Source: https://www.ifaffm.de/en/faq/id/44.html
Timestamp: 2019-05-19 13:30:02
Document Index: 96687131

Matched Legal Cases: ['§ 13', '§ 2', '§ 4', '§ 13', '§ 13', '§ 52', '§ 4', '§ 52', '§ 52']

What do the abbreviations mean in connection with the distribution channels?
The following abbreviations are used in the IFA documentation with the channels of distribution information:
- KVA/Krankenh.Apo. // VWeg KVA – distribution to hospital pharmacies
- pharm. Großhandel // VWeg GH – distribution to pharmaceutical wholesale trade
- Apotheken // VWeg APO – distribution to pharmacies
- Einzelhandel // VWeg sonst. EH – distribution to other retail trade
What should be considered when choosing the status discontinued?
A product is labelled as discontinued (AV), the item is removed from the market and will not be re-supplied. However, stock may be sold-off. The discontinued status is permanent and irreversible.
Products with a temporary delivery discontinuation or inability to deliver should remain on the market unless the production has ceased.
I'm a manufacturer of a product published in the IFA information services. Why can’t I change the data of my product without approval of the listed supplier?
Agreements between manufacturer and supplier can be very complex. It is impossible for the IFA GmbH to judge who possesses the rights in each and every case. Thus we only allow order forms from the currently listed supplier. In the case of a change in the distribution law, this must be made known to the IFA GmbH immediately from both sides (supplier change). If there are disagreements between the manufacturer and distributor, it is up to both to resolve them and inform the IFA GmbH accordingly. In both cases, the IFA GmbH requires consensual letters to take change orders in the future.
What considerations are necessary during a supplier change?
A supplier change will only be processed if there is an order from the new supplier and the approval of the old supplier are handed into the IFA. Both, already published as well as pre-allocated PZN´s can be switched. It is also possible to switch only a number of PZN´s.
Why is a manufacturing/wholesale licence required?
A manufacturing authorization (Herstellungserlaubnis) according to § 13 of German Medicinal Products Act (Arzneimittelgesetz – AMG) is required by all entrepreneurs, that manufacture medicinal products commercially or professionally within the meaning of § 2 AMG. Manufacturing here includes the production, extraction, preparation and offering of medicinal products. This requirement applies to any company that is involved in any step of the production of medicinal products. This applies regardless of whether the company also acts as a pharmaceutical entrepreneur pursuant to § 4 (18) AMG - or as holder of the authorization or markets medicinal products under his name. Contract manufacturers which perform certain manufacturing steps on behalf of the pharmaceutical company, are also required to have a manufacturing authorization. A manufacturing license is required for the production of medicinal products which are not yet approved - e.g. for medicinal products that are used in a clinical trial (so-called investigational medicinal products) or other medicinal products which do not require approval. If you hold a Herstellungserlaubnis according to § 13 AMG, please send a copy thereof to us. For more information see: § 13 AMG.
A wholesale license according to § 52a AMG is required by all companies which trade in medicinal products either professionally or commercially. According to § 4 (22) AMG, trading involves the procurement, storage and sale or export of medicinal products. The transfer of medicinal products to clinicians, veterinarians or hospitals is exempted from this rule. Exceptions to this permit requirement are in the travel industry, gases for medicinal purposes, in the normal course of operation of pharmacies as well as in the context of purchasing groups. If you hold a Großhandelserlaubnis according to § 52a AMG, please send a copy thereof to us. For more information see: § 52a AMG.
Can the distributor be named?
No, the distributor cannot be named. The phone number, fax number and email address of the distributor can be stored.