Key Benefits:
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 |
(+ + + 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
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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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, |