FAQ

Generally, only authorised (zugelassen or registriert) medicinal products may be marketed. Since the MA documents constitute proof of legitimate authorization or registration, they constitute the prerequisite for the marketing of a medicinal product. Thus the MA documents must be submitted with each first publication into IFA's Database of medicinal products obliged to authoristaion or registration.

The product information is used i. a. to:

The specifications in the software of for example pharmacies or pharmaceutical wholesalers shall match as closely as possible the ones on the pack. This aids linking the product itself to its entry in the software and especially concerns specifications such as Produktnamen, Darreichungsform and Menge und Einheit (Packungsgröße).

The product information is also used to correctly classify the product for example Medical Device, Food Supplement, Biocidal Product etc.

For data changes regarding the legal classification or the attribute apothekenpflichtig, the product information must be added to the order for further inspection.

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.

Stating the producer's address for Nahrungsergänzungsmittel is used for a transparent country of origin.

Please notify your product’s Battery registration number by stiftung ear for publication in the IFA database if the following applies:

• You are supplier of a product with a registration obligation according to Batteriegesetz (BattG).
• You received an 8-digit Melderegister number upon registration obligation from stiftung-elektro-altgeräte register (stiftung ear).
• The product was marketed for the first time in Germany by you or a different supplier.

Batteries and accumulators are obliged under Batteriegesetzes (BattG) and not under Elektro- und Elektronikgerätegesetz (ElektroG).

Yes, please notify stiftung ear’s number (WEEE-Reg.-Nr. DE) in the following cases, so that it can be published in  IFA's Database:

• You are 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) launch the product in Germany for the first time.

Yes, all products listed with “ja” in the following attributes should be registered with a Registrierungsnummer:

• ElektroStoffV: yes underlies regulation Elektro- und Elektronikgeräte-Stoff-Verordnung
• stiftung ear: yes, the manufacturer of the product underlies the obligatory registration with stiftung elektro-altgeräte register (stiftung ear) according to Elektro- und Elektronikgerätegesetz (ElektroG)

Participants of the pharmaceutical market can gather information from the attribute WEEE-Reg.-Nr. DE (Registry 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.

Verbandmittel gemäß § 31 Abs. 1a SGB V may be prescribed or billed to the health insurer. Thus the correct notification is important to the supplier's interests.

§ 31 paragraph 1a SGB V defines a Verbandmittel. Further information on Verbandmittel and their circumscription to other wound care products is regulated through the Gemeinsame Bundesausschuss.

These attributes are used by pharmaceutical wholesalers, pharmacies and doctors to i. a. handle the products legally conform and to use them correctly – in general but also unexpected cases such as for example an accident.

Relevant people are obliged to obey hazardous substances legislation and technical regulations and to fulfil their vigilance obligation for hazardous substances. Upon receipt of the products, certain information must be available and recognisable in the data.

The UN-Nummer is stated on the Sicherheitsdatenblätter (safety data sheet) for products with hazardous substances.

Yes, if the product is a hazardous substance.