Narcotics Ordinance on Charges (Betäubungsmittel-Kostenverordnung) Introductory clause

Transcription

1 Narcotics Ordinance on Charges (Betäubungsmittel-Kostenverordnung) (locator: BGBl. I 2009, 1675) Introductory clause On the basis of section 25 subsection 2 of the Narcotics Act (Betäubungsmittelgesetz), last amended by Article 18 number 2 of the Ordinance of 25 th November 2003 (BGBl. I p. 2304), in conjunction with Part 2 of the Administrative Expenses Act (Verwaltungskostengesetz) of 23 rd 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 Medizinprodukte) shall levy fees and expenses for tests and analyses, for the processing of applications 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 processing, 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. Section 3 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 appeal proceeding fails only because the violation of a procedural or formal rule pursuant to section 45 of the Law on Administrative Proceedings (Verwaltungsverfahrensgesetz) is irrelevant

2 - 2 - (2) If an administrative appeal proceeding is withdrawn after the initiation of the technical processing but before its completion, the fee shall not be less than 50 euros, but not more than 75 per cent of the fee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 administrative 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 pursuant 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 payable 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 16 th December 1981 (BGBl. I. p. 1433), last amended by Article 3 section 5 of the Law of 24 th June 1994 (BGBl. I. p. 1416), shall continue to apply if the specific official act was applied for before 4 th July 2009 or, if no application is required, completed. Section 6 Entry into force, expiry This Ordinance shall enter into force on the day following its promulgation. Annex 1 (to section 1) Table of fees - 3 -

3 - 3 - (locator: BGBl. I 2009, ) 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: Cultivation including extraction Manufacture (with the exception of intermediary products that arise during manufacture and are directly processed further Domestic trade but per site not more than a total of Foreign trade incl. domestic trade but per site not more than a total of Where the operation only serves scientific or analytical purposes or if no economic purpose is pursued, the following fee shall be levied for each of the following operations per narcotic drug and site: Cultivation including extraction Manufacture (with the exception of intermediary products that arise during manufacture and are directly processed further and preparations for in-house scientific purposes) Acquisition Supply - 4 -

4 Import Export 1.3 For each of the following types of operation, the following fee shall be levied per exempt preparation and site: Manufacture (with the exception of intermediary products that arise during manufacture and are directly processed further Import Export Processing of a notification pursuant to section 4 subsection 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 pharmacies Notification of a change of name or address of the pharmacy or pharmacy operator 35 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 3.2 Issue of a new licence due to a change of the person holding the licence 50 per cent of the fee 3.3 Issue of a new licence due to a change of the site location, other than inside a building 50 per cent of the fee 4 In the cases of section 8 subsection 3 sentence 3 of the Narcotics Act, the following fees shall be levied per site: - 5 -

5 Amendment of the licence if the operation only serves scientific or analytical purposes or if no economic purpose is pursued, for each change 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 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 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 Destruction of narcotic drugs by the Federal Institute for Drugs and Medical Devices pursuant to section 16 subsection 2 of the Narcotics Act, for substances and nonapportioned preparations per each kilogram and parts of a kilogram, for apportioned preparations per each 500 unit package and partly used package Other official acts performed on application 11.1 Written technical information unless of a simple nature 50 to

6 Applied for technical certifications and authentications 50 to Provision of technical counselling to the applicant to 0