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Drug Pricing Regulation

Original Language Title: Arzneimittelpreisverordnung

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Drug Pricing Regulation (AMPrice V)

Unofficial table of contents

AMPrice V

Date of completion: 14.11.1980

Full quote:

" Drug Price Regulation of 14 November 1980 (BGBl. 2147), the most recent of which is Article 2b of the Law of 27 March 2014 (BGBl. I p. 261) "

Status: Last amended by Art. 2b G v. 27.3.2014 I 261

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.1.1981 + + +) 

Unofficial table of contents

Input formula

On the basis of § 78 of the Pharmaceutical Act of 24 August 1976 (BGBl. 2445, 2448), the Federal Minister for Youth, Family and Health, the Federal Minister for Labour and Social Affairs and the Federal Minister for Food, Agriculture and Forestry, with the approval of the Federal Council, is responsible for the following: Unofficial table of contents

Section 1 Scope of the Regulation

(1) For medicinal products which are manufactured in advance and placed on the market in a pack intended for delivery to the consumer (ready-to-use medicinal product) and whose delivery is reserved to pharmacies in accordance with Section 43 (1) of the Medicines Act, shall be determined by this Regulation
1.
the price margins of the wholesale trade in the sale of the resale to pharmacies or veterinarians (§ 2);
2.
the price margins and the prices for the special services of pharmacies in the sale in resale (§ § 3, 6 and 7),
3.
the price margins of veterinarians in the sale of animal owners in resale (§ 10).
(2) For medicinal products manufactured in pharmacies or by veterinary surgeons and whose duty is reserved for pharmacies in accordance with Article 43 (1) and (3) of the Medicines Act, this Regulation shall lay down the provisions of this Regulation.
1.
the price margins and the prices for special services of pharmacies (§ § 4 to 7),
2.
the price margins of veterinarians (§ 10).
(3) The prices and prices of pharmacies shall be withdrawn if the levy is a charge.
1.
by hospital pharmacies,
2.
to hospitals and to establishments treated as such pursuant to Article 14 (8), second sentence, of the Pharmacy Act, as well as to prisons and juvenil-performing institutions;
3.
the persons and entities referred to in Article 47 (1), first sentence, points 2 to 9 of the Medicinal Products Act, in accordance with the conditions laid down therein,
3a.
of vaccines which are used for the purposes of applying publicly recommended protective vaccinations within the meaning of Section 20 (3) of the Infection Protection Act of 20 July 2000 (BGBl. 1045), and these vaccines are given to hospitals, health care centres and doctors,
4.
of vaccines intended for use in general, in particular administrative or operational, influenza preparedness measures,
5.
health authorities for measures of revenge prevention,
6.
blood concentrates intended for use in blood diseases, as well as medicinal products intended for use in the dialysis of kidney vans,
7.
subsets taken from finished medicinal products, in so far as their pharmaceutical form, composition and strength remains unchanged,
8.
of ready-to-use medicinal products in parenteral preparations.
In the case of the first sentence of paragraph 7, social security institutions, private health insurance undertakings or their associations may apply the procedure for calculating the prices of pharmacies for the medicinal products to be charged to the pharmacies or associations thereof. (4) The prices and prices of medicinal products not subject to medical prescription shall be withdrawn. Unofficial table of contents

§ 2 wholesale surcharges for ready-to-use medicinal products

(1) In the case of the supply of ready-to-use medicinal products intended for use in humans, the wholesale sale of pharmacies or veterinarians shall not exceed a supplement of 3.15 without the turnover tax of the pharmaceutical entrepre %, but not more than EUR 37,80, plus a fixed surcharge of 70 cents, and the VAT. In the case of the supply of ready-to-use medicinal products intended for use in animals, the wholesale distribution of pharmacies or veterinarians shall not exceed the surcharge referred to in paragraph 2, or shall not exceed the turnover tax of the pharmaceutical entreprenter, The calculation of the surcharges in accordance with the first sentence shall be based in each case on the amount to which the pharmaceutical entrepreate shall issue the medicinal product in accordance with Article 78 (3) or (3a) of the Medicines Act. (2) The The maximum surcharge referred to in the second sentence of paragraph 1 shall be at a dispensing price of the pharmaceutical Contractor
up to 0,84 Euro 21.0 percent
(Span 17.4 percent),
from 0,89 Euro up to 1,70 Euro 20.0 percent
(Span 16.7 percent),
from 1.75 Euro up to 2,56 Euro 19.5 percent
(Span 16.3 percent),
from 2,64 Euro up to 3.65 Euro 19.0 percent
(Span 16.0 percent),
from 3,76 Euro up to 6.03 Euro 18.5 percent
(Margin 15.6 percent),
from 6,21 Euro up to 9,10 Euro 18.0 percent
(Margin 15.3 percent),
from 10,93 Euro to 44.46 Euro 15.0 percent
(Margin 13.0%),
from 55,59 Euro to 684,76 Euro 12.0 percent
(Margin 10.7 percent),
from 684,77 Euro 3.0 percent
plus 120.53 euros.
(3) The maximum surcharge referred to in the second sentence of paragraph 1 shall be the case of a dispensing price of the pharmaceutical entrepre
from 0,85 Euro to 0,88 Euro EUR 0.18,
from 1.71 Euro to 1,74 Euro EUR 0.34,
from 2,57 Euro to 2,63 Euro 0,50 Euro,
from 3,66 Euro to 3,75 Euro EUR 0.70,
from 6,04 Euro to 6,20 Euro EUR 1.12,
from 9,11 Euro to 10,92 Euro EUR 1.64,
from 44,47 Euro to 55,58 Euro 6.67 Euro.
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§ 3 pharmacy surcharges for ready-made medicinal products

(1) In the case of the supply of ready-to-use medicinal products intended for use in humans, pharmacies shall be subject to a fixed surcharge of 3 per cent plus EUR 8.35 plus 16 cents for the purpose of calculating the pharmacy delivery price. To collect the emergency service and the sales tax. To the extent that ready-to-use medicinal products intended for use in humans are administered by pharmacies for use in animals, a maximum of 3% surcharge may be added for the calculation of the price of the pharmacy, by way of derogation from the first sentence. 8.10 Euro as well as the sales tax. In the case of the supply of ready-to-use medicinal products intended for use in animals, the pharmacies may, for the purposes of calculating the price of the pharmacy, charge no more than surcharges referred to in paragraphs 3 or 4 and the turnover tax. (2) The fixed supplement is to be collected
1.
the amount resulting from the aggregation of the selling price of the pharmaceutical carrier in respect of the supply to the wholesale trade, without the turnover tax and the wholesale surcharge of the wholesale trade referred to in paragraph 2,
2.
in the case of ready-to-use medicinal products which, in accordance with Article 52b (2), third sentence, of the Medicinal Products Act are to be directly referred to by the pharmaceutical operator, on the dispensing price of the pharmaceutical entreponse which applies to the supply of the pharmacy without the Turnover tax; § 2 (1) sentence 3 shall apply accordingly.
(3) The maximum surcharge referred to in the third sentence of paragraph 1 shall be the sum of:
up to 1,22 Euro 68 percent
(Margin 40.5%),
from 1,35 Euro up to 3.88 Euro 62 percent
(Span 38.3 percent),
from 4,23 Euro up to 7,30 Euro 57 percent
(Span 36.3 percent),
from 8,68 Euro up to 12,14 Euro 48 percent
(Margin 32.4 percent),
from 13,56 Euro up to 19,42 Euro 43 percent
(Margin 30.1%),
from 22,58 Euro to 29,14 Euro 37 percent
(Span 27.0 per cent),
from 35,95 Euro up to 543,91 Euro 30 percent
(Span 23.1 percent),
from 543,92 Euro 8.263 percent
plus 118.24 euros.
(4) The maximum surcharge referred to in the third sentence of paragraph 1 shall be the sum of:
from 1,23 Euro to 1,34 Euro EUR 0.83,
from 3,89 Euro to 4,22 Euro 2,41 Euro,
from 7,31 Euro to 8,67 Euro 4.16 Euro,
from 12,15 Euro to 13,55 Euro EUR 5.83,
from 19,43 Euro to 22,57 Euro EUR 8.35,
from 29,15 Euro to 35,94 Euro 10,78 euros.
(5) In so far as the quantity to be dispensed is not prescribed or prescribed by law in the prescription, the pharmacies shall, in so far as nothing else has been agreed with the cost carriers, have to calculate the smallest package placed on the market. (6) For the The pharmacy shall be returned to the pharmacy for a redistribution of 5.80 euros for the fixed surcharge. Unofficial table of contents

§ 4 Pharmacy surcharges for substances

(1) When a substance is transferred, packed, packed or labelled in pharmacies in unaltered state, a fixed surcharge of 100 per cent (50 per cent) on the purchase price of the pharmacy without sales tax for substance shall be a fixed supplement. and the required packaging and the turnover tax. (2) The amount of the quantity of the substance to be dispensed shall be the price of the pharmacy purchase price, the purchase price of the usual packaging being decisive. (3) The price of the purchase price shall be the price of the usual packaging. economic interests, the leading organization of the pharmacists By way of derogation from paragraphs 1 and 2, the fixed surcharge for the charges covered by these agreements shall be fixed by the Confederation of Health Insurance Agreements on the basis of agreements on the purchase of pharmacy for which the calculation is to be based on the calculation. on these prices. The same shall apply where social service providers, private health insurance companies or their associations meet with pharmacies or their associations; if such an agreement is not available, the agreement may be agreed upon in accordance with the first sentence of sentence 1. Prices are dislodged. Unofficial table of contents

§ 5 pharmacy surcharges for preparations of substances

(1) When a preparation is dispensed from a substance or several substances produced in pharmacies, the following shall be:
1.
a fixed surcharge of 90 per cent on the purchase price of the pharmacy without VAT on substances and the necessary packaging;
2.
a recipe supplement as referred to in paragraph 3
as well as the turnover tax. (2) The amount of the quantity of substances and finished medicinal products required for the preparation of the pharmacy shall be paid by the pharmacy purchase price of the pharmacy. Authoritative
1.
in the case of substances, the purchase price of the usual packaging;
2.
in the case of ready-to-use products, the purchase price referred to in Article 3 (2) of the required pack size, but at most the price of the purchase of pharmacy, which shall apply to ready-to-use medicinal products in public pharmacies.
(3) The recipe supplement shall be for:
1. the preparation of a medicinal product by preparation 
Of a substance or of several substances
up to the basic quantity of 500 g,
the production of a mixed teas, production
a solution without the use of heat, mixing of
Liquids
up to the basic amount of 300 g 2,50 Euro,
2. the production of powder, undivided powders,
Ointments, pastes, suspensions and emulsions
up to the basic quantity of 200 g,
the production of solutions using
Heat, macerations, gunshots and cocings
up to the basic quantity of 300 g 5,00 Euro,
3. the production of pills, tablets and pastilles
up to the basic amount of 50 pieces,
the production of divided powders, pens,
Vaginal balls and for the filling of capsules
up to the basic amount of 12 pieces,
the manufacture of medicinal products with implementation
a sterilization, sterile filtration or
Aseptic preparation
up to the basic quantity of 300 g,
the melting of ampoules
up to the basic amount of 6 pieces 7,00 Euro.
For each smaller to equal quantity exceeding the basic quantity, the recipe surcharge increases by 50 per cent each. (4) The relevant top organisation of the pharmacists, which is formed for the perception of economic interests, is expected to increase. By way of derogation from the charges referred to in paragraph 1 (1), the fixed surcharge referred to in paragraph 1 (1) for the duties covered by these agreements shall be subject to the rules governing the purchase of pharmacy by the Federation of the Sickness Insurance Funds. Paragraphs 1 and 2 shall apply to these prices. The same shall apply where social service providers, private health insurance companies or their associations meet with pharmacies or their associations; if such an agreement is not available, the agreement may be agreed upon in accordance with the first sentence of sentence 1. Prices are dislodged. Where there is no agreement on eligible purchase prices for ready-made medicinal products in preparations as set out in the first or second sentence of the first sentence or the second sentence, the maximum rate of purchase of the pharmacy shall be calculated on the basis of this Regulation in the case of supply to the consumer. (5) If the relevant leading organisation of pharmacists for the exercise of economic interests meets with the Association of the Federal Government of the Health Insurance Funds agreements on the amount of the fixed or prescription supplement referred to in paragraph 1 (1) or (1) Notwithstanding paragraph 1 or paragraph 3, the agreed surcharges shall be applied to the Price calculation shall be taken into account. The same shall apply where social service providers, private health insurance companies or their associations meet with pharmacies or their associations; if such an agreement is not available, the agreement may be agreed upon in accordance with the first sentence of sentence 1. (6) If there is no agreement on pharmacy surcharges for the preparation of substances referred to in the first or second sentence of paragraph 5, the contract for parenteral solutions shall be different from the provisions of paragraph 1 or 3 for the preparation of the products.
1.
Cytostatic solutions 90 Euro,
2.
Solutions with monoclonal antibodies 87 Euro,
3.
Antibiotic and virustaticahaltige solutions 51 Euro,
4.
Solutions with painkillers 51 euros,
5.
Food solutions 83 Euro,
6.
Calcium folinate solutions 51 Euro,
7.
Other solutions 70 Euro.
Unofficial table of contents

§ 6 Emergency service

In the case of use in the period from 20 a.m. to 6 p.m., on Sundays and public holidays, as well as on 24 December, when this day falls on a working day, until 6 a.m. and from 2 p.m., the pharmacies can have an additional amount of 2.50 euros including sales tax calculating. Unofficial table of contents

§ 7 Narcotics

In the case of the release of a narcotic agent, its whereabout in accordance with § 15 of the Narcotic Prescription Prescription regulation as amended by the Notice of 25 April 1978 (BGBl. I p. 537), the pharmacies may charge an additional amount of 0.26 Euro including VAT. Unofficial table of contents

Section 8 Special procurement

Unavoidable telegram fees, telephone charges, porti, customs duties and other costs of procuring medicinal products, which are normally not held in stock in pharmacies or wholesalers, may be made by pharmacies with the consent of the cost carrier. separately. Unofficial table of contents

§ 9 Information on prescriptions

The prescription shall be indicated individually by the pharmacies on the prescription.
1.
in the case of ready-made medicinal products, the price of the pharmacy, in addition calculated amounts and the sum of the individual amounts,
2.
in the case of medicinal products manufactured in pharmacies, the individual amounts of the price of the pharmacy,
3.
in the case of an amount in accordance with § 6, the period of use.
Unofficial table of contents

§ 10 Zubeats of the veterinarians

(1) In the case of veterinary medicinal products by veterinarians, no more than surcharges may be levied in accordance with § 3 (1) sentence 2 and 3 and (2) to (4), § 4 (1) and (2) and § 5 (1) to (3) and the sales tax. (2) Surcharge in accordance with Section 3 (2) of the relevant amount over EUR 51,13, the following surcharges shall be levied for the amount of 51,13 Euro:
from 51,13 Euro to 127,82 Euro at most 25 percent,
from more than 127.82 euros at most 20 percent. (3) (dropped) Unofficial table of contents

§ 11 Prices in special cases

In the case of the delivery of finished pharmaceuticals in the cases of § 78 (4) of the Medicines Act, the dispensing price of the pharmaceutical entrepre shall be replaced by the country-selling price in the case of the application of this Regulation. For the purpose of calculating the purchase price of the pharmacy and in the case of agreements on the purchase of pharmacy in accordance with § 4 (3) and § 5 (4), the country discharge price shall also be used for the purpose of calculating the price of the purchase of pharmacies. By way of derogation from § 4 (3) and § 5 (4) and 5 (5), the associations of pharmacists with the health insurance companies or their associations, which are formed for the perception of the economic interests, may also have agreements on the purchase of pharmacy purchase prices and Surcharges. Unofficial table of contents

§ 12 Entry into force, Resolved provisions

(1) This Regulation shall enter into force on 1 January 1981. (2) Unofficial table of contents

Final formula

The Federal Minister for Economic Affairs