The IFA Notification - A Challenge-Filled Adventure

The IFA (Informationsstelle für Arzneispezialitäten) is undoubtedly known to everyone in the pharmaceutical industry. Serving as a neutral and central information hub for stakeholders in healthcare, it holds significant importance in the complex web of national and European regulations concerning social welfare, pricing, billing, safety and logistics. Through its standardized and quality-assured information, it acts as a pivotal interface for the communication of data. Its range of tasks includes the recording and normalization of package-related reports from pharmaceutical companies, thereby aiding them in meeting their reporting obligations.

For those like me who regularly report medicinal products to the IFA, the complexities and challenges are well known. Filling out the notification tables can be compared to playing an EXIT game where puzzles and tasks must be solved unter intense time pressure. It feels as if a master's course in "IFA notifications" just to navigate the the labyrinth of paragraphs without getting lost.

Thanks to my passion for EXIT games, I am practiced in searching for details, combining data and solving puzzles. Nevertheless, the battle through the legal jungle (AMG, AMPreisV, BtMG, PackungsV, PAngV, SGB V, VerpackG and many more*) and the plausibility check remain a challenge. The reporting table is not exactly intuitive or self-explanatory, and contradictory entries are not always acknowledged with an alarm, which unfortunately means that errors sometimes go undetected. A wrong cross can sometimes have devastating consequences. Although incorrect information can be corrected on the next publication date, dealing with the resulting consequences can be complicated, nerve-wracking and time-consuming. Errors should be avoided wherever possible, especially when it comes to information on prices, refunds or discounts that affect cash flows.

Although the registration process has become significantly more intricate over the time due to the addition of numerous fields, digitization has simultaneously simplified the procedure considerably. A standout feature for me is the user-friendly online portal with its ingenious price calculator, which has alleviated much of my stress! Additionally, the option to add new items via the portal improves efficiency and is very impressive.

A well-intentioned tip from me: Do not underestimate the IFA notification process! For a seamless release, careful preparation is essential to identify and assemble all the puzzle pieces correctly and on time. To ensure a timely launch, I also recommend that you do not ignore the timelines, as the deadlines in the IFA editorial calendar are binding. Failure to stick to the deadlines could result in losing almost a month if the notification is submitted too late.

The next time you are faced with an IFA notification, we will be happy to assist you with our expertise and many years of experience. Let's navigate the labyrinth together and emerge successfully!

An article by Dr. Corinna Lender, Pharma Affairs Manager at Saidia Pharma Services

_{* Medicinal Products Act (AMG), Medicinal Products Price Ordinance (AMPreisV), Battery Act (BattG), Narcotics Act (BtMG), Electrical and Electronic Equipment Act (ElektroG), Electrical and Electronic Equipment Substances Ordinance (ElektroStoffV), Falsified Medicines Directive 2011/62/EU (FMD), Hazardous Substances Ordinance (GefStoffV), Medical Device Law Implementation Act (MPDG), Medical Device Regulation (EU)2017/745 (MDR), Food Supplements Ordinance (NemV), Packaging Size Ordinance (PackungsV), Price Indication Ordinance (PAngV), Social Security Code Fifth Book (SGB V), Veterinary Medicines Act (TAMG), Packaging Act (VerpackG)}

‍

‍