FAQ active substance manufacturers (ALBVVG)
What ist the German Act to Combat and Improve the Supply of Medicines (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz, ALBVVG)?
The Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz (ALBVVG) is a law that defines measures to combat supply shortages of medicinal products and to improve the supply of medicinal products.
What are the new reporting obligations under the ALBVVG?
When the ALBVVG came into force, new reporting obligations were introduced, including the obligation to report the active substance manufacturers - actually used - of medicinal products that fulfill certain criteria.
Which medicinal products are subject to the reporting obligation?
- Medicinal products that are subject to regular data transmission in accordance with Section 52b sub-section 3f AMG
- Medicinal products that are queried by hearings of the higher federal authorities in accordance with Section 52b sub-section 3e AMG
- Medicinal products that are eligible for an EU lot in health insurance discount contract tenders. Currently, this includes off-patent antibiotics in accordance with Section 130a sub-section. 8a and 8b SGB V
- other active substances, provided that a classification is published by the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) in the Federal Gazette
To whom can the health insurance funds send applications in accordance with Section 130a sub-section 8a SGB V?
Applications can be sent to the following e-mail address:
LE-Rabattvertraege@bfarm.de
For Section 52 sub-section 3f AMG: Which batches must be reported?
All newly released batches must be reported. Previously released batches should not be recorded retroactively.
What is to be stated under batch size?
The batch size refers to the number of packs of the released batch in relation to the respective reported pharmaceutical central number (PZN). The calculation is not based on the unit ZE (counting unit; e.g. tablet), but on the packaging unit.
Where can I find the portal for reporting active substance manufacturers?
The PharmNet.Bund application for reporting active substance manufacturers can be accessed via the following link:
What requirements must be met to use the portal?
A valid RuBen account and an assignment of the PharmNet.Bund application by the company's main user are required to use the portal. Furthermore, the terms of use and information on data protection must be accepted once.
What is meant by the "batch release date" in the notification form for active substance manufacturers?
The term "batch release date" refers to the date when a qualified person (QP) releases a batch of medicines.
Can I correct errors in the reported data on active substance manufacturers in the PharmNet.Bund portal?
When reporting active substance manufacturers in the PharmNet.Bund portal, you can correct certain fields, while others cannot be corrected.
Correctable fields:
- All fields below the ENR (processing number, "Einreichungsnummer") and the batch number can be corrected.
Non-correctable fields:
- The ENR and the batch number serve as base values for the determined data and therefore cannot be corrected.
- If there are errors when entering the ENR or batch number, you must make a separate message and add an additional identifier to the existing record to indicate that this record is invalid.
We recommend reporting any error messages or need for correction in the PharmNet.Bund portal.
Is it possible to upload multiple reports simultaneously?
Yes, you have the option of downloading a file in a compatible format via “Download sample file”.
The file is in *.json format and must be saved as such after entering the data.
The medicinal product to be reported contains two active substances (active ingredients). How can these be entered in the *.json file?
If there is more than one active substance, it will look like this:
"Active substance mapping": [
{
"Active substance-ASK1": "ASK of active substance",
"PNR1": "PNR of manufacturer of active substance"
},
{
"Active substance-ASK2": "ASK of active substance",
"PNR2": "PNR of manufacturer of active substance"
}
]
Multiple entries can be added using commas in the square brackets.