IFA Current Information

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

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

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

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

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11/30/2020 | VAT increase on 1st January 2021

"... At the turn of the year 2020/2021, the German legislator will repatriate the VAT to the values valid as of 30th June 2020, namely from 1st January 2021 the full VAT rate from 16 % to 19 % and the reduced VAT rate from 5 % to 7 %.

As a result, all pharmacy retail prices (AVP) for price-controlled medicinal products must be calculated including 19 % VAT as from 1st January 2021.

We would like to support you with the upcoming price changes due to value added tax.

Enclosed you will find an electronic order file (EAD) with your product range file. In this file, the pharmacy retail prices of your price-controlled pharmaceuticals as of publication status January 1st 2021 have been calculated by us – free of charge - on the basis of the APU, including now 19 % VAT.

The pharmacy retail prices of the non- price-controlled articles remain unchanged, as these are recommended prices of the supplier. However, from 1st January 2021 they will also include 19 % and 7 % value added tax.
 
If you seek to receive further price changes on 1st January 2021, please update the file and send us your notification as soon as possible, but no later than Monday 7th December 2020, to ead@ifaffm.de.

For this date, we expect an extraordinary amount of notifications that must be processed within a very short time. Therefore it is imperative that you send us your notification in good time.

The following contact persons are at your disposal for any questions you may have:

Benjamin Böttinger
E-Mail: benjamin.boettinger@ifaffm.de
Telefon: +49 69 979919-49
 
Carsten Schölles
E-Mail: carsten.schoelles@ifaffm.de
Telefon: +49 69 979919-51

We thank you in advance for checking and, if necessary, updating your data at short notice. ..."

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11/16/2020 | Pre-notification: VAT increase on 1st January 2021

"... at the turn of the year 2020/2021, the German legislator will repatriate the VAT to the values valid as of 30th June 2020, namely from 1st January 2021 the full VAT rate from 16 % to 19 % and the reduced VAT rate from 5 % to 7 %.

As a result, all pharmacy retail prices (AVP) for price-controlled medicinal products must be calculated including 19 % VAT as from 1st January 2021.

We would like to support you with the upcoming price changes due to value added tax.
 
You will receive an electronic order file (EAD) with your product range file by 30th November 2020. This file will contain the pharmacy sales prices of your price-controlled pharmaceuticals with publication status as of 1st January 2021 calculated by us – free of charge - on the basis of the APU including the 19 % VAT which will in future apply.

The pharmacy retail prices of the non- price-controlled articles are unchanged, as these are recommended prices of the supplier. However, as from 1st January 2021 they will also include 19 % and 7 % value added tax. If you wish to change the UVP (recommended retail price), we await your change order.
 
The following contact persons are at your disposal for any questions you may have:

Benjamin Böttinger
E-Mail: benjamin.boettinger@ifaffm.de
Telefon: +49 69 979919-49
 
Carsten Schölles
E-Mail: carsten.schoelles@ifaffm.de
Telefon: +49 69 979919-51

We thank you in advance for checking and, if necessary, updating your data at short notice. ..."

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10/01/2020 | Extension of the IFA Pharmaceutical Forms on 1st October 2020

"... due to applications to extend the IFA pharmaceutical form, IFA GmbH has expanded the IFA pharmaceutical form table as of 1st October 2020. The extension of the pharmaceutical form table may lead to changes in article-identifying characteristics with possible effects on the reference price allocations 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 forms are available since 1st October 2020 for first publication on 1st October 2021:

  • Konzentrat zur Herstellung einer Infusionsdispersion (KID)
    Concentrate for preparing an infusion dispersion

  • Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension (PLS)
    Powder and solvent for suspension for injection

  • Sublingualspray, Lösung (SUL)
    Sublingual spray, solution

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 01.10.2021.

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

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

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06/10/2020 | Reduction of VAT on 1st July 2020

"... as part of the measures to stimulate the economy, the Federal Government will reduce the full value added tax from 19 % to 16 % and the reduced value added tax rate from 7 % to 5 % for the period 1st July to 31st December 2020. For taxable drugs this means, that all pharmacy retail prices (AVP) must be calculated including 16 % VAT from 1st July 2020.

We would like to support you with the upcoming price changes due to value added tax.
 
Enclosed you will find an electronic order file (EAD) with your product range file. The pharmacy sales prices of your taxable pharmaceuticals with publication status as of 1st July 2020 have been calculated by us on the basis of the APU and now include 16 % VAT, in this file.
 
The pharmacy retail prices of the non-taxable articles are unchanged, as these are recommended prices of the supplier. However, from 1st July 2020 they will also include 16 % and 5 % value added tax.
 
If you wish to receive further price changes on 1st July 2020, please update the file and send us your notification as soon as possible, but no later than Friday 12th June 2020, to ead@ifaffm.de.
 
At this date, we expect an extraordinary number of notifications that must be processed within a very short time. Therefore it is imperative that you send us your report in good time.

The following contact persons are at your disposal for any questions you may have:

Benjamin Böttinger
E-Mail: benjamin.boettinger@ifaffm.de
Telefon: +49 69 979919-49
 
Carsten Schölles
E-Mail: carsten.schoelles@ifaffm.de
Telefon: +49 69 979919-51 ..."

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