BfArM - Federal Institute for Drugs and Medical Devices

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Annual report 2017/18 PDF, 1MB, File does not meet accessibility standards Date: 23. August 2018 Topics: About BfArM Type: Download

Annual report 2017/18

Where in the notice on fees and expenses can I find the data relevant for allocation of the subject notice (e.g. notice of marketing authorisation/renewal etc.)? Date: 26. October 2017 Topics: About BfArM Type: FAQ

Since the BfArM is an institution within the portfolio of the Ministry of Health, it has to fulfil the tasks assigned by the legislator with regard to budgetary and financial affairs. These tasks are carried out as instructed by the Ministry of …

Manual - only available in German PDF, 423KB, File is accessible Date: 10. July 2017 Topics: About BfArM Type: Download

Joint Advice through the BfArM or PEI and the Federal Joint Committee (G-BA)

Annual report 2014/15 PDF, 6MB, File does not meet accessibility standards Date: 30. May 2016 Topics: About BfArM Type: Download

Annual report 2012/13

Contact persons Date: 30. January 2016 Topics: About BfArM Type: Article

Contact persons

Annual report 2012/13 PDF, 9MB, File does not meet accessibility standards Date: 30. April 2014 Topics: About BfArM Type: Download

Annual report 2012/13

What does the term "the party liable for fees" mean? Date: 10. March 2014 Topics: About BfArM Type: FAQ

For claims that arose before the Federal Fees Act (Bundesgebührengesetz) came into effect on 15 August 2013, the term "party liable for costs" applies in the sense of Section 13 of the Administrative Costs Act (Verwaltungskostengesetz). …

When is a claim due? Date: 10. March 2014 Topics: About BfArM Type: FAQ

Hitherto, costs were strictly due from the party liable for fees upon announcement of the decision on costs, unless the authorities had specified a later point in time (Section 17 of the Administrative Costs Act (Verwaltungskostengesetz) cf.

When must a late payment penalty be paid? Date: 10. March 2014 Topics: About BfArM Type: FAQ

For claims that arose before the Federal Fees Act (Bundesgebührengesetz) came into effect on 15 August 2013, Section 18 of the Administrative Costs Act (Verwaltungskostengesetz) is still valid. According to this, a late payment penalty of one …

Joint Declaration of Intent Swissmedic - BfArM PDF, 31KB, File is accessible Date: 14. February 2014 Topics: About BfArM Type: Download

Declaration of Intent

Disclaimer Date: 15. April 2013 Topics: About BfArM Type: Article

Disclaimer

Fees Ordinance
Relating to the Medical Devices Act (MDA) and the statutory instruments for its implementation
(MDA Fees Ordinance)
PDF, 32KB, File is accessible
Date: 04. July 2011 Topics: About BfArM Type: Download

Fees Ordinance
Relating to the Medical Devices Act (MDA) and the statutory instruments for its implementation
(MDA Fees Ordinance)

What does the term 'applicant' mean in connection with the AMGKostV? Date: 31. January 2011 Topics: About BfArM Type: FAQ

The law generally applicable for licensing procedures is the Administrative Procedures Act (Verwaltungsverfahrensgesetz, VwVfG). In accordance with this act, the applicant is defined as the party who files an application on its own behalf with …

Who is the party liable to pay the costs? Date: 31. January 2011 Topics: About BfArM Type: FAQ

In accordance with Section 13 of the Administrative Cost Act (Verwaltungskostengesetz = VwKostG) the party liable to pay the costs ( = debtor of the costs) is the party requesting the official act ( = initiator) or the party to whose advantage …

How to settle payments? Date: 08. October 2010 Topics: About BfArM Type: FAQ

At present, payments can be settled within seven days free of costs by cheque or by bank transfer. However, paying by cheque can only be accepted in well-founded exceptions.

Ordinance on Medicinal Products for Compassionate Use – AMHV PDF, 88KB, File is accessible Date: 08. September 2010 Topics: About BfArM Type: Download

Ordinance on Medicinal Products for Compassionate Use

What is the legal basis for the BfArM to charge costs? Date: 04. June 2010 Topics: About BfArM Type: FAQ

Costs are charged on the basis of the administrative cost act (Verwaltungskostengesetz = VwKostG) and other special statutory regulations:

Besondere Gebührenverordnung BMG (BMGBGebV) (German version)

AMG-Kostenverordnung (AMGKostV) englische …

Who provides information on the expected amount of fee? Date: Topics: About BfArM Type: FAQ

The final fee is not determined until the end of a procedure. The classification of a procedure (application for a series or identical series, application for authorisation with partial or complete reference, etc.) including the resulting …

Has EU Regulation No. 1234/2008 (Variation Regulation) any consequences for the fees charged for notification of variations? Date: Topics: About BfArM Type: FAQ

EU Regulation No. 1234/2008 has currently no consequences for the cost assessments. Processing of variations is charged according to the terms and rates laid down in the valid version of the Fee Regulation concerning pharmaceuticals (AMG

Can the BfArM include purchase order numbers or the tax number of a pharmaceutical company in the notice of fees and expenses? Date: Topics: About BfArM Type: FAQ

No, this is not possible. Notices of fees and expenses are no invoices under private law but administrative acts under public law, where no individual purchase order numbers or tax numbers of debtors are added.