FAQ
The following FAQ (Frequently Asked Questions) consist of recurring questions to IFA GmbH. They are grouped under a topic and followed by their answer. If your question is not mentioned, please do not hesitate to contact us directly.
The attribute solitäres Fertigarzneimittel (solitary proprietary medicinal product) is used to notify packs of medicinal products that are excempt from the manufacturer's discount according to § 130a paragraph 3b SGB V (so-called Generikaabschlag). Further information can be found in the consensus guideline between relevant manufacturers' associations and the GKV-Spitzenverband.
A Generikaabschlag (generics discount) is the manufacturer's discount according to § 130a paragraph 3b SGB V. Further information can be found in the consensus guideline between relevant manufacturers' associations and the GKV-Spitzenverband. To identify packs of medicinal products affected by the Generikaabschlag, information from the notified attributes Wirkstoffpatent, Unterlagenschutz, biologisches Arzneimittel and solitäres Fertigarzneimittel.
You can notify this by entering the applicable value in the EAD file EAD total in column Ablösung § 130a SGB V – Overruled discount Section 130a SGB V.
The manufacturer discount according to § 130a SGB V is calculated by ABDATA Pharma-Daten-Service with exception to the discount of vaccines. If and to what amount the generic discount applies, depends on the provided information (see IFA-Auftragstabelle B1 – First Publication Medicinal Product > Rechtsinformationen). Thus when in doubt about calculating the manufacturer's discount, these attributes should be checked first. For further questions on the calculation please contact your manufacturing association directly.
Please note that marking your medicinal product as generic according to § 10 (1) of Directive 2001/83/EC (German: Bezugnehmende Zulassung Generikum) does not result in a generic discount for the product.
The manufacturer discounts are regulated in § 130a SGB V for medicinal products billed to the GKV, and in § 1 AMRabattG for medicinal products billed to the PKV or civil services. You can find an overview to facilitate reading the paragraphes of § 130a SGB V:
Paragraph 1 manufacturer discount
- 7% discount for medicinal products
- 6% for generics and off-patent medicinal products
- 7% for OTC
- 7% for finished medicinal products in parenteral preparations
- 7% for outpatient treatment in hospitals
Paragraph 2 discount for vaccines
Paragraph 3 no manufacturer / vaccine discount for reference-priced medicinal products
Paragraph 3a price freeze
- No price freeze for reference-priced medicinal products
- Discount resulting from the price freeze will be charged in addition to the manufacturer discount and generic discount
Paragraph 3b generic discount
- 10% discount for generic and off-patent medicinal products
- Price cuts reduce the generic discount
- Generic discount does not apply to medicinal products 30% below reference price
(in addition to this please see faq What is a Generikaabschlag?)
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Paragraph 8 discount contracts
- Manufacturer / vaccine discount can be credited on discount contracts
- Manufacturer / vaccine discount can also be credited on arrangements for a refund according to § 130 b paragraph 1 sentence 4 SGB V
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