal Protection of the Applicant and Marketing Authorisation Holder in case of Marketing Authorisation Decisions)

published: Editio Cantor Verlag 1996

 

2.

Handbuch der EU-Zulassung, editor, 6 co-authors (published in German/ English translation of the title: Handbook of EU marketing authorisation)

published: Editio Cantor Verlag 1998

 

3. Guide to Drug Regulatory Affairs,
edited by Brigitte Friese, Barbara Jentges, Usfeya Muazzam
  published: Editio Cantor Verlag 2006/ 2007 in print- and online-Version

 

  Publications, Commentations
 
1.

Zulässigkeit der Konkurrentenklage nach dem EWG-Vertrag gegen Zulassungsentscheidungen im zukünftigen zentralen europäischen Zulassungsverfahren für Arzneimittel

in: Pharma Recht 1994, 66

 

2.

Auswirkungen der zukünftigen Regelungen des Zulassungsverfahrens auf die Zulässigkeit staatlicher Schutzmaßnahmen gemäß Art. 36 EGV

in: Pharma Recht 1994, 98

 

3.

Die zukünftigen europäischen Zulassungsverfahren - Zügige Verfahren zur Erlangung von Arzneimittelzulassungen?

in: Die Pharmazeutische Industrie (pharmind) 1994, 869

 

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

 

   

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