Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) and the Federal Office for Consumer Protection and Food Safety (Bundesamt für 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 Regulation-AMGKostV) are responsible for the cost regulation for the registration and registration of medicinal products.

Unofficial table of contents

AMGKostV

Date of completion: 10.12.2003

Full quote:

" AMG Cost Ordinance of 10 December 2003 (BGBl. 2510), as last amended by Article 1 of the Regulation of 3 March 2015 (BGBl). I p. 195, 1007).

V up. By Art. 4 (13) G v. 7.8.2013 I 3154 mWv 14.8.2018
Status: Last amended by Art. 1 V v. 3.3.2015 I 195, 1007

For more details, please refer to the menu under 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

Pursuant to Section 33 (2) of the Medicinal Products Act, as amended by the Notice of 11 December 1998 (BGBl. 3586) in conjunction with the second section of the Administrative Costing Act of 23 June 1970 (BGBl). 821), § 1 of the Jurisdiction Adjustment Act of 16 August 2002 (BGBl. 3165), the organisation of the organisation of 22 January 2001 (BGBl. 127) and 22. October 2002 (BGBl. 4206), the Federal Ministry of Health and Social Security decrees in agreement with the Federal Ministry for Economic Affairs and Labour: Unofficial table of contents

§ 1 Principle

(1) The Federal Institute for Drugs and Medical Devices and the Federal Office for Consumer Protection and Food Safety collect fees and charges for decisions on the basis of the applicable fee list and the following regulations. 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 activities carried out in the context of the collection and evaluation of Pharmaceutical risks, for opposition proceedings against the background of (2) In the case of the notice in the Federal Gazette (Bundesanzeiger), in the case of the Federal Gazette (Bundesanzeiger), the Federal Gazette (Bundesanzeiger) shall be responsible for the application of the provisions of this Regulation. (2) the erasure or the glory of an authorisation shall not be levied. Unofficial table of contents

§ 2 Fees in the event of rejection or withdrawal of an application

In the event of rejection of an application for an individually attributable public service for reasons other than the lack of competence or the withdrawal of an application after the commencement of the factual processing, a fee of 75% shall apply. Percent of the fee to be determined for the public service that is individually attributable. 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. Unofficial table of contents

§ 3 Discounts

(1) The fee may be reduced to one-half of the intended fee if the amount of personnel and material associated with the individual attributable public service, on the one hand, and the significance, economic value or other (2) The fees to be charged pursuant to points 1 to 25 of the list of fees may, on the request of the charge debtor, unless otherwise specified, be subject to the following: , paragraph 1 shall apply, up to a quarter of the intended fee , if the applicant cannot expect an economic benefit appropriate to development and authorisation costs, and
1.
there is a public interest in the marketing of the medicinal product on the basis of the area of application; or
2.
the use cases are rare or the target group for which the medicinal product is intended is small.
Unofficial table of contents

§ 4 Instatement of costs for experts

Where one of the individually attributable public services referred to in points 1 to 13 and 18 to 25 of the list of fees is provided in the cases provided for by law, on the basis of the assessment of documents by independent In the case of experts, the costs to be reimbured shall be charged to the fee to be fixed. Unofficial table of contents

§ 5 Transitional provisions

(1) The AMG Cost Regulation shall continue to be applied in the version dated 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 service has been requested or started before 7 March 2015, but has not yet been fully provided. This shall not apply if, for the individually attributable public service, a fee has already been charged pursuant to the AMG Costing Regulation as amended on December 10, 2003, the last of which is provided by Article 2 (26) of the Law of 7 August 2013 (BGBl. I p. 3154), and the fee to be charged thereafter is higher than the fee provided for in the AMG Costing Regulation as amended on 7 March 2015. In this case, fees will be charged according to the AMG cost regulation as amended on 7 March 2015. (2) The cost regulation for the registration of homeopathic medicinal products by the Federal Institute for Drugs and Medical Devices and the Federal Institute for Medical Devices (BfM) The Federal Office of Consumer Protection and Food Safety continues to be in the version of the notice of 24. October 2003 (BGBl. 2157), as defined by Article 2 (25) of the Law of 7 August 2013 (BGBl). I p. 3154), if the underlying individually attributable public service has been requested or started before 7 March 2015, 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 by Article 2 (25) of the Law of 7 August 2013 (BGBl). I p. 3154), and the fee to be charged thereafter is higher than the fee provided for in the AMG Costing Regulation as amended on 7 March 2015. In this case, fees are levied according to the AMG Costing Ordinance as amended on 7 March 2015. (3) Charges may be made for individually attributable public services, which have been made before 7 March 2015, in accordance with the AMG Cost Regulation as amended on 7 March 2015, insofar as a cost decision has been expressly reserved for the individually attributable public services, having regard to the forthcoming addition of this Regulation. is. Sentence 1 shall apply accordingly, provided that an individually attributable public service has already been applied for or commenced before 7 March 2015, but has not yet been fully provided. (4) The following shall be made according to the charge numbers 10 of the fee list a 50 percent increase in fees if the underlying individually attributable public service has been requested until 7 March 2016, if a request is required. The fees to be charged according to the charge numbers 10 of the charge list shall be reduced by 25 per cent if the underlying individually attributable public service, if a request is necessary, is requested by 7 March 2017 has been made. Unofficial table of contents

§ 6 Entry into force, expiry of the external force

This Regulation shall enter into force on 1 January 2004. Unofficial table of contents

Annex (to § 1)

The following list of fees means: known substance: medicinal product in which the conditions of section 22 (3) (1), (2) or (3) of the Medicines Act are fulfilled. New substance: medicinal product in which none of the conditions of § 22 (3) Full reference: reference of a second applicant to a file of a prior applicant pursuant to Section 24b (1) of the Medicinal Products Act: Second applicant for parts of the documents of a pre-applicant (with Exception to the quality documentation) and submission of own sublagen.Dublette: Full reference of an applicant to an identical medicinal product of the same applicant, its authorisation or registration at the time of application not longer than five years. Reference in accordance with § 24a of the Medicines Act: reference of the same applicant or of another applicant with the consent of the applicant to all documents including the quality documents an authorised medicinal product according to § 24a of the Pharmaceutical legislation series: Several applications filed at the same time by the same applicant (in the case of renewals: the same marketing authorisation holder or the registration holder) for medicinal products identical to the active substance, which are in the form of administration, Strength and possibly 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 registration holder) for an identical medicinal product.

TollyThe charges for individually attributable public services are determined in accordance with the following fee list: Fee-based, individually attributable public service charge in euro
1 National authorisation of a medicinal product
1.1 Authorisation of a medicinal product/new substance
1.1.1 Authorisation of a medicinal product/new substance/no reference
1.1.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 57 800
1.1.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 51 100
1.1.2 Authorisation of a medicinal product/new substance in the case of partial reference, in so far as a significant reduction in the staff and material costs is achieved
1.1.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 40 400
1.1.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 33 700
1.1.3 Authorisation of a medicinal product/new substance/full reference
1.1.3.1 with evaluation of possible environmental risks by the Federal Environment Agency 30 600
1.1.3.2 without evaluation of possible environmental risks by the Federal Environment Agency 23 900
1.2 Authorisation of a medicinal product/known substance
1.2.1 Authorisation of a medicinal product/known substance/no reference
1.2.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 28 200
1.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 21 500
1.2.2 Authorisation of a medicinal product/known substance/for partial reference, in so far as this will result in a significant reduction in the staff and material costs
1.2.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 25 800
1.2.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 19 100
1.2.3 Authorisation of a medicinal product/known substance/full reference
1.2.3.1 with evaluation of possible environmental risks by the Federal Environment Agency 22 300
1.2.3.2 without evaluation of possible environmental risks by the Federal Environment Agency 15 600
1.2.4 Approval of a doublet as well as approval with reference in accordance with § 24a AMG
2 200
1.3 Approval of a series or similar series, in addition to the fee for the first authorisation, per authorisation
1.3.1 Approval of a series 6 000
1.3.2 Approval of a similar series 2 800
1.4 Authorisation of a medicinal product imported in parallel, which is not considered to be approved in accordance with Section 105 (1) AMG
1.4.1 with an importing country 2 200
1.4.2 Each additional importing country in the application for authorisation, in addition to the fee number 1.4.1
240
1.5 Authorisation of a medicinal product, including doublet, which is subject to the authorisation requirement only because it is treated with ionising radiation, or authorisation of a medicinal product, including doublet, which has already been authorised or is considered to be authorised, to the extent that: Authorisation with regard to treatment with ionising radiation



4 500
2 Authorisation of a medicinal product in the mutual recognition procedure (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
2.1.1 Authorisation of a medicinal product/new substance
2.1.1.1 Authorisation of a medicinal product/new substance/no reference
2.1.1.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 56 100
2.1.1.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 47 400
2.1.1.2 Authorisation of a medicinal product/new substance/partial reference
2.1.1.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 46 500
2.1.1.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 37 800
2.1.1.3 Authorisation of a medicinal product/new substance/full reference
2.1.1.3.1 with evaluation of possible environmental risks by the Federal Environment Agency 34 200
2.1.1.3.2 without evaluation of possible environmental risks by the Federal Environment Agency 25 500
2.1.2 Authorisation of a medicinal product/known substance
2.1.2.1 Authorisation of a medicinal product/known substance/no reference
2.1.2.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 33 900
2.1.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 25 200
2.1.2.2 Authorisation of a medicinal product/known substance/partial reference
2.1.2.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 31 200
2.1.2.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 22 500
2.1.2.3 Authorisation of a medicinal product/known substance/full reference
2.1.2.3.1 with evaluation of possible environmental risks by the Federal Environment Agency 28 100
2.1.2.3.2 without evaluation of possible environmental risks by the Federal Environment Agency 19 400
2.1.3 Authorisation of a medicinal product in the repeat use procedure
(further MRP after completion of an MRP according to toll number 2.1 for additional EU Member States)
2.1.3.1 with new substance
2.1.3.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 27 600
2.1.3.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 18 900
2.1.3.2 with known substance
2.1.3.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 23 100
2.1.3.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 14 400
2.1.4 Approval of a series or similar series, in addition to the fee for the first authorisation, per authorisation
2.1.4.1 Approval of a series 9 700
2.1.4.2 Approval of a similar series 4 800
2.2 with Germany as a Member State concerned (CMS)
2.2.1 Authorisation of a medicinal product/new substance
2.2.1.1 Authorisation of a medicinal product/new substance/no or partial reference
2.2.1.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 21 400
2.2.1.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 17 100
2.2.1.2 Authorisation of a medicinal product/new substance/full reference
2.2.1.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 19 000
2.2.1.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 14 700
2.2.2 Authorisation of a medicinal product/known substance
2.2.2.1 Authorisation of a medicinal product/known substance/no or partial reference
2.2.2.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 18 100
2.2.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 13 800
2.2.2.2 Authorisation of a medicinal product/known substance/full reference
2.2.2.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 15 900
2.2.2.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 11 600
2.2.3 Approval of a series or similar series, in addition to the fee
for the first authorisation, per authorisation
2.2.3.1 Approval of a series 5 700
2.2.3.2 Approval of a similar series 3 400
3 Authorisation of a medicinal product in the decentralised procedure according to § 25b (3) AMG
3.1 with Germany as the reference Member State (RMS)
3.1.1 Authorisation of a medicinal product/new substance
3.1.1.1 Authorisation of a medicinal product/new substance/no reference
3.1.1.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 98 000
3.1.1.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 89 300
3.1.1.2 Authorisation of a medicinal product/new substance/partial reference
3.1.1.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 73 800
3.1.1.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 65 100
3.1.1.3 Authorisation of a medicinal product/new substance/full reference
3.1.1.3.1 with evaluation of possible environmental risks by the Federal Environment Agency 53 600
3.1.1.3.2 without evaluation of possible environmental risks by the Federal Environment Agency 44 900
3.1.2 Authorisation of a medicinal product/known substance
3.1.2.1 Authorisation of a medicinal product/known substance/no reference
3.1.2.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 51 200
3.1.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 42 500
3.1.2.2 Authorisation of a medicinal product/known substance/partial reference
3.1.2.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 46 600
3.1.2.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 37 900
3.1.2.3 Authorisation of a medicinal product/known substance/full reference
3.1.2.3.1 with evaluation of possible environmental risks by the Federal Environment Agency 40 500
3.1.2.3.2 without evaluation of possible environmental risks by the Federal Environment Agency 31 800
3.1.3 Approval of a series or similar series, in addition to the fee for the first authorisation, per authorisation
3.1.3.1 Approval of a series 14 400
3.1.3.2 Approval of a similar series 7 000
3.2 with Germany as a Member State concerned (CMS)
3.2.1 Authorisation of a medicinal product/new substance
3.2.1.1 Authorisation of a medicinal product/new substance/no or partial reference
3.2.1.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 24 100
3.2.1.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 19 500
3.2.1.2 Authorisation of a medicinal product/new substance/full reference
3.2.1.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 20 700
3.2.1.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 16 100
3.2.2 Authorisation of a medicinal product/known substance
3.2.2.1 Authorisation of a medicinal product/known substance/no or partial reference
3.2.2.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 20 500
3.2.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 15 900
3.2.2.2 Authorisation of a medicinal product/known substance/full reference
3.2.2.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 18 500
3.2.2.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 13 900
3.2.3 Approval of a series or similar series, in addition to the fee for the first authorisation, per authorisation
3.2.3.1 Approval of a series 5 500
3.2.3.2 Approval of a similar series 3 100
4 Creation or updating of an assessment report in accordance with § 25 paragraph 5a AMG, insofar as the fee numbers 2 or 3 are not already recorded
4.1 Preparation of an assessment report
4.1.1 on a medicinal product with a new substance 22 400
4.1.2 on a medicinal product with a known substance 14 000
4.2 Update of an assessment report
4.2.1 on a medicinal product with a new substance 8 700
4.2.2 on a medicinal product with a known substance 5 800
4.3 Creation or updating of a review report on a series or similar series, in addition to the fee numbers 4.1 and 4.2

4 500
5 Renewal of authorisations in accordance with § 105 (3) AMG
5.1 chemically defined medicinal product
5.1.1 Basic Fee 12 600
5.1.2 Series or similar series, in addition to the fee of the first authorisation, per authorisation
2 700
5.2 phytotherapeutic medicinal product
5.2.1 Basic Fee 9 600
5.2.2 Series or similar series, in addition to the fee of the first authorisation, per authorisation
2 700
5.3 Homeopathic or anthroposophic medicinal product with Commission participation in accordance with § 25 (7) AMG
5.3.1 Basic Fee 7 700
5.3.2 Series or similar series, in addition to the fee of the first authorisation, per authorisation
6 100
5.4 Homeopathic or anthroposophic medicinal product without Commission involvement in accordance with § 25 (7) AMG
5.4.1 Basic Fee 6 900
5.4.2 Series or similar series, in addition to the fee of the first authorisation, per authorisation
5 400
5.5 Medicinal products according to § 109a AMG
5.5.1 Basic Fee 5 700
5.5.2 Series or similar series, in addition to the fee of the first authorisation, per authorisation
1 600
6 Renewal of an authorisation pursuant to § 31 (3) AMG
6.1 Medicinal product with new or known substance
6.1.1 Basic Fee
6.1.1.1 with evaluation of possible environmental risks by the Federal Environment Agency
(only in the case of medicinal products intended for use in animals)

13 300
6.1.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 6 200
6.1.2 Series or similar series, in addition to the fee for the first extension, the extension
3 100
6.2 Extension completely on the basis of a model made known by the competent federal authority
6.2.1 Basic Fee 2 300
6.2.2 Series or similar series, in addition to the fee for the first extension, the extension
1 500
6.3 Extension of a parallel imported product
6.3.1 Basic Fee 2 100
6.3.2 with change of reference authorisation in the context of the renewal procedure 2 600
7 Renewal of an authorisation in the mutual recognition procedure (MRP) 2 or in the decentralised procedure (DCP)
7.1 with Germany as the reference Member State (RMS)
7.1.1 Medicinal product with new or known substance, basic fee
7.1.1.1 with evaluation of possible environmental risks by the Federal Environment Agency
(only in the case of medicinal products intended for use in animals)

18 300
7.1.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 9 600
7.1.2 Series or similar series, in addition to the fee for the first extension, the extension
4 200
7.2 with Germany as a Member State concerned (CMS)
7.2.1 Medicinal product with new or known substance, basic fee
7.2.1.1 with evaluation of possible environmental risks by the Federal Environment Agency
(only in the case of medicinal products intended for use in animals)

8 400
7.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 4 000
7.2.2 Series or similar series, in addition to the fee for the first extension, the extension
2 000
8 Examination of advertisements in accordance with § 29 AMG and decision on the approval of advertisements in accordance with § 29 AMG
8.1 Amendments to Section 29 (2a) (1) to (4) AMG, except for the amendments referred to in toll number 8.11
2 000
8.2 Amendments pursuant to § 29 (1) or (2b) and (2a) (5) AMG, with the exception of the changes in charge numbers 8.6 and 8.7, and the indication of any other importing country in the case of parallel import, provided that the authorisations for both the Import medicinal products in the country of origin and for the reference authorisation have been granted in the context of a procedure in accordance with fee number 2 (mutual recognition procedure) or charge number 3 (decentralised procedure)





300
8.3 Indication of each other importing country in the case of parallel import, if the authorisation for the reference authorisation has been granted in accordance with a procedure in accordance with the charge number 1 (national authorisation)

350
8.4 Change of reference authorisation in the case of parallel imported medicinal products or the indication of another importing country, provided that this leads to a renewed overall evaluation of the authorisation

560
8.5 Transfer to another pharmaceutical entrepre, notification of a co-sales or local representative, indication of a medicinal product imported in parallel in accordance with § 105 AMG, deletion of active ingredients

240
8.6 Change of address, telephone number 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
8.7 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 of its legal form, provided that this amendment affects all authorisations of the authorisation holder at the same time and shall be submitted separately from other changes in an ad, without prejudice to the number of authorisations




140
8.8 Modification of the name 500
8.9 Change notifications pursuant to § 29 (1b) and 1c AMG 100
8.10 Display in accordance with § 29 Paragraph 1e AMG 100
8.11 Amendments requiring approval in accordance with Section 29 (2a) (1) and (6) of the AMG
8.11.1 Amendments to Section 29 (2a) (1) of the AMG if the addition of one or more changes to an indication in the same therapeutic area as well as changes in accordance with § 29 (2a) (6) AMG
8.11.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 8 500
8.11.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 2 400
8.11.2 Amendment in accordance with § 29 (2a) AMG, which leads to the determination of the obligation to re-admission in accordance with § 29 (3) AMG
2 400
8.12 Amendment of the texts of use and subject information in adaptation to a text published by the competent national authority or the European Commission, per authorisation

430
8.13 Amendments pursuant to Article 61 (3) of Directive 2001 /83/EC, which are processed in accordance with the procedure laid down in the CMDh procedure for the procedures referred to in Article 61 (3) of Directive 2001 /83/EC ("P" procedure)
8.13.1 with Germany as the reference Member State (RMS) 560
8.13.2 with Germany as a Member State concerned (CMS) 300
8.14 for a number of changes submitted at the same time on an ad (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 in the case of parallel imports) for a medicinal product, in addition to the fee for the change with the highest fee rate (basic fee), for each further change
The fee according to the fee number 8.14 may not exceed the fee according to the fee number 1.2.3.2.
50 percent of the
Fee according to charge numbers 8.1
to 8.6, 8.11 and 8.12
8.15 If the change in the package leaflet is adjusted to the results of the consultation with patients ' target groups according to § 22 (7) sentence 2 AMG, the fee can be reduced by 25 percent.
9 Consideration of amendments and decision on the approval of amendments pursuant to Commission Regulation (EC) No 1234/2008 of 24 November 2008 on the examination of changes to the authorisations of medicinal products for human and veterinary use (OJ L 378, 27.12.2008, p. 7), as amended by Regulation (EU) No 712/2012 (OJ L 334, 12.12.2012, p. OJ L 209, 4.8.2012, p.
9.1 With Germany as reference Member State (RMS) or reference authority in accordance with Article 7 or Article 20 of Regulation (EC) No 1234/2008
9.1.1 Type I A
9.1.1.1 in the case of individual submission
Change per authorisation per communication/application
?
370
9.1.1.2 in the case of a summary of amendments pursuant to Article 7 (2) of Regulation (EC) No 1234/2008
9.1.1.2.1 for the first change per message 370
9.1.1.2.2 for each additional change per message 300
9.1.1.3 Series, similar series, or any further affected approval per communication, 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, provided that such shall be submitted separately from other indications in a notification pursuant to Article 7 (2) of Regulation (EC) No 1234/2008, per authorisation




140
9.1.2 Type I B
9.1.2.1 each for the first change per message
9.1.2.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 6 100
9.1.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 1 800
9.1.2.2 for any further amendment referred to in Article 7 (2) of Regulation (EC) No 1234/2008
9.1.2.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 5 700
9.1.2.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 1 400
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 amendments or amendments pursuant to Article 20 (1) of Regulation (EC) No 1234/2008
9.1.3.1 in each case for the first change per request 4 300
9.1.3.2 for any further amendment referred to in Article 7 (2) of Regulation (EC) No 1234/2008
3 500
9.1.3.3 Series, similar series, or any further affected approval per communication, in addition to the fee for the first change, the change
1 900
9.1.4 Type II/complex amendments or amendments pursuant to Article 20 (1) of Regulation (EC) No 1234/2008
9.1.4.1 in each case for the first change per request
9.1.4.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 15 600
9.1.4.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 7 500
9.1.4.2 for any further amendment referred to in Article 7 (2) of Regulation (EC) No 1234/2008
9.1.4.2.1 with evaluation of possible risks by the Federal Environment Agency 10 300
9.1.4.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 6 000
9.1.4.3 Series, similar series, or any further affected approval per communication, in addition to the fee for the first change, the change
2 900
9.1.5 The fee for amendments submitted in accordance with Article 7 (2) of Regulation (EC) No 1234/2008 or dealt with in the procedure provided for in Article 20 of Regulation (EC) No 1234/2008 shall be subject to a summary of changes or changes in the summary of changes or modifications. in accordance with Article 20 of Regulation (EC) No 1234/2008 as a whole, the fee shall not exceed 2.1.2.3.2 as a whole.
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
9.2.1 Type I A
9.2.1.1 in the case of individual submission
Change, per approval per communication/application
?
190
9.2.1.2 in the case of a summary of amendments pursuant to Article 7 (2) of Regulation (EC) No 1234/2008
9.2.1.2.1 for the first change, per message 190
9.2.1.2.2 for each additional change, per message 150
9.2.1.3 Series, similar series, or any further affected approval per communication, in addition to the fee for the first change, the change
120
9.2.1.4 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, provided that such shall be submitted separately from other indications in a notification pursuant to Article 7 (2) of Regulation (EC) No 1234/2008, per authorisation




140
9.2.2 Type I B
9.2.2.1 each for the first change per message
9.2.2.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 4 700
9.2.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 400
9.2.2.2 for any further amendment referred to in Article 7 (2) of Regulation (EC) No 1234/2008
9.2.2.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 4 620
9.2.2.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 320
9.2.2.3 Series, similar series, or any other authorisation concerned, per communication, in addition to the fee for the first change, the change
220
9.2.3 Type II/simple amendments 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 in each case for the first change per request 1 700
9.2.3.2 for any further amendment referred to in Article 7 (2) of Regulation (EC) No 1234/2008
1 400
9.2.3.3 Series, similar series, or any other authorisation concerned, per communication, in addition to the fee for the first change, the change
1 100
9.2.4 Type II/complex changes or Germany as a Member State concerned (CMS) in the procedure provided for in Article 20 of Regulation (EC) No 1234/2008
9.2.4.1 in each case for the first change per request
9.2.4.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 7 800
9.2.4.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 2 800
9.2.4.2 for any further amendment referred to in Article 7 (2) of Regulation (EC) No 1234/2008
9.2.4.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 6 500
9.2.4.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 2 200
9.2.4.3 Series, similar series or any other authorisation concerned in the procedure provided for in Article 20 of Regulation (EC) No 1234/2008, in addition to the fee for the first change, as amended

1 500
9.2.5 The fee for amendments submitted in accordance with Article 7 (2) of Regulation (EC) No 1234/2008 or dealt with in the procedure provided for in Article 20 of Regulation (EC) No 1234/2008 shall be subject to a summary of changes or changes in the summary of changes or modifications. in accordance with the procedure laid down in Article 20 of Regulation (EC) No 1234/2008 as a whole, the fee shall not exceed the charge according to the number 2.2.2.2.2.
9.3 Changes in purely national authorisations
9.3.1 Type IA
9.3.1.1 in the case of individual submission
Change, per approval per communication/application
?
250
9.3.1.2 in the case of a summary of amendments pursuant to Article 13d (2) of Regulation (EC) No 1234/2008
9.3.1.2.1 for the first change, per message 250
9.3.1.2.2 for any further change 200
9.3.1.3 Series, similar series, or any further affected approval per communication, in addition to the fee for the first change, the change
150
9.3.1.4 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, provided that such shall be submitted separately from other indications in a notification pursuant to Article 13d (2) of Regulation (EC) No 1234/2008, per authorisation




140
9.3.2 Type IB
9.3.2.1 each for the first change per message
9.3.2.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 5 060
9.3.2.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 760
9.3.2.2 for any further amendment referred to in Article 13d (2) of Regulation (EC) No 1234/2008
9.3.2.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 4 860
9.3.2.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 560
9.3.2.3 Series, similar series, or any other authorisation concerned, per communication, in addition to the fee for the first change, the change
360
9.3.3 Type II/simple amendments or amendments pursuant to Article 20 (1) of Regulation (EC) No 1234/2008
9.3.3.1 in each case for the first change per request 1 600
9.3.3.2 for any further amendment referred to in Article 13d (2) of Regulation (EC) No 1234/2008
1 300
9.3.3.3 Series, similar series, or any other authorisation concerned, per communication, in addition to the fee for the first change, the change
810
9.3.4 Type II/complex amendments or amendments pursuant to Article 20 (1) of Regulation (EC) No 1234/2008
9.3.4.1 in each case for the first change per request
9.3.4.1.1 with evaluation of possible environmental risks by the Federal Environment Agency 8 750
9.3.4.1.2 without evaluation of possible environmental risks by the Federal Environment Agency 3 750
9.3.4.2 for any further amendment referred to in Article 13d (2) of Regulation (EC) No 1234/2008
9.3.4.2.1 with evaluation of possible environmental risks by the Federal Environment Agency 7 300
9.3.4.2.2 without evaluation of possible environmental risks by the Federal Environment Agency 3 000
9.3.4.3 Series, similar series or any further affected approval, per communication, 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 shall be subject to a summary of changes or changes in the summary of changes or modifications. in accordance with Article 20 of Regulation (EC) No 1234/2008 as a whole, the fee shall not exceed 1.2.3.2 as a whole.
10 Registration of homeopathic medicinal products
10.1 National registration procedure
10.1.1 Registration/Basic Fee 6 400
10.1.2 Registration of a series, in addition to the fee for the first registration,
per registration

2 100
10.1.3 Registration of a Dublette or similar series 1 600
10.1.4 Registration of a medicinal product imported in parallel 1 600
10.2 Registration of a drug in the mutual recognition procedure (MRP)
10.2.1 with Germany as Reference Member State (RMS), in addition to the fees according to charge numbers 10.1.1 to 10.1.4
10.2.1.1 Registration/Basic Fee 11 800
10.2.1.2 Registration of a series, in addition to the fee for the first registration,
per registration

5 900
10.2.1.3 Registration of a similar series, in addition to the fee for the first registration, per registration
2 900
10.2.2 with Germany as a Member State concerned (CMS)
10.2.2.1 Registration/Basic Fee 7 100
10.2.2.2 Registration of a series, in addition to the fee for the first registration,
per registration

3 500
10.2.2.3 Registration of a similar series, in addition to the fee for the first registration, per registration
2 100
10.3 Registration of a medicinal product in the decentralised procedure (DCP)
10.3.1 with Germany as the reference Member State (RMS)
10.3.1.1 Registration/Basic Fee 18 200
10.3.1.2 Registration of a series, in addition to the fee for the first registration,
per registration

8 000
10.3.1.3 Registration of a similar series, in addition to the fee for the first registration, per registration
4 500
10.3.2 with Germany as a Member State concerned (CMS)
10.3.2.1 Registration/Basic Fee 10 200
10.3.2.2 Registration of a series, in addition to the fee for the first registration,
per registration

4 000
10.3.2.3 Registration of a similar series, in addition to the fee for the first registration, per registration
2 200
10.4 Renewal of registration pursuant to § 39 (2c) AMG
10.4.1 Renewal of a registration/basic fee 2 700
10.4.2 Series or similar series, in addition to the fee for the first extension, per extension or parallel import
1 400
10.5 Extension of registration in the Mutual Recognition Procedure (MRP) or in the decentralised procedure (DCP)
10.5.1 with Germany as the reference Member State (RMS)
10.5.1.1 Renewal of a registration/basic fee 3 300
10.5.1.2 Series or similar series, in addition to the fee for the first extension
1 700
10.5.2 with Germany as a Member State concerned (CMS)
10.5.2.1 Renewal of a registration/basic fee 1 500
10.5.2.2 Series or similar series, in addition to the fee for the first extension
800
10.6 Examination of changes to a registration pursuant to § 39 paragraph 2b AMG and decision on the approval of changes to a registration pursuant to § 39 paragraph 2b AMG
10.6.1 Changes in accordance with § 39 paragraph 2b AMG in conjunction with Section 29 (2a) (1) to (4) AMG
2 000
10.6.2 Amendments pursuant to § 39 (2b) sentence 1 AMG as well as in accordance with § 39 (2b) AMG in conjunction with Section 29 (2a) (5) AMG, with the exception of the changes mentioned in fee numbers 10.6.5 and 10.6.6, in conjunction with Section 29 (2b) AMG as well as the display each other importing country in parallel import



300
10.6.3 Indication of another importing country, if this results in a further overall evaluation of the registration
560
10.6.4 Transfer to another pharmaceutical entrepre, notification of a co-sales or local representative, indication of a medicinal product imported in parallel in accordance with § 105 AMG, deletion of active ingredients

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

140
10.6.6 change of 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 all registrations of the registrar's registration , at the same time and is submitted separately from other change indicators on an ad, without prejudice to the number of registrations




140
10.6.7 Modification of the name 500
10.6.8 Display in accordance with § 39 paragraph 2b in conjunction with § 29 paragraph 1e AMG 100
10.6.9 Amendment in accordance with § 39 (2b) AMG, which leads to the determination of the re-registration obligation pursuant to § 39 paragraph 2b sentence 4 AMG
2 400
10.6.10 in the case of a number of amendments requested at the same time (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 in the case of parallel imports) for a medicinal product, in addition to the fee for the change with: the highest charge rate (basic fee), for each additional change
The fee according to the fee number 10.6.10 may not exceed the fee according to the fee number 10.1.1.
50 per cent of the fee according to the fee numbers 10.6.1
to 10.6.5 and 10.6.8
10.7 Arrangement of the temporary rest of the registration pursuant to § 39 paragraph 2d AMG in conjunction with § 30 (1) sentence 3 and 2 sentence 2 AMG, provided that the order is not based on a request by the pharmaceutical entreprenchman, depending on the personnel and Expenditure


30 to 5 000
10.8 Reimbursement of an exception according to § 39 paragraph 2c sentence 2 AMG in conjunction with § 31 paragraph 1 sentence 2 AMG, per registration
200
10.9 The basic fees to be charged in accordance with the fee 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 charging list increase by 10% of the basic fee for homeopathic medicinal products with more than one active substance. for each active substance, but not more than twice the basic fee.
11 Registration of traditional herbal medicinal products according to § § 39a ff. AMG
11.1 national registration procedure
11.1.1 Procedure without lists/monographs
11.1.1.1 Registration/Basic Fee 15 600
11.1.1.2 Registration of a series, in addition to the fee for the first registration,
Further registration

6 000
11.1.1.3 Registration of a similar series, in addition to the fee for the first registration, the further registration as well as registration of duplicates
2 800
11.1.2 Procedure with lists/monographs
11.1.2.1 Registration/Basic Fee 9 900
11.1.2.2 Registration of a series, in addition to the fee for the first registration,
Further registration

5 000
11.1.2.3 Registration of a similar series, in addition to the fee for the first registration, the further registration as well as registration of duplicates
2 800
11.1.3 Registration of a medicinal product imported in parallel 2 200
11.2 Registration of a medicinal product in the mutual recognition procedure
11.2.1 with Germany as the reference Member State (RMS), in addition to the fees according to the fee number 11.1.2
11.2.1.1 Registration/Basic Fee 19 400
11.2.1.2 Registration of a series, in addition to the fee for the first registration,
Further registration

9 700
11.2.1.3 Registration of a similar series, in addition to the fee for the first registration, the further registration
4 800
11.2.2 with Germany as a Member State concerned (CMS)
11.2.2.1 Registration/Basic Fee 11 600
11.2.2.2 Registration of a series, in addition to the fee for the first registration,
Further registration

5 700
11.2.2.3 Registration of a similar series, in addition to the fee for the first registration, the further registration
3 400
11.3 Registration of a medicinal product in the decentralised procedure
11.3.1 with Germany as the reference Member State (RMS)
11.3.1.1 Registration/Basic Fee 31 800
11.3.1.2 Registration of a series, in addition to the fee for the first registration,
Further registration

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

5 500
11.3.2.3 Registration of a similar series, in addition to 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 (3) AMG, in addition to the fees according to charge number 11.1.1, depending on the personnel and material expenses

6 000 to 25 000
11.5 Registration in case of execution of a procedure according to § 39d paragraph 4 AMG, in addition to the fees according to charge number 11.1.1, depending on personnel and material expenses

6 000 to 25 000
11.6 Renewal of registration pursuant to § 39c (3) in conjunction with § 31 (3) AMG
11.6.1 Renewal of a registration/basic fee 6 200
11.6.2 Series or similar series, in addition to the fee for the first extension, per extension or parallel import
3 100
11.7 Extension of registration in the Mutual Recognition Procedure (MRP) or in the decentralised procedure (DCP)
11.7.1 with Germany as the reference Member State (RMS)
11.7.1.1 Renewal of a registration/basic fee 7 600
11.7.1.2 Series or similar series, in addition to the fee for the first extension, the extension
3 700
11.7.2 with Germany as a Member State concerned (CMS)
11.7.2.1 Renewal of a registration/basic fee 3 400
11.7.2.2 Series or similar series, in addition to the fee for the first extension, the extension
1 700
11.8 Examination of changes to a registration pursuant to § 39d paragraph 7 AMG and decision on the approval of changes to a registration pursuant to § 39d paragraph 7 AMG
11.8.1 Amendments to § 39d (7) AMG in conjunction with Section 29 (2a) (1) to (4) AMG
2 000
11.8.2 Amendments pursuant to Section 39d (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
11.8.3 Indication of another importing country, if this results in a further overall evaluation of the registration
560
11.8.4 Transfer to another pharmaceutical entrepre, notification of a co-sales or local representative, indication of a medicinal product imported in parallel in accordance with § 105 AMG, deletion of active ingredients

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

140
11.8.6 change of 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 all registrations of the registrar's registration , at the same time and is submitted separately from other change indicators on an ad, without prejudice to the number of registrations




140
11.8.7 Modification of the name 500
11.8.8 Display in accordance with § 39d paragraph 7 AMG in conjunction with § 29 paragraph 1e AMG 100
11.8.9 Amendment according to § 39d paragraph 7 AMG, which leads to the determination of the re-registration obligation pursuant to Section 39d (7) sentence 3 AMG
2 400
11.8.10 Amendments pursuant to Article 61 (3) of Directive 2001 /83/EC, which are processed in accordance with the procedure laid down in the CMDh procedure for the procedures referred to in Article 61 (3) of Directive 2001 /83/EC ("P" procedure)
11.8.10.1 with Germany as the reference Member State (RMS) 560
11.8.10.2 with Germany as a Member State concerned (CMS) 300
11.8.11 Amendments pursuant to section 39d (7) AMG, also in conjunction with § 29 (2b) AMG, with the exception of the fee numbers 11.8.1 to 11.8.10
300
11.8.12 in the case of a number of amendments requested at the same time (with the exception of changes according to charge 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 fee rate (basic fee), for each additional change
The fee according to charge number 11.8.12 may not exceed the fee according to the fee number 11.1.2.1.
50 percent of the fee after
the charge numbers 11.8.1
until 11.8.5 and 11.8.8 to 11.8.9
11.8.13 If the change in the package leaflet is adjusted to the results of the consultation with patients ' target groups according to § 22 (7) sentence 2 AMG, the fee can be reduced by 25 percent.
11.9 Arrangement of the temporary rest of the registration pursuant to Section 39d (8) AMG in conjunction with the second sentence of Article 30 (1) and the second sentence of the second sentence of the AMG, unless the arrangement is based on a request from the marketing authorisation holder, depending on the staff and the staff. Expenditure


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

5 000 to 25 000
13 Individually attributable public services in the context of clinical trials
13.1 Approval in accordance with § 40 (1) sentence 2 AMG, § 42 (2) AMG
13.1.1 Initial presentation of a test plan for a test preparation in Phase I, II or III
13.1.1.1 Basic Fee 3 800
13.1.1.2 during the submission of an integrated study protocol with additional partial studies according to the fee number 13.1.1 per additional partial study, in addition to the basic fee

900
13.1.2 Follow-up study of a test preparation evaluated according to fee number 13.1.1 in Phase I, II or III
13.1.2.1 Follow-up study without re-evaluation of documents 1 500
13.1.2.2 Follow-up study on the re-evaluation of documents in Phase I
13.1.2.2.1 Basic Fee 1 900
13.1.2.2.2 during the submission of an integrated study protocol with additional partial studies according to the fee number 13.1.2.2 per additional partial study, in addition to the basic fee

800
13.1.2.3 Follow-up study with re-evaluation of documents in Phase II or III
13.1.2.3.1 Basic Fee 2 100
13.1.2.3.2 during the submission of an integrated study protocol with additional partial studies according to fee number 13.1.2.3 per additional partial study, in addition to the basic fee

900
13.1.3 Approval of a clinical trial with an investigational medicinal product which has a marketing authorisation in an EU Member State at the time of application; the use of the investigational medicinal product shall be carried out within or outside the approved and in the Technical information designated application conditions
13.1.3.1 Basic Fee 1 700
13.1.3.2 during the submission of an integrated study protocol with additional partial studies according to the fee number 13.1.3 per additional partial study, in addition to the basic fee

900
13.1.4 Test for the detection of bioequivalence 2 100
13.1.5 Approval in accordance with § 42 (3) AMG in conjunction with Section 9 (2) sentences 2 and 3 of the GCP-V on presentation of supplementary documents requiring scientific processing

740
13.1.6 Authorisation of clinical trials with medicinal products consisting of or containing a genetically modified organism or a combination of genetically modified organisms

9 500
13.1.7 Approval of changes after the start of a clinical trial in accordance with § 42 Paragraph 3 AMG in conjunction with § 10 GCP-V
13.1.7.1 Amendments requiring scientific processing subject to approval
13.1.7.1.1 Basic Fee 1 100
13.1.7.1.2 Changes to be made subject to a permit subject to a number of approved changes according to the fee number 13.1.7.1, per additional change

700
13.1.7.2 other changes 730
13.2 Evaluation of annual reports on the safety of the test participants according to § 42 paragraph 3 AMG in conjunction with § 13 paragraph 6 GCP-V
13.2.1 Annual reports on monocentric clinical trials 500
13.2.2 Annual reports on multicentre clinical trials 1 000
13.2.3 Annual reports on a number of more than five clinical trials with the same investigational medicinal product
2 500
13.3 Examination of approval-related information in accordance with § 42 (3) AMG
in conjunction with Section 9 (5) of the GCP-V (GCP-inspections), depending on the personnel and material costs involved


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

250
14 Evaluation of reports in accordance with § 63d and § 63h § 5 AMG and verifications pursuant to § 62 paragraph 6, § 63c paragraph 4 AMG in conjunction with § 62 Paragraph 6 AMG and § 63h Paragraph 6 AMG in conjunction with § 62 Paragraph 6 AMG
14.1 Report evaluation in national proceedings
14.1.1 within ten years of the first authorisation of the medicinal product in Germany
1 400
14.1.2 later than ten years after the first authorisation of the drug in Germany
700
14.2 Report assessment in the mutual recognition procedure (MRP) or in the decentralised procedure in accordance with § 25b (3) AMG
14.2.1 with Germany as the reference Member State (RMS)
14.2.1.1 within ten years of the first authorisation of the medicinal product in Germany
4 800
14.2.1.2 later than ten years after the first authorisation of the drug in Germany
1 400
14.2.2 with Germany as a Member State concerned (CMS)
14.2.2.1 within ten years of the first authorisation of the medicinal product in Germany
1 400
14.2.2.2 later than ten years after the first authorisation of the drug in Germany
700
14.3 At the same time identical periodic reports are presented and evaluated in accordance with the charge numbers 14.1 and 14.2, the fee shall be charged according to the charge numbers 14.1 or 14.2 only once. For each other identical periodic report, the fee shall 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 (6) AMG, depending on the personnel and material costs involved

1 000 to 27 500
15 Individually attributable public services in the context of non-interventional safety assessments
15.1 Non-interventional safety checks carried out on their own initiative
15.1.1 Examination of advertisements in accordance with § 63f (1) AMG 260
15.1.2 Examination of requested documents in the case of § 63f (1) sentence 2 AMG, depending on the personnel and material costs
500 to 4 200
15.1.3 Examination of the final report 300 to 4 200
15.2 Non-interventional safety tests arranged only in the domestic sector when carrying out the test
15.2.1 Approval of the draft test protocol according to § 63g (2) AMG, depending on the personnel and material costs
500 to 4 200
15.2.2 Approval of significant changes to the protocol according to § 63g (3) AMG, per change
250
15.2.3 Examination of the final report 300 to 4 200
16 Examination of advertisements in accordance with § 67 (5) AMG 100
17 Examination of advertisements in accordance with § 67 (6) AMG 260
18 Arrangement of a requirement in accordance with § 28, § 30 paragraph 2a, § 39 paragraph 1 sentence 4 to 6, § 39 paragraph 2d AMG in conjunction with § 30 paragraph 2a, § 39c (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 provision according to § 36 VwVfG, depending on personnel and material costs




30 to 10 000
19 Measures according to § 25c AMG, depending on personnel and material costs 30 to 10 000
20 Measures pursuant to § 30 (1) sentence 4, paragraph 1a sentence 3, paragraph 2 sentence 2, paragraph 2a sentence 1, § 31 (4) sentence 2, § 42a para. 1 sentence 2, paragraph 2 sentence 2, paragraph 3 sentence 3, and paragraph 5 AMG
20.1 Arrangement of the temporary suspension of an admission pursuant to section 30 (1) sentence 4, paragraph 1a, sentence 3, paragraph 2, sentence 2 AMG as well as measures pursuant to section 30 (2a) sentence 1 AMG, with the exception of those referred to in fee number 18, and measures pursuant to § 31 (4) sentence 2 AMG, Depending on the personnel and material costs



30 to 10 000
20.2 Measures pursuant to the second sentence of Article 42a (1), second sentence of the second sentence of paragraph 2, third sentence of paragraph 3 and paragraph 5 AMG, depending on the personnel and material costs involved.
30 to 3 700
21 Decisions pursuant to § 21 paragraph 4 AMG
21.1 Decision on the authorisation requirement, depending on the personnel and material costs
900 to 6 000
21.2 Decision on the obligation to approve a clinical trial, depending on the personnel and material costs involved
900 to 3 700
22 Reimbursement of an exemption pursuant to § 31 (1) sentence 2 AMG, per authorisation
200
23 Determination of a reasonable waiting period in accordance with § 59 (2) sentence 2 AMG
23.1 in the case of a medicinal product with a substance other than the classification referred to in Article 14 (2) (a), (b) or (c) of Regulation (EC) No 470/2009

4 300
23.2 in the case of a medicinal product with a substance corresponding to the classification referred to in Article 14 (2) (a), (b) or (c) of Regulation (EC) No 470/2009
1 800
24 Other individually attributable public services
24.1 scientific opinions on the quality, therapeutic efficacy or safety of a medicinal product

100 to 500
24.2 Decision on a request for re-establishment of rights in accordance with § 32 VwVfG
260
24.3 Decision on a request for resurrecting of the proceedings pursuant to § 51 VwVfG
260
24.4 Non-simple written information 50 to 500
24.5 Inspection of authorisation files outside of a pending administrative procedure according to the fee numbers 1 to 12, 24.2 or 24.3

30 to 260
24.6 Advising the applicant 200 to 10 000
24.7 Issuing of a certificate in accordance with § 73a (2) AMG 100
24.8 certificates, with the exception of those referred to in fee number 24.7, and certifications
10 to 150
25 Opposition proceedings
25.1 Contradictions against substantive decisions
25.1.1 Reject as inappropriate 160; where a lower fee is provided for the substantive decision to be verified, these; where frame fees are provided and the mean value of which is lower, this
25.1.2 partial or complete rejection as unfounded, to the extent that the contradiction is not successful only because the violation of a procedure or form provision according to § 45 VwVfG is inconformable At most, the fee provided for in this Regulation for the substantive decision to be verified by the opposition procedure; in so far as a framework fee is provided for, at the most, the upper value of the fee;
, however, at least 160; where a lower fee is provided for the substantive decision to be verified,
25.1.3 in the event of an objection after the commencement of factual processing, but before the end of the substantive processing a maximum of 75 per cent of the fee referred to in this Regulation for the substantive decision to be verified by the opposition procedure; in so far as a framework fee is provided for, a maximum of 75 per cent of its upper value;
, however, at least 160; if, in the case of the substantive decision to be verified, a lower fee than 160 is provided for, the
25.2 Contradictions against charges and offload
25.2.1 Reject as inappropriate 160; to the extent that 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 provision according to § 45 VwVfG is inconformable a maximum of 10 per cent of the contested amount;
, however, at least 160; where the contested amount is less than 160,
25.2.3 in the event of an objection after the commencement of factual processing, but before the end of the substantive processing a maximum of 75 per cent of the contested amount;
, however, at least 160; where the contested amount is less than 160,
1
Procedures in accordance with Chapter 4 of Title III of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 327, 22.12.2001, 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 November 2001 on the Community code relating to veterinary medicinal products (OJ L 378, 27.12.2001, 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.
2
Procedures in accordance with Chapter 4 of Title III of Directive 2001 /83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 327, 22.12.2001, 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 November 2001 on the Community code relating to veterinary medicinal products (OJ L 378, 27.12.2001, 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.