BfArM - Federal Institute for Drugs and Medical Devices

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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.