IFA current information

"... recently we informed you in a German-speaking mailing about the new possibilities to comfortably view and edit your published product data via IFA portal. In the course of this innovation process, we would like to inform you that orders via order forms in PDF format will still be possible until 30.06.2023.

This means that EAD (Electronic Order Data Processing), the IFA order tables and the IFA portal (currently available in German) will be available to you as ways of placing orders from 01.07.2023:

PZN pre-allocations prior to market launch
Excel order file A

First publication of products
Excel order file B1 Medicinal product
Excel order file B3 Medical devices
Excel order file B2 other pharmacy-typical products

Changes and additions
IFA-Portal (platform and support currently only available in German)
EAD files (Electronic Order Data Processing)
Excel order file C also for deletions of product data

Change of address data
Excel order file D

When using the order tables, please always use the current version from the IFA homepage.

If you have any questions, please send them to ifa@ifaffm.de. ..."

"... due to changes in legislation and the extension of the pharmaceutical form table, there are new and amended data fields in IFA database on the following publication dates:

For publication date of 15.04.2023:

1. New Data field: APU § 130a Abs. 3c Satz 6 SGB V vereinbart – sales price of the pharmaceutical entrepreneur Section 130a (3c) clause 6 German Social Code Book V (SGB V) agreed

2. New Data field: Datum, ab dem der vereinbarte APU § 130a Abs. 3c Satz 6 SGB V gilt – Date from which the agreed APU Section 130a (3c) clause 6 German Social Code Book V (SGB V) applies

3. Expanded and renamed data field: TAMG Tierarzneimittelgesetz – TAMG Veterinary medicinal products Act (former: Tierarzneimittel – Veterinary medicinal product)

For publication date of 01.07.2023:

4. New IFA pharmaceutical form

Below you will find information about the data fields and which entries IFA has made for you. You will find further information in the IFA-Guidelines for Notifying Product and Address data.

To 1: APU § 130a Abs. 3c Satz 6 SGB V vereinbart – sales price of the pharmaceutical entrepreneur Section 130a (3c) clause 6 German Social Code Book V (SGB V) agreed:

GKV-Finanzstabilisierungsgesetz (GKV-FinStG) contains Section 130a (3c) SGB V. Accordingly, pharmaceutical entrepreneurs may apply for an exemption from the extended price moratorium pursuant to Section 130a (3a) clause 4 or 5 SGB V under certain conditions. In the case of affected medicinal products, it must be stated whether sales price of the pharmaceutical entrepreneur has been agreed for them in accordance with Section 130a (3c) clause 6 SGB V.

• IFA has preset this data field for you with the value 0= 
• If you have agreed on an APU in accordance with Section130a (3c) clause 6 of the German Social Code, Book V, please arrange for the correction to value 1 = yes in one of the following ways:
  Either in a currently requested EAD file to ead@ifaffm.de or in the IFA reporting portal or with the IFA order table C - Changes to ifa@ifaffm.de.
• If you have not agreed on an APU in accordance with Section 130a (3c) clause 6 of SGBV, there is no need for you to take any action.

To 2: Datum, ab dem der vereinbarte APU § 130a Abs. 3c Satz 6 SGB V gilt – Date from which the agreed APU Section 130a (3c) clause 6 German Social Code Book V (SGB V) applies

For medicinal products for which a new sales price has been agreed by the pharmaceutical entrepreneur with the GKV-Spitzenverband on the basis of Section130a (3c) clause 6 SGB V, the date from which this price applies must be stated.

• IFA does not preset any data in this data field.
• If you have agreed on an APU in accordance with Section130a (3c) clause 6 of the German Social Code, Book V, please submit the corresponding date by using one of the following methods:
  Either in a currently requested EAD file to ead@ifaffm.de or in the IFA reporting portal or with the IFA order table C - Changes to ifa@ifaffm.de.
• If you have not agreed on an APU in accordance with Section 130a (3c) clause 6 of SGBV, there is no need for you to take any action.

To 3: TAMG Tierarzneimittelgesetz – TAMG Veterinary medicinal products Act

This data field is the renamed data field Veterinary Medicinal Product. It must be indicated whether the product is subject to the Veterinary Medicinal Products Act (TAMG) as a veterinary medicinal product (value 1) or as a veterinary medical technology device subject to authorization (VMTP; value 2). The regulations of the TAMG apply to both types of products. Their approval must be evidenced by a proof of marketing authorisation, e.g. from Federal Office of Consumer Protection and Food Safety (BVL).

• IFA takes over the previous identification of the data field Tierarzneimittel – Veterinary medicinal product.
• If you have a product in your assortment that is a VMTP, please initiate a data change of this PZN in one of the following ways:
  Either in the IFA reporting portal or with the IFA order table C - Changes to ifa@ifaffm.de and provide the proof of marketing authorisation.
• If you do not have VMTP in your assortment, there is no need for you to take action.

To 4: New IFA pharmaceutical form

Furthermore, we would like to inform you that the IFA pharmaceutical form table will be extended by the following value as of 01.04.2023 for a first publication on 01.07.2023:

• Dispersion for injection (Injektionsdispersion IJD)

Details on the extension of the pharmaceutical form table can be found in the guideline IFA-Richtlinien zu Darreichungsformen.

We kindly ask you to always use the updated and most recent notification order documents.

If you have any questions, please send them to ifa@ifaffm.de. We will be glad to help you ...."

"... GKV-Finanzstabilisierungsgesetz has been published in Bundesgesetzblatt on 11 November 2022 and is effective in wide parts since 12 November 2022. To implement the requirements of this law, the range of the data field Ablösung Abschlag § 130a (1/8) SGB V – Overruled discount Section 130a (1/8) SGB V will be extended by two new values and will be renamed to Ablösung Abschlag § 130a SGB V – Overruled discount Section 130a SGB V as of publication date 01 January 2023:

Data field Ablösung Abschlag nach § 130a SGB V – Overruled discount Section 130a SGB V

• 0 – no
• 1 – yes, agreement to overrule the discount according to Section 130a (1/8) SGB V
• 2 – yes, agreement to overrule the discount according to Section 130a (1b) clause 1 SGB V
• 3 – yes, agreement to overrule the discounts according to Section 130a (1b) clause 2 SGB V

The data field does not exclusively relate to overrule the discount pursuant to Section 130a (1) SGB V according to Section 130b (1) clause 4 SGB V in combination with Section 130a (8) clause 6 SGB V, but also includes the information to overrule the discounts according to Section 130a (1b) SGB V.

Changes for this data field only need to be submitted, if a reimbursement amount agreement has been concluded as from 12 November 2022 that explicitly overrules the increased manufacturer discount.

If you do not have made such an agreement there is no need for you to take any action.

Please find more detailed information regarding the meaning of the values in our IFA Guidelines for Notifying Product and Address data.

We kindly ask you to use the updated and most recent notification order documents to be able to submit all the necessary data for the data fields included in IFA Database for your future orders.

The following contact person will be glad to answer any questions you may have:

Mr. Benjamin Böttinger
Email: benjamin.boettinger@ifaffm.de
Phone: +49 69 979919-49 ..."

"... IFA Database will have new and modified data fields for publication date 01 December 2022. Medicinal products, medical devices and other pharmacy typical products are affected. The documents listed below have relevant additional information for all the affected product types:

• Information for medicinal products
• Information for medical devices and other pharmacy typical products

The documents contain the following explanations:

• new, updated and removed data fields
• entries in new data fields done by IFA
• your obligations for checking and acting

Additionally please find attached a current EAD file with the complete products’ data of your product range. Please check the submitted data. If additions or changed need to be made, please enter the data accordingly and submit the updated table to ead@ifaffm.de exclusively.

Orders we receive by EAD up to Friday 04 November 2022 will be processed free of charge and confirmed by an order confirmation. If you could check your product range only partially please submit the already checked data as a partial order.

If your products are published completely and correctly we do not need to receive a reply.

We thank you in advance for checking and completing your products’ data.

To be able to submit all the necessary data for the data fields included in IFA Database for your future orders we kindly ask you to use the updated and most recent notification order documents published on IFA homepage.

The following contact person will be glad to answer any questions you may have:

Mr. Benjamin Böttinger
Email: benjamin.boettinger@ifaffm.de
Phone: +49 69 979919-49 ..."

"... for medicinal products subject to marketing authorization, § 131 Para. 4 SGB V requires for first publication in the IFA database to notify inter alia the relevant Zulassungs-Nr. and BfArM-Eingangsnummer (BfArM Submission Number).

To complete the data of your published products, we kindly aks you to update your products data today. A current EAD file is attached. It lists all the medicinal products in your product range for which the Zulassungs-Nr. or the BfAfM-Eingangsnummer (BfArM Submission Number) are missing.

Please complete the missing Zulassungs-Nr. and BfArM-Eingangsnummer (BfArM Submission Numbers) in the attached EAD file and send it to ead@ifaffm.de.

We will process orders received by EAD up to and including Friday, 24.06.2022, free of charge and subsequently send you an order confirmation. If you can only check part of your data during this time, you have the option of sending us the checked data as a (partial) order.

Until Friday, 15.07.2022, updates can be submitted by EAD order at a charge. After that, updating Zulassungs-Nr. or the BfArM-Eingangsnummer (BfArM Submission Number) is only possible via Anlage C – Product Changes and corresponding evidence to ifa@ifaffm.de - also subject to charge.

For first publication orders in the future (not applying to the products in the table in the appendix), we kindly ask you to add an AMIce database excerpt as proof of authorization, which shows both the authorization number and - if available - the BfArM-Eingangsnummer (BfArM Submission number).

The following contact person will be glad to answer any questions you may have:

Mr Benjamin Böttinger
E-Mail: benjamin.boettinger@ifaffm.de
Phone: +49 69 979919-49

Thank you very much in advance for checking and completing your product data. ..."