Medicine Pricing Regulation

Original Language Title: Arzneimittelpreisverordnung

Read the untranslated law here: http://www.gesetze-im-internet.de/ampreisv/BJNR021470980.html

Medicine pricing Regulation (AMPreisV) AMPreisV Ausfertigung date: 14.11.1980 full quotation: "medicine pricing Decree of November 14, 1980 (BGBl. I S. 2147), most recently by article 2 b of the Act of 27 March 2014 (BGBl. I p. 261) has been changed" stand: last amended by art. 2 b G v. 27.3.2014 I 261 for more information on the stand number you see in the menu see remarks footnote (+++ text detection from: 1.1.1981 +++) input formula on the basis of § 78 of the medicines Act of 24 August 1976 (BGBl. I p. 2445) , 2448) is in agreement with the Federal Minister for youth, family and health, the Federal Minister for labour and Social Affairs and the Federal Ministry of food, agriculture and forestry with the consent of the Federal Council decreed: article 1 scope of the Regulation (1) for medicinal products which are manufactured in advance and placed in a package destined for delivery to the consumer in the traffic (finished product) and their distribution according to § 43 para. 1 of the German medicines Act reserved the pharmacies is , 1 set by this regulation, the price ranges of wholesale distribution in the resale to pharmacies or veterinarians (§ 2), 2nd the price ranges, as well as the prices for special services of pharmacies at the levy in the resale (§§ 3, 6 and 7), 3. the price ranges of the veterinarians at the levy in the resale to pet owners (§ 10).
(2) for medicinal products which are manufactured in pharmacies or veterinarians and their dispensing pharmacies is reserved according to § 43 para. 1 and 3 of the medicines Act, 1 set by this regulation, the price ranges, as well as the prices for special services of pharmacies (articles 4 to 7), 2nd the price ranges of veterinarians (§ 10).
(3) except the prices pharmacies and price ranges are 1 through hospital pharmacies, 2 institutions assimilated to hospitals and this according to § 14 paragraph 8 sentence 2 of the pharmacy Act, as well as in prisons and juvenile detention centers, if it's a tax 3 to in article 47, paragraph 1, sentence 1 number 2 to 9 of the German medicines Act listed individuals and entities under the designated conditions , 3a.
of vaccines, the vaccinations recommended for use in public in the sense of § 20 para 3 of the infection Protection Act of 20 July 2000 (Federal Law Gazette I p. 1045) are determined and these vaccines are delivered to hospitals, health departments and doctors, 4 by vaccines, which are intended for use in General, in particular regulatory or operational flu precautionary measures 5 to health authorities for measures of rickets prevention, 6 of blood concentrates , to the application for hemophilia, as well as of medicinal products which are intended for use in kidney patients dialysis, 7 of subsets taken from finished product, as far as their dosage form, composition and strength remains unchanged, 8 of finished medicinal product in parenteral preparations.
In the case of set, social service providers, private health insurance, or their associations may agree the procedure for the calculation of the selling prices in pharmacies for the drugs given at your expense with pharmacies or their associations 1 Nr. 7.
(4) excluded are the price ranges and prices of non-prescription medicines.

§ 2 wholesale supplements for medicinal (1) be in the dispensing of finished medicinal products intended for use in humans by wholesalers to pharmacies or veterinarians may at most receive a supplement of 3.15 percent, but not more than 37,80 euros, on the selling price of the marketing authorisation without the sales tax plus a fixed surcharge of 70 cents and the turnover tax levied. Distribution of finished medicinal products intended for use in animals by wholesalers to pharmacies or veterinarians, maximum charges according to paragraph 2 or 3, as well as the sales tax may be levied on the selling price of the marketing authorisation without the sales tax. Is the amount of calculation of charges pursuant to sentence 1 each to be based at the pharmaceutical entrepreneur are the medicines according to section 78, paragraph 3 or paragraph 3a of the medicines Act.
(2) the maximum aggregate rate referred to in paragraph 1 is at a selling price of the marketing authorisation to 0.84 euros 21.0 2 percent (range 17.4 percent), 0.89 euros to €1.70-20.0% (range 16.7 percent), 1.75 euros up to 2.56 euro 19.5 percent (range 16.3 per cent), 2.64 euros up to 3.65 euros 19.0 percent (range 16.0 percent), by 3.76 euro up 6.03 euro 18.5 percent (margin 15.6 percent) , 6.21 euros to 9,10 EUR 18.0% (range 15.3 percent), 10.93 euros to 44,46 euro 15.0 percent (range 13.0 percent), 55,59 euros to 684,76 euros-12.0 percent (range 10.7 per cent), from 684,77 Euro 3.0 percent plus 120,53 euro.
(3) the maximum surcharge referred to in paragraph 1 is set 2 at a selling price of the marketing authorisation of 0.85 euros up 0.88 Euro 0.18 euros, 1.71 euros to 1.74 euros 0.34 euros, 2.57 euros up 2.63 Euro 0.50 euro, from 3.66 euros to 3.75 Euro 0.70 euros, 6.04 euros to 6.20 euros 1.12 euros, 9.11 EUR 10.92 EUR 1.64 euros to , by receiving 44.47 Euro 55,58 Euro 6.67 euro up.

§ 3 pharmacy supplements for medicinal (1) distribution of finished medicinal products intended for use in people, through the pharmacies are to calculate the price of the pharmacy dispensing a fixed surcharge of 3 percent plus 8.35 euros plus 16 cents to promote the provision of emergency service, as well as the sales tax. As far as finished medicinal products intended for use in humans, are delivered through the pharmacies for use in animals, at most a surcharge of 3 percent plus 8.10 euros, as well as the sales tax may be levied to calculate the pharmacy dispensing price notwithstanding sentence 1. At submission of finished medicinal products intended for use in animals, through the pharmacies are allowed to calculate the pharmacy dispensing price maximum surcharges after paragraph 3 or 4, as well as the sales tax be imposed.
(2) the fixed charge is to raise the amount from the aggregation of the current supply of wholesale tax price of the marketing authorisation without the sales tax and the related wholesale maximum surcharge referred to in paragraph 2 arising, 2nd at finished product that are directly to obtain b paragraph 2 sentence 3 of the German medicines Act only by the pharmaceutical entrepreneur, on the applicable for delivery of Pharmacy selling price of the marketing authorisation without the VAT according to § 52 1. Section 2, paragraph 1, sentence 3 shall apply accordingly.
(3) the maximum charge rate is 3 referred to in paragraph 1 amount to 1.22 euros 68 per cent (40.5 per cent range), from 1.35 euros up to 3.88 euros 62 percent (range 38.3 per cent), 4.23 euros to 7,30 Euro 57 percent (range 36.3 per cent), 8.68 euros to 12,14 euro 48 per cent (range 32.4 percent), 13.56 euros to 19.42 euros 43 percent (range 30.1 percent) , 22,58 euros to 29,14 euro 37 percent (range 27.0 per cent), 35.95 euros to 543,91 euros-30 percent (range 23.1 percent), from 543,92 Euro 8,263 percent plus 118,24 euro.
(4) the maximum penalty sentence 3 is referred to in paragraph 1 at 1.23 euros to 1.34 EUR 0.83 euros, 3.89 euros to 4.22 euros 2.41 euros, from 7.31 euro up 8.67 euros 4.16 euros, 12.15 euros to 13.55 euros 5.83 euros, 19.43 euros to 22,57 Euro 8.35 euros, 29,15 EUR to 35,94-EUR 10.78 euros.
(5) if the amount to be not in the prescription is required or legally determined, the pharmacies have, unless with the payers unless otherwise agreed, to calculate the smallest Pack on the market.
(6) for the renewed delivery of prescription medicinal returned to a pharmacy by the pharmacy, the fixed penalty is 5.80 euros.

§ 4 pharmacy charges for fabric (1) when a substance, which is racked, bottled, packaged in pharmacies in an unaltered state or marked, are a fixed surcharge of 100 percent (50 percent range) to raise on the pharmacy purchase price without VAT for fabric and required packaging, as well as the sales tax.
(2) is by the pharmacy purchase price of the disposal quantity of the substance, whichever is the purchase price of the usual packaging.
(3) if the authoritative umbrella organization formed for the protection of economic interests of pharmacists with the organisation Federal of health insurance fund agreements about pharmacy purchase price, which will be based the calculation, so the fixed premium for the taxes covered by this agreement by way of derogation from paragraphs 1 and 2 on these prices to rise. The same is true when social security institutions, private health insurance, or their associations with pharmacies or their associations make appropriate arrangements; such an agreement does not exist, can be placed on the prices agreed pursuant to sentence 1.

§ 5 pharmacy charges for preparations of substances (1) at the output of a preparation of a fabric or several materials, which is made in pharmacies, are 1 a fixed surcharge of 90 percent on the pharmacy purchase price without VAT for substances and required packaging, 2. a formula supplement according to raise paragraph 3, as well as the sales tax.
(2) is by the pharmacy purchase price of the quantities required for preparing substances and medicinal. Decisive is the purchase price of the usual packaging, 2 1 substances.
in finished product the purchase price pursuant to section 3 para 2 of the required size of the package, but no more than the pharmacy purchase price which applies to delivery in public pharmacies for medicinal.
(3) the recipe is for 1. the manufacture of a medicinal preparation in a fabric or several substances up to the basic amount of 500 g, the preparation of a mixed tees, manufacture a solution without the use of heat, mixing of liquids up to the basic amount of 300 g 2,50 euro, 2. the preparation of powders, undivided powders, ointments, pastes, suspensions and emulsions up to the basic amount of 200 g, the preparation of solutions under application of heat maceration, infusions and decoctions to the base quantity of 300 g 5,00 euro, 3. the manufacture of pills, tablets and pastilles to the base quantity of 50 pieces, the making of separate powders, suppositories, vaginal balls and for filling capsules up to the basic set of 12 pieces, the manufacture of drugs with implementing a sterilization, sterile filtration, or aseptic preparation up to the basic amount of 300 g, for melting of ampoules up to the basic set of 6 pieces 7.00 euro.
For each beyond the basic amount smaller equal amount, the recipe surcharge to each 50 per cent up.
(4) meets the relevant umbrella organization formed for the protection of economic interests of pharmacists with the organisation Federal of health insurance fund agreements about pharmacy purchase price, which should be based the calculation, is to raise paragraph 1 No. 1 of the taxes covered by this agreement notwithstanding the fixed charge after by paragraphs 1 and 2 on these prices. The same is true when social security institutions, private health insurance, or their associations with pharmacies or their associations make appropriate arrangements; such an agreement does not exist, can be placed on the prices agreed pursuant to sentence 1. No agreement about a billable purchase prices for finished medicinal preparations is set 1 or set 2, the pharmacy purchase price is not more than to calculate, which applies to sales to consumers on the basis of this regulation.
(5) the authoritative umbrella organization formed for the protection of economic interests of pharmacists meets with the Association of top federal of health insurance fund agreements over the height of the fixed or recipe urzuschlages to in paragraph 1 so are no. 1 or no. 2, to take into account the agreed charges by way of derogation from paragraph 1 or paragraph 3 in the price calculation. The same is true when social security institutions, private health insurance, or their associations with pharmacies or their associations make appropriate arrangements; such an agreement does not exist, can be placed on the prices agreed pursuant to sentence 1.
(6) no agreement on pharmacy charges for the preparation of materials under paragraph 5 is set 1 or set 2, the surcharge for parenteral solutions by way of derogation from paragraph 1 or paragraph 3 for 1 is zytostatikahaltige solutions 90 euro, 2. solutions with monoclonal antibodies 87 euros, 3. antibiotika-and virustatikahaltige solutions 51 euros, 4. solutions with painkillers 51 euro, 5. nutrition solutions 83 euro , 6 Calciumfolinatlösungen 51 euros, 7 other solutions 70 euro.

Pharmacies § 6 emergency services for use in the period from 20 to 6 o'clock, on Sundays and public holidays as well as on the 24th of December, if this day on a working day, until 6: 00 and from 14: 00 can charge an additional amount of 2.50 including VAT.

§ 7 narcotics in giving an anesthetic, whose whereabouts after § 15 of the drug prescription regulation as amended by the notice of April 25, 1978 (BGBl. I S. 537) is to prove pharmacies can charge an extra amount of 0.26 euros including VAT.

§ 8 special procurement unavoidable telegram charges, distance, postage, customs duties and other costs of the procurement of pharmaceutical products, which usually kept in stock be in pharmacies nor in the wholesale trade, the pharmacies with the consent of the ledger separately calculate.

Information on the prescription the prescription are article 9 pharmacies individually to indicate 1 in medicinal the pharmacy selling price in addition calculated amounts and the sum of the individual amounts, 2. for medicinal products which are manufactured in pharmacies, also the individual amounts of the pharmacy dispensing price, 3. amount according to § 6 the time of use.

§ 10 supplements of veterinarians (1) distribution of medicines by veterinarians at pet owners may be levied a maximum surcharges according to section 3, subsection 1, sentence 2 and 3 and 2 to 4, article 4, paragraph 1 and 2 and § 5 para 1 to 3 as well as the sales tax.
(2) is the authoritative for the contract according to § 3 par. 2 amount of 51.13 euros, so are to rise following surcharges for exceeding 51.13 euros: from 51.13 euros to 127,82 euros more than 25 percent, from more than 127,82 euros more than 20 per cent.
(3) (dropped out) § 11 prices in special cases with the supply of finished medicinal in the cases of § 78 para 4 of the medicines Act the selling price of the marketing authorisation is replaced in application of this regulation through the country selling price. With emission of substances or preparations the country selling price is for the calculation of the cost of pharmacy as well as agreements on pharmacy purchase price according to § 4 section 3 and section 5 para 4 also to be based. By way of derogation of § 4 para 3 as well as article 5 par. 4 and 5 associations also formed for the economic interests of the pharmacist with the health insurance companies or their associations can meet agreements about the pharmacy purchase price and supplements.

§ 12 entry into force, superseded provisions (1) this regulation enters into force on January 1, 1981.
(2) the closing formula of the Federal Minister for economic