Drug Cost Regulation

Original Language Title: Betäubungsmittel-Kostenverordnung

Read the untranslated law here: http://www.gesetze-im-internet.de/btmkostv_2009/BJNR167500009.html

30.06.2009 drug cost Regulation (BtMKostV) BtMKostV Ausfertigung date: full quotation: "drug cost regulation by June 30, 2009 (BGBl. I S. 1675), by article 2 paragraph 21 of the Act of August 7, 2013 (Gazette I p. 3154) is has been modified" V go to. by article 4 paragraph 8 G v. 7.8.2013 I 3154 mWv 14.8.2018 stand: amended by art. 2 paragraph 21 G v. 7.8.2013 3154 for details on the stand number you find in the menu see remarks footnote (+++ text detection from: 4.7.2009 +++) input formula on the basis of § 25 paragraph 2 of the law on Narcotics, most recently by article 18 number 2 of the Decree of 25 November 2003 (BGBl. I S. 2304) is has been modified , in conjunction with the 2nd section of the administrative expenses Act of 23 June 1970 (BGBl. I p. 821), directed the Federal Ministry of health: § 1 scope the Federal Institute for drugs and medicine products rises for individually attributable public services in the field of narcotics traffic fees and expenses according to the following rules and the fee schedule of the plant.

§ 2 fees in special cases for the revocation or the withdrawal of a permit, for the refusal of a permit or authorisation, as well as for the withdrawal of an application by the applicant after the beginning of the substantive processing will be charged a fee in the amount of 75 per cent of the fee determined for carrying out of the public individually attributable performance. The proposed fee can be up to 25 per cent he determined fee is reduced for any modification or their collection can quite apart from be, if this is equitable.

Article 3 fees in opposition proceedings (1) for the partial or complete dismissal of an objection against a decision by a fee is at least 100 euros, but not exceeding the fee laid down for the contested administrative act. This does not apply if the opposition simply has no success because the breach of a procedural or formality is irrelevant to article 45 of the Administrative Procedure Act.
(2) If an opposition after the beginning of substantive editing, but before the termination is withdrawn, the fee is at least 50 euros, but not more than 75 per cent of the fee referred to in paragraph 1 (3) for the partial or complete rejection and withdrawal of an objection directed exclusively against the fees or delivery notice the fee is at least 50 euros, but no more than 10 percent of the disputed amount. The disputed amount is less than 50 euro, will be charged a fee in the amount of the disputed amount.
(4) If an opposition completely as inadmissible is rejected, so the fee is paragraphs 1 and 3 at least 50 euro, a maximum of 100 euros after.
(5) If an opposition is partially rejected, the fee is to reduce paragraphs 1 and 3 according to the proportion of the grant; must not fall below the minimum charge under paragraphs 1 and 3.

§ 4 can be seen off 1, 3 to 9 and 11 partially or completely discounts from charging a fee or delivery in cases of charges numbers, if individually attributable public performance is scientific, analytical or other included in the public interest for purposes of special importance or if the collection in an obvious mismatch for the economic benefit of the debtors of the charges.

Section 5 transitional provision the drug cost regulation of 16 December 1981 (BGBl. I p. 1433), most recently by article 3 section 5 of the Act of 24 June 1994 (BGBl. I p. 1416) has been modified, shall continue to apply if the underlying individually attributable public performance has been requested before July 4, 2009 or, terminated when no application is required,.

Article 6 entry into force, expiry this regulation enter into force on the day after the announcement.

Appendix 1 (to section 1) schedule of fees (site: BGBl. I 2009, 1676 - 1677) fees number paid individually attributable public performance fee in euro is 1 a licence pursuant to section 3 of the Narcotic Drugs Act 1.1 for each of the following types of traffic per narcotics and facility fee following: 1.1.1 cultivation including gaining 190 1.1.2 production (with the exception of intermediates, incurred in the production and are processed immediately) 380 1.1.3 trade 470 1.1.4 - but a total per establishment not exceeding 7 050 1.1.5 trade including trade
830 1.1.6 - but as far as the traffic is only scientific or analytical purposes or without economic purpose is is not more than 12 450 1.2 per establishment for each of the following types of traffic per narcotics and facility fee following: 1.2.1 cultivation including gaining 150 1.2.2 production (with the exception of intermediates, incurred in the production and are immediately processed and of preparations for in-house scientific purposes) 150 1.2.3 purchase 150 1.2.4 release 150 1.2.5 import 150 1.2.6 export 150 1.3  
Following fee is charged for each of the following types of traffic each exempted preparation and establishment: 1.3.1 manufacturing (with the exception of intermediates, incurred in the production and are processed immediately) 380 1.3.2 import 400 1.3.3 export 400 2 editing of an ad after section 4, paragraph 3, of the Narcotic Drugs Act 2.1 display a new Foundation, of a change of operator or a change of legal form of a pharmacy or a pharmacy network 70 2.2 display a change in the name or address of the pharmacy or pharmacy operator 35 3 in cases of section 8 paragraph 3 sentence 2 of the Narcotics Law following charges will apply: 3.1 new licences on the basis of new forms of transport, narcotic drugs or exempted preparations according to fees number 1 3.2 new licences on the basis of a change in the person of the holder of the permit after 50 percent of the fee charges number 1 3.3 new licences on the basis of a change in the location of the permanent establishment , except inside a building, 50 percent of the fee after fee number 1 4 in the cases of § 3 set 8(3) of the Narcotic Drugs Act following per facility charges collected: 4.1 change a permit, as far as the traffic is only scientific or analytical purposes or without economic purpose is changed a permission in all other cases, each change 150 per change 75 4.2 5 extension one by § 9 paragraph 2 No. 1 of the Narcotic Drugs Act temporary permit 25 per cent of the fee after charges number 1 6 change of a permission by virtue in the sense of article 9, paragraph 2 number 2 of the Narcotic Drugs Act 150 7 an injunction after section 15 of the Narcotic Drugs Act 150 8 visits pursuant to section 22 paragraph 1 number 3 of the Narcotic Drugs Act 200 4 000 9 issue of an import permit for section 3 paragraph 1, export permit according to article 9, paragraph 1, as well as a transit permit pursuant to section 13, subsection 2, of the narcotics trade regulation , narcotic drugs or each exempted preparation 60 10 destruction of narcotic drugs by the Federal Institute for drugs and medicine products according to section 16, subsection 2, of the Narcotic Drugs Act, substances and preparations not allocated per prisoner to kilogram, in sectioned preparations per commenced 500 piece 30 11 other individually attributable public services carried out at the request of 11.1 not simple written technical information 50 to 500 11.2 requested technical certifications and accreditations 50 to 250 11.3 expert advice the applicant's 150 to 1 500