- 2 - (Betäubungsmittel-Kostenverordnung)
(locator: BGBl. I 2009, 1675)
On the basis of section 25 subsection 2 of the Narcotics Act (Betäubungsmittelgesetz), last amended by Article 18 number 2 of the Ordinance of 25th November 2003 (BGBl. I p. 2304), in conjunction with Part 2 of the Administrative Expenses Act (Verwaltungskostengesetz) of 23rd June 1970 (BGBl. I. p. 821), the Federal Ministry of Health hereby orders the following:
Section 1 Scope of application
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und
Mediz-inprodukte) shall levy fees and expenses for tests and analyses, for the processing of
applica-tions as well as for other official acts relating to the trade in narcotic drugs, in accordance with the following provisions and the list of fees in the Annex.
Section 2 Fees in special cases
For the revocation or withdrawal of a licence, for the refusal of a licence or authorisation as well as for the withdrawal of an application by the applicant after the initiation of its technical proc-essing, a fee amounting to 75 per cent of the fee to be fixed for the performance of the official act shall be levied. The envisaged fee can be reduced by up to 25 per cent of the fee to be charged for the performance or waived altogether as a matter of equity.
Fees in administrative appeal proceedings
(1) The fee levied for the partial or complete rejection of an administrative appeal proceeding against a decision on the merits of the case shall not be less than 100 euros, but not more than the fee chargeable for the challenged official act. This shall not apply if the administrative ap-peal proceeding fails only because the violation of a procedural or formal rule pursuant to sec-tion 45 of the Law on Administrative Proceedings (Verwaltungsverfahrensgesetz) is irrelevant.
- 3 - (2) If an administrative appeal proceeding is withdrawn after the initiation of the technical proc-essing but before its completion, the fee shall not be less than 50 euros, but not more than 75 per cent of the fee stipulated in subsection 1.
(3) The fee payable for the partial or complete rejection and in case of the withdrawal of an ad-ministrative appeal proceeding that exclusively refers to the fee or expenses notice, shall be not less than 50 euros, but not more than 10 per cent of the contentious amount. If the contentious amount is less than 50 euros, a fee equivalent to the contentious amount shall be levied.
(4) If an administrative appeal proceeding is completely rejected as inadmissible, the fee pursu-ant to subsections 1 and 3 shall not be less than 50 euros, but not more than 100 euros.
(5) If an administrative appeal proceeding is rejected in part, the fee pursuant to subsections 1 and 3 shall be reduced in proportion to the extent to which the appeal is granted; the fee pay-able may not be less than the minimum fee pursuant to subsections 1 and 3.
Section 4 Reductions
A fee or expense may be partly or completely waived in the cases of fee numbers 1, 3 to 9 and 11 if the official act serves scientific, analytical or other purposes of public interest which are of particular importance or if the fee stands in clear disproportion to the economic benefit accruing to the party liable to pay.
Section 5 Transitional provision
The Narcotics – Ordinance on Charges of 16th December 1981 (BGBl. I. p. 1433), last amended by Article 3 section 5 of the Law of 24th June 1994 (BGBl. I. p. 1416), shall continue to apply if the specific official act was applied for before 4th July 2009 or, if no application is required, com-pleted.
Entry into force, expiry
This Ordinance shall enter into force on the day following its promulgation.
Annex 1 (to section 1) Table of fees
- 4 - (locator: BGBl. I 2009, 1676 – 1677)
Number Official act requiring the collection of fees Fee in euros
1 Issue of a licence pursuant to section 3 of the Narcotics Act
1.1 For each of the following types of operation, the following fee shall be levied per narcotic drug and site:
1.1.1 Cultivation including extraction 190
1.1.2 Manufacture (with the exception of intermediary products that arise during manufacture and are directly processed further
1.1.3 Domestic trade 470
1.1.4 - but per site not more than a total of 7 050
1.1.5 Foreign trade incl. domestic trade 830
1.1.6 - but per site not more than a total of 12 450
1.2 Where the operation only serves scientific or analytical purposes or if no economic purpose is pursued, the fol-lowing fee shall be levied for each of the folfol-lowing opera-tions per narcotic drug and site:
1.2.1 Cultivation including extraction 150
1.2.2 Manufacture (with the exception of intermediary products that arise during manufacture and are directly processed further and preparations for in-house scientific purposes)
1.2.3 Acquisition 150
- 5 -
1.2.5 Import 150
1.2.6 Export 150
1.3 For each of the following types of operation, the following fee shall be levied per exempt preparation and site:
1.3.1 Manufacture (with the exception of intermediary products that arise during manufacture and are directly processed further
1.3.2 Import 400
1.3.3 Export 400
2 Processing of a notification pursuant to section 4 subsec-tion 3 of the Narcotics Act
2.1 Notification of the new establishment, change of operator or form of organisation of a pharmacy or group of phar-macies
2.2. Notification of a change of name or address of the phar-macy or pharphar-macy operator
3 In the cases of section 8 subsection 3 sentence 2 of the Narcotics Act, the following fees shall be levied:
3.1 Issue of a new licence based on new forms of operation, narcotic drugs or exempt preparations
according to number 1
3.2 Issue of a new licence due to a change of the person holding the licence
50 per cent of the fee according to number 1
3.3 Issue of a new licence due to a change of the site loca-tion, other than inside a building
50 per cent of the fee according to number 1
4 In the cases of section 8 subsection 3 sentence 3 of the Narcotics Act, the following fees shall be levied per site:
- 6 - 4.1 Amendment of the licence if the operation only serves
scientific or analytical purposes or if no economic pur-pose is pursued, for each change
4.2 Amendment of the licence in all other cases, for each change
5 Extension of a time-limited licence according to section 9 subsection 2 of the Narcotics Act
25 per cent of the fee according to number 1
6 Amendment of a licence ex officio as set out in section 9 subsection 2 of the Narcotics Act
7 Ordering of a security measure pursuant to section 15 of the Narcotics Act
8 Inspections pursuant to section 22 subsection 1 number 3 of the Narcotics Act
200 to 4000
9 Issue of an import authorisation pursuant to section 3 subsection 1, export authorisation pursuant to section 9 subsection 1, as well as transit authorisation pursuant to section 13 subsection 2 of the Ordinance concerning the Foreign Trade in Narcotics (
Betäubungsmittel-Außenhandelsverordnung), for each narcotic drug or
each exempt preparation
10 Destruction of narcotic drugs by the Federal Institute for Drugs and Medical Devices pursuant to section 16 sub-section 2 of the Narcotics Act, for substances and non-apportioned preparations per each kilogram and parts of a kilogram, for apportioned preparations per each 500 unit package and partly used package
11 Other official acts performed on application
11.2 Applied for technical certifications and authentications 50 to 250