Drug Cost Regulation

Original Language Title: Betäubungsmittel-Kostenverordnung

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Narcotic Costs Ordinance (BtMKostV)

Unofficial Table Of Contents


Date Of Delivery: 30.06.2009

Full Quote:

" Narcotics Cost Ordinance of 30. June 2009 (BGBl. 1675), as defined in Article 2 (21) of the Law of 7. August 2013 (BGBl. I p. 3154) has been changed "

V up. by Article 4 (8) G v. 7.8.2013 I 3154 mWv 14.8.2018
Stand:As amended by Art. 2 para. 21 G v. 7.8.2013 I 3154

For details, see the Notes


(+ + + Text Evidence: 4.7.2009 + + +)

menu for details. name="BJNR167500009BJNE000100000 " />Non-Official Table of Contents

Inbox Formula

Based on Section 25 (2) of the Narcotics Act, the last of which is Article 18 (2) of the Regulation of 25 November 2003 (BGBl. 2304), in conjunction with the 2. Section of the Administrative Costing Act of 23. June 1970 (BGBl. 821), is assigned by the Federal Ministry of Health: Non-official table of contents

§ 1 Scope of application

The Federal Institute for Drugs and Drug Administration (Bundesinstitut für Arzneimittel und Bundesinstitut für Arzneimittel und Medical products charges for individually attributable public services in the field of narcotics traffic charges and outlays according to the following regulations and the charging directory of the plant. Non-official table of contents

§ 2 Fees in special cases

For revocation or withdrawal of a permit, for the refusal of a permit or approval as well as for the withdrawal of an application by the applicant after the commencement of the factual processing, a fee of 75 per cent of the fee to be determined for the acceptance of the public service which can be individually attributed collected. The fee may be reduced by up to 25 per cent of the fee to be fixed for the take-up, or may be waivedby its collection if this is equal to the cost of the collection. Unofficial Table Of Contents

§ 3 Charges in Opposition Procedure

(1) For a partial or complete rejection of an appeal against a The relevant decision shall be at least EUR 100, but not more than the fee fixed for the contested administrative act. This does not apply if the contradiction is not successful only because the infringement of a procedural or formal provision according to § 45 of the Administrative Procedure Law is inconformable.(2) Where an objection is withdrawn after the commencement of factual processing but before its termination, the fee shall be at least 50 euro, but not more than 75 per cent of the fee referred to in paragraph 1.(3) For the partial or complete rejection and the withdrawal of an objection exclusively directed against the fee or delivery notice, the fee shall be at least 50 euros, but not more than 10 percent of the contested amount. If the contested amount is less than EUR 50, a fee shall be charged at the level of the contested amount.(4) Where an objection is rejected in its entirety as inadmissible, the fee referred to in paragraphs 1 and 3 shall be at least EUR 50, not more than 100 euro.(5) Where an objection is partially rejected, the fee referred to in paragraphs 1 and 3 shall be reduced in accordance with the share of the taking place; the minimum fee referred to in paragraphs 1 and 3 shall not be undershot. Non-official table of contents

§ 4 Discounts

From the collection of a fee or delivery, in the cases of charge numbers 1, 3 to 9, and 11 in part or in part, where the individually attributable public performance is of particular importance for scientific, analytical or other purposes in the public interest, or where the survey is carried out in a the obvious disproportion to the economic benefits for the fee debtor. Non-official table of contents

§ 5 Transitional provision

The narcotics cost ordinance of 16. December 1981 (BGBl. 1433), as last amended by Article 3 (5) of the Law of 24. June 1994 (BGBl. I p. 1416) shall continue to apply if the underlying individually attributable public performance is before the 4. or, if no application is required, has been terminated. Non-official table of contents

§ 6 Entry into force, override

This Regulation enters into force the day after the announcement. Non-official table of contents

Appendix 1 (to § 1)
Fees Directory

(Fundstelle: BGBl. I 2009, 1676-1677)
Fees to be charged individually payable public service charge in euros
1Grant of a permission in accordance with § 3 of the Narcotics Act
1.1For each of the following traffic types, Deception agent and premises charged:
1.1.1Cultivation including extraction190
1.1.2Manufacture (with the exception of intermediate products that are produced during manufacture and are directly processed)380
1.1.3Internal trading 470
1.1.4-but no more than7 050
1.1.5 Foreign trade including internal trade830
1.1.6-but all in total no more than12 450
1.2 If the traffic is for scientific or analytical purposes only or without economic purpose, the following fee will be charged for each of the following types of transport per narcotics and plant:
1.2.1Cultivation including recovery150
1.2.2Manufacture (with the exception of intermediate products used in the production process) ()150
1.2.3Acquisition 150
1.2.4 levy150
1.2.6Export 150
1.3For each of the following traffic types, The following fee is charged:
1.3.1Manufacture (with the exception of intermediate products that are produced during manufacture and directly processed )380
2Machining an ad according to § 4 paragraph 3 of the Narcotics Act
2.1The display of a new establishment, change of operator, or a change in the legal form of a pharmacy or a pharmacist Pharmacy Composite70
2.2Display of a change in the name or address of the pharmacy or the pharmacist's address 35
3In the cases of § 8 (3) sentence 2 of the The following charges are levied:
3.1Grant of a new permit due to newly recorded modes of transport, narcotics or other authored Preparationscorresponding to
fee number 1
3.2Issuing a new permit due to a change in the person of the permission holder 50 percent of the charge after charge number 1
3.3Granting of a new permit due to a change in location of the site, except inside a building,50 Percent of Charge by Charge Number 1
4In the cases of § 8 paragraph 3 sentence 3 of the Narcotics Act shall be charged for each permanent establishment:
4.1Change of a permit to the extent that the traffic is only scientific or analytical. Purpose, or without economic purpose, for each change75
4.2Change of permission in all other cases, per change 150
5Extension of one of the number 1 in accordance with § 9, paragraph 2, point 1 of the Anesthetic Law Temporary permission25 percent of the fee by fee number 1
6Change of a permit from officiale for the purposes of Section 9 (2) (2) of the Narcotics Act150
7Order of a backup measure in accordance with § 15 of the Narcotics Act 150
8Visits according to § 22 Paragraph 1 (3) of the Narcotics Act200 to 4 000
9 Grant of an import permit pursuant to § 3 (1), export authorisation pursuant to § 9 (1), and a transit authorisation in accordance with § 13 (2) of the German Narcotics Trade Ordinance, per narcotics or 60
10 Destruction of narcotic drugs by the Federal Institute for Drugs and Medical Devices according to § 16 (2) of the Narcotics Act, in the case of substances and undivided preparations per kilogram of kilograms, at Split preparations per 500 pcs.30
11 Other individually attributable public services made on request
11.1Non-simple written subject-specific information 50 to 500
11.2Beanworn technical certificates and certifications50 to 250
11.3Applicant's expert advice 150 to 1 500