Announcement regarding changes in the administrative practice in the processing of national notifications of variations to the name of a medicinal product in accordance with Section 29 sub-section 2 AMG

1 August 2010
(available in German only)

Announcement regarding the Electronic Submission of Marketing Authorisation Dossiers for Medicinal Products Intended for Use in Humans in accordance with Section 21 et seqq. AMG to the Federal Institute for Drugs and Medical Devices and to the Paul-Ehrlich-Institute of 26 March 2010

26 March 2010

(available in German only)

Report on adverse drug reactions (available in German only)

Report on adverse drug reactions

Announcement on the Registration and Authorisation of Medicinal Products
ACE Inhibitors, Angiotensin II Antagonists, and Hydrochlorothiazide as well as Combination Products thereof

30 March 2009(available in German only)
text of the graduated plan procedure

Announcement regarding Medicinal Products Containing Lenalidomide or Thalidomide

08 December 2008
(available in German only)

Announcement on the Registration and Authorisation of Medicinal Products
Antiepileptic Drugs and Suicidal Behaviour

04 September 2008(available in German only)
text of the graduated plan procedure

2nd Announcement regarding the Renewal of Marketing Authorisations for Medicinal Products in accordance with Section 31 sub-section 3 AMG, the Renewal of Registrations of Homoeopathic Medicinal Products in accordance with Section 39 sub-section 2b AMG, and the Renewal of Registrations of Traditional Phytotherapeutic Medicinal Products in accordance with Section 39c sub-section AMG

02 September 2008
(available in German only)

Announcement regarding Marketing Authorisations respectively Registrations for which Suspension of Marketing Authorisation or Limited Expiry were Ordered upon Request of the Marketing Authorisation Holder due to Lacking Proof of Pharmaceutical Quality or Based on the CFC Prohibition Ordinance

29 April 2008
(available in German only)

Announcement regarding Recommendations for the Presentation of the Package Leaflet under Section 11 AMG for Human Medicinal Products (in accordance with Section 77 sub-section 1 AMG)

30 November 2006
(available in German only)

Announcement regarding the Interim Regulations for Renewals of Marketing Authorisations of Medicinal Products under Section 31 AMG and on the Renewal of Registrations of Homoeopathic Medicinal Products under Section 39 sub-section 2b AMG on the Occasion of the 14^th Law Amending the German Medicines Act (27 March 2006)

27 March 2006
(available in German only)

Announcement regarding the Granting of Special Licenses for Customs Authorities in accordance with Article 3 paragraph 2 Regulation (EC) No. 273/2004 in conjunction with Article 12 paragraph 2 Regulation (EC) No. 1277/2005 dated 16 January 2006 (Federal Gazette No. 20 dated 28 January 2006, p. 592)

16 January 2006

Announcement regarding the Notification of Variations to Marketing Authorisations and Registrations in accordance with Section 29 AMG

19 October 2005
(available in German only)

Announcement regarding the Submission of Periodic Safety Update Reports on Medicinal Products in accordance with Section 63b sub-section 5 AMG

14 September 2005
(available in German only)

Announcement regarding the Granting of Special Licenses for Pharmacies in accordance with Article 3 paragraph 2 Regulation (EC) No. 273/2004 dated 2 August 2005 (Federal Gazette No. 151 dated 12 August 2005, p. 12297)

2 August 2005

Announcement regarding the Authorisation and Registration as well as the Renewal of Marketing Authorisations for Medicinal Products – Exceptions from the Prohibition of Certain Ozone-depleting Halogenated Hydrocarbons according to the CFC Halon Prohibition Ordinance

19 October 2004
(available in German only)

Announcement of the Federal Institute for Drugs and Medical Devices, the Paul-Ehrlich-Institute as well as the Federal Office of Consumer Protection and Food Safety regarding the Regulations of the Specific Mechanism pursuant to Annex IV No. 2 of the Act of Accession of the EU Treaty of Accession of 16 April 2003 concerning the Parallel Import of Human or Veterinary Medicinal Products from the Republics Estonia, Latvia, Lithuania, Poland, Slovenia, Hungary, the Slovak Republic, or Czech Republic to the Federal Republic of Germany

30 April 2004
(available in German only)

Announcement regarding the Authorisation and Registration as well as the Renewal of Marketing Authorisations for Medicinal Products – Exceptions from the Prohibition of Certain Ozone-depleting Halogenated Hydrocarbons according to the CFC Halon Prohibition Ordinance

13 October 2003
(available in German only)

Announcement on the Authorisation of Medicinal Products in accordance with Section 21 AMG (Bioavailability/Bioequivalence)

18 December 2002
(available in German only)

Announcement regarding the Amendment of the Recommendations for the Presentation of the Package Leaflet under Section 11 AMG for Human Medicinal Products (in accordance with Section 77 sub-section 1 AMG)

2 October 2002
(available in German only)

Announcement regarding the Revised Wording of the Recommendations for the Presentation of the Package Leaflet under Section 11 AMG for Human Medicinal Products (in accordance with Section 77 sub-section 1 AMG)

15 March 2002
(available in German only)

Announcement regarding the Notification of Variations to Marketing Authorisations and Registrations

29 March 2001
(available in German only)

Announcement regarding the Renewal of Marketing Authorisations pursuant to Section 31 AMG and the Renewal of Registrations of Homeopathic Medicinal Products pursuant to Section 39 sub-section 2b AMG

3 January 2001 (German Federal Gazette No. 33, 16 February 2001)
(available in German only)

Annex  Application Form (file size: 167 KB) (available in German only)

Announcement regarding the Authorisation and Registration as well as the Renewal of Marketing Authorisations for Medicinal Products – Exceptions from the Prohibition of Certain Ozone-depleting Halogenated Hydrocarbons according to the CFC Halon Prohibition Ordinance

4 October 2000
(available in German only)

Announcement regarding the authorisation and registration of medicinal products for human use and the safety of marketable medicinal products for human use

– Prevention of drug-associated risks, stage II –
(medicinal products for human use derived from human blood or tissues)

14 January 1999
(available in German only)

Announcement on the Authorisation and Registration of Medicinal Products
- Recommendations for Design and Conduct of Non-interventional Studies

12 November 1998
(available in German only)