| Title |
Date |
Download |
6th Announcement relating to the Notification of Undesirable Effects and Abuse of Medicinal Products pursuant to Section 63b sub-sections 1 to 9 AMG
19 January 2010
(available in German only)
 Guide and Explanatory Notes regarding the Electronic Transmission of ADR Reports to the BfArM (available in German only) (Größe: 63.64 KB)
Report on adverse drug reactions (available in German only) (Größe: 219.05 KB) |
19.01.2010 |
download (Größe: 288.12 KB) |
Report on adverse drug reactions (available in German only)
Report on adverse drug reactions |
19.01.2010 |
download (Größe: 219.05 KB) |
Guide and Explanatory Notes regarding the Electronic Transmission of ADR Reports to the BfArM (available in German only)
Guide and Explanatory Notes regarding the Electronic Transmission of ADR Reports to the BfArM |
19.01.2010 |
download (Größe: 63.64 KB) |
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 |
30.03.2009 |
download (Größe: 69.61 KB) |
Announcement regarding the Ordinance Regulating the Prescription Requirement for Medicinal Products (AMVV)
08 December 2008
(available in German only)
Annex (Größe: 459.68 KB) |
08.12.2008 |
download (Größe: 20.29 KB) |
Announcement regarding Medicinal Products Containing Lenalidomide or Thalidomide
08 December 2008
(available in German only) |
08.12.2008 |
download (Größe: 757.53 KB) |
Announcement regarding Medicinal Products Containing Lenalidomide or Thalidomide
08 December 2008
(available in German only) |
08.12.2008 |
download (Größe: 757.53 KB) |
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 |
04.09.2008 |
download (Größe: 25.12 KB) |
Announcement regarding the Registration or Authorisation of Medicinal Products:
Medicinal Products Containing Carbamazepine, Stevens-Johnson syndrome
04 September 2008
(available in German only) |
04.09.2008 |
download (Größe: 34.15 KB) |
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) |
02.09.2008 |
download (Größe: 32.39 KB) |
Announcement on the Registration, Authorisation, and Post-marketing Authorisation of Medicinal Products,
Prevention of Drug-associated Risks: Medicinal Products Containing Paracetamol
14 May 2008
(available in German only) |
14.05.2008 |
download (Größe: 14.96 KB) |
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) |
29.04.2008 |
download (Größe: 20.25 KB) |
5th Announcement relating to the Notification of Undesirable Effects and Abuse of Medicinal Products
05 December 2007
Information and Explanations for the Electronic Transmission of ADR Reports to the BfArM (Größe: 41.24 KB) |
05.12.2007 |
download (Größe: 542.85 KB) |
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) |
30.11.2006 |
download (Größe: 24.63 KB) |
3rd Announcement on Clinical Trials of Medicinal Products in Humans
10 August 2006
|
10.08.2006 |
download (Größe: 1.04 MB) |
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 14th Law Amending the German Medicines Act (27 March 2006)
27 March 2006
(available in German only) |
27.03.2006 |
download (Größe: 41.07 KB) |
Announcement regarding the Granting of Special Licenses for the Federal Armed Forces in accordance with Article 3 paragraph 2 Regulation (EC) No. 273/2004 dated 16 January 2006 (Federal Gazette No. 20 dated 28 January 2006, p. 592)
16 January 2006 |
16.01.2006 |
download (Größe: 34.97 KB) |
Announcement regarding the Granting of Special Licenses for Police 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 |
16.01.2006 |
download (Größe: 29.51 KB) |
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 |
16.01.2006 |
download (Größe: 29.52 KB) |
Announcement regarding the Notification of Variations to Marketing Authorisations and Registrations in accordance with Section 29 AMG
19 October 2005
(available in German only) |
19.10.2005 |
download (Größe: 44.27 KB) |
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
29 September 2005
(available in German only) |
29.09.2005 |
download (Größe: 30.43 KB) |
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) |
14.09.2005 |
download (Größe: 76.14 KB) |
Announcement regarding Safety Requirements to Minimise the Risk of Transmission of Animal Transmissible Spongiforme Encephalopathies
16 August 2005
(available in German only) |
16.08.2005 |
download (Größe: 880.92 KB) |
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 |
02.08.2005 |
download (Größe: 29.84 KB) |
Announcement regarding the Renewal of Marketing Authorisations for Medicinal Products Intended for Use in Humans in accordance with Section 105 AMG in conjunction with Section 109a AMG
(published in the German Federal Gazette No. 220, 10 November 2004, p. 23089)
25 October 2004
(available in German only) |
25.10.2004 |
download (Größe: 65.65 KB) |
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) |
19.10.2004 |
download (Größe: 62 KB) |
Amendment to the Announcement on the Authorisation and Registration of Medicinal Products for Use in Humans
13 July 2004
(available in German only) |
13.07.2004 |
download (Größe: 739.24 KB) |
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) |
30.04.2004 |
download (Größe: 132.79 KB) |
Announcement regarding Medicinal Products Containing Thalidomide
22 December 2003
(available in German only) |
22.12.2003 |
download (Größe: 14.5 KB) |
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) |
13.10.2003 |
download (Größe: 93 KB) |
Announcement on the Authorisation of Medicinal Products - New Set of Forms for Application for Marketing Authorisation of a Medicinal Product by the Federal Institute for Drugs and Medical Devices and by the Paul-Ehrlich-Institut/Federal Agency for Sera and Vaccines
21 January 2003
(available in German only) |
21.01.2003 |
download (Größe: 29.02 KB) |
Announcement on the Authorisation of Medicinal Products in accordance with Section 21 AMG (Bioavailability/Bioequivalence)
18 December 2002
(available in German only) |
18.12.2002 |
download (Größe: 79.01 KB) |
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
24 October 2002
(available in German only) |
24.10.2002 |
download (Größe: 69.91 KB) |
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) |
02.10.2002 |
download (Größe: 34.88 KB) |
Announcement regarding the Renewal of Marketing Authorisations pursuant to Section 31 AMG on the Basis of BfArM Core SPCs and Package Leaflets, 12 July 2002 (German Federal Gazette No. 146, 8 August 2002)
12 July 2002 (German Federal Gazette No. 146, 8 August 2002)
(available in German only) |
12.07.2002 |
download (Größe: 232.2 KB) |
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) |
15.03.2002 |
download (Größe: 65.84 KB) |
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
11 October 2001
(available in German only) |
11.10.2001 |
download (Größe: 43.37 KB) |
Announcement regarding the Notification of Variations to Marketing Authorisations and Registrations
29 March 2001
(available in German only) |
29.03.2001 |
download (Größe: 33.36 KB) |
Announcement regarding the Authorisation and the Renewal of Marketing Authorisations for Medicinal Products Intended for Use in Humans in accordance with Section 105 AMG - Statutory Declaration in accordance with Section 109a sub-section 2 AMG
30 January 2001
(available in German only) |
30.01.2001 |
download (Größe: 8.49 KB) |
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 (Größe: 171.32 KB) (available in German only) |
03.01.2001 |
download (Größe: 84.66 KB) |
Announcement on the Authorisation of Medicinal Products (Requirements regarding Documentation of Pharmaceutical Quality in connection with Variations in accordance with Section 9 AMG)
27 November 2000
(available in German only) |
27.11.2000 |
download (Größe: 56.59 KB) |
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) |
14.10.2000 |
download (Größe: 22.66 KB) |
46th Announcement regarding the Renewal of Marketing Authorisations for Medicinal Products Intended for Use in Humans in accordance with Section 105 AMG in conjunction with Section 109a AMG
(German Federal Gazette No. 130, 14. July 2000, page 13705 et seq., Volume 52)
7 July 2000
(available in German only)
|
07.07.2000 |
download (Größe: 112 KB) |
Announcement on the Authorisation, Post-marketing Authorisation, and Registration of Medicinal Products (Recommendations of the Commission D pursuant to Section 25 sub-sections 6 and 7 AMG for Design and Conduct of Tests on Homoeopathic Medicinal Products)
18 November 1998
(available in German only) |
18.11.1998 |
download (Größe: 204.06 KB) |
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) |
12.11.1998 |
download (Größe: 30.13 KB) |
4th Announcement on the Possibility of Submitting Marketing Authorisation Documents for Medicinal Products for Human Use under Section 21 AMG to the Federal Institute for Drugs and Medical Devices on Optical Storage Media
11 December 1997
(available in German only) |
11.12.1997 |
download (Größe: 243.32 KB) |
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