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.

Who is the addressee of a notice of fees and expenses? Can a notice be sent to someone other than the ordering party? Date: Topics: About BfArM Type: FAQ

In the case of administrative acts the debtor of the fee is usually the applicant so that he is the receiver of a notice of fees and expenses. This can be different for clinical trials where the sponsor is always the debtor. If the applicant is …

Why are several notices of fees and expenses generated when similar type variations are notified to the BfArM via the Sunset Clause portal? Date: Topics: About BfArM Type: FAQ

Notifications pursuant to Section 29 sub-sections 1b and 1c AMG are subject to fees. Complete and finalised notifications via the Sunset Clause portal are principally charged. So, when a notification is identified as “finalised” in the survey …

What is BfArM’s tax ID number? Date: Topics: About BfArM Type: FAQ

Tax ID number is DE 165 893 456.

I have received a notice of fees and expenses for a variation although I did not submit a variation to the BfArM on the designated day. Date: Topics: About BfArM Type: FAQ

This may happen with Sunset Clause notifications (Section 29 sub-sections 1b, 1c AMG). They are formally no notifications of variation but just information on a variation. The fee number and the relevant AMG section referred to in the notice …

How can I check a notice of fees and expenses? Date: Topics: About BfArM Type: FAQ

A notice of fees and expenses is an administrative act and if you file an objection to it within one month, the BfArM will re-check the notice in form and content. It is recommendable, though, that you contact the undersigned person before you …

What does the BfArM charge for the approval of clinical trials according to Section 42 AMG? Date: Topics: About BfArM Type: FAQ

Fees for approval of clinical trials depend on the clinical trial phase and the scientific assessment work to be invested. Clinical trials with a non-authorised investigational product for which no clinical trial has been approved at the time …

In which cases does the AMGKostV allow for a reduction of fees and what are the rates of reduction? Date: Topics: About BfArM Type: FAQ

Reductions are only possible in the cases defined in Sections 2 and 3 of the AMGKostV. Fees are reduced by at least 25% if an application for a chargeable official act is declined or if such an application is withdrawn after processing has already …

Why am I sent a notice of fees and expenses for a medicinal product for which I do no longer hold the underlying marketing authorisation? Date: Topics: About BfArM Type: FAQ

This has to do with fees for variations, which are usually levied from the pharmaceutical company holding the marketing authorisation at the time of submission of the variation. Fees for notification of a change of the marketing authorisation …