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Our FAQs (Frequently Asked Questions) contain answers to frequently asked questions. All questions are listed in their specific topic. If you miss your question in our FAQs, do not hesitate to contact us.



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Legal Information

Why is a CE marking necessary for medical devices?
According to § 6 of the Medical Devices Act (MPG), medical devices may only be marketed with a valid CE Marking.

Please send us proof of the CE marking together with your registration for first publication of new medical devices.
What special rules apply to the marketing of sterile medical devices?
According to DIN 58953-8:2010-05, sterile medical devices should be delivered, transported and stored in a so-called packaging system, consisting of a primary (sterile barrier system) and an additional (non-sterile) outer secondary packaging (protective packaging).

This means that there are only two possibilities for the assignment of the PZN as follows:

1. PZN assignment for a single sterile medical device that is properly packed in a sterile barrier system and protective outer packaging.

2. PZN assignment for a protective package. The protection packing (e.g. the pack size 10 pieces) contains several sterile medical devices without individual protective packaging. The PZN should only be applied to the protective packaging, as the individually packaged sterile medical devices have no specific protective packaging.

Consequently, the PZN may not be used for sterile medical devices in a sterile barrier system without protective packaging.
Why do I need to state the manufacturer´s name for food supplements?
If, in the case of food supplements (NEM – Nahrungsergänzugnsmittel), the supplier and manufacturer are not one and the same, both companies must be named. The reason for requiring the name of the manufacturer is for transparency of the origin of the product.
Which products can have a BOPST number and what it its purpose?
A BOPST number can be assigned to either narcotic drugs according to § 1 of the German Narcotic Drugs Act (BTMG) or “ausgenommene Zubereitungen” according to § 2 BtMG. This 8-digit numeric attribute characterizes “ausgenommene Zubereitungen”, that are (partially) subject to narcotic drugs regulations and serves furthermore for the foreign trade with narcotic drugs.
Why do I need to send authorisation documents (Zulassungsunterlagen) with every first publication of a medicinal product?
When notifying zulassungs- oder registrierungspflichtigen (marketing authorisation or mandatory registration) medicinal products, you must prove that they are authorised or registered.

For medicinal products which marketing authorisation is more than six months old, it suffices to state the date of the authorisation – with the following exception: suppliers that notify a mandatory verification medicinal product in accordance with counterfeit protection policy for the very first time in the IFA Database, must submit the authorisation documents (Zulassungsunterlagen) even though it may be older than six months. This comes with the more detailed eligibility checks in the legal framework of the counterfeit protection directive.
Why do I have to include product information to my product which I wish to publish or change certain legal information?
In the above mentioned cases, IFA GmbH cooperates with ABDATA Pharma-Daten-Service, a business branch of the Werbe- und Vertriebs-gesellschaft Deutscher Apotheker GmbH. ABDATA checks the legal classification of each new published product on its credibility. All data needed for the classification such as ingredients, p.r.n. stated field of application or information on the effect is taken from the product information. Moreover, ABDATA gathers further information from the product information of certain product types such as medicinal products or surgical dressings and stores the data in different databases – for example in the ABDA-Datenbank – which is made available to expert groups for specific questions and as source for researching. That is why product information has to be included when placing an order of the above mentioned kinds.
Does the supplier need to notify the Melderegister number of the UBA to IFA?
Please notify your product’s Melderegisternummer of the UBA for publication in the IFA database if the following applies:

 - You are supplier of a product with a compulsory notification according to Batteriegesetz (BattG).
 - You received an 8-digit Melderegister number upon compulsory notification from the Umweltbundesamt (UBA).
 - The product was marketed for the first time in Germany by you or a different supplier.
Which law regulates the return of batteries and accumulators?
Batteries and accumulators are obliged under Batteriegesetzes (BattG) and not under Elektro- und Elektronikgerätegesetz (ElektroG).
Should you register a Registrierungsnummer with stiftung ear (WEEE-Reg.-Nr. DE) for all electric appliances?
Yes, all products listed with “ja” in the following attributes should be registered with a Registrierungsnummer:

- ElektroStoffV: Ja, unterliegt der Elektro- und Elektronikgeräte-Stoff-Verordnung
- ElektroG/ear: Ja, der Hersteller des Artikels unterliegt der Registrierungspflicht durch die stiftung elektro-altgeräte register (stiftung ear) gemäß Elektro- und Elektronikgerätegesetz (ElektroG)
What is the purpose of the attribute WEEE-Reg.-Nr. DE in the IFA Database?
Participants of the pharmaceutical market can gather information from the attribute WEEE-Reg.-Nr. DE (Registrierungs number of stiftung ear according to ElektroG) such as the number itself under which the producer of electronics, for which the PZN has been assigned to, is registered in Germany. And thus the return of the device is regulated.
I am a supplier; do I need to notify IFA GmbH with my WEEE-Reg.-Nr. DE number?
Please notify the stiftung ear’s number (WEEE-Reg.-Nr. DE) in the following cases, so that we can publish it in our IFA Database:

- You are a supplier of a product whose producer underlies the mandatory registration by stiftung elektro-altgeräte register (stiftung ear) according to Elektro- und Elektronikgerätegesetz (ElektroG).
- The product received an 8-digit WEEE-Reg.-Nr. DE by stiftung ear (www.stiftung-ear.de).
- You or another supplier (both underlying the mandatory registration) launched the product in Germany for the first time.
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IFA Codingsystem
SecurPharm
Informationsstelle für Arzneispezialitäten – IFA GmbH