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 Finance by way of the payment monitoring procedure (Zahlungsüberwachungsverfahren, ZÜV). Private sector accounting systems are not considered in this connection. The BfArM does not have a commercial accounting system with debtors and creditors, but instead creates an account with a 12-digit ZÜV transaction number and an individual number for each notice on fees and expenses. Unlike as in commercial accounting, the Federal Government does not keep accounts receivable accounts, but only transaction numbers for individual notices on fees and expenses due to its single-entry bookkeeping system.

The notices on fees and expenses are not invoices under private law but are rather administrative acts under public law, which are issued in the context of the administrative proceedings pending here. Notices on fees and expenses always contain all information the fee debtor needs to allocate the fee (date the application was received, reference number relating to the notice concerned, name and processing number of the medicinal product as well as the fee debtor if a corresponding absorption of costs was declared). In view of the large number of notices on fees and expenses we issue, we could not justify responding to special requests from individual pharmaceutical entrepreneurs regarding the notice data and sending out individualised notices on fees and expenses. The same applies to separate invoice addresses and order numbers. Pursuant to Section 6 of the Federal Fees Act (BGebG), the person to whom the public service can be attributed individually (= the fee debtor), is obligated to pay the fee and the notice on fees and expenses is only to be directed to this person, as otherwise no valid notification will have taken place. Thus, it is not possible for legal reasons to specify contact persons in the address field; it is always the legal entity that is liable for payment.

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 percent of the outstanding amount can be charged for each new month of late payment, if this in excess of 100 Deutsche Mark.

For claims which arose after the Federal Fees Act came into effect on 15 August 2013, Section 16 of the Federal Fees Act applies. According to this, a late payment penalty of one percent of the rounded outstanding amount is to be paid for each new month of late payment. The late payment penalty is only charged if the outstanding amount is in excess of 50 Euro and the period of late payment amounts to longer than three days.

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. Section 3 sub-section 2 c) of the Administrative Enforcement Act (Verwaltungsvollstreckungsgesetz)). They were to be settled free of charge within seven days.

For claims which arose after the Federal Fees Act (Bundesgebührengesetz) came into effect on 15 August 2013, Section 14 of the Federal Fees Act applies. According to this, the fee is due from the party liable for fees 10 days after the fees are announced, as long as the authorities have not set another point in time.

For all fees announced after 10 March 2014, however, a period of 30 days applies, independent of the point in time in which the liability for fees arose.

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). According to this, the party who prompted the official action or who benefited from it being carried out is strictly obliged to pay the costs (see also the FAQ regarding "Who is the party liable for costs?" („Wer ist Kostenschuldner?“)).

For all claims which arose after the Federal Fees Act came into effect on 15 August 2013, only the terms "party liable for fees" in the sense of Section 6 of the Federal Fees Act and the “individually attributable public service” in the sense of Section 3 of the Federal Fees Act now apply. According to this, the party obliged to pay the fees is strictly that to which the public service is individually attributable.

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 Fassung (English version)

Medizinprodukte-Kostenverordnung (BKostV-MPG) vom 27. März 2002 (German version)

According to Section 1 of the VwKostG costs include fees and expenses. Fees are the money charged for official acts conducted by the BfArM. Expenses are the money paid by the BfArM to third parties to the advantage of the requested official act. Expenses are levied from the applicant pursuant to Section 33 sub-section 1 of the German Medicines Act (AMG) in connexion with Section 10 of the VwKostG. Expenses are either included in the overall fee or they are separately charged to the applicant’s account as specified in a notice of expenses (Auslagenbescheid). Costs for the involvement of external experts in cases defined in Section 4 of the AMG Fees Ordinance (AMG Kostenverordnung = AMGKostV) are credited against the finally fixed overall fees.

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 the aim of achieving an administrative act (in this case, the marketing authorisation for a medicinal product). The application must be filed on one’s own behalf and must not be filed for a third party (Kopp/Ramsauer, Section 13 VwVfG marginal no. 17; Stelkens/Bonk/Sachs, Section 13 VwVfG marginal no. 15). Of course the applicant can designate a representative and can mandate another company to submit an application (by way of power of attorney). However, in that case, said company would only be the submitter and would not be acting for itself but on behalf of the company to receive the marketing authorisation. Should the statements made in paragraph 2.4.1 of the application form – proposed marketing authorisation holder – in separate applications submitted in parallel differ from those in other applications submitted at the same time, the applicant is no longer considered to be the same. Of course the submitter cannot effect a marketing authorisation without a power of attorney from the proposed marketing authorisation holder.

In conclusion: the applicant is basically always the company referred to by name at the end of the licensing procedure in Germany in the notice of marketing authorisation. Thus, in the German administrative law and law of costs it does not depend on the applicant according to the application form – this is merely the submitter of the application – but on the proposed marketing authorisation holder in Germany throughout the entire duration of the procedure.

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 this act is performed. As a rule, the applicant (cf. FAQ “What does the term 'applicant' mean?“) is the first to be called upon as the party liable for costs.

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 costs, may change during processing. Therefore, any information about expected fees is preliminary and without obligation until the the fee is finally determined.

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 started. Fees may be reduced to the half if it is justified by the staff costs and operating expenditures incurred in connection with the official act, and by the importance, the economic benefit or any other benefit arising from the official act for the debtor of the fee. The aforementioned conditions apply cumulatively.

Furthermore, fees can be reduced down to 25% if the applicant cannot expect a benefit adequate to the costs incurred for the drug development and the marketing authorisation procedure, and if there is a public interest in placing the medicinal product on the market due to its therapeutic indication or if the cases are rare or the target group is small for which the medicinal product is intended to be used.

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 file an objection. Often your questions are easy to resolve in this informal way so that a formal procedure and resulting fees can be avoided.

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 not identical with the sponsor, the applicant must inform the sponsor, as the debtor, about a notice. It is also possible that a third party will take over the fees. In such a case it is necessary that a written declaration of assumption of debt (Kostenübernahmeerklärung) is enclosed, in a separate letter and easily visible, in the application documents or a later submission.

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 (first submission) cost more than those where clinical trials have already been approved for the product (successive trials). Therefore, you should always make mention in your cover letter of previous trials with the same investigational product, if any. Variations submitted in connection with the clinical trial and the annual reports are subject to fees.

Official acts conducted by the BfArM in connection with non-commercial clinical trials initiated by the investigator are principally subject to fees like any other clinical trials in accordance with Section 33 sub-section 1 AMG.

On 1 May 2008.

Yes.

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 holder are usually charged to the previous authorisation holder’s account.

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 will show you that the money is charged for the processing of the information on a variation.

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 of the electronic Sunset Clause procedure it is automatically subject to fees. Pharmaceutical companies have the possibility to correct the status within 28 days of the first notification without incurring further costs. They can replace incorrect information on a variation on the day of the first notification, free of charge, by contrary notification of the same date. For multiple notifications of the same type (marketing or discontinuation) per product and day (date of application), only the notification with the highest number is charged.

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-Kostenverordnung).

This applies likewise to the cases where the Regulation allows the new procedure of “Grouping” of variations. Also in these cases the individual variation is charged according to the specifications under fee number 9 on the basis of the general categories in the national Fee Regulation. This continues until the Fee Regulation gets amended to adapt it to the new conditions of Regulation No. 1234/2008, as appropriate.

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.

Tax ID number is DE 165 893 456.

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.