IFA current information

Here you’ll be informed about notifications and get to read excerpt from our letter to the suppliers:

06/17/2022 | Checking the Zulassungs-Nr. and BfArM-Eingangs

"... 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. ..."

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04/01/2022 | IFA pharmaceutical form extension as of 1st April 2022

"... Due to applications to extend the IFA pharmaceutical form, IFA GmbH has expanded the IFA pharmaceutical form table as of 1st April 2022. 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 the 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 form is available since 1st April 2022 for first publication on 1st April 2023:

  • Powder and solvent for prolonged-release suspension for injection (PLD)

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 the 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 2023.

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.

Mr Axel Röpke will be pleased to answer any questions you may have:

E-Mail: axel.roepke@ifaffm.de

Phone: +49 69 979919-27 ..."

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01/17/2022 | Verification of the data on the calculation of the generic disc.

"... We kindly ask you to revise the listed medicinal products in the attached data file especially concerning the information on the calculation of the generic discount and, if necessary, to complete or correct it. The discount according § 130a Abs. 3b SGB V is determined on the basis of the following data fields:

  • Unterlagenschutz (Data Exclusivity Period)
  • Wirkstoffpatent (Compound Patent)
  • Biologisches Arzneimittel (Biological Medicinal Product)
  • Solitär (Solitaire)

The legally regulated discount does not apply, if one of these data fields is set to yes. An incorrect entry will lead to an incorrect calculation of the discount. Further information can be found in Leitfaden zur Definition des Generikaabschlags nach § 130a Abs. 3b SGB V (the guideline on the definition of the generic discount according to § 130a Abs. 3b SGB V).

You’ll find attached a range data chart of your currently listed medicinal products. We kindly ask you to check those data and to use the EAD-file, if the current information needs to be completed or corrected. If changes on the data is necessary please enter the correct data in the file and send it to ead@ifaffm.de exclusively.

As long as your product and address data are completely and correctly, there is no action required. Should there be any questions please feel free to contact the following contact persons:

Ms Ibtissame Charrai
E-Mail: Ibtissame.Charrai@ifaffm.de
Phone: +49 69 979919-53

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

We thank you in advance for your assessment and update of your data. ..."

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11/17/2021 | Amendment to the Pharmaceutical Price Ordinance as of 15.12.2021

"... The Arzneimittelpreisverordnung changes on 15th December 2021 for prescription-only medicinal products.
Because of a 0.20 Euro fee for additional pharmaceutical services the calculation of the Apothekenverkaufspreis (AVP) changes as follows:

Abgabepreis des pharmazeutischen Unternehmers (APU)
+ 3.15 percent (max. 37.80 Euro)
+ 0.70 Euro
= Apothekeneinkaufspreis (AEP)

AEP
+ 3 percent
+ 8.56 Euro
+ 0.20 Euro (fee for additional pharmaceutical serivces)
+ VAT
= AVP

The attached excel EAD file contains your company’s affected prescription-only medicinal products with the new AVPs from 15.12.2021. If you consider it is necessary to correct the prices reported, please send us the corrected list by Friday, 26.11.2021 to ead@ifaffm.de exclusively. Thank you in advance.

In case of any further questions, please contact:

Ms. Ibtissame Charrai
E-Mail: Ibtissame.Charrai@ifaffm.de
Phone: +49 69 979919-53 ..."

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11/08/2021 | Pre-notification: Pharmaceutical Price Ordinance on 15.12.2021

"... As of 15.12.2021, the Arzneimittelpreisverordnung (Pharmaceutical Price Ordinance) for prescription-only medicinal products will change. To finance additional pharmaceutical services, the fixed supplement on the pharmacy purchase price (AEP) will be increased by 0.20 euros. This means that all pharmacy retail prices (AVP) will have to be recalculated from 15.12.2021 for every medicines subject to taxation.

On Wednesdays, 17.11.2021 you will receive an electronic order file (EAD) with your product range file. In this file, the pharmacy sales prices of your medicinal products subject to tax will be calculated by us - free of charge for you - on the basis of the APU and will contain the AVP valid in the future.

If you wish to report changes to these prices, please return the amended file to us at ead@ifaffm.de by Friday 26.11.2021 at the latest.

In case of any further questions, please contact: 

Ms. Ibtissame Charrai
E-Mail: ibtissame.charrai@ifaffm.de
Phone: +49 69 979919-53

Thank you in advance for checking and updating your data at short notice. ..."

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08/31/2021 | Update of the IFA information services on 1st October 2021

"... The following address information will no longer be maintained in the IFA database as of the publication date 1st October 2021:

  • Telephone 3 to Telephone 10
  • Telephone service section 1 to telephone service section 10
  • Fax Service section 1 to Fax Service section 2
  • E-mail address 3 to E-mail address 10
  • E-mail address Service area 1 to E-mail address Service area 10

Our updated file of orders and form D1 for address data (Auftragstabelle D1 – Supplier Address Data and Anlage D1 – Supplier Address Data) can be found on our website at First publication and change in address data.

If you have any questions, please do not hesitate to ask the following contact person:

Ibtissame Charrai
E-Mail: ibtissame.charrai@ifaffm.de ..."

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07/05/2021 | IFA Specification UDI 2.0

"... We would like to inform you about the attached version 2.0 of the IFA Coding Specification UDI. The IFA Coding Specification UDI laid the foundation for the successful implementation of UDI requirements. Since then, numerous customer inquiries were received in connection with UDI. An exchange with the new customer groups revealed that IFA Coding is used for medical devices and medical device software distributed throughout Europe in practices, hospitals, laboratories as well as in the German pharmacy market. Providing the best possible support to IFA Coding users while at the same time ensuring interoperability for all actors in healthcare remain at the forefront of IFA’s activities. IFA has carried out an intensive review of the new requirements and incorporated particularly the following features in the update of the IFA Coding Specification UDI: 

  • For the different market segments, the suitable services of IFA were clarified.
  • A packaging level index has been added to the HPC. This allows multiple UDI-DI to be generated with one item reference as well as package sizes to be implemented in a UDI-DI.
  • Direct part marking specifications have been introduced as the MDR requires this for certain products such as surgical instruments.
  • New examples for the implementation of UDI requirements were included, such as for software. 

With the update of the IFA Coding Specification UDI, IFA supports actors in healthcare to keep in line with expanding legal requirements.

Should there be any question please feel free to contact the following contact person:

Axel Röpke
Email: axel.roepke@ifaffm.de
Phone: +49 69 979919-27"

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04/16/2021 | Check of the medical devices classes

"... As known, Regulation (EU) 2017/745 (MDR) will be effective from 26th May 2021. In addition to a large number of changes resulting from this date of application, we would like to emphasise the obligation arising from Art. 123 Para. 3 Subpara. f) MDR. According to this, manufacturers of implantable medical devices and class III medical devices are obliged to provide such devices with a UDI code from 26th May 2021.

The correct reporting of the medical device class is therefore of particular importance for the trade levels. Please check whether your implants/medical devices of class III in particular have been reported correctly.

You’ll find attached a range data chart of your current listed medical devices, except for medical device class I. Class I medical devices are not listed, as they are not affected by the change. We kindly ask you to check the affected products. If changes are necessary, please fill them in the EAD-file and send it back to us only to ead@ifaffm.de.

Changes, which are send via EAD-file until the 22nd April 2021 are free of charge and will be confirmed with an order confirmation. As far as you are capable to check only a part of your range data chart during this time, you have the opportunity to send those partly checked requests.

As long as your product data are completely and correctly, there is no action required.

Should there be any question please feel free to contact the following contact persons:

Ibtissame Charrai
E-Mail: ibtissame.charrai@ifaffm.de
Phone: +49 69 979919-53

Claudia Niemeyer
E-Mail: claudia.niemeyer@ifaffm.de
Phone: +49 69 979919-31

We thank you in advance for your assessment and update of your data. ..."

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12/22/2020 | Medical devices: Information on medical device class required

"... The Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish a system for the worldwide unique identification of medical devices. It is based on UDI (Unique Device Identification), the generic term for a unique product identifier consisting of UDI-DI and UDI-PI, as well as the Basic UDI-DI as the primary identifier of a device model.

From the date of MDR’s application on 26. May 2021 for every medical device falling under the MDR a UDI-DI must be assigned. For in-vitro diagnostics, the date of application of the regulation (EU) 2017/746 for in-vitro diagnostics from 05.04.2017 (IVDR) is on 26.05.2022.

In addition, depending on the class of the medical device, medical devices must be labelled with the UDI within 1 to 5 years after 26 May 2020 (Art. 123 para. 3 lit. f) MDR).

We do not yet have any information on the medical device class or in-vitro diagnostics class for the medical devices in your range of products listed in the attachment.

To enable your trading partners to meet the legal requirements for handling your products, we would ask you to add the missing information in the attached file.

Please return your additions to ead@ifaffm.de by Wednesday, 13.01.2021 at the latest.

Further information on the UDI can be found at: https://www.ifaffm.de/de/ifa-codingsystem/udi.html.

For any other questions, the following contact persons are at your disposal:

Charrai Ibtissame
Email: ibtissame.charrai@ifaffm.de
Phone: +49 69 979919-53

Carsten Schölles
Email: carsten.schoelles@ifaffm.de
Phone: +49 69 979919-51

We thank you in advance for checking and updating your data. ..."

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