Cost regulation for official acts of the Paul-Ehrlich-Institut in accordance with the Medicines Act

Unofficial table of contents

PEhrlInstKostV 1996

Date of completion: 16.12.1996

Full quote:

" Cost Ordinance for Official Acts of the Paul-Ehrlich-Institut in accordance with the Medicines Act, as amended by the announcement of 26 March 2010 (BGBl. 331), as last amended by Article 2 (15) of the Law of 7 August 2013 (BGBl). I p. 3154).

V up. By Article 4 (2) G v. 7.8.2013 I 3154 mWv 14.8.2018
Status:	New by Bek. v. 26.3.2010 I 331
	Last amended by Art. 2 para. 15 G v. 7.8.2013 I 3154

For more details, please refer to the menu under Notes

Footnote

(+ + + Text proof: 24.12.1996 + + +) 

  

Unofficial table of contents

§ 1

(1) The Paul-Ehrlich-Institut shall make decisions concerning the authorisation of a medicinal product, the authorisation of a tissue preparation or a medicinal product for advanced therapies, the release of batches, and the authorisation of a medicinal product for other medicinal products. Individually attributable public services according to the Medicines Act Fees and deposits under this Regulation. (2) For the rejection of an application for the acceptance of an individually attributable public service as well as in the cases of Withdrawal of an application for a performance of an individual attributable Fees are levied in accordance with § 15 of the Administrative Costing Act in the version valid up to 14 August 2013. Unofficial table of contents

§ 2

(1) For admission, fees must be paid in the case of:

1.	Sera			16 110 Euro,
2.	Bacteria, toxoid, parasite and fungal vaccines
	a)	against an infectious disease		EUR 12 530,
	b)	against several infectious diseases per species		EUR 10 740,
3.	Virusimpfsubstances
	a)	against an infectious disease		EUR 21 470,
	b)	against several infectious diseases per species		EUR 13 800,
	c)	in addition, using monkeys		EUR 40 900,
3a.	Combination vaccines against bacterial and viral diseases the sum of the relevant fee rates referred to in points 2 and 3 respectively
4.	a)	Therapeutic allergens and test allergens with the exception of epicutaneous test		EUR 11 250,
	b)	Epidermic testing		EUR 6 750,
5.	Xenogenic medicinal products			10 000 to EUR 27 000,
6.	Blood preparations
	a)	Clotting factors		EUR 27 100,
	b)	Albumin		EUR 14 830,
	c)	virus-activated plasmas		16 360 Euro,
	d)	non-virus-activated erythrocyte concentrates, platelet concentrates and fresh plasmas		EUR 12 780,
	e)	Stem cells and other blood preparations		10 230 to EUR 25 560,
6a.	Tissue preparations			10 230 to EUR 25 560,
7.	an authorisation pursuant to Section 25b (2) of the Medicinal Products Act			EUR 3 830,
8.	an authorisation of medicinal products imported in parallel			EUR 1 530.

(2) Where the authorisation of additional concentrations, strengths or pharmaceutical forms of a medicinal product is applied for, half of the fee referred to in paragraph 1 shall be levied for the authorisation of such medicinal product; in the case of allergens and allergens, a a tenth of the fee referred to in paragraph 1 and, in the case referred to in paragraph 3, one tenth of the reduced fee referred to in paragraph 3. If a medicinal product is authorised for different routes or options, an additional fee of 500 euro will be charged. (3) If a pharmaceutical entrepreneur requests authorisation at the same time for

1.

Therapeutic allergens and test allergens of biologically uniform groups,

2.

Epidermot,

For the first authorisation, the full fee and for each additional authorisation shall be a tenth of the fee referred to in paragraph 1. (4) If the authorisation in individual cases requires an exceptionally high cost, the fee referred to in paragraph 1 may be without prejudice to of § 4c shall be increased to twice the amount. The fee debtor is to be heard if an increase in the fee is to be expected. (5) If the authorisation has required an exceptionally low cost, the fee may be up to a quarter of the fee referred to in paragraph 1 and in the case referred to in paragraph 3. a tenth of the reduced fee referred to in paragraph 3 shall be reduced. (6) For the purpose of creating or updating an assessment report, a fee of 510 euro shall be charged up to the amount of the fee provided for in paragraph 1. (7) Mutual recognition procedure if the Federal Republic of Germany is Without prejudice to the fee referred to in paragraph 6, the reference Member State shall be charged a fee of EUR 2 050 to 12 780 euro. In the case of an arbitration procedure pursuant to Articles 30, 32, 33 or 34 of Directive 2001 /83/EC, the fee shall be doubled. Paragraphs 4 and 5 shall apply accordingly. In order to carry out the decentralised procedure within the meaning of Section 25b (3) of the Medicines Act, a fee of EUR 2 050 to EUR 12 780 is to be levied in addition to the fee in accordance with § 2 (1) (1) (1) to (6a). Paragraphs 2 to 5 and 7 sentence 2 shall apply accordingly. (8) A fee of EUR 2 760 will be charged for the processing of a plasma stock documentation, and a fee of EUR 1 180 will be charged for the processing of a donation stock documentation. Paragraphs 4 and 5 shall apply accordingly. (9) A fee of EUR 200 for the failure to obtain authorisation within the meaning of Article 25 (6) of the Medicines Act due to the dependence of an authorisation procedure in another Member State shall be subject to the following conditions: (10) A fee of 800 euros will be charged for the extension of the term of protection pursuant to Section 24b (1) sentence 3 of the Medicines Act. Unofficial table of contents

§ 2a

(1) For the approval of tissue preparations and blood stem cell preparations according to § 21a paragraph 1 of the Medicines Act, fees shall be payable at:

1.	Stem cell preparations of blood and bone marrow	EUR 6 250,
2.	Musculo-skeletal tissue preparations, including skin, amnion, soft tissue (tendons, fascias), placenta, tumor tissue, embryonal/foetal tissue and tissue preparations of thyroid tissue	EUR 8 000,
3.	Cardiovascular tissue preparations	EUR 7 350,
4.	Tissue preparations from eyes	EUR 6 250,
5.	Other tissue preparations	2 000 to EUR 10 000.

(2) Where tissue preparations as referred to in points 2 to 4 of paragraph 1 are produced in accordance with essentially the same production process, or where an applicant has submitted a number of applications for authorisation, the processing effort shall therefore be reduced. (3) For the decision to issue a certificate within the meaning of § 21a (9) sentence 1 of the German Medicines Act, a fee of 250 euros will be charged. (4) Has the approval a requires exceptionally low effort, the fee may be up to a quarter of the fee, according to Paragraph 1 and, in the case referred to in paragraph 2, shall be reduced to one quarter of the fee referred to in paragraph 2. Unofficial table of contents

§ 2b

(1) A fee of EUR 4 250 to 17 000 is charged for the authorisation of advanced therapy medicinal products pursuant to Section 4b (3) of the Medicinal Products Act. (2) If the authorisation has required an exceptionally high level of effort, § 2 (4) shall apply. accordingly. Unofficial table of contents

§ 3

In accordance with § 36 of the Administrative Procedure Act or pursuant to Section 21a (5), § 28 or Section 30 (2a) of the Medicinal Products Act after the granting of the authorisation pursuant to Section 21 of the Medicinal Products Act or in the context of the authorisations pursuant to § 4b (3) or § 21a (1) of the Medicines Act, in conjunction with Section 21a (5) of the Medicines Act, a fee of 260 to 1 020 euros is charged for this. Section 2 (2) and (3) shall apply accordingly. If the same requirement is placed on further medicinal products of a pharmaceutical entrepre, and if this does not result in a substantially further processing effort, the fee for each additional medicinal product shall be one tenth of the one for the first medicinal product for the first Medicines for a certain fee. Where the same requirement applies to several pharmaceutical companies, the fee shall be calculated on the basis of the actual expenditure and the number of pharmaceutical companies concerned. In such cases, the fee shall be at least 100 euro, as a derogation from the first sentence. Unofficial table of contents

§ 4

(1) In the case of the following decisions concerning the admission according to § 21 of the German Medicines Act or a permit pursuant to § 21a or § 4b of the Medicines Act, fees must be charged for

1.	the arrangement of temporary fame an authorisation pursuant to Article 30 (2) Sentence 2 of the Medicines Act or a permit after Section 21a, paragraph 8, or in accordance with § 4b (3) of the Pharmaceutical Act			EUR 1 020,
2.	the renewal of an authorisation to Section 31 (3) of the Medicines Act			EUR 3 120,
2a.	the renewal of an authorisation in parallel imported medicinal products			800 Euro,
2b.	the prolongation of epidermic tests			EUR 1 560,
3.	the processing of the change of Authorisations under Article 21a (1) or pursuant to Section 4b (3) of the Medicines Act and of change indicators according to § 21a Paragraph 9, sentence 4 of the Medicines Act
	a)	in the event of enlargement of Application Area		EUR 930,
	b)	in the event of a change of nature or Duration of application		EUR 1 120,
	c)	in the event of a change Processing or testing procedures		at least EUR 1 120, Maximum for the Approval in each case in § 2a provided for fee,
	d)	in the event of a change in on the extraction, donor testing, conservation, storage, the duration of durability and the nature of storage		800 Euro,
	e)	when changing the name		220 Euro,
	f)	when changing the name or the company or address of the processor or the Requirements laid down in Article 21a (9) Sentence 4 of the Medicines Act or a change in the sense of Point 4 (e)		100 Euro,
4.	the processing of the modification of an authorisation
	a)	in the case of consent Changes with the exception of Modification of the pack size and the modification of the test and Manufacturing process		EUR 1 120,
	b)	in the case of the amendment of the test and Manufacturing process		at least EUR 1 120, Maximum which are the authorisation provided for fee,
	c)	with the inclusion of a Certificate of the European Drug Agency via a plasma Root documentation in Marketing authorisation documents		260 Euro,
	d)	when a plasma is changed, Root documentation or a Donations-Root Documentation		at least 260 Euro, Maximum § 2 paragraph 8 Sentence 1 in each case provided for fee,
	e)	for all other change screens, as far as they are not Point (f) or (g),		260 Euro,
	f)	when changing the name or the company or address of the the manufacturer or the applicant, in the case of transmission to a other producers, or pharmaceutical entrepreneurs or with co-distribution		100 Euro,
	g)	in the event of a change to the Adaptation of the manufacturing or Verification procedure for a change a monograph of the European the pharmacopoeia,		100 Euro,
5.	the processing of the change of Authorisation of medicinal products after of Regulation (EC) No 1084/2003 the Commission of 3 June 2003 on the examination of amendments an authorisation for human and Veterinary medicinal products authorised by a competent authority Authority of a Member State (OJ C 327, L 159 of 27.6.2003, p. 1), in the case of a change
	a)	within the meaning of Article 3 (2) of Regulation (EC) No 1084/ 2003 (type I A), if:
		aa)	Germany as reference Member State is specified	660 Euro,
		bb)	Germany concerned Member State is	430 euros,
	b)	within the meaning of Article 3 (2) of Regulation (EC) No 1084/ 2003 (type I B), if:
		aa)	Germany as reference Member State is specified	EUR 1 250,
		bb)	Germany concerned Member State is	800 Euro,
	c)	within the meaning of Article 3 (3) of Regulation (EC) No 1084/ 2003 (type II), if:
		aa)	Germany as reference Member State is specified	at least 550 Euro, Maximum the fee for a Authorisation § 2 (1) Number 1 to 6),
		bb)	Germany concerned Member State is	at least 500 Euro, Maximum the fee for a Authorisation § 2 (1) Number 1 to 6a).

(2) In the event of a change in the change in the labelling, package leaflet or specialist information, no additional fee shall be charged for this change in the consequent change. No fee will be charged on an indication of compliance with a requirement. (3) If the same change is indicated for several medicinal products of a pharmaceutical entrepre, the full charge for a medicinal product and for each other medicinal product is: to the extent that no substantial further effort is incurred during the processing, to collect one tenth of the standard fee. Where amendments are also indicated in accordance with Regulation (EC) No 1084/2003, the full charge referred to in paragraph 1 (5) shall be charged and, for the same changes as referred to in paragraph 1, point 4, one tenth of the fee shall be charged. (4) In the case of paragraph 1 (2), (2a), (2b), (4) and (5), § 2 (3) and (5) shall apply, the fee being at least EUR 100. (5) In the case of paragraph 1, additional concentrations, strengths or forms of administration shall apply to § 2 (2) (3) (3) (3)). (6) In the case referred to in paragraph 1 (4) (a), the following shall apply in the case of parallel imported (7) In the case referred to in point (2) and (5) (c) of paragraph 1, Article 2 (4) and (5) shall apply. (8) If an amendment is made in accordance with paragraph 1 (3) (c) or (4) (b), or in accordance with paragraph 1 (5) (c), in so far as it concerns the modification of the test procedure, including in the public interest, the fee may be reduced to one quarter; shall result in the amendment to replace or to avoid animal testing, (9) In the case referred to in paragraph 1 (3) (a) to (d), the the envisaged fee will be reduced to a quarter if the amount of processing required by the change indicator is particularly low and therefore the fee or minimum fee is not appropriate. Unofficial table of contents

Section 4a

(1) The following fees shall be charged for individually attributable public services in connection with the clinical trial:
Approval of the clinical trial in accordance with Section 42 (2) of the Medicines Act,

1.	of a Phase I study, provided that: Medicinal products not included in point 2			EUR 3 000,
2.	of a Phase I study of medicinal products,
	a)	which are listed in Part A of the Annex to Regulation (EEC) No 2309/93 of 22 July 1993 Establishment of Community procedures for the authorisation and monitoring of human and animal-* medicinal products and Creation of a European Agency for the Evaluation of Medicinal products No. L 214 p. 1) Fall		EUR 3 500,
	b)	the somatic cell therapeutics, xenogenic cell therapeutics, Gene transfer drugs are		EUR 4 000,
	c)	whose active substance is a biological Product of human or animal is of origin or biological Components of human or animal origin or the manufacture of which such Components required		EUR 3 500,
	d)	that genetically modified Organisms are or are contained		EUR 7 500,
3.	a Phase II or III study, provided that: the medicinal products not under point 4 Fall			EUR 4 000,
4.	of a Phase II and III study of medicinal products,
	a)	which are listed in Part A of the Annex to Regulation (EEC) No 2309/93 Fall		EUR 5 000,
	b)	the somatic cell therapeutics, xenogenic cell therapeutics, Gene transfer drugs are		EUR 6 000,
	c)	whose active substance is a biological Product of human or animal is of origin or biological Components of human or animal origin or the manufacture of which such Components required		EUR 5 000,
	d)	or genetically modified Organisms are or are contained		EUR 9 500,
5.	A Phase IV study			EUR 3 000,
6.	a)	in the event of substantial changes Section 42 (3) of the Medicines Act in conjunction with Section 10 (1) of the GCP Regulation		780 Euro,
	b)	for other changes that are displayed		85 Euro.

(2) If the authorisation in individual cases requires an exceptionally high cost, the fee referred to in paragraph 1 may be increased to twice as much as possible, without prejudice to § 4c. The fee debtor is to be heard if an increase in the fee is to be expected. If the permit has an exceptionally low cost, or if a follow-up study is requested, the evaluation of which data can be used from prior approval procedures of clinical trials with the same investigational medicinal product, the fee referred to in paragraph 1 may be reduced to a quarter. The same shall apply where the approval of a study with an authorised medicinal product authorised pursuant to § 21a or § 4b of the Medicinal Products Act, which is to be examined outside the conditions of use indicated in the technical information, (3) The following fees are levied for further public services which are individually attributable:

1.	for the arrangement of the temporary Retire of approval after Article 42a, paragraph 1, sentence 2 or paragraph 2 Sentence 2 of the Medicines Act			EUR 1 000,
2.	for the arrangement of measures within the meaning of Section 42a (5) of the Pharmaceutical Law			250 to EUR 1 000,
3.	a)	for the transmission of information to those at the European Pharmaceutical Agency established European database for clinical trial (EudraCt database) pursuant to Article 42 (3) of the Pharmaceutical Law in conjunction with Section 14 (3) of the GCP Regulation		340 euros.
	b)	If the information is presented on the template a full XML file has been submitted, the Fee		85 Euro.

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§ 4b

(1) The evaluation of the regular, updated report on the safety of the medicinal product pursuant to Section 63b (5) of the Medicines Act shall be subject to fees if:

1.	the medicinal product shall be applied only in the rich in the pharmaceutical law, is to be
	a)	without evaluation report		EUR 1 800,
	b)	with detailed evaluation report		EUR 2 250,
2.	the medicinal product in the procedure of: recognition or in the de- authorised centralised procedures and the Federal Republic of Germany Germany Reference Member State is			EUR 3 600,
3.	the medicinal product in the procedure of: recognition or in the de- authorised centralised procedures and the Federal Republic of Germany Germany affected Member State is			2 400 Euro.

(2) A fee of EUR 1 000 is levied for the evaluation of the annual reports on the safety of the participants in accordance with § 42 (3) of the German Medicines Act in conjunction with Section 13 (6) of the GCP Regulation. (3) For the evaluation of the updated report on the safety of a medicinal product on the basis of the obligations referred to in § 63c (4) of the Medicines Act shall be charged as follows:

1.	without evaluation report	EUR 1 800,
2.	with detailed evaluation Report	2 250 Euro.

(4) A fee of 400 euros will be charged for the extension of the reporting intervals pursuant to § 63b (5) sentence 5 of the German Medicines Act. Unofficial table of contents

§ 4c

In order to verify the admission-related information in accordance with § 25 (5) of the German Medicines Act or to review the collection and evaluation of medicinal products risks as well as the coordination of measures within the meaning of Section 63b (5a) of the Pharmaceutical Act or for the examination of the approval-related information pursuant to § 42 (3) of the German Medicines Act in conjunction with Section 9 (5) of the GCP Regulation or for the review of the collection and evaluation of drug risks in accordance with § 63b (5a) or Section 63c (5) of the Medicinal Products Act shall be subject to an inspection, the The fee is charged at a maximum of EUR 25 000. The fee debtor shall be heard if such an inspection is intended if the estimated fee exceeds EUR 5 000. Unofficial table of contents

§ 5

(1) The fee for the release of a batch shall be:

1.	Sera
	a)	monoclonal antibodies		EUR 2 150,
	b)	other Sera		EUR 1 430,
2.	Bacterial and toxoid vaccines
	a)	against an infectious disease		EUR 1 480,
	b)	against several infectious diseases -- nature per species		970 Euro,
	c)	by using tempo in addition,		EUR 1 500,
3.	Parasites and fungal vaccines			970 Euro,
4.	Virusimpfstoffe
	a)	against an infectious disease		EUR 2 660,
	b)	against several infectious diseases -- nature per species		EUR 1 530,
4a.	in the case of combination vaccines against bacterial and viral diseases, the fee shall be the sum of the relevant fee rates referred to in point 2 (b), (2) (c) and (4) (b) respectively,
5.	Therapeutic allergens			610 Euro,
6.	Test allergens
	a)	from biological materials		310 Euro,
	b)	from biological materials, if the medicines are already Allergen extract solutions tested are produced,		150 Euro,
	c)	from other materials		150 Euro,
7.	Tuberculins			EUR 1 020,
8.	(dropped)
9.	Blood preparations
	a)	PPSB		EUR 3 630,
	b)	factor VIII (human and veterinarian), Factor IX		EUR 3 320,
	c)	other clotting factors, Fi- bringlue		EUR 3 020,
	d)	Albumin		EUR 1 790,
	e)	Plasmas		EUR 2 660.

(2) If, at the same time, the release of several batches of a blood preparation, which differ only in their concentration, is requested, the full charge for the release of the first batch and half of the total charge for the release of each additional batch shall be the release of the first batch. (3) If, at the same time, the release of several batches of a therapy allergen, which differ only in their concentration, is requested, the full charge and for the release of the first batch shall be the full charge and the fee for the first batch. Release of each additional charge half of the fee referred to in paragraph 1 (5). (4) If a batch requires an exceptionally high level of effort, the fee may be increased up to the rates referred to in § 2 (1). The fee debtor is to be heard if an increase in the fee is to be expected. (5) You can check an already released batch or a batch submitted at the same time for the examination in the decision on the release of a batch. The fee can be reduced to a quarter. (6) For the exemption from the state batch examination in accordance with § 32 (4) of the German Medicines Act (Medicines Act) the fee shall be three times the rate referred to in paragraph 1 for the medicinal product concerned , and in the case of medicinal products imported in parallel, 300 euro. (7) The release of a batch shall be carried out on the basis of the examination by the competent authority of a Member State of the European Union or of another Contracting State of the Agreement on the European Economic Area , or if the charge has been certified by the Paul-Ehrlich-Institut within the meaning of § 8 (5), the fee shall be 100 euros. Unofficial table of contents

§ 6

The fees to be charged pursuant to § § 2 to 5 may be reduced to half if the value, the economic value or the other benefits of the individually attributable public service for the debtor and his/her personal data are to be paid. economic circumstances so justifiable. Unofficial table of contents

§ 7

The fees to be levied in accordance with § § 2 to 5 may be reduced up to a quarter at the request of the fee debtor if the medicinal product is placed on the market as a result of the area of application of a public interest and if the application area is Applicants as a result of the rarity of the use cases cannot expect an economic benefit commensurate with these charges and the development effort. The levying of charges may be quite apart if the economic benefits to be expected are particularly low in relation to development costs. Unofficial table of contents

§ 8

In the case of the following individually attributable public services, which are made on request, fees must be charged for

1.	scientific opinions to the manufacturing process, to the Qua -the therapeutic effect of the nature or safety of the Arz Tiltable			260 to EUR 22 000,
2.	independent deliberations and their Pre-and post-processing			68 Euro per employee per hour,
3.	Non-simple written information			100 Euro,
4.	certificates, secondary and secondary documents; and Certifications			50 Euro,
5.	Certification of batch testing for batches which do not apply in accordance with § 32 1 sentence 1 of the medicinal product are released			§ 5 paragraph 1 provided for fee,
6.	Certificates for batches, which according to § 32 (1), the first sentence of the medicinal product have been released			50 Euro,
7.	Plasma pool testing
	a)	per NAT marker		80 Euro,
	b)	Virus serology including egg NAT Markers		100 Euro,
8.	Reinstatation of the previous Status in accordance with Section 32 of the Administrative- Procedural law			200 Euro.

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§ 9

(1) For the clinical examination of medicinal products for which, before 6 August 2004, the documents required for the head of the clinical trial in accordance with Section 40 (1), second sentence, of the Medicinal Products Act, in the version valid up to 5 August 2004, are required have been submitted for the processing of documents for the clinical trial in accordance with § 40 (1) of the German Medicines Act in the version valid until 5 August 2004:

1.	in the event of a consent Evaluation of an Ethics Committee- Sion	770 Euro,
2.	as far as no consant of an Ethics Committee, is located	EUR 4 090.

(2) The cost regulation in the version in force as from 24 July 2005 shall also apply to cases in which individually attributable public services within the meaning of § § 4a and 4b have been carried out before 24 July 2005 and the fee collection With a view to supplementing the cost regulation for official acts of the Paul-Ehrlich-Institut according to the Medicines Act, the applicant has been reserved for a corresponding fee and the applicant before the completion of the services on the the estimated fee level. (3) The cost regulation in the 24 July 2005 shall continue to apply to amendments to the authorisation within the meaning of Article 4 of Regulation (EC) No 1084/2003, which shall apply between the 1. It was indicated in October 2003 and the entry into force of the Second Regulation amending the Costing Ordinance for Official Acts of the Paul-Ehrlich-Institut in accordance with the Medicines Act. Unofficial table of contents

§ 10

(1) A contradiction shall be made against a

1.

Decision

a)

dismissed as unfounded, the fee is EUR 200, and if the processing of the objection has not only required a simple technical assessment, at least EUR 200 up to the level of the substantive decision taken in this case Regulation, as provided for in

b)

is rejected as inadmissible, the fee is 200 euros,

2.

Charge fixing

a)

as unfounded, the fee shall be 10 per cent of the contested amount, but not more than EUR 500, and if the processing of the objection has not only required a simple technical assessment, a maximum of EUR 1 750,

b)

shall be rejected as inadmissible, the fee shall be 10 per cent of the contested amount, but not more than 200 euro. Fees of less than 40 Euro are not to be charged.

(2) Where an appeal is partially granted, the fee referred to in paragraph 1 shall be reduced in accordance with the share of the event. (3) If an appeal has been commenced after the substantive processing has commenced, it shall be withdrawn before the end of the appeal; the fee to be charged shall not exceed 75% of the fee referred to in paragraph 1. Unofficial table of contents

§ 11

Expositions are levied in accordance with § 23 (6) of the Federal Law on Fees. Unofficial table of contents

§ 12

(1) This Regulation, as amended on 4 July 2009, shall also apply to cases in which individually attributable public services within the meaning of Section 2a have been carried out before 4 July 2009 and the charging of fees for the purposes of to supplement the expenses regulation for official acts of the Paul-Ehrlich-Institut with a corresponding fee and the applicant has been informed of the estimated fee level. (2) This regulation in the 12 April 2011 shall also apply to cases in which prior to the 12. Public services within the meaning of Section 4b (3) of the German Medicines Act (Medicinal Products Act) have been made and the fee collection for the purpose of supplementing the Costing Ordinance for official acts of the German Medicines Act ("Act of the Federal Government") Paul-Ehrlich-Institut has been reserved for a corresponding fee collection and the applicant has been informed of the estimated fee level.