Cost Of Regulation For The Approval And Registration Of Medicinal Products By The Federal Institute For Drugs And Medical Devices And The Federal Office Of Consumer Protection And Food Safety

Original Language Title: Kostenverordnung für die Zulassung und Registrierung von Arzneimitteln durch das Bundesinstitut für Arzneimittel und Medizinprodukte und das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit

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The Federal Institute for Drugs and Medical Devices and the Federal Office for Consumer Protection and Food Safety (AMG-Cost Ordinance-AMGKostV)

href="index.html"> unofficial table of contents

AMGKostV

expiration date: 10.12.2003

full quote:

" AMG cost regulation from 10. December 2003 (BGBl. 2510), as last amended by Article 1 of the Regulation of 3. March 2015 (BGBl. I p. 195, 1007) has been changed "

V up. by Article 4 (13) G v. 7.8.2013 I 3154 mWv 14.8.2018
Stand:Last modified by Art. 1 V v. 3.3.2015 I 195, 1007

For more information, see the Notes

Footnote

(+ + + text evidence from: 1.1.2004 + + +)





























Heading: IdF d. Art. 1 No. 1 V v. 3.3.2015 I 195 mWv 7.3.2015 unofficial table of contents

input formula

On the basis of section 33 (2) of the Medicines Act, the version of the Notice of 11. December 1998 (BGBl. 3586) in conjunction with the 2. Section of the Administrative Costing Act of 23. June 1970 (BGBl. 821), Section 1 of the Law on Jurisdiction Adjustment of 16. August 2002 (BGBl. I p. 3165), the organisation of the 22. January 2001 (BGBl. 127) and 22. October 2002 (BGBl. 4206), the Federal Ministry of Health and Social Security, in agreement with the Federal Ministry for Economic Affairs and Labour, prescries: Non-official Table of contents

§ 1 Principle

(1) The Federal Institute for Medicinal Products and Medical Devices and the Federal Office for Consumer Protection and Food Safety collect according to the applicable fee list and the following regulations Fees and expenses for decisions on the authorisation of medicinal products, for decisions on the registration of homeopathic medicinal products and traditional herbal medicinal products, for the processing of applications, for the operation of in the context of the collection and evaluation of medicinal products risks, for opposition proceedings against administrative acts adopted pursuant to the Medicines Act, or against the fixing of fees and outlays under this Regulation, and for other Individually attributable public services.(2) The notice in the Federal Gazette shall not be subject to exposition in the cases of the extinguishing or the glory of an authorisation. Non-official table of contents

§ 2 Fees upon rejection or withdrawal of an application

In the event of rejection of an application for an individual request, an application For other reasons than due to lack of competence or the withdrawal of an application after the commencement of factual processing, a fee of 75 per cent of the public service which can be attributed to the individual is charged the fee to be fixed. It may discounted up to a quarter of the intended fee or it may be waivedfrom its survey if this is equal to the equity. Non-official table of contents

§ 3 Discounts

(1) The fee may be reduced to one-half of the intended fee if the fee is charged with the Personal and material expenses relating to individual attributable public performance, on the one hand, and the importance, economic value or other benefits of the individually attributable public service for the charge debtor on the other hand.The fees to be charged pursuant to points 1 to 25 of the list of fees may, at the request of the fee debtor, unless paragraph 1 is applied, be reduced to one quarter of the intended fee if the applicant is entitled to: an economic benefit that is appropriate to development and approval costs cannot be expected and
1.
a public interest in the marketing of the medicine due to the application area, or
2.
the use cases are rare or the target group for which the medicine is intended is small.
A non-official table of contents

§ 4 Invoice of expenses for experts

Will be one of the individually attributable items listed in the numbers 1 to 13 and 18 to 25 of the fee list In the case of public services in the cases provided for by law, on the basis of the assessment of documents carried out by independent experts, the costs to be reimburzed shall be charged on the fee to be determined. Non-official table of contents

§ 5 Transitional rules

(1) The AMG Cost Regulation is to continue to be applied in the version of 10. December 2003 (BGBl. 2510), as last amended by Article 2 (26) of the Law of 7. August 2013 (BGBl. I p. 3154), if the underlying individually attributable public performance is before the 7. March 2015 has been requested or started, but has not yet been fully provided. This shall not apply if, for the public service which is individually attributable, there is already a charge level according to the AMG cost regulation in the version of 10. December 2003, as last amended by Article 2 (26) of the Law of 7 June 2003. August 2013 (BGBl. I p. 3154), and the fee to be charged thereafter is higher than that in the AMG Costing Regulation, as amended by the 7th Regulation of the European Parliament and of the Council of the European Union. The fee is scheduled for March 2015. In this case, fees will be charged according to the AMG cost regulation in the version of the 7. March 2015.(2) The cost regulation for the registration of homeopathic medicinal products by the Federal Institute for Medicinal Products and Medical Devices and the Federal Office for Consumer Protection and Food Safety continues to be published in the version of the notice of the 24. October 2003 (BGBl. 2157), as defined in Article 2 (25) of the Law of 7. August 2013 (BGBl. I p. 3154), if the underlying individually attributable public performance is before the 7. March 2015 has been requested or started, but has not yet been fully provided. This shall not apply if, for the individual attributable service, a fee has already been charged in the cost regulation in the version of the notice of 24. October 2003 (BGBl. 2157), as defined in Article 2 (25) of the Law of 7. August 2013 (BGBl. I p. 3154), and the fee to be charged thereafter is higher than that in the AMG Costing Regulation, as amended by the 7th Regulation of the European Parliament and of the Council of the European Union. The fee is scheduled for March 2015. In this case, fees will be charged according to the AMG cost regulation in the version of the 7. March 2015.(3) For individually attributable public services, prior to the 7. In accordance with the provisions of the AMG Costing Regulation, charges may be made in accordance with the provisions of the AMG Costing Act of March 2015. As far as a cost decision has been expressly reserved for the individually attributable public services, with reference to the forthcoming addition to this Regulation, the collection is subject to a decision of March 2015. The first sentence shall apply, provided that an individually attributable public service is already available before the 7. March 2015 has been requested or started, but has not yet been fully provided.(4) The fees to be charged in accordance with the charge numbers 10 of the tariff list shall be reduced by 50 per cent if the underlying individually attributable public service, insofar as a request is necessary, shall be up to the 7th. March 2016. The fees to be charged in accordance with the charge numbers 10 of the tariff list shall be reduced by 25 per cent if the underlying individually attributable public service, insofar as a request is necessary, shall be up to the seventh. March 2017 has been requested. Non-official table of contents

§ 6 Entry into force, expiry

This regulation occurs on the 1. January 2004 in force. Non-official table of contents

Asset (to § 1)

In the list of fees below: Known substance: Medicines in which the requirements are met Article 22 (3) (1), (2) or (3) of the Medicinal Products Act. New substance: medicinal product in which none of the conditions set out in Article 22 (3) (1), (2) or (3) of the Medicines Act are fulfilled. a second applicant on a file from a preceding applicant in accordance with Article 24b (1) of the German Medicinal Products Act: Subwise reference to: a second applicant's reference to parts of the documents of a prior applicant (with the exception of the Quality records) and submission of their own subplant. Dublette: Full reference of an applicant to an identical medicinal product of the same applicant, whose authorisation or registration at the time of application is no longer than Reference in accordance with § 24a of the Medicinal Products Act: reference of the same applicant or of another applicant with the consent of the applicant to all documents, including the quality documents of an approved Medicinal product according to § 24a of the Medicinal Products Act: Several applications submitted at the same time by the same applicant (in the case of renewals: the same marketing authorisation holder or holder) for medicinal products identical to those of the active substance, which: in the form of administration, strength and, where appropriate, Indication distinguishable. Same-type series: Several applications submitted at the same time by the same applicant (in the case of renewals: the same marketing authorisation holder or the registrar) for an identical Medicines.

Fees directory Charges for individually attributable public services are fixed in accordance with the following list of fees: Charge duty fee-based individual public service charge in euros





140
1National approval of a Medicinal product
1.1Authorisation of a medicinal product/new substance
1.1.1Authorisation of a medicinal product/new substance/no reference
1.1.1.1with the assessment of possible environmental risks by the Federal Environment Agency 57 800
1.1.1.2without assessment of possible environmental risks by the Federal Environment Agency 51 100
1.1.2Authorisation of a medicinal product/new substance in the case of partial reference, insofar as this is a significant Reduction of personnel and material costs entry
1.1.2.1with evaluation of possible Environmental risks by the Federal Environment Agency40 400
1.1.2.2without evaluation of possible Environmental risks by the Federal Environment Agency33 700
1.1.3Authorisation of a medicinal product/new Fabric/Full Reference
1.1.3.1with the assessment of possible environmental risks by the Federal Environment Agency30 600
1.1.3.2without evaluation of possible environmental risks by the Federal Environment Agency23 900
1.2Authorisation of a medicinal product/known substance
1.2.1Authorisation of a drug/known substance/no reference
1.2.1.1with assessment of possible environmental risks by the Federal Environment Agency 28 200
1.2.1.2without assessment of possible environmental risks by the Federal Environment Agency 21 500
1.2.2Authorisation of a medicinal product/known substance/for partial reference, insofar as this is a significant Reduction of personnel and material costs
1.2.2.1with possible evaluation of possible Environmental risks by the Federal Environment Agency25 800
1.2.2.2without evaluation of possible Environmental risks by the Federal Environment Agency19 100
1.2.3Approval of a Medicinal product/known substance/full reference
1.2.3.1with evaluation of possible Environmental risks by the Federal Environment Agency22 300
1.2.3.2without evaluation of possible Environmental risks by the Federal Environment Agency15 600
1.2.4Approval of a doublet as well as Approval with reference to § 24a AMG
2 200
1.3Approval of a series or a similar series, in addition to the fee for the first admission, per approval
1.3.1 Approval of a series6 000
1.3.2Approval of a similar type Series2 800
1.4Authorisation of a drug that is imported in parallel, not according to § 105 Paragraph 1 AMG is considered to be approved
1.4.1with an import country 2 200
1.4.2any other importing country in the permit application, in addition to the fee number 1.4.1
240
1.5Approval of a medicinal product, including doublet, that only is subject to ionizing radiation, or is subject to the authorisation of a medicinal product, including duplicates, which have already been authorised or are considered to be authorised, to the extent that an authorisation has been granted for treatment with ionising radiation;



4 500
2Approval of a medicine in the procedure of mutual recognition (MRP) 1
2.1 with Germany as the reference member state (RMS), in addition to the fees according to the fee numbers 1.1 to 1.3
2.1.1Authorisation of a medicinal product/new substance
2.1.1.1 Admission of a drug/new substance/no reference
2.1.1.1.1 with the assessment of possible environmental risks by the Federal Environment Agency56 100
2.1.1.1.2 without assessment of possible environmental risks by the Federal Environment Agency47 400
2.1.1.2 Admission of a medicinal product/new substance/partial reference
2.1.1.2.1 with the assessment of possible environmental risks by the Federal Environment Agency46 500
2.1.1.2.2 without evaluation of possible environmental risks by the Federal Environment Agency37 800
2.1.1.3 Approval of a drug/new substance/full reference
2.1.1.3.1 with the assessment of possible environmental risks by the Federal Environment Agency34 200
2.1.1.3.2 without assessment of possible environmental risks by the Federal Environment Agency25 500
2.1.2 Approval of a drug/known substance
2.1.2.1 Admission of a drug/known substance/no reference
2.1.2.1.1 with assessment of possible environmental risks by the Federal Environment Agency33 900
2.1.2.1.2 without assessment of possible environmental risks by the Federal Environment Agency25 200
2.1.2.2 Admission of a drug/known substance/partial reference
2.1.2.2.1 with assessment of possible environmental risks by the Federal Environment Agency31 200
2.1.2.2.2 without assessment of possible environmental risks by the Federal Environment Agency22 500
2.1.2.3 Admission of a drug/known substance/full reference
2.1.2.3.1 with the assessment of possible environmental risks by the Federal Environment Agency28 100
2.1.2.3.2 without assessment of possible environmental risks by the Federal Environment Agency19 400
2.1.3 Admission of a medicinal product in repeat use procedure
(further MRP after MRP has been completed according to fee number 2.1 for additional EU Member States)
2.1.3.1with new fabric
2.1.3.1.1 with assessment of possible environmental risks by the Federal Environment Agency27 600
2.1.3.1.2 without assessment of possible environmental risks by the Federal Environment Agency18 900
2.1.3.2 with known fabric
2.1.3.2.1with rating Possible environmental risks by the Federal Environment Agency23 100
2.1.3.2.2without evaluation Possible environmental risks by the Federal Environment Agency14 400
2.1.4Approval of a series or of a similar series, in addition to the fee for the first admission, per approval
2.1.4.1 Approval of a series9 700
2.1.4.2Approval of a similar type Series4 800
2.2with Germany as a Member State affected (CMS)
2.2.1Authorisation of a drug/new substance
2.2.1.1Authorisation of a drug/new substance/no or partial reference
2.2.1.1.1with the assessment of possible environmental risks by the Federal Environment Agency 21 400
2.2.1.1.2without evaluation of possible environmental risks by the Federal Environment Agency 17 100
2.2.1.2Authorisation of a medicinal product/new substance/full reference
2.2.1.2.1with the assessment of possible environmental risks by the Federal Environment Agency 19 000
2.2.1.2.2without assessment of possible environmental risks by the Federal Environment Agency 14 700
2.2.2Authorisation of a medicinal product/known substance 
2.2.2.1Authorisation of a medicinal product/known substance/No or partial reference 
2.2.2.1.1with the assessment of possible environmental risks by the Federal Environment Agency18 100
2.2.2.1.2without assessment of possible environmental risks by the Federal Environment Agency13 800
2.2.2.2Authorisation of a medicinal product/known substance/full reference 
2.2.2.2.1with the assessment of possible environmental risks by the Federal Environment Agency15 900
2.2.2.2.2without assessment of possible environmental risks by the Federal Environment Agency11 600
2.2.3Admission of a series or similar series, in addition to the
fee for the first admission, the Approval
2.2.3.1Approval of a series 5 700
2.2.3.2Approval of a similar series3 400
3Authorisation of a medicinal product in the decentralized procedure according to § 25b (3) AMG 
3.1with Germany as Reference Member State (RMS)
3.1.1Authorisation of a medicinal product/new substance
3.1.1.1Authorisation of a medicinal product/new substance/no reference
3.1.1.1.1with the assessment of possible environmental risks by the Federal Environment Agency98 000
3.1.1.1.2without evaluation of possible environmental risks by the Federal Environment Agency89 300
3.1.1.2Authorisation of a medicinal product/new substance/partial reference
3.1.1.2.1with the assessment of possible environmental risks by the Federal Environment Agency73 800
3.1.1.2.2without evaluation of possible environmental risks by the Federal Environment Agency65 100
3.1.1.3Authorisation of a medicinal product/new substance/full reference
3.1.1.3.1with the assessment of possible environmental risks by the Federal Environment Agency53 600
3.1.1.3.2without evaluation of possible environmental risks by the Federal Environment Agency44 900
3.1.2Authorisation of a drug/known substance
3.1.2.1 Admission of a drug/known substance/no reference
3.1.2.1.1 with the assessment of possible environmental risks by the Federal Environment Agency51 200
3.1.2.1.2 without assessment of possible environmental risks by the Federal Environment Agency42 500
3.1.2.2 Admission of a drug/known substance/partial reference
3.1.2.2.1 with the assessment of possible environmental risks by the Federal Environment Agency46 600
3.1.2.2.2 without evaluation of possible environmental risks by the Federal Environment Agency37 900
3.1.2.3 Admission of a drug/known substance/full reference
3.1.2.3.1 with assessment of possible environmental risks by the Federal Environment Agency40 500
3.1.2.3.2 without assessment of possible environmental risks by the Federal Environment Agency31 800
3.1.3 Admission of a series or a similar series, in addition to the fee for the first admission, per approval
3.1.3.1Admission of a series14 400
3.1.3.2 Approval of a similar series7 000
3.2 with Germany as a affected Member State (CMS)
3.2.1Approval of a Medicinal product/new substance
3.2.1.1Authorisation of a medicinal product/new substance/none or partial reference
3.2.1.1.1with the assessment of possible environmental risks by the Federal Environment Agency24 100
3.2.1.1.2without evaluation of possible environmental risks by the Federal Environment Agency19 500
3.2.1.2Authorisation of a medicinal product/new substance/complete Reference
3.2.1.2.1with the assessment of possible environmental risks by the Federal Environment Agency20 700
3.2.1.2.2without evaluation of possible environmental risks by the Federal Environment Agency16 100
3.2.2Authorisation of a medicinal product/known substance
3.2.2.1Authorisation of a drug/known substance/no or partial reference
3.2.2.1.1with the assessment of possible environmental risks by the Federal Environment Agency 20 500
3.2.2.1.2without assessment of possible environmental risks by the Federal Environment Agency 15 900
3.2.2.2Authorisation of a drug/known substance/full reference
3.2.2.2.1with the assessment of possible environmental risks by the Federal Environment Agency 18 500
3.2.2.2.2without assessment of possible environmental risks by the Federal Environment Agency 13 900
3.2.3Admission of a series or similar series, in addition to the fee for the first approval, per approval
3.2.3.1Approval of a series 5 500
3.2.3.2Approval of a similar series3 100
4Creation or update of an assessment report in accordance with § 25 paragraph 5a AMG, if not already by the fee numbers 2 or 3 captured
4.1Creation of an assessment report
4.1.1to a medicinal product with new fabric22 400
4.1.2to a medicine with a known substance14 000
4.2update of an assessment report
4.2.1 to a medicine with new fabric8 700
4.2.2 to a medicine with a known substance5 800
4.3 or update a review report for a series or similar series, in addition to the fee numbers 4.1 and 4.2

4 500
5Extension of approvals according to § 105 paragraph 3 AMG
5.1 chemically defined medicine
5.1.1 Basic Fee12 600
5.1.2Series or similar series, in addition to the First admission fee, per permit
2 700
5.2phytotherapeutic Medicines
5.2.1Basic Fee9 600
5.2.2Series or similar series, in addition to the fee of the first admission, per admission
2 700
5.3homeopathic or anthroposophic medicinal product with Commission participation in accordance with § 25 (7) AMG
5.3.1Basic Fee7 700
5.3.2Series or similar series, in addition to the fee of the first admission, per admission
6 100
5.4homeopathic or anthroposophic medicinal product without Commission participation in accordance with § 25 (7) AMG
5.4.1Basic Fee6 900
5.4.2Series or similar series, in addition to the fee of the first admission, per admission
5 400
5.5Medicines according to § 109a AMG
5.5.1base fee5 700
5.5.2 Series or similar series, in addition to the fee of the first admission, per approval
1 600
6Extension of an approval pursuant to § 31 Paragraph 3 AMG
6.1 Medicines with new or known fabric
6.1.1 Basic Fee
6.1.1.1with assessment of potential environmental risks by the Federal Environment
(UBA)
(only for medicinal products intended for use in animals)

13 300
6.1.1.2 without assessment of possible environmental risks by the Federal Environment Agency6 200
6.1.2 Series or similar series, in addition to the fee for the first extension, per extension
3 100
6.2Extension fully on the basis of a pattern made known by the competent federal authority 
6.2.1Basic Fee2 300
6.2.2Series or similar series, in addition to the fee for the first extension, per extension
1 500
6.3Extension of a parallel imported medicine
6.3.1base fee2 100
6.3.2 with Change of Reference approval within the extension process2 600
7 Extension of an admission procedure in the mutual recognition procedure (MRP) 2 or in the Decentralised Procedure (DCP)
7.1with Germany as Reference Member State (RMS)
7.1.1Medicinal products with new or known fabric, base fee 
7.1.1.1with the assessment of possible environmental risks by the Federal Environment
(Umweltbundesamt)
(only in the case of medicinal products for use in animals) )

18 300
7.1.1.2without the assessment of possible environmental risks by the Federal Environment Agency9 600
7.1.2series or similar series, in addition to the fee for the first extension, each extension
4 200
7.2with Germany as the affected Member State (CMS)
7.2.1Medicines with new or known substance, Basic fee
7.2.1.1with the assessment of possible environmental risks by the Federal Environment Agency
(only for medicines that are intended for use in animals)

8 400
7.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency4 000
7.2.2 Series or similar series, in addition to the fee for the first extension, per extension
2 000
8 Examination of ads in accordance with § 29 AMG and decision on the approval of ads in accordance with § 29 AMG
8.1Changes in Section 29 (2a) number 1 to 4 AMG except for the changes mentioned in fee number 8.11
2 000
8.2Changes in accordance with § 29 (1) or (2b) and (2a) (5) AMG, with the exception of those in the fee numbers 8.6 and 8.7 , and the indication of any other importing country in the case of parallel imports, provided that the authorisations for both the import medicinal product in the country of origin and the reference authorisation within the framework of a procedure in accordance with the fee number 2 (Mutual Recognition Procedure) or charge number 3 (decentralized procedure)






8.3Display of each importing country in parallel import if the approval for the reference authorisation within the scope of a procedure according to fee number 1 (national approval)

350
8.4Change of reference approval for parallel imported medicinal products or the indication of another importing country, provided that this leads to a renewed overall approval rating

560
8.5Transfer to another pharmaceutical entrepre, notification of a co-sales or local representative, indication of a parallel imported product according to § 105 AMG, removal of effective components

240
8.6Change of address, the Telephone or fax number or e-mail address of the marketing authorisation holder, manufacturer, co-driver or local representative, change of the company or legal form, per authorisation

140
8.7Change of address, telephone number or fax number or e-mail address of the marketing authorisation holder, modification of the company of the Authorisation holder or its legal form, provided that this amendment affects all authorisations of the authorisation holder at the same time and is submitted separately from other change indications on an ad, without prejudice to the number of authorisations





8.8Change name 500
8.9Change notifications in accordance with § 29 paragraph 1b and 1c AMG 100
8.10Display according to § 29 paragraph 1e AMG100
8.11Changes subject to approval pursuant to section 29 (2a) (1) and (6) AMG
8.11.1Changes according to § 29 (2a) (1) AMG if it is the addition of one or more indications to an indication in the same therapeutic area as well as Changes according to § 29 paragraph 2a Number 6 AMG
8.11.1.1with evaluation of possible Environmental risks by the Federal Environment Agency8 500
8.11.1.2without evaluation of possible Environmental risks by the Federal Environment Agency2 400
8.11.2Change in accordance with § 29 (2a) AMG, which leads to the determination of the obligation to re-admission in accordance with § 29 Paragraph 3 AMG
2 400
8.12 Amendment of the texts of usage and professional information in adaptation to a text published by the competent authority of the federal authority or the European Commission, per authorisation

430
8.13Changes in accordance with Article 61 (3) of Directive 2001 /83/EC, which are based on the procedure of the CMDh procedure for procedures after Article 61 (3) of Directive 2001 /83/EC ("P" procedure)
8.13.1 with Germany as Reference Member State (RMS)560
8.13.2with Germany As a affected Member State (CMS)300
8.14with several simultaneous displays (with the exception of changes according to the fee numbers 8.7 to 8.10, 8.13 and the indication of each other importing country for parallel imports) for a medicinal product, in addition to the fee for the change with the highest Charge rate (base fee), for each additional change
The fee according to charge number 8.14 may not exceed the fee according to the fee number 1.2.3.2.
50 percent of the
fee after the charge numbers 8.1
to 8.6, 8.11, and 8.12
8.15Following the change in the package leaflet before the results of the Consultation with patients ' target groups according to § 22 paragraph 7 sentence 2 AMG, the fee can be reduced by 25 percent.
9 Review of changes and decision on approval of changes pursuant to Commission Regulation (EC) No 1234/2008 of 24 June 2008. November 2008 on the examination of amendments to the authorisations of medicinal products for human and veterinary use (OJ L 327, 28.12.2008, p 7), as amended by Regulation (EU) No 712/2012 (OJ L 334, 12.12.2012, p. OJ L 209, 4.8.2012, p. 4)
9.1with Germany as Reference Member State (RMS) or reference authority as referred to in Article 7 or Article 20 of Regulation (EC) No 1234/2008
9.1.1 Type I A
9.1.1.1for single submission
Change per approval per message/request
?
370
9.1.1.2when summarization of Amendments pursuant to Article 7 (2) of Regulation (EC) No 1234/2008
9.1.1.2.1for The first change per message370
9.1.1.2.2for each additional change per message Message300
9.1.1.3Series, similar series, or any other affected approval for each message, in addition to the fee for the first change, the change
200
9.1.1.4 Change of address, telephone number or fax number or e-mail address of the marketing authorisation holder, change of the company of the marketing authorisation holder or its legal form, introduction or modification of the pharmacovigilance master data documentation, where it is submitted separately from other ads in a notification as referred to in Article 7 (2) of Regulation (EC) No 1234/2008, per authorisation






140
9.1.2Type I B
9.1.2.1 each time for the first change per message
9.1.2.1.1 with the assessment of possible environmental risks by the Federal Environment Agency6 100
9.1.2.1.2 without assessment of possible environmental risks by the Federal Environment Agency1 800
9.1.2.2 for any further change pursuant to Article 7 (2) of Regulation (EC) No 1234/2008
9.1.2.2.1 with assessment of possible environmental risks by the Federal Environment Agency5 700
9.1.2.2.2 without assessment of potential environmental risks by the Federal Environment Agency1 400
9.1.2.3 Series or similar series in addition to the fee for the first change,
per change

900
9.1.3 Type II/simple changes or changes pursuant to Article 20 (1) of Regulation (EC) No 1234/2008
9.1.3.1each for the first change per request4 300
9.1.3.2 for any other change in accordance with Article 7 (2) of Regulation (EC) No 1234/2008
3 500
9.1.3.3series, similar series or any further affected approval per message, in addition to the fee for the first change, per change
1 900
9.1.4Type II/Complex changes or changes pursuant to Article 20 (1) of Regulation (EC) No. 1234/2008
9.1.4.1in each case for the first change per application
9.1.4.1.1with assessment of possible environmental risks by the Federal Environment Agency 15 600
9.1.4.1.2without assessment of possible environmental risks by the Federal Environment Agency 7 500
9.1.4.2for each additional change pursuant to Article 7 (2) of Regulation (EC) No 1234/2008
9.1.4.2.1with the assessment of possible risks by the Federal Environment Agency 10 300
9.1.4.2.2without assessment of possible environmental risks by the Federal Environment Agency 6 000
9.1.4.3Series, similar series, or any other affected approval per message, in addition to the fee for the first change, per change
2 900
9.1.5The fee for changes that have been made after the change has been made. Article 7 (2) of Regulation (EC) No 1234/2008 is to be submitted or processed in accordance with the procedure laid down in Article 20 of Regulation (EC) No 1234/2008, the summary of amendments shall be subject to a summary of amendments. The procedure laid down in Article 20 of Regulation (EC) No. 1234/2008 as a whole, do not exceed the fee according to the fee number 2.1.2.3.2.
9.2 with Germany as a Member State concerned (CMS) or as a Member State concerned in accordance with Article 7 or Article 20 of Regulation (EC) No 1234/2008
9.2.1Type I A
9.2.1.1 for single submission
Change, per approval per message/request
?
190
9.2.1.2 when making a summary of changes pursuant to Article 7 (2) of Regulation (EC) No 1234/2008
9.2.1.2.1for the first change, per message190
9.2.1.2.2 for each additional change, per message150
9.2.1.3 Series, similar series, or any other affected approval per message, in addition to the fee for the first change, per change
120
9.2.1.4Change of address, telephone number or fax number or email address of the marketing authorisation holder, change of the company of the marketing authorisation holder or of its Legal form, introduction or amendment of the pharmacovigilance master data documentation, provided that it is submitted separately from other indications in a notification as referred to in Article 7 (2) of Regulation (EC) No 1234/2008, per authorisation





9.2.2Type I B
9.2.2.1each for the first change per message
9.2.2.1.1with assessment of possible environmental risks by the Federal Environment Agency4 700
9.2.2.1.2without evaluation of possible environmental risks by the Federal Environment Agency400
9.2.2.2for each additional change pursuant to Article 7 (2) of Regulation (EC) No 1234/2008 
9.2.2.2.1with the assessment of possible environmental risks by the Federal Environment Agency4 620
9.2.2.2.2without assessment of possible environmental risks by the Federal Environment Agency 320
9.2.2.3series, similar series, or any further affected approval, per message, in addition to the fee for the first change, change per change
220
9.2.3Type II/simple changes or Germany as a Member State concerned (CMS) in the procedure provided for in Article 20 of Regulation (EC) No 1234/2008
9.2.3.1 each for the first change per request1 700
9.2.3.2for any further amendment as referred to in Article 7 (2) of Regulation (EC) No 1234/2008
1 400
9.2.3.3 Series, similar series, or any other affected approval, per message, in addition to the fee for the first change, per change
1 100
9.2.4Type II/complex changes or Germany as the affected Member State (CMS) in the procedure provided for in Article 20 of Regulation (EC) No 1234/2008
9.2.4.1each for the first change per request
9.2.4.1.1with the assessment of possible environmental risks by the Federal Environment Agency 7 800
9.2.4.1.2without evaluation of possible environmental risks by the Federal Environment Agency 2 800
9.2.4.2for each additional change pursuant to Article 7 (2) of Regulation (EC) No 1234/2008
9.2.4.2.1with the assessment of possible environmental risks by the Federal Environment Agency 6 500
9.2.4.2.2without assessment of possible environmental risks by the Federal Environment Agency 2 200
9.2.4.3Series, similar series, or any other affected approval in the procedure provided for in Article 20 of the Regulation (EC) No 1234/2008, in addition to the fee for the first change, per change

1 500
9.2.5 The fee for changes submitted in accordance with Article 7 (2) of Regulation (EC) No 1234/2008 or processed in the procedure provided for in Article 20 of Regulation (EC) No 1234/2008 may be subject to a summary of the changes made by the Changes and/or in accordance with the procedure laid down in Article 20 of Regulation (EC) No 1234/2008 as a whole, the fee shall not exceed 2.2.2.2.2 as a whole.
9.3Changes in purely national authorisations
9.3.1 Type IA
9.3.1.1for single submission
Change, per approval per message/request
?
250
9.3.1.2when summarization of Amendments pursuant to Article 13d (2) of Regulation (EC) No 1234/2008
9.3.1.2.1for the first change, per message250
9.3.1.2.2for each additional change 200
9.3.1.3series, similar series, or any further affected approval per message, in addition to the fee for the first change, per change
150
9.3.1.4Change the address, telephone number or fax number or e-mail address of the marketing authorisation holder, modification of the company of the marketing authorisation holder or its legal form, introduction or modification of the pharmacovigilance master data documentation, provided that such data are separated submitted by other advertisements in a notification pursuant to Article 13d (2) of Regulation (EC) No 1234/2008, per authorisation






140
9.3.2Type IB
9.3.2.1 each for the first change per message
9.3.2.1.1with Assessment of potential environmental risks by the Federal Environment Agency5 060
9.3.2.1.2without Assessment of possible environmental risks by the Federal Environment Agency760
9.3.2.2for each additional Amendment in accordance with Article 13d (2) of Regulation (EC) No 1234/2008
9.3.2.2.1with Assessment of potential environmental risks by the Federal Environment Agency4 860
9.3.2.2.2without Assessment of possible environmental risks by the Federal Environment Agency560
9.3.2.3series, similar series or any other affected approval, per message, in addition to the fee for the first change, the change
360
9.3.3Type II/simple changes or changes pursuant to Article 20 (1) of Regulation (EC) No 1234/2008
9.3.3.1each time for the first change per application1 600
9.3.3.2for each further change in accordance with Article 13d (2) of Regulation (EC) No 1234/2008
1 300
9.3.3.3series, similar series or any further affected approval, per message, in addition to the fee for the first change, each Change
810
9.3.4Type II/complex changes or changes referred to in Article 20 Paragraph 1 of Regulation (EC) No 1234/2008
9.3.4.1in each case for the first change pro Application
9.3.4.1.1with the assessment of possible environmental risks by the Federal Environment Agency8 750
9.3.4.1.2without evaluation of possible environmental risks by the Federal Environment Agency3 750
9.3.4.2for each further change pursuant to Article 13d (2) of the Regulation (EC) No 1234/2008
9.3.4.2.1with the assessment of possible environmental risks the Federal Environment Agency7 300
9.3.4.2.2without the assessment of possible environmental risks by the Federal Environment Agency3 000
9.3.4.3series, similar series, or any other affected Approval, per message, in addition to the fee for the first change, per change
1 900
9.3.5 The fee for changes submitted in accordance with Article 13d (2) of Regulation (EC) No 1234/2008 or processed in the procedure provided for in Article 20 of Regulation (EC) No 1234/2008 may be subject to a summary of the changes made by Changes and/or in accordance with the procedure laid down in Article 20 of Regulation (EC) No 1234/2008 as a whole, the fee shall not exceed 1 1.2.3.2.
10Registration of homeopathic medicines
10.1 National registration procedure
10.1.1 Registration/Basic Fee6 400
10.1.2Registration of a series, in addition to the fee for the first registration,
per registration

2 100
10.1.3 Enrollment of a Dublette or similar series1 600
10.1.4 Registration of a medicine imported in parallel1 600
10.2 Registration of a medicine in the mutual recognition procedure (MRP)
10.2.1 with Germany as the reference member state (RMS), in addition to the fees according to charge numbers 10.1.1 to 10.1.4
10.2.1.1Registration/Basic Fee11 800
10.2.1.2 Registration of a series, in addition to the fee for the first registration,
per registration

5 900
10.2.1.3Registration of a similar series, in addition to the fee for the first registration, per registration
2 900
10.2.2with Germany as a Member State affected (CMS)
10.2.2.1enrollment/base fee7 100
10.2.2.2Registration of a series, in addition to the fee for the first registration,
per registration

3 500
10.2.2.3Registration of a similar series, in addition to the fee for the first registration, per registration
2 100
10.3Registration of a medicine in the decentralized procedure (DCP)
10.3.1with Germany as Reference Member State (RMS)
10.3.1.1Registration/Basic Fee18 200
10.3.1.2Registration of a series, in addition to the fee for the first registration,
per registration

8 000
10.3.1.3Registration of a similar series, in addition to the fee for the first registration, per registration
4 500
10.3.2with Germany as a Member State affected (CMS)
10.3.2.1Registration/Basic Fee10 200
10.3.2.2Registration of a series, in addition to the fee for the first registration,
per registration

4 000
10.3.2.3Registration of a similar series, in addition to the fee for the first registration, Registration
2 200
10.4Extension of a registration pursuant to § 39 paragraph 2c AMG
10.4.1Extension of a registration/base fee 2 700
10.4.2series or similar series, in addition to the fee for the first extension, the extension or parallel import
1 400
10.5Extension of a registration in the procedure of the mutual recognition (MRP) or in the decentralised procedure (DCP)
10.5.1with Germany as Reference Member State (RMS)
10.5.1.1Extension of a Registration/Basic Fee3 300
10.5.1.2Series or similar series, in addition to the First Extension Fee
1 700
10.5.2with Germany as Affected Member State (CMS)
10.5.2.1Extension of a registration/basic fee 1 500
10.5.2.2series or similar series, in addition to the fee for the first Extension
800
10.6Review of changes to a registration in accordance with § 39 paragraph 2b AMG and decision on the approval of changes to a registration pursuant to § 39 paragraph 2b AMG
10.6.1 Changes according to § 39 paragraph 2b AMG in conjunction with § 29 paragraph 2a number 1 to 4 AMG
2 000
10.6.2 Changes according to § 39 paragraph 2b sentence 1 AMG as well as in accordance with § 39 paragraph 2b AMG in conjunction with § 29 paragraph 2a number 5 AMG, with the exception of the changes mentioned in the fee numbers 10.6.5 and 10.6.6, in Connection with § 29 paragraph 2b AMG as well as the display of each other importing country in parallel import





300
10.6.3 Display another importing country, if this results in a new overall registration rating
560
10.6.4Transfer to another pharmaceutical entrepre, display of a drive or local representative, display of a parallel imported Medicinal product according to § 105 AMG, deletion of effective ingredients

240
10.6.5 Change of address, telephone number or fax number or e-mail address of the registrar, manufacturer, driver or local representative, change of company or legal form, per registration

140
10.6.6Change of address, phone number, fax number, or email address of the registrar, modification of the registrar's company or its legal form, provided that this change affects all registrations of the registrar at the same time and separately from other change ads in a display is submitted, without prejudice to the number of registrations





140
10.6.7 Change the label500
10.6.8Show in accordance with § 39 paragraph 2b in Connection with § 29 paragraph 1e AMG100
10.6.9Change in accordance with § 39 paragraph 2b AMG, which is Determination of the re-registration obligation pursuant to § 39 paragraph 2b sentence 4 AMG leads
2 400
10.6.10 for several concurrent changes (with the exception of changes according to the fee numbers 10.6.6 and 10.6.7 and the indication of each other importing country for parallel imports) for a medicinal product, in addition to the fee for the Change with the highest fee rate (base fee), for each additional change
The fee for the fee number of 10.6.10 may not exceed the fee according to the fee number 10.1.1.
50 Percent of fee according to charge numbers 10.6.1
to 10.6.5 and 10.6.8
10.7Enrollment Fixed Term Order in accordance with § 39 (2d) AMG in conjunction with Section 30 (1) sentence 3 and second sentence of the second sentence of AMG, unless the arrangement is based on a request from the pharmaceutical entreptite, depending on the personnel and material costs.



to 5 000
10.8The design of an exception in accordance with § 39 paragraph 2c sentence 2 AMG in conjunction with § 31 Paragraph 1, second sentence, AMG, per registration
200
10.9The one after the charge numbers 10.1.1 to 10.1.4, 10.2.1 to 10.3.2.3 and 10.4.1 to 10.5.2.2 of the fee list to be charged basic fees increase with more than one active substance in homeopathic medicinal products by 10 per cent of the basic fee for each medicinal product an effective component, but not more than twice the basic fee.
11 Registration of traditional herbal medicinal products according to § § 39a ff. AMG
11.1national registration process
11.1.1Procedure without Lists/Monographs
11.1.1.1Registration/Basic Fee15 600
11.1.1.2 Registration of a series, in addition to the fee for the first registration,
per additional registration

6 000
11.1.1.3Registration of a similar series, in addition to the fee for the first registration, the further registration as well as the registration of Dublets
2 800
11.1.2Lists/Monographs
11.1.2.1Registration/Basic Fee9 900
11.1.2.2Registration of a series, in addition to the fee for the first registration,
per additional registration

5 000
11.1.2.3Registration of a similar series, in addition to the fee for the first registration, Further registration and registration of duplicates
2 800
11.1.3 Registration of a medicine imported in parallel2 200
11.2 Registration of a medicine in the mutual recognition procedure
11.2.1 with Germany as the reference member state (RMS), in addition to the fees according to fee number 11.1.2
11.2.1.1 Registration/Basic Fee19 400
11.2.1.2 Registration of a series, in addition to the fee for the first registration,
per additional registration

9 700
11.2.1.3Registration of a similar series, in addition to the fee for the first registration, per additional registration
4 800
11.2.2with Germany as a Member State affected (CMS)
11.2.2.1enrollment/base fee11 600
11.2.2.2Registration of a series, in addition to the fee for the first registration,
per additional registration

5 700
11.2.2.3Registration of a similar series, in addition to the fee for the first registration, the more Registration
3 400
11.3Registration of a drug in the decentralized Procedure
11.3.1with Germany as Reference Member State (RMS)
11.3.1.1Registration/Basic Fee31 800
11.3.1.2Registration of a series, in addition to the fee for the first registration,
per additional registration

14 400
11.3.1.3Registration of a similar series, in addition to the fee for the first registration, Other registration
7 000
11.3.2with Germany as the affected Member State (CMS)
11.3.2.1Registration/Basic Fee 13 900
11.3.2.2Registration of a series, in addition to the fee for the first registration,
the more Registration

5 500
11.3.2.3Registration of a similar series, in addition for the fee for the first registration, the further registration
3 100
11.4 Registration in case of execution of a procedure in accordance with § 39d paragraph 3 AMG, in addition to the fees according to fee number 11.1.1, depending on the personnel and material expenses

6 000 up to 25 000
11.5Registration in case of execution of a procedure in accordance with § 39d paragraph 4 AMG, in addition to the fees in accordance with Due number 11.1.1, depending on personnel and material costs

6 000 to 25 000
11.6 Extension of a registration in accordance with § 39c paragraph 3 in conjunction with § 31 Paragraph 3 AMG
11.6.1 Extension of registration/base fee6 200
11.6.2 Series or similar series, in addition to the fee for the first extension, per extension or parallel import
3 100
11.7Extension of a mutual recognition procedure (MRP) or devolved procedure (DCP) 
11.7.1with Germany as Reference Member State (RMS)
11.7.1.1Extension of a registration/base fee7 600
11.7.1.2Series or similar series, in addition to the fee for the first extension, per extension
3 700
11.7.2with Germany as a Member State affected (CMS)
11.7.2.1Renewal of a registration/base fee3 400
11.7.2.2Series or similar series, in addition to the fee for the first extension, per extension
1 700
11.8Examination of changes to a registration pursuant to § 39d paragraph 7 AMG and decision on approval of changes to a Registration according to § 39d paragraph 7 AMG
11.8.1Changes in accordance with § 39d paragraph 7 AMG in Connection with § 29 Paragraph 2a Number 1 to 4 AMG
2 000
11.8.2Changes by § 39d paragraph 7 in conjunction with Section 29 (2a) (5) AMG, with the exception of the amendments mentioned in charge number 11.8.5 and the indication of each other importing country in the case of parallel import

300
11.8.3Display another importing country, if this leads to a new overall registration evaluation
560
11.8.4Transfer to another pharmaceutical contractor, display of a Co-sales or local representative, indication of a parallel imported medicine according to § 105 AMG, deletion of effective components

240
11.8.5Change of address, telephone or fax number or email address of the registrar, manufacturer, co-publisher or local representative, change The Company or the legal form, per registration

140
11.8.6Change of the Address, telephone number or fax number or e-mail address of the registrar, change of the registrar's company or its legal form, provided that this change is subject to all registrations of the registration holder
valign="top "charoff=" 50"> 11.8.7Change name500
11.8.8 Display in accordance with § 39d paragraph 7 AMG in conjunction with § 29 paragraph 1e AMG100
11.8.9 Modification according to § 39d paragraph 7 AMG, which leads to the determination of the re-registration obligation pursuant to § 39d paragraph 7 sentence 3 AMG
2 400
11.8.10Changes pursuant to Article 61 (3) of Directive 2001 /83/EC, which are based on the procedure of the CMDh procedure for the procedures referred to in Article 61 (3) of the Directive 2001 /83/EC ("P" procedure)
11.8.10.1with Germany as Reference Member State (RMS)560
11.8.10.2with Germany as the Member State concerned (CMS)300
11.8.11Changes in accordance with § 39d paragraph 7 AMG, also in conjunction with § 29 paragraph 2b AMG, with the exception of toll numbers 11.8.1 to 11.8.10
300
11.8.12at a number of amendments requested at the same time (with the exception of changes according to toll numbers 11.8.6 and 11.8.7 and the indication of each other importing country in the case of parallel imports) for a medicinal product, in addition to the fee for the change with the highest charge rate (base fee), for each additional change
The fee according to fee number 11.8.12 may not exceed the fee according to fee number 11.1.2.1.
50 percent of the fee after
the charge numbers 11.8.1
to 11.8.5 and 11.8.8 to 11.8.9
11.8.13The change to adjust the Package leaflet for results of the consultation with patient target groups according to § 22 paragraph 7 sentence 2 AMG, the fee can be reduced by 25 percent.
11.9Order of the temporary rest of the registration pursuant to § 39d paragraph 8 AMG in conjunction with § 30 paragraph 1 sentence 2 and paragraph 2 sentence 2 AMG, if the order does not apply to an application by the Marketing Authorisation Holder, depending on the personnel and material expenses



30 to 10 000
11.10 Design of an exception according to § 39c paragraph 3 sentence 2 AMG in conjunction with § 31 paragraph 1 sentence 2 AMG, per registration
200
12Examination of admission-related information in accordance with § 25 (5) AMG,
according to personnel and material expenses

5 000 to 25 000
13Individual attributable public services in the context of clinical trials
13.1Authorisation grant in accordance with § 40 paragraph 1 sentence 2 AMG, § 42 paragraph 2 AMG
13.1.1First submission of a test plan to a test preparation in Phase I, II, or III
13.1.1.1Basic Fee3 800
13.1.1.2upon submission of an integrated study protocol with additional partial studies according to fee number 13.1.1 per additional partial study, in addition to the Base Fee

900
13.1.2Follow-up study according to fee number 13.1.1 evaluated test specimens in Phase I, II or III
13.1.2.1Follow-up study without Reassessment of documents1 500
13.1.2.2Follow-up study with reassessment of Documents in Phase I
13.1.2.2.1Basic Fee 1 900
13.1.2.2.2upon submission of an integrated study protocol with additional partial studies by fee number 13.1.2.2 per additional sub-study, in addition to the base fee

800
13.1.2.3 Follow-up Study with Reevaluation of Documents in Phase II or III
13.1.2.3.1 Basic Fee2 100
13.1.2.3.2when you submit an integrated Study protocol with additional partial studies according to fee number 13.1.2.3 per additional partial study, in addition to the base fee

900
13.1.3Approval of a clinical trial with an investigational medicinal product that has a marketing authorisation in an EU Member State at the time of application; the application of the Test specimens are carried out inside or outside the approved application conditions and in the subject information
13.1.3.1 Basic Fee1 700
13.1.3.2 Submission of an integrated study protocol with additional partial studies according to fee number 13.1.3 per additional sub-study, in addition to the basic fee

900
13.1.4Bioequivalence verification test2 100
13.1.5Approval pursuant to § 42 (3) AMG in conjunction with § 9 (2) sentence 2 and 3 of the GCP-V on presentation of additional documents, which are subject to scientific processing require

740
13.1.6Clinical Trials Approval Medicinal products consisting of or containing a genetically modified organism or a combination of genetically modified organisms

9 500
13.1.7Approval of changes after the start of a clinical trial in accordance with § 42 Paragraph 3 AMG in conjunction with § 10 GCP-V
13.1.7.1Changes that are subject to approval that require scientific editing
13.1.7.1.1Basic Fee1 100
13.1.7.1.2approved changes that include multiple approval changes by fee number 13.1.7.1, per additional Change

700
13.1.7.2Other Changes 730
13.2Evaluation of annual reports on the safety of the test participants in accordance with § 42 paragraph 3 AMG in Connection with § 13 paragraph 6 GCP-V
13.2.1Annual reports on monocentric clinical trials Tests500
13.2.2Annual multi-center clinical trial reports 1 000
13.2.3Annual reports on a number of more than five clinical trials with the same test preparation
2 500
13.3Review of approval-related information by § 42 Paragraph 3 AMG
in conjunction with § 9 paragraph 5 GCP-V (GCP inspections), depending on the personnel and material costs


5 000 to 50 000
13.4Examination, matching and transmission of the information specified for the EudraCT database in accordance with § 14 paragraph 3 of the GCP-V, insofar as not covered by the fee number 13.1

250
14Evaluation of reports in accordance with § 63d and § 63h paragraph 5 AMG and verifications in accordance with § 62 (6), § 63c (4) AMG in conjunction with § 62 (6) AMG and § 63h (6 AMG) in conjunction with § 62 (6) AMG
14.1 Report Assessment in National Procedure
14.1.1 within ten years of first-time approval of the medicinal product in Germany
1 400
14.1.2 later than ten years after first-time approval of the drug in Germany
700
14.2Report evaluation in the Mutual Recognition Procedure (MRP) or in the decentralised procedure in accordance with § 25b Paragraph 3 AMG
14.2.1with Germany as Reference Member State (RMS)
14.2.1.1within ten years of first-time approval of the drug in Germany
4 800
14.2.1.2later than ten years after the first approval of the drug in Germany
1 400
14.2.2with Germany as a Member State affected (CMS) 
14.2.2.1within ten years after the first approval of the drug in Germany
1 400
14.2.2.2later than 10 years after the first authorisation of the drug in Germany
700
14.3will simultaneously report identical periodic reports according to the charge numbers 14.1 and 14.2, the fee shall be charged according to the fee numbers 14.1 or 14.2 only once. For each other identical periodic report, the fee will be reduced to


300
14.4 Review of the collection and evaluation of drug risks and the coordination of necessary measures in accordance with § 62 Paragraph 6 AMG, depending on personnel and material expenses

1 000 to 27 500
15Individually attributable public services in the context of non-interventional Safety checks
15.1performed on your own initiative non-interventional safety checks
15.1.1Review of ads by § 63f Paragraph 1 AMG260
15.1.2Examination of requested documents in the case of § 63f Paragraph 1, second sentence, AMG, depending on the amount of personnel and equipment required
500 to 4 200
15.1.3 Final Report Review300 to 4 200
15.2Anordered non-interventional safety tests when performing the test only in Germany
15.2.1 Approval of the design of the test protocol according to § 63g (2) AMG, depending on the personnel and material costs
500 to 4 200
15.2.2Approval of significant changes to the protocol according to § 63g paragraph 3 AMG, per change
250
15.2.3Final Report Review300 to 4 200
16Review of ads in accordance with § 67 Paragraph 5 AMG100
17 Verification of ads according to § 67 Paragraph 6 AMG260
18 Order of an edition according to § 28, § 30 paragraph 2a, § 39 paragraph 1 sentence 4 to 6, § 39 paragraph 2d AMG in conjunction with § 30 paragraph 2a, § 39c paragraph 1 sentence 4 to 6, § 39d paragraph 8 AMG in conjunction with § 30 paragraph 2a, § 105 paragraph 5 AMG or a warning in accordance with § 110 AMG or a secondary determination according to § 36 VwVfG, depending on personnel and material expenses






30 to 10 000
19Measures in accordance with § 25c AMG, depending on personnel and material costs30 to 10 000
20Measures in accordance with § 30 paragraph 1 sentence 4, paragraph 1a sentence 3, paragraph 2 sentence 2, paragraph 2a sentence 1, § 31 paragraph 4 sentence 2, § 42a paragraph 1 sentence 2, paragraph 2 sentence 2, paragraph 3 sentence 3 and Paragraph 5 AMG
20.1Order of the temporary fame of an admission pursuant to § 30 paragraph 1 Sentence 4, paragraph 1a, sentence 3, paragraph 2, sentence 2 AMG, as well as measures pursuant to § 30 (2a) sentence 1 AMG, with the exception of those referred to in fee number 18, and measures in accordance with § 31 paragraph 4 sentence 2 AMG, depending on the personnel and material expenses




30 to 10 000
20.2Measures pursuant to § 42a, paragraph 1, sentence 2, paragraph 2, sentence 2, paragraph 3 Set 3 and 5 AMG, depending on the personnel and material requirements
30 to 3 700
21 Decisions according to § 21 paragraph 4 AMG
21.1Decision on the Permit requirement, depending on the personnel and material requirements
900 to 6 000
21.2 Decision on the requirement for clinical trials to be approved, depending on the personnel and material requirements
900 to 3 700
22 Gestatation of an exception according to § 31 paragraph 1 sentence 2 AMG, per approval
200
23 Setting a reasonable waiting period in accordance with § 59 paragraph 2 sentence 2 AMG
23.1 for a medicinal product with a substance that does not correspond to the classification referred to in Article 14 (2) (a), (b) or (c) of Regulation (EC) No 470/2009

4 300
23.2for a medicinal product containing a substance which is classified in accordance with Article 14 (2) (a), (b) or (c) of Regulation (EC) No 470/2009 equals
1 800
24Other individually attributable public Services
24.1Scientific opinions on quality, therapeutic Efficacy or safety of a medicinal product

100 to 500
24.2 Decision on a request for reinstatment to the previous level according to § 32 VwVfG
260
24.3 Decision on a request for recovery of the procedure according to § 51 VwVfG
260
24.4uneasy written information50 to 500
24.5 Inview in admission files outside of a pending administrative procedure according to charge numbers 1 to 12, 24.2 or 24.3

30 to 260
24.6Applicant advising200 to 10 000
24.7exhibition of a certificate according to § 73a paragraph 2 AMG100
24.8Certificates, with the exception of those mentioned in fee number 24.7, and certifications
10 to 150
25contradiction 
25.1contradictions against substantive decisions
25.1.1Reject as inappropriate160; to the extent that A lower fee is provided for in-kind decision to be verified; if frame fees are provided and the mean value is lower, this
25.1.2partial or complete rejection as unfounded, to the extent that the contradiction is not successful only because the violation of a procedure or form rule according to § 45 VwVfG shall not be mindfulat most the fee provided for in this Regulation for the substantive decision to be verified by the opposition procedure, provided that a framework fee is provided for, no more than its upper value;
, however, at least 160; where a lower fee is provided for the substantive decision to be verified, this
25.1.3 if there is an appeal at the start of factual editing, but before it is terminatedat most 75 percent of the for the in the Objection to the substantive decision to be verified in this Regulation; in so far as a framework fee is provided for, not more than 75 per cent of its upper value;
, however, at least 160; to the extent necessary for the decision to be verified a lower fee than 160 is provided, these
25.2Appeals against charges-and Release fixtures
25.2.1Reject as 160; if the contested amount is less, this
25.2.2 partial or complete rejection as unfounded, to the extent that the contradiction is not successful only because the violation of a procedure or form rule according to § 45 VwVfG is incontedible not more than 10 percent of the strike amount; but
at least 160; if the contested amount is less than 160, this
25.2.3on withdrawal of an appeal after the start of factual editing, but before it ends but not more than 75 percent of the contested amount;
, however, at least 160; if the contested amount is less than 160, this
1
Procedure in accordance with Title III, Chapter 4 of Directive 2001 /83/EC of the European Parliament and of the Council of 6 June 2001. November 2001 on the Community code relating to medicinal products for human use (OJ L 327, 28.12.2001, p. 67), as last amended by Regulation (EC) No 1901/2006 (OJ L 311, 28.11.2006, p. 1), or in accordance with Chapter 4 of Title III of Directive 2001 /82/EC of the European Parliament and of the Council of 6 June 2001 on the European Parliament and of the Council of the European Parliament and of the Council of 6 June 2006 on the implementation of the European November 2001 on the Community code relating to veterinary medicinal products (OJ L 327, 28.12.2001, p. 1), as last amended by Regulation (EC) No 596/2009 (OJ L 311, 28.11.2009, p. 14).
2
Procedure in accordance with Title III, Chapter 4 of Directive 2001 /83/EC of the European Parliament and of the Council of 6 June 2001. November 2001 on the Community code relating to medicinal products for human use (OJ L 327, 28.12.2001, p. 67), as last amended by Regulation (EC) No 1901/2006 (OJ L 311, 28.11.2006, p. 1), or in accordance with Chapter 4 of Title III of Directive 2001 /82/EC of the European Parliament and of the Council of 6 June 2001 on the European Parliament and of the Council of the European Parliament and of the Council of 6 June 2006 on the implementation of the European November 2001 on the Community code relating to veterinary medicinal products (OJ L 327, 28.12.2001, p. 1), as last amended by Regulation (EC) No 596/2009 (OJ L 311, 28.11.2009, p. OJ L 188, 18.7.2009, p.
.