FAQ
The following FAQ (Frequently Asked Questions) consist of recurring questions to IFA GmbH. They are grouped under a topic and followed by their answer. If your question is not mentioned, please do not hesitate to contact us directly.
Information on implementing the Falsified Medicines Directive 2011/62/EU (FMD) and its Delegated Regulation (EU) 2016/161 (DR) in the IFA database can be found in Guidelines for Notifying Product and Address Data.
Further information can be found here:
Obliged to verification are all prescription-only medicinal products for human use that are not mentioned as an exception in the White List (i. a. some homoepathics). Furthermore, OTC medicinal products mentioned in the Black List are obliged to verification (currently medicinal products with the active agent omeprazole in two potencies). White and Black List can be found in the appendix of the Delegated Regulation (EU) 2016/161.
Yes, clinic packs of medicinal products obliged to verification must be verified.
No, clinic components (smallest unit of a clinic pack) may not be verified. However, the clinic pack to which the clinic component belongs must be verified if the medicinal product in question is obliged to verification.
Yes, physician samples according to AMG are, if the medicinal product itself is obliged to verification, also obliged to verification according to Article 41 DR. Prior to dispense, the physician sample obliged to verification must be checked out by the pharmaceutical entrepreneur. In contrast OTC, non-prescription-only, physician samples do not have to be verified unless they are stated in the Black List.
There are three variants of physician samples for pharmaceutical entrepreneurs:
a) smallest sales pack with additional marking as physician sample (physician sample bears PZN of sales pack)
b) physician sample in unique pack (physician sample bears own PZN); package size equals the smallest sales pack
c) physician sample in unique pack (physician sample bears own PZN); package size smaller than smallest sales pack
For variants b) and c), product types physician sample will be published in the IFA Database with their own PZNs.
Affixing a PZN in clear print or Code 39 to medicinal products dispensed as physician samples (product type Ärztemuster gemäß AMG in the IFA database) is legally not obliged. However, physician samples obliged to verification must be affixed with the DMC including the 4 data elements (product code, serial number, expiry date, batch number) and their clear print information. Generally it is recommended to print the PZN in clear print since this eases usage and documentation in medication plan.
The pack's security features of medicinal products obliged to verification are:
a) anti-tampering device
b) unique identifier, consisting of four data elements in the Data Matrix Code.
The unique identifier consists of:
a) product number
b) individual serial number
c) batch number
d) expiry date
The anti-tampering decive, preventing interferance with the product, makes the first opening of the pack evident. Further information on the different options can be found on the website of the Deutsches Institut für Normung and the Europäisches Komitee für Normung (DIN EN 16679:2015-03).
ACS PharmaProtect GmbH is the system operator responsible for the contractual and technical connection of the relevant pharmaceutical entrepreneurs on the German market. In order to connect to their system, pharmaceutical entrepreneurs have to contact ACS PharmaProtect GmbH directly.
European Medicines Verification Organisation - emvo's task within the scope of implementing the FMD is coordinating the verification on a European level. It hosts the European hub organising verification queries from European countries. Pharmaceutical entrepreneurs affected by the FMD and registered with ACS PharmaProtect GmbH must also register with EMVO.
IFA Guide