IFA current information

"... following the entry into force of the Medizinforschungsgesetz (MFG), the IFA database will receive the following

new data fields for medicinal products with a reimbursement amount as of the publication date 01 January 2025:

• Bestimmung nach § 130b Abs. 1c SGB V – Determination according to Section 130b (1c) SGB V
• Datum, ab dem der APU § 78 Abs. 3a Satz 1 AMG mit Bestimmung nach § 130b Abs. 1c SGB V gilt – Date from which the APU Section 78 (3a) clause 1 of the German Medicinal Products Act (AMG) with determination according to Section 130b (1c) SGB V applies
• Zuzahlung nach § 61 Satz 1 SGB V – Copayment according to Section 61 (1) SGB V
• Rabatt nach § 130a SGB V – Discount according to Section 130a SGB V

Please find a description of the new features in the following information sheet: Information for medicinal products

IFA GmbH has assigned the value 0 = no in the data field Bestimmung nach § 130b Abs. 1c SGB V for all products in the database. First publications from the publication date 01.01.2025 are also included with the value 0 = no. For this reason, the message does not contain a product range file in the attachment.

You only need to take action if you have medicinal products with a reimbursement amount for which a determination has been made according to Section 130b (1c) SGB V. Details can be found in the information sheet.

For any questions, please contact us at ifa@ifaffm.de. ..."

"... on publication date 01 November 2024 two new data fields will be added to the IFA database.

Below you will find information on the new data fields and which details the IFA has stored for you - as far as possible. Please find more information in the IFA Guidelines for Notifying Product and Address data.

MedCanG – Medizinal-Cannabisgesetz – Medical Cannabis Act

In this data field it must be indicated whether the product is cannabis for medical or medical-scientific purposes in accordance with Section 2 (1) or (2) MedCanG.

We have entered the value 0 = no in this data field for products that are not subject to the MedCanG in our view. All other products have no entry.

If you need to make additions or corrections to this data field, please enter your details in the attached product range file and send the amended table to ifa@ifaffm.de.

Lagertemperatur beachten – Note storage temperature

In this data field it must be indicated whether the storage temperature must be noted for the product.

If value 1 is notified, the information for Lagertemperatur minimal/maximal must also be stated.

For this data field, all products that have the value 1 = yes in the data field Cold chain or an entry in the data fields Storage temperature minimum/maximum have been assigned the value 1 = yes.

To review these data fields and if you need to make additions or corrections, it is advisable to order your changes inexpensively in the IFA portal or request a current EAD file ‘EAD - storage’ on the IFA homepage. Please send this amended EAD file to ead@ifaffm.de. ..."

"... within a short period of time, the IFA portal has become an established and convenient platform for your IFA notifications. A large number of suppliers use the opportunity to quickly and easily order first publications and changes to product data.
 
We have received positive feedback from our users about this innovative notification channel and would like to take this opportunity to thank you. We are therefore all the more pleased to be able to offer you the option of notifying PZN pre-allocations in the IFA portal with immediate effect.
 
The following functions have now been added in detail:

• Display of unpublished PZN pre-allocations 
• Ordering of PZN pre-allocations prior to market launch as well as their changes
• Direct transfer option of a PZN pre-allocation into a first publication of PZN and product data (“megaphone” symbol)

You do not have access to the IFA portal yet? Click here to request your user ID.
 
Please note that IFA portal platform and support is only available in German. If you have any questions, please send them to ifa@ifaffm.de. We will be glad to help you. ..."

"... Due to applications to extend the IFA pharmaceutical form, IFA GmbH has expanded the IFA pharmaceutical form table as of 1st April 2024.

The extension of the pharmaceutical form table may lead to changes in article-identifying characteristics with possible effects on the reference price allocations (Festbeträge) or aut idem. Therefore, the extension is made in accordance with a procedure agreed with the expert groups, with a lead time before first publication.

If you carry medicinal products in your range, you are obliged to report the pharmaceutical form in line with section 3 of the SPC according to § 131 paragraph 4 SGB V (German Social Code Book 5).

The following new pharmaceutical forms are available from 1st April 2024 for first publication on 1st April 2025:

• Oral lyophilisate (LYE)
• Oral powder (PUE)

If any corrections need to be made in the data field pharmaceutical form in connection with the current pharmaceutical form extension, please let us know. With correct data notification, you make a significant contribution to ensure that data users can properly dispense and invoice your products. Please use Auftragstabelle für Änderungen an IFA-Darreichungsformen and send it to us in the case of changes to pharmaceutical data with the current SPC. In this exceptional case, we will process your notification free of charge until the specified publication date while maintaining the PZN. After a successful assessment we will change the pharmaceutical form and publish it for the first time on 1st April 2025.

The e-mail address for your change notifications is ifa@ifaffm.de.

Our website holds the Auftragstabelle für Änderungen an IFA-Darreichungsformen and Richtlinie zu den IFA-Darreichungsformen ready for you.

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

"... as of 01.02.2024, the IFA database was expanded to include the requirements of the Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz (ALBVVG). The notification situation for the four new data fields for the elimination of supply bottlenecks suggests that there is still some need for information left. We therefore have explained the characteristics of these fields for you in more detail in the following information sheet: ALBVVG information

The new data fields are relevant to settle billing of your products. We therefore urge you to check this product data, complete any missing notifications and correct any incorrect information.

Please request your changes and additions in the IFA portal or request your current EAD file on the IFA website and send the amended EAD file to ead@ifaffm.de.

For any questions, please contact us at ifa@ifaffm.de. ..."

"... on publication date 01 February 2024 the IFA database will receive new and modified data fields for medicinal products. Relevant information on the changes and the need to notify your products accordingly can be found here: Information for medicinal products

Please find attached a current EAD file with the medicinal products of your product range. Please check the product data if corrections and additions are required and submit the updated table to ead@ifaffm.de.

Please find more detailed information regarding to the database changes in our IFA Guidelines for Notifying Product and Address data.

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

For any questions, please contact us at ifa@ifaffm.de. ..."