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

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

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Read the untranslated law here: http://www.gesetze-im-internet.de/amgkostv/BJNR251000003.html

Cost regulation for the approval and registration of medicinal products by the Federal Institute for drugs and medical devices and the Federal Office of consumer protection and food safety (AMG costs regulation AMGKostV) AMGKostV Ausfertigung date: 10.12.2003 full quotation: "AMG costs Ordinance of 10 December 2003 (BGBl. I S. 2510), most recently by article 1 of the Decree of March 3, 2015 (BGBl. I p. 195, 1007) has been modified" V go up. by article 4 paragraph 13 G v. 7.8.2013 I 3154 mWv 14.8.2018 stand: last amended by art. 1 V v. 3.3.2015 I 195, 1007 for more information on the stand number you see in the menu see remarks footnote (+++ text detection from: 1.1.2004 +++) heading: IdF d. Article 1 No. 1 V v. 3.3.2015 I 195 mWv 7.3.2015 input formula on the basis of § 33 para 2 of the medicines act as amended by the notice of 11 December 1998 (BGBl. I S. 3586) in conjunction with the 2nd section of the Administrative costs Act of 23 June 1970 (BGBl. I p. 821), § 1 of the jurisdiction adjustment Act of 16 August 2002 (BGBl. I p. 3165), the Organization adopted from January 22, 2001 (BGBl. I p. 127) and 22 October 2002 (BGBl. I S. 4206), ordered the Ministry of health and social security in consultation with the Federal Ministry of Economics and labour: section 1 principle of (1) the Federal Institute for drugs and medical devices and the Federal Office of consumer protection and food safety raise according to the attached schedule of fees and the following Rules for fees and expenses for decisions on approval of medicinal products, for decisions on the registration of homeopathic medicinal products and traditional herbal medicines, for the processing of applications, for the activity in the context of the collection and evaluation of drug risks, for opposition proceedings against administrative acts adopted under the medicines Act or the fixing of fees and costs under this regulation, as well as for other individually attributable public services.
(2) for the publication in the Federal Gazette, expenses are not applicable in cases of lapse or suspension of a licence.

§ 2 fees for refusing or withdrawing an application In case of rejection of an application for making an individually attributable public service for reasons other than because of lack of jurisdiction or the withdrawal of an application after the beginning of the substantive editing will be a fee amounting to 75 per cent of the fee determined for the individually attributable public performance. She can be seen from up to one-quarter of which provided fee is reduced or there may by their survey, if this is equitable.

§ 3 discounts (1) until can be reduced to the half of the appropriate fee the fee, if justified by the performance public with the individually attributable-related staff and expenses on the one hand and the meaning, the economic value or other benefit of individually attributable public performance for the fees borrowers, on the other hand.
(2) the fees to be collected by the numbers 1 to 25 of the fees may, upon request of the debtor of the charges, does not (1) on the application, to be reduced to a quarter of the planned fee, if the applicant can expect the development and approval costs reasonable economic benefits a and 1 on the placing on the market of the medicinal product as a result of the application area is a public interest , or 2. the rare use cases or the target group for which the medicinal product is intended, is small.

§ 4 deduction of costs for experts is made one of the individually attributable public services referred to in points 1 to 13 and 18 to 25 of fees in the prescribed cases on the basis of the evaluation of documents by an independent expert, to offset the costs to be reimbursed to the fixed fee.

Article 5 transitional provisions (1) is the AMG costs Ordinance continue to apply in the version of December 10, 2003 (BGBl. I S. 2510), most recently by article 2 paragraph 26 of the law of 7 August 2013 (Gazette I p. 3154) is has been modified, if the underlying individually attributable public performance was requested or started before 7 March 2015 but have not yet fully provided. This does not apply, if individually attributable public performance already a fees facts according to the AMG costs Ordinance in the version of December 10, 2003, most recently by article 2 paragraph 26 of the law of 7 August 2013 (Federal Law Gazette I p. 3154) is changed, was present, and then to fee is higher than the fee provided for in the AMG costs Ordinance as amended by March 7, 2015. In this case, fees are charged according to the AMG costs Ordinance in the version of March 7, 2015.
(2) the costs Ordinance for the registration of homeopathic medicines by the Federal Institute for drugs and medical devices and the Federal Office of consumer protection and food safety is still in the version of the notice of 24 October 2003 (Federal Law Gazette I p. 2157), by article 2 paragraph 25 of the law of 7 August 2013 (BGBl. I p. 3154) has been amended is to apply, if the underlying individually attributable public performance before March 7, 2015 requested or started , but not yet delivered was. This a fees facts in the cost regulation as amended by the notice of October 24, 2003 does not apply, if the individually attributable performance already (BGBl. I p. 2157), by article 2 paragraph 25 of the law of 7 August 2013 (Gazette I p. 3154) is changed, was present, and then to fee is higher than the fee provided for in the AMG costs Ordinance as amended by March 7, 2015. In this case, fees are charged according to the AMG costs Ordinance in the version of March 7, 2015.
(3) for individually attributable public services which have been made prior to March 7, 2015, charges may apply in accordance with the AMG costs Ordinance in the version of March 7, 2015, unless individually attributable public services having regard to the forthcoming supplement of this regulation a decision as to costs is been expressly reserved. Sentence 1 shall apply mutatis mutandis if an individually attributable public performance already was requested or started before 7 March 2015 but still incompletely provided.
(4) the fees to be collected by fees number 10 of the fees shall be reduced by 50 percent when the underlying individually attributable public performance, unless a request is necessary, has been requested by March 7, 2016. The fees to be collected by fees number 10 of the fees shall be reduced by 25 percent, if the underlying individually attributable public performance, unless a request is necessary, has been requested by March 7, 2017.

Article 6 entry into force, expiry this regulation enters into force on 1 January 2004.

Annex (to section 1) In the following list of charges mean: well-known fabric: medicinal products where the requirements of article 22, paragraph 3 number are 1, 2, or number 3 of the medicines Act.
New fabric: medicines, where none of the conditions of article 22 paragraph 3 number is 1, 2 or point 3 of the medicines Act.
Full reference: reference of second subject on documents of a Vorantragen controller in accordance with section 24 b of paragraph 1 of the German medicines Act.
Partial reference: reference of second subject on parts of the a Vorantragen controller (with the exception of the quality documents) and your own submission.
Duplicate: Full reference of an applicant on an identical drug of the same applicant, which approval or registration at the time of the application is not more than five years.
Reference to section 24a of the Drugs Act: reference of the same applicant or of another subject with the consent of the Vorantragen bridge on all documents including the quality documents of an authorized medicinal product according to section 24a of the medicines Act.
Series: Multiple simultaneously submitted applications of the same applicant (with extensions: the same marketing authorisation holder or the registration holder) for medicinal products identical to the active ingredient, which differ in the dosage form, strength, and any indication.
Similar series: multiple simultaneously submitted applications of the same applicant (with extensions: of the same marketing authorisation holder or the owner of the registration) for an identical drug.
Schedule of fees the fees for paid individually attributable public services be set in accordance with the following fees: fees number paid individually attributable public performance fee in euro 1 national marketing authorisation for a medicinal 1.1 approval of medicinal/new fabric 1.1.1 approval a medicinal/new fabric / no reference of 1.1.1.1 with rating possible environmental risks by the German Federal Environmental Agency of 57 800 1.1.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 51 100 1.1.2 admission one medicinal/new material at partial reference , as far as this, a significant reduction of personnel and other operating expenses occurs 1.1.2.1 rating possible environmental risks by the German Federal Environmental Agency of 40 400 1.1.2.2 without assessment of possible environmental risks by the Federal Environmental Agency
33 700 1.1.3 approval a medicinal/new / full reference of 1.1.3.1 rating possible environmental risks by the German Federal Environmental Agency of 30 600 1.1.3.2 possible without review environmental risks through the German Federal Environmental Agency 23 900 1.2 approval a medicinal/known fabric 1.2.1 approval a medicinal/known / no reference of 1.2.1.1 rating possible environmental risks by the German Federal Environmental Agency of 28 200 1.2.1.2 possible without review environmental risks through the German Federal Environmental Agency 21 500 1.2.2 approval a medicinal/known fabric / in partial reference , as far as this, a significant reduction of personnel and other operating expenses occurs 1.2.2.1 rating possible environmental risks by the German Federal Environmental Agency of 25 800 1.2.2.2 possible without review environmental risks through the German Federal Environmental Agency 19 100 1.2.3 approval of medicinal/known fabric / full reference of 1.2.3.1 rating possible environmental risks by the German Federal Environmental Agency of 22 300 1.2.3.2 possible without review environmental risks through the German Federal Environmental Agency 15 600 1.2.4 approval a duplicate, as well as certification with reference in accordance with § 24a AMG 2 200 1.3 approval a series or a series of similar , in addition to the fee for the first authorisation, per registration 1.3.1 approval a series of 6 000 1.3.2 approval a similar series 2 800 1.4 approval a parallel imported medicinal product, that does not apply to article 105, paragraph 1 as approved AMG 1.4.1 with 2 200 import country 1.4.2 more each importer in the admission application, in addition to 1.4.1 fees number 240 1.5 authorisation of a medicinal product, also duplicate, that authorisation only is subject to , because it is treated with ionising radiation, or authorisation of a medicinal product, also duplicate, which is already approved or 2 authorisation of a medicinal product in the procedure of mutual recognition (MRP) 1 is approved, as long as an authorisation in terms of the treatment with ionising radiation 4 500 2.1 with Germany as a reference Member State (RMS), in addition to the fees referred to in paragraphs 1.1 to 1.3 fees 2.1.1 approval of medicinal/new fabric 2.1.1.1 approval a medicinal/new / no reference 2.1.1.1.1 rating possible Environmental risks by the German Federal Environmental Agency 56 100 2.1.1.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 47 400 2.1.1.2 approval of medicinal/new material/part reference 2.1.1.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 46 500 2.1.1.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 37 800 2.1.1.3 approval a medicinal/new fabric / full reference 2.1.1.3.1 with assessment of possible environmental risks by the German Federal Environmental Agency 34 200 2.1.1.3.2 without assessment of possible environmental risks by the German Federal Environmental Agency 25 500 2.1.2 approval a medicinal/known fabric 2.1.2.1 approval a medicinal/known / no reference 2.1.2.1.1 with assessment of possible environmental risks by the German Federal Environmental Agency 33 900 2.1.2.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 25 200 2.1.2.2 approval a medicinal/known fabric partially reference 2.1.2.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 31 200 2.1.2.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 22 500 2.1.2.3 approval a medicinal/known fabric / full reference 2.1.2.3.1 with assessment of possible environmental risks by the German Federal Environmental Agency 28 100 2.1.2.3.2 without assessment of possible environmental risks by the Federal Environmental Agency
19 400 2.1.3 authorisation of a medicinal product in the repeat use procedures (another MRP after completing a MRP referred to fees 2.1 for additional EU Member States) 2.1.3.1 with new material 2.1.3.1.1 rating possible environmental risks by the German Federal Environmental Agency 27 600 2.1.3.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 18 900 2.1.3.2 with familiar fabric 2.1.3.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 23 100 2.1.3.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 14 400 2.1.4 approval a series or a similar series , in addition to the fee for the first authorisation, per admission 2.1.4.1 approval a series 9 700 2.1.4.2 approval a similar series 4 800 2.2 with Germany as a concerned Member State (CMS) 2.2.1 approval of medicinal/new fabric 2.2.1.1 approval a medicinal/new fabric / no or partial reference 2.2.1.1.1 with assessment of possible environmental risks by the German Federal Environmental Agency 21 400 2.2.1.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 17 100 2.2.1.2 approval a medicinal/new fabric / full reference 2.2.1.2.1 with assessment of possible environmental risks through the Umweltbundesamt 19 000 2.2.1.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 14 700 2.2.2 approval of medicinal/known fabric 2.2.2.1 approval a medicinal/known fabric / no or partial reference 2.2.2.1.1 with assessment of possible environmental risks by the German Federal Environmental Agency 18 100 2.2.2.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 13 800 2.2.2.2 approval a medicinal/known fabric / full reference 2.2.2.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 15 900 2.2.2.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 11 600 2.2.3 approval a Series or a similar series, in addition to the fee for the first authorisation, per admission 2.2.3.1 approval a series 5 700 2.2.3.2 approval a similar series 3 400 3 authorisation of a medicinal product in the decentralised procedure in accordance with section 25 b of paragraph 3 AMG 3.1 with Germany as a reference Member State (RMS) 3.1.1 approval a medicinal/new fabric 3.1.1.1 approval a medicinal/new fabric / no reference 3.1.1.1.1 with assessment of possible environmental risks by the Federal Environmental Agency 98 000 3.1.1.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 89 300 3.1.1.2
Approval of medicinal/new material/part reference 3.1.1.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 73 800 3.1.1.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 65 100 3.1.1.3 approval a medicinal/new fabric / full reference 3.1.1.3.1 with assessment of possible environmental risks by the German Federal Environmental Agency 53 600 3.1.1.3.2 without assessment of possible environmental risks by the German Federal Environmental Agency 44 900 3.1.2 approval a medicinal/known fabric 3.1.2.1 approval a medicinal/known fabric / no reference 3.1.2.1.1 with assessment of possible environmental risks by the German Federal Environmental Agency 51 200 3.1.2.1.2
no assessment of possible environmental risks by the German Federal Environmental Agency 42 500 3.1.2.2 approval a medicinal/known fabric partially reference 3.1.2.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 46 600 3.1.2.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 37 900 3.1.2.3 approval a medicinal/known / full reference 3.1.2.3.1 with assessment of possible environmental risks by the German Federal Environmental Agency 40 500 3.1.2.3.2 without assessment of possible environmental risks by the German Federal Environmental Agency 31 800 3.1.3 approval a series or a series of similar , in addition to the fee for the first authorisation, per admission 3.1.3.1 approval a series 14 400 3.1.3.2 approval a similar series of 7 000 3.2 with Germany as a concerned Member State (CMS) 3.2.1 approval a medicinal/new materials 3.2.1.1 approval a medicinal/new fabric / no or partial reference 3.2.1.1.1 with assessment of possible environmental risks by the German Federal Environmental Agency 24 100 3.2.1.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 19 500 3.2.1.2 approval a medicinal/new / full reference 3.2.1.2.1 with assessment of possible environmental risks through the Umweltbundesamt 20 700 3.2.1.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 16 100 3.2.2 approval of medicinal/known fabric 3.2.2.1 approval a medicinal/known fabric / no or partial reference 3.2.2.1.1 with assessment of possible environmental risks by the German Federal Environmental Agency 20 500 3.2.2.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 15 900 3.2.2.2 approval a medicinal/known fabric / full reference 3.2.2.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 18 500 3.2.2.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 13 900 3.2.3 approval a Series or a similar series, in addition to the fee for the first authorisation, per admission 3.2.3.1 approval a series 5 500 3.2.3.2 approval a similar series 3 100 4 create or update an evaluation report pursuant to § 25 paragraph 5a AMG, unless already charges numbers 2 or 3 captured by 4.1 create of an assessment report 4.1.1 to a drug with new fabric 22 400 4.1.2 to a drug with known fabric 14 000 4.2 update of assessment report of 4.2.1 to a drug with the new Fabric 8-700 4.2.2 to a drug with known fabric 5 800 4.3 creating or updating an assessment report to a series or a similar series, in addition to the numbers of fees 4.1 and 4.2 4 500 5 renewal of authorisations according to article 105, paragraph 3 AMG 5.1 chemically defined drugs 5.1.1 basic fee 12 600 5.1.2 series or similar series, in addition to the fee of the first registration , phytotherapeutisches per admission 2 700 5.2 medicinal products 5.2.1 basic fee 9 600 5.2.2
Series or similar series, in addition to the fee of the first registration, each approval 2 700 5.3 homeopathic medicine or anthroposophisches medicines with Commission participation according to § 25 paragraph 7 AMG 5.3.1 basic fee 7 700 5.3.2 series or similar series, in addition to the fee of the first registration, each admission 6 100 5.4 homeopathic medicine or anthroposophisches drugs without the participation of the Commission pursuant to § 25 paragraph 7 AMG 5.4.1 basic fee 6 900 5.4.2 series or similar series , in addition to the fee of the first registration, each admission 5 400 5.5 medicinal products under section 109a AMG 5.5.1 basic fee 5 700 5.5.2 series or similar series, in addition to the fee of the first registration, each admission 1 600 6 renewal of an authorisation according to article 31, paragraph 3 AMG 6.1 medicines with new or unknown substances 6.1.1 fee of 6.1.1.1 communication with rating possible environmental risks by the Federal Environmental Agency (only in case of medicinal , which are intended for use in animals) 13 300 6.1.1.2 possible without review environmental risks through the German Federal Environmental Agency 6 200 6.1.2 series or similar series, in addition to the fee for the first extension, each extension 3 100 6.2 extension completely on the basis of one of the competent federal authority 6.2.1 known made pattern fee 2 300 6.2.2 series or similar series, in addition to the fee for the first extension , per extension 1 500 6.3 renewal of a parallel imported medicinal product 6.3.1 basic fee 2 100 6.3.2 with change of reference approval in the renewal procedure 2 600 7 renewal of authorisation in the mutual recognition procedure (MRP) 2or in the decentralised procedure (DCP) 7.1 with Germany as a reference Member State (RMS) 7.1.1 medicines with new or familiar fabric, basic fee of 7.1.1.1 rating possible environmental risks by the Federal Environmental Agency (only in case of medicinal , which are intended for use in animals) 18 300 7.1.1.2 possible without review environmental risks through the German Federal Environmental Agency 9 600 7.1.2 series or similar series, in addition to the fee for the first extension, each extension 4 200 7.2 with Germany as a concerned Member State (CMS) 7.2.1 medicines with new or familiar fabric, basic fee of 7.2.1.1 potential assessment environmental risks by the Federal Environmental Agency (only in case of medicinal , which are intended for use in animals) 8 400 7.2.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 4 000 7.2.2 series or similar series, in addition to the fee for the first extension, each extension 2 000 8 testing of ads according to § 29 AMG and decision about the consent to viewing according to § 29 AMG 8.1 changes according to § 29 paragraph 2a number 1 to 4 AMG with exception of changes referred to in 8.11 charges number 2 000 8.2 changes according to article 29, paragraph 1 or Paragraph 2 (b) and paragraph 2a number 5 AMG except in paragraphs fees 8.6 and 8.7 these changes, as well as the display of any other country of import parallel import, provided that the permits for the import of medicines in the country of origin as well as for the reference approval in the course of proceedings under charge number 2 (mutual recognition procedure) or fees number 3 (decentralised procedure) had been issued 300-8.3 display of every other country of import parallel import , if approved for the reference approval in the course of proceedings fees referred to in 1 (national approval) has been 350 8.4 replacement of reference approval in parallel imported medicinal products or display a further import country, unless this is a renewed overall rating of approval runs 560 8.5 transfer to an other pharmaceutical entrepreneur, display a joint sales or local representative, display a parallel imported medicinal product according to § 105 AMG , Removal effective components 240 8.6 change of address, telephone or fax number or E-Mail address of the marketing authorisation holder, manufacturer, with distributors or local representative, change the company or the legal form, per admission 140 8.7 change of address, telephone or fax number or email address of the authorisation holder, change the company of the marketing authorisation holder or its legal form, provided that this change affects all approvals of the authorisation-holder at the same time and is filed separately from other change ads in an ad , regardless of the number of authorisations 140 8.8 change the denomination 500 8.9 change notifications according to article 29 paragraph 1 b and 1 c AMG 100 8.10 ads according to § 29 paragraph 1e AMG 100 8.11 requiring consent changes according to § 29 paragraph 2a number 1 and number 6 AMG 8.11.1 changes according to § 29 paragraph 2a number 1 AMG, if it concerns one or change in an indication in the same treatment area the infliction and changes according to § 29 paragraph 2a number 6 AMG 8.11.1.1 with rating possible Environmental risks by the German Federal Environmental Agency of 8 500 8.11.1.2 possible without assessing environmental risks by the Federal Environment Agency 2 400 8.11.2 amendment to § 29 paragraph 2a of the AMG, which leads AMG for establishing the new authorisation requirement pursuant to section 29, paragraph 3 2 400 8.12 change the texts of instructions and information for professionals in adapting to one of the competent federal authority or the European Commission made text, per admission known 430 8.13 amendments referred to in article 61 (3) of Directive 2001/83/EC , which was edited after the procedure of the CMDh for procedures pursuant to article 61 (3) of Directive 2001/83/EC be 8.13.1 with Germany as a reference Member State (RMS) 560 ("P" procedures) 8.13.2 with Germany as a concerned Member State (CMS) 300 8.14 at multiple amendments submitted at the same time in a display (with the exception of changes to paragraphs 8.7 and 8.10, fees 8.13, as well as the display of each other importing country when parallel imports) for a medicinal , in addition to the fee for the change with the highest rate (basic charge) for each additional change the fee referred to charges 8.14 total fee referred to fees 1.2.3.2 not exceed.
50 percent of the fee according to paragraphs fees 8.1 to 8.6, 8.11, and 8.12 8.15 the change in adjustment of the leaflet on results of consultations with target patient groups AMG in accordance with article 22, paragraph 7, sentence 2, the fee by 25 percent can be reduced.
 
9 examination of changes and deciding on the approval of amendments pursuant to Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of changes of the approvals of human and veterinary medicinal products (OJ L 334 of December 12, 2008, p. 7), by the Regulation (EU) No. 712 / 2012 (OJ L 209 of the 4.8.2012, p. 4) has been modified is 9.1 with Germany as reference Member State (RMS) or reference authority referred to in article 7 or article 20 of Regulation (EC) No. 1234/2008 9.1.1 type I A 9.1.1.1 single filing change each approval per message/request?
370 9.1.1.2 at summary of changes referred to in 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 300 9.1.1.3 series change per message, similar series or any other affected approval per message, 200 9.1.1.4 change of address, telephone or fax number or E-Mail address of the authorisation holder in addition to the fee for the first amendment ever change , Change the company of the marketing authorisation holder or its legal form, introduction or change of the pharmacovigilance system master file unless these separately (2) of Regulation (EC) No. 1234/2008 will be submitted by other ads in a notification pursuant to article 7, per admission 140 9.1.2 type I B 9.1.2.1 respectively for the first change per message 9.1.2.1.1 with assessment of possible environmental risks by the German Federal Environmental Agency 6 100 9.1.2.1.2 without assessment of possible environmental risks by Umweltbundesamt 1 800 9.1.2.2 for each additional change in accordance with article 7 paragraph 2 Regulation (EC) No 1234/2008 9.1.2.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 5 700 9.1.2.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 1 400 9.1.2.3 series or similar series in addition to the fee for the first amendment ever change 900 9.1.3 type II / simple modifications or amendments referred to in article 20 (1) of Regulation (EC) No. 1234/2008 9.1.3.1 respectively for the first change per request 4 300 9.1.3.2 for each further change in accordance with article 7 paragraph 2 of Regulation (EC) No 1234 / 2008 3 500 9.1.3.3 series, similar series or any other affected approval per message, in addition to the fee for the first amendment ever change 1 900 9.1.4 type II / complex edits or changes referred to in article 20 (1) of Regulation (EC) No 1234/2008 9.1.4.1 respectively for the first change per request 9.1.4.1.1 rating possible environmental risks by the German Federal Environmental Agency 15 600 9.1.4.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 7 500 9.1.4.2 for each further change in accordance with article 7 (2) of Regulation (EC) No 1234 / 2008 9.1.4.2.1 with assessment of possible risks by the German Federal Environmental Agency 10 300 9.1.4.2.2 no assessment of possible environmental risks by the German Federal Environmental Agency 6 000 9.1.4.3 series, similar series or any other affected approval per message, in addition to the fee for the first amendment ever change 2 900 9.1.5
After fees number 2.1.2.3.2 not exceed the fee for changes that are submitted (2) of Regulation (EC) No 1234/2008 referred to in article 7 or in the procedure under article 20 of Regulation (EC) No. 1234/2008 editable, 20 of Regulation (EC) allowed per summary of changes or per procedure under article no. 1234 / 2008 the fee.
 
9.2 with Germany as a concerned Member State (CMS) or Member State concerned pursuant to article 7 or article 20 of Regulation (EC) No 1234/2008 9.2.1 type I A 9.2.1.1 single filing change, each approval per message/request?
190 9.2.1.2 at summary of changes referred to in article 7 (2) of Regulation (EC) No 1234/2008 9.2.1.2.1 for the first amendment, per message 190 9.2.1.2.2 for each additional change, per message 150 9.2.1.3 series, similar series, or any more affected approval per message, 120 9.2.1.4 change of address, telephone or fax number or E-Mail address of the authorisation holder in addition to the fee for the first amendment ever change , Change the company of the marketing authorisation holder or its legal form, introduction or change of the pharmacovigilance system master file unless these separately (2) of Regulation (EC) No. 1234/2008 will be submitted by other ads in a notification pursuant to article 7, per admission 140 9.2.2 type I B 9.2.2.1 respectively for the first change per message 9.2.2.1.1 with assessment of possible environmental risks by the German Federal Environmental Agency 4 700 9.2.2.1.2 without any environmental risk assessment by the Umweltbundesamt 400 9.2.2.2 for each further change in accordance with article 7 paragraph 2 of the Regulation (EC) No 1234 / 2008 9.2.2.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 4 620 9.2.2.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 320 9.2.2.3 series, similar series or any other affected approval per message, in addition to the fee for the first amendment ever change 220 9.2.3 type II / simple changes or Germany as a concerned Member State (CMS) in the procedure under article 20 of Regulation (EC) No 1234/2008 9.2.3.1 respectively for the first change per 1 700 9.2.3.2 for each request other change pursuant to article 7 (2) of Regulation (EC) No 1234 / 2008 1 400 9.2.3.3 series, similar series or any more affected approval per message, in addition to the fee for the first amendment ever change 1 100 9.2.4 type II / complex edits or Germany as a concerned Member State (CMS) in the procedure under article 20 of Regulation (EC) No 1234/2008 9.2.4.1 respectively for the first change per request 9.2.4.1.1 rating possible environmental risks by the German Federal Environmental Agency 7 800 9.2.4.1.2 without review possible environmental risks by the German Federal Environmental Agency 2 800 9.2.4.2 for each change more referred to in article 7 (2) of Regulation (EC) No 1234 / 2008 9.2.4.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 6 500 9.2.4.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 2 200 9.2.4.3 series, similar series or any other affected admission in the proceedings under article 20 of Regulation (EC) No 1234/2008 , in addition to the fee for the first amendment ever change 1 500 9.2.5 the fee for changes that are submitted (2) of Regulation (EC) No 1234/2008 or in the procedure under article 20 of Regulation (EC) No. 1234/2008 be processed 20 of Regulation (EC) allowed per summary of changes or per procedure under article no. 1234 article 7 / 2008 the fee after fee number 2.2.2.2.2 not exceed.
 
9.3 changes to purely national authorisations 9.3.1 type IA 9.3.1.1 single filing change, each approval per message/request?
250 9.3.1.2 at summary of changes referred to in article 13d (2) of Regulation (EC) No 1234/2008 9.3.1.2.1 for the first amendment, per message 250 9.3.1.2.2 for each additional change 200 9.3.1.3 series, similar series or any other affected approval per message, 150 9.3.1.4 change of address, telephone or fax number or E-Mail address of the authorisation holder in addition to the fee for the first amendment ever change , Change the company of the marketing authorisation holder or its legal form, introduction or variation of the pharmacovigilance data file if these separated No. 1234/2008 will be submitted by other ads in a notice referred to in article 13d (2) of Regulation (EC), per admission 140 9.3.2 type IB 9.3.2.1 respectively for the first change per message 9.3.2.1.1 with assessment of possible environmental risks by the German Federal Environmental Agency 5 060 9.3.2.1.2 no assessment of possible environmental risks by the German Federal Environmental Agency 760 9.3.2.2 for each further change referred to in article 13d (2) of the Regulation () EC) No 1234 / 2008 9.3.2.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 4 860 9.3.2.2.2 without assessment of possible environmental risks by the German Federal Environmental Agency 560 9.3.2.3 series, similar series or any other affected approval per message, in addition to the fee for the first amendment ever change 360 9.3.3 type II / simple modifications or amendments referred to in article 20 (1) of Regulation (EC) No. 1234/2008 9.3.3.1 respectively for the first change per request 1 600 9.3.3.2 for each further change referred to in article 13d (2) of Regulation (EC) No 1234 / 2008 1 300 9.3.3.3 series, similar series or any more affected approval per message, in addition to the fee for the first amendment ever change 810 9.3.4 type II / complex edits or changes referred to in article 20 (1) of Regulation (EC) No 1234/2008 9.3.4.1 respectively for the first change per request 9.3.4.1.1 rating possible environmental risks by the German Federal Environmental Agency 8 750 9.3.4.1.2 without assessment of possible environmental risks by the German Federal Environmental Agency 3 750 9.3.4.2 each more amendments referred to in article 13d (2) of Regulation (EC) No. 1234/2008 9.3.4.2.1 with assessment of possible environmental risks by the German Federal Environmental Agency 7 300 9.3.4.2.2 no assessment of possible environmental risks by the German Federal Environmental Agency 3 000 9.3.4.3 series, similar series or any other affected approval per message, in addition to the fee for the first amendment ever change 1 900 9.3.5 the fee for changes , in article 13d (2) of Regulation (EC) No. 1234/2008 be submitted or in the procedure under article 20 of Regulation (EC) No. 1234/2008 be processed 20 of Regulation (EC) allowed per summary of changes or per procedure under article no. 1234 / 2008 overall the fee after fee number 1.2.3.2 not exceed.
 
10 registration of homeopathic medicinal products 10.1 national registration procedures 10.1.1 registration/fee 6 400 10.1.2 registration a series, in addition to the fee for the first registration, each registration 2 100 10.1.3 registration a duplicate or similar series 1 600 10.1.4 registration one parallel imported medicinal product 1 600 10.2 registration of a medicinal product in the procedure of mutual recognition (MRP) 10.2.1 with Germany as a reference Member State (RMS), in addition to the fees in accordance with fee numbers 10.1.1 to 10.1.4 10.2.1.1 registration/fee 11 800 10.2.1.2 registration a series , in addition to the fee for the first registration, each registration 5 900 10.2.1.3 registration a similar series, in addition to the fee for the first registration, each registration 2 900 10.2.2 with Germany as a concerned Member State (CMS) 10.2.2.1 registration/fee 7 100 10.2.2.2 registration a series, in addition to the fee for the first registration, each registering 3 500 10.2.2.3 registration a similar series, in addition to the fee for the first registration , per registration 2 100 10.3 registration of a pharmaceutical product in the decentralised procedure (DCP) 10.3.1 with Germany as a reference Member State (RMS) 10.3.1.1 registration/fee 18 200 10.3.1.2 registration a series, in addition to the fee for the first registration, each registration 8 000 10.3.1.3 registration of a similar series, in addition to the fee for the first registration, each registering 4 500 10.3.2 with Germany as a concerned Member State (CMS) 10.3.2.1 registration/fee 10 200 10.3.2.2 registration a series , in addition to the fee for the first registration, each registering 4 000 10.3.2.3 registration of a similar series, in addition to the fee for the first registration, each registration 2 200 10.4 extension of registration section 39 paragraph 2c according to AMG 10.4.1 extension a registration/fee 2 700 10.4.2 series or similar series, in addition to the fee for the first renewal, extension or parallel import 1 400 10.5 extension of a registration in the procedure of mutual recognition (MRP) or in the decentralized procedure (DCP) 10.5.1 with Germany as Reference Member State (RMS) 10.5.1.1 extension a registration/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 concerned Member State (CMS) 10.5.2.1 extension a registration/fee 1 500 10.5.2.2 series or similar series, in addition to the fee for the first extension 800 10.6 exam changes a registration in accordance with article 39, paragraph 2 b AMG and decision about the consent to change a registration in accordance with article 39, paragraph 2 b AMG 10.6.1 changes according to section 39 paragraph 2b AMG in conjunction with § 29 paragraph 2a number 1 to 4 AMG 2 000 10.6.2
Changes to section 39 paragraph 2 b set 1 AMG and pursuant to section 39 paragraph 2 b AMG in conjunction with § 29 paragraph 2a number 5 AMG with exception of fees points 10.6.5 and 10.6.6 referred to changes, in conjunction with article 29, paragraph 2 b AMG and the display of any other country of import parallel import 300 10.6.3 display a further import country, provided that this leads to a total re-evaluation of the registry 560 10.6.4 transfer to an other pharmaceutical entrepreneur , Display a joint sales or local representative, display a parallel imported medicinal product according to § 105 AMG, removal effective components 240 10.6.5 change of address, telephone or fax number or E-Mail address of the registration holder, manufacturer, with distributors or local representative, change the company or the legal form, per registration 140 10.6.6 change of address, telephone or fax number or E-Mail address of the registration holder, change the company of the holder of the registration or its legal form , provided that this change affects all registrations of the registration holder at the same time and separately from other change ads in an ad is submitted, regardless of the number of registrations of 140 10.6.7 change the denomination of 500 10.6.8 ads pursuant to article 39, paragraph 2 (b) in connection with section 29 paragraph 1e AMG 100 10.6.9 amendment to section 39 paragraph 2 b AMG, which will b set 4 AMG for establishing the new registration obligation according to section 39 paragraph 2 2 400 10.6.10 several at the same time requested changes (with the exception of changes to fees numbered 10.6.6 10.6.7 as well as indicating any further import country in parallel imports) for a medicinal product, in addition to the fee for the change with the highest rate (basic fee), for each additional change the fee referred to fees 10.6.10 total fee fees point 10.1.1 not exceed.
50 percent of the fee charges paragraphs 10.6.1 10.6.5 and 10.6.8 10.7 arrangement of temporary suspension of the registration in accordance with section 39 paragraph 2d AMG in conjunction with section 30, paragraph 1, sentence 3 and paragraph 2 set 2 AMG, if the arrangement is not based on a request of the marketing authorisation, according to personnel and administrative expenses 30 to 5 000 10.8 permission of an exception pursuant to section 39 paragraph 2 c set 2 AMG in connection with article 31, paragraph 1, sentence 2 AMG , per registration 200 10.9 which paragraphs 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 fees to gathering basic fees fees increase homeopathic medicines with more than an active ingredient to 10% of the basic fee for each excipients, but no more than to double the fee.
 
11 registering of traditional herbal medicinal pursuant to § 39a et seq. AMG 11.1 national registration procedure 11.1.1 procedure without lists/monographs 11.1.1.1 registration/fee 15 600 11.1.1.2 registration a series, in addition to the fee for the first registration, each extra registry 6 000 11.1.1.3 registration a similar series, in addition to the fee for the first registration, each extra registration and registration of duplicates 2 800 11.1.2 procedure with lists/monographs 11.1.2.1 registration/fee 9 900 11.1.2.2 registration a series , in addition to the fee for the first registration, ever more registration 5 000 11.1.2.3 registration a similar series, in addition to the fee for the first registration, each extra registry and registration of duplicates 2 800 11.1.3 registration one parallel imported medicinal 2 200 11.2 registry of a medicinal product in the procedure of mutual recognition 11.2.1 with Germany as a reference Member State (RMS), in addition to the fees referred to in fee paragraph 11.1.2 11.2.1.1 registration/fee 19 400 11.2.1.2 registration a series , in addition to the fee for the first registration, ever more registration 9 700 11.2.1.3 registration a similar series, in addition to the fee for the first registration, each extra registry 4 800 11.2.2 with Germany as a concerned Member State (CMS) 11.2.2.1 registration/fee 11 600 11.2.2.2 registration a series, in addition to the fee for the first registration, each extra registry 5 700 11.2.2.3 registration a similar series , in addition to the fee for the first registration, each registering 3 400 11.3 registration of a pharmaceutical product in the decentralised procedure 11.3.1 with Germany as a reference Member State (RMS) 11.3.1.1 registration/fee 31 800 11.3.1.2 registration a series, in addition to the fee for the first registration, each extra registry 14 400 11.3.1.3 registration a similar series, in addition to the fee for the first registration, each extra registry 7 000 11.3.2 with Germany as a concerned Member State (CMS) 11.3.2.1 registration/fee 13 900 11.3.2.2 registration a series , in addition to the fee for the first registration, each registration 5 500 11.3.2.3 registration a similar series, in addition to the fee for the first registration, each registering 3 100 11.4 registration in the case of proceedings section 39B, paragraph 3, AMG, in addition fees fees referred to in 11.1.1, depending on the staff and non-staff expenses 6 000 and 25 000 11.5 registration in the case of proceedings after section 39B, paragraph 4 AMG , in addition to the fees fees referred to in 11.1.1, depending on the staff and non-staff expenses 6 000 and 25 000 11.6 extension of a registration according to § 39 c paragraph 3 in conjunction with article 31, paragraph 3 AMG 11.6.1 extension a registration/fee 6 200 11.6.2 series or similar series, in addition to the fee for the first renewal, extension or parallel import 3 100 11.7 extension of a registration in the procedure of mutual recognition (MRP) or in the decentralized procedure (DCP) 11.7.1 with Germany as a reference Member State (RMS) 11.7.1.1 extension a registration/fee 7 600 11.7.1.2 series or similar series, in addition to the fee for the first extension, each extension 3 700 11.7.2 with Germany as a concerned Member State (CMS) 11.7.2.1 extension a registration/fee 3 400 11.7.2.2 series or similar series, in addition to the fee for the first extension, each extension 1 700 11.8 exam changes a registration according to article 39B, paragraph 7, AMG and decision about the consent to change a registration according to article 39B, paragraph 7, AMG 11.8.1 amendments under section 39B Paragraph 7 AMG in conjunction with § 29 paragraph 2a number 1 to 4 AMG 2 000 11.8.2 changes under section 39B paragraph 7 in conjunction with article 29 paragraph 2a number 5 AMG with exception of changes referred to in fee section 11.8.5, as well as the display of any other country of import parallel import 300 11.8.3 display a further import country, provided that this leads to a total re-evaluation of registry 560 11.8.4 transfer to an other pharmaceutical entrepreneur , Display a joint sales or local representative, display a parallel imported medicinal product according to § 105 AMG, removal effective components 240 11.8.5 change of address, telephone or fax number or E-Mail address of the registration holder, manufacturer, with distributors or local representative, change the company or the legal form, per registration 140 11.8.6 change of address, telephone or fax number or E-Mail address of the registration holder, change the company of the holder of the registration or its legal form , provided that this change affects all registrations of the registration holder at the same time and separately from other change ads in an ad is submitted, regardless of the number of registrations of 140 11.8.7 change the denomination of 500 11.8.8 ads according to section 39B paragraph 7 AMG in conjunction with § 29 paragraph 1e AMG 100 11.8.9 change according to article 39B, paragraph 7, AMG, finding the new registration requirement under section 39B paragraph 7 sentence 3 AMG leads 2 400 11.8.10 amendments referred to in article 61 (3) of Directive 2001/83/EC , which was edited after the procedure of the CMDh for procedures pursuant to article 61 (3) of Directive 2001/83/EC are changes ("P" procedures) 11.8.10.1 with Germany as a reference Member State (RMS) 560 11.8.10.2 with Germany as a concerned Member State (CMS) 300 11.8.11 to article 39B, paragraph 7, AMG, also in conjunction with article 29, paragraph 2 b AMG, with the exception of fees numbers 11.8.1 until 11.8.10 300 11.8.12 with several at the same time requested changes (with the exception of changes to fees numbers 11.8.6 and 11.8.7 and indicating each other) Parallel imports of the importing country) for a medicinal product, in addition to the fee for the change with the highest rate (basic fee), for each additional change the fee referred to fees 11.8.12 total the fee charges number 11.1.2.1 not exceed.
50 percent of the fee fees paragraphs 11.8.1 11.8.5 and 11.8.8 until 11.8.9 11.8.13 is the change in adjustment of the leaflet on results of consultations with target patient groups according to article 22, paragraph 7, sentence 2 AMG, can be reduced the fee by 25 percent.
 
11.9 arrangement of temporary suspension of the registration in accordance with article 39B paragraph 8 AMG in conjunction with section 30, paragraph 1, sentence 2 and paragraph 2 sentence 2 AMG, if the arrangement is not based on a request of the marketing authorisation, according to personnel and administrative expenses 30 to 10 000 11.10 permitting of an exception pursuant to § 39 c paragraph 3 set 2 AMG in connection with article 31, paragraph 1, sentence 2 AMG , per registration 200 12
Examination of registration-related information according to § 25 paragraph 5 AMG, depending on the staff and non-staff expenses 5 000 to 25 000 13 individually attributable public services in the context of clinical trials 13.1 receiving authorisation according to article 40, paragraph 1, sentence 2 AMG, § 42 paragraph 2 AMG 13.1.1 first submit of a test plan to an investigational drug in phase I, II, or III 13.1.1.1 fee 3 800 13.1.1.2 when filing an integrated study protocol with additional studies after fees number 13.1.1 per additional study , in addition to the basic fee 900 13.1.2 follow-up study of an investigational medicinal product assessed fees point 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 with re-evaluation of documents in phase I 13.1.2.2.1 fee 1 900 13.1.2.2.2 submitting an integrated study protocol with additional studies after fees number 13.1.2.2 per additional 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 2 100 basic fee 13.1.2.3.2 when filing an integrated study protocol with additional studies after charges number 13.1.2.3 per additional study, in addition to the basic fee 900 13.1.3 approval of a clinical trial with an investigational drug, which has a marketing authorisation in a Member State of the EU at the time of the application; the application of the investigational product is inside or outside the approved and designated in the prescribing information application conditions 13.1.3.1 fee 1 700 13.1.3.2 when filing an integrated study protocol with additional studies after fees number 13.1.3 per additional study, in addition to fee 900 13.1.4 testing to demonstrate of the bioequivalence of 2 100 13.1.5 permission according to § 42 paragraph 3 AMG in connection with article 9, paragraph 2, sentence 2 and documents complementary 3 GCP V template , a scientific editing require 740 13.1.6 approval of clinical trials with medicines, the genetically modified organism from a consist a combination of genetically modified organisms or those contain 9 500 13.1.7 approval of changes after the start of a clinical trial according to § 42 paragraph 3 AMG in conjunction with § 10 GCP-V 13.1.7.1 subject to approval, a scientific editing require fee 1 100 13.1.7.1.1 13.1.7.1.2 approval changes , the multiple subject to authorisation fees referred to under 13.1.7.1 contain changes, per additional change 700 13.1.7.2 other changes in 730 13.2 evaluation of annual reports on the safety of trial subjects according to § 42 paragraph 3 AMG in conjunction with article 13, paragraph 6 GCP V 13.2.1 annual reports to Mono-centric clinical trials 500 13.2.2 annual reports to multi-centre clinical trials 1 000 13.2.3 annual reports on a number of more than five clinical trials with the same IMP 2 500 13.3 testing of permit-related information according to § 42 paragraph 3 AMG in connection with § 9 paragraph 5 GCP-V (GCP inspections), depending on the staff and non-staff expenses 5 000 to 50 000 13.4 testing, matching and for the EudraCT database-specific information according to § 14 paragraph 3 covered 250 GCP-V, if not by the fees number 13.1 14 review reports according to article 63d and section 63 h paragraph 5 AMG and checks according to § 62 paragraph 6, section 63 c paragraph 4 AMG in conjunction with article 62 paragraph 6 AMG and section 63 h 6 AMG in conjunction with section 62, paragraph 6 AMG
 
14.1 report review in the national proceedings 14.1.1 ten years after initial approval of the medicinal substance in Germany 1 400 14.1.2 later than ten years after the initial approval of the medicinal substance in Germany 700 14.2 report review in the procedure of mutual recognition (MRP) or in the decentralised procedure according to § 25 paragraph 3 b AMG 14.2.1 with Germany as a reference Member State (RMS) 14.2.1.1 ten years after initial approval of the medicinal substance in Germany 4 800 14.2.1.2 later than ten years after the initial approval of the medicinal substance in Germany 1 400 14.2.2 with Germany as a concerned Member State (CMS) 14.2.2.1 ten years after initial approval of the medicinal substance in Germany 1 400 14.2.2.2 later than ten years after the initial approval of the medicinal substance in Germany 700 14.3 are at the same time identical periodic reports referred to in paragraphs fees 14.1 and 14.2 submitted and evaluated, the fee by the number of charges is 14.1 or 14.2 only once. For every consecutive identical periodic report the fee decreases AMG to 300 14.4 review of collection and evaluation of drug risks and coordination necessary measures according to § 62, paragraph 6, depending on the personnel and administrative expenses 1 000 and 27 500 15 individually attributable public services in the context of non-Interventional safety tests 15.1 non-Interventional safety tests conducted on its own initiative 15.1.1 test ads to article 63f paragraph 1 AMG 260 15.1.2 examination of the documents requested in the case of § 63f (1) sentence 2 AMG, depending on the staff and non-staff expenses 500 to 4 200 15.1.3 test report 300 to 4 200 15.2 arranged non-Interventional safety assessments of conducting the examination only domestically 15.2.1 approval of the design of the testing protocol after section 63 g paragraph 2 AMG, depending on the staff and non-staff expenses 500 to 4 200 15.2.2 permit essential amendments to the Protocol after section 63 g paragraph 3 AMG per amendment 250 15.2.3 verification of the completion report 300 to 4 200 16 testing of ads according to § 67 paragraph 5 AMG
100 17 test ads pursuant to section 67, paragraph 6 AMG 260 18 arrangement of a circulation under section 28, § 30 § 39, paragraph 2a, section 39 paragraph 1 sentence 4 to 6 paragraph 2d AMG in conjunction with § 30 paragraph 2a, § 39 c paragraph 1 set 4 to 6, article 39B paragraph 8 AMG in conjunction with section 30 paragraph 2a, section 105, paragraph 5 AMG or a warning notice according to § 110 AMG or ancillary provision under § 36 VwVfG , depending on the personnel and administrative expenses 30 to 10 000 19 measures according to § 25 c AMG, depending on the personnel and administrative expenses 30 to 10 000 20 measures pursuant to § 30 paragraph 1 sentence 4, paragraph 1a set 3, paragraph 2 sentence 2, paragraph 2a set 1, section 31 (4) sentence 2, section 42a (1) sentence 2, paragraph 2 sentence 2, paragraph 3 sentence 3 and paragraph 5 AMG 20.1 arrangement of the temporary suspension of a registration according to § 30 paragraph 1 sentence 4 , Paragraph 1a sentence 3, paragraph 2 set 2 AMG and measures according to § 30 paragraph 2a set 1 AMG, with the exception of referred to in fee section 18, and measures pursuant to article 31, paragraph 4, sentence 2 AMG, depending on the personnel and administrative expenses 30 to 10 000 20.2 measures under section 42a (1) sentence 2, paragraph 2 sentence 2, paragraph 3 sentence 3 and paragraph 5 AMG , depending on the personnel and administrative expenses 30 to 3 700 21 decisions pursuant to § 21 paragraph 4 AMG 21.1 decision on the authorisation requirement, depending on the staff and non-staff expenses 900 up to 6 000 21.2 decision on the authorisation of a clinical trial, according to staff and non-staff expenses 900 to 3 700 22 permitted of an exception pursuant to article 31, paragraph 1, sentence 2 AMG, per admission 200 23 set of a reasonable waiting period according to article 59, paragraph 2, sentence 2 AMG 23.1 for a drug with a fabric , the not the classification referred to in article 14 paragraph 2 letter a, b or c of to Regulation (EC) no 470 / 2009 corresponds to 4 300 23.2 for a drug with a substance which the classification referred to in article 14 paragraph 2 letter a, b or c of to Regulation (EC) no 470 / 2009 corresponds to 1 800 24 other individually attributable public services 24.1 scientific opinions on the quality , therapeutic efficacy or safety of a medicinal 100 to 500 24.2 decision on an application for restitutio in integrum according to § 32 VwVfG 260 24.3 decision on a request for revisiting the procedure according to § 51 VwVfG 260 24.4 not simple written information 50 to 500 24.5 consultation of authorisation files outside of a pending administrative proceeding after the fee numbers of 1 to 12, 24.2 or 24.3 30 to 260 24.6 advice the applicant's 200 to 10 000 24.7 issue of a certificate pursuant to section 73a paragraph 2 AMG 100 24.8 certificates, except for the referred to in fee section 24.7, and certification 10 to 150 25 opposition 25.1 contradictions against thing decisions 25.1.1 rejection as inadmissible 160; as far as for the decision by to canvass for a lower fee is provided, this; as far as frame charges are and their mean is low, this 25.1.2 partial or complete rejection as unfounded as far as the opposition has not only because no success because the breach of a procedural or formality under section 45 is irrelevant VwVfG maximum for the charge provided for in to be tested after the opposition proceedings decision in this regulation; as far as a border fee is provided, not more than the upper value.
However, at least 160; as far as for the end of the test according to decision by a lower fee is provided, this 25.1.3 withdrawal of opposition after the beginning of the substantive editing, but prior to their termination not more than 75 per cent of the fee laid down for the examiners to in opposition proceedings to decision in this regulation; as far as a fee of part of is provided, not more than 75 per cent of whose upper value;
However, at least 160; as far as for the decision by to canvass for a lower fee than 160 is envisaged this 25.2 contradictions against fees and expense determinations 25.2.1 rejection as inadmissible
160; as far as the disputed amount is low, this 25.2.2 partial or complete rejection as unfounded as far as the opposition has not only because no success because the breach of a procedural or formality under section 45 is irrelevant VwVfG no more than 10 percent of the disputed amount.
However, at least 160; the contested amount less than 160 is this 25.2.3 at redemption of a conflict after beginning the substantive editing, but prior to their termination not more than 75 percent of the disputed amount.
However, at least 160; as far as the contested amount less than 160 is, this 1 in accordance with title III, Chapter 4 of Directive 2001/83/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311 of 28.11.2001, p. 67), most recently by Regulation (EC) No. 1901/2006 (OJ OJ L 378 of 27.12.2006, p. 1) is has been modified, or in accordance with title III, Chapter 4 of Directive 2001/82/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311 of 28.11.2001, p. 1), most recently by Regulation (EC) no 596 / 2009 (OJ L 188 of the astronomy, p. 14) has been modified.
2 in accordance with title III, Chapter 4 of Directive 2001/83/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311 of 28.11.2001, p. 67), most recently by Regulation (EC) No. 1901/2006 (OJ OJ L 378 of 27.12.2006, p. 1) is has been modified, or in accordance with title III, Chapter 4 of Directive 2001/82/EC of the European Parliament and of the Council of the 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311 of 28.11.2001, p. 1), most recently by Regulation (EC) no 596 / 2009 (OJ L 188 of the astronomy, p. 14) has been modified.