FAQ

Information on implementing the Falsified Medicines Directive 2011/62/EU (FMD) and its Delegated Regulation (EU) 2016/161 (dVO) in the IFA database can be found in Guidelines for Notifying Product and Address Data.

Legal background to verificationcan can be found here:

• Falsified Medicines Directive 2011/62/EU (FMD)
• Delegated Regulation (EU) 2016/161 (dVO)

Further information can be found here:

• FAQ of the EU Commission on Delegated Regulation
  
• Website of EU measures to protect patients against falsified medicinal products in the legeal distribution chain
• BfArM's and PEI's notice on anti-tamper device

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. Clinic packs of medicinal products obliged to verification, hoewever, need to be verified.

Yes, physician samples according to AMG are, if the medicinal product itself is obliged to verification, also obliged to verification. They must be serialised just like any other sales pack. All four data elements must be uploaded into the PU system. Prior to dispense, the physician sample must be checked out by the pharmaceutical entrepreneur. Thus 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.

If a product is no longer subject to prescription, the verification obligation is usually also not required. The manufacturer is obliged to recall the product with the affected safety features and simultaneously inform IFA GmbH that the prescription obligation and the verification data have to be changed or deleted.

Only changing these attributes allows for smooth-selling of the OTC packages in the pharmacy. The simultaneous sale of products with and without safety features under the same PZN is not possible.

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 physician practice.

From the FMD's effective date 09.02.219, pharmaceutical entrepreneurs may only market medicinal products obliged to verification when the packs bear the two necessary security features. These packs are only dispensable after their successful verification.

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

It is used to check the medicinal product's authenticity and to identify individual packs. The data elements are printed onto the pack in a Data Matrix Code and generally in plain text. This information is uploaded by the pharmaceutcial entrepreneur into the PU system.

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).

Packs of medicinal products obliged to verification not bearing the security features made dispensable before 09.02.2019 remain as such until the end of their expiration date.

Packs of medicinal products obliged to verification marketed from 09.02.2019 onwards are only dispensable when bearing the necessary security features.

securPharm e. V., a non-profit-orientated organisation, as so-called National Medicines Verification Organisation, NMVO is responsible for the setup of the system to validate medicinal products in Germany. Pharmaceutical entrepreneurs must join securPharm's system in order to meet the legal obligation to notify the necessary data into the national database.

ACS PharmaProtect GmbH has been made system operator by securPharm e. V. in the context of implementing the FMD. It is responsible for the contractual and technical connection of pharmaceutical entrepreneurs concerned in the German pharmaceutical market (PU system). In order to connect to their system, pharmaceutical entrepreneurs have to contact ACS PharmaProtect GmbH directly via email info@pharmaprotect.de or telephone +49 30 577037-900.

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.

NGDA (Netzgesellschaft Deutscher Apotheker mbH) runs the pharmacy server aiding pharmacists and other market participants medicinal products' verification. Scanning each pack before its dispense verifies the authenticity of the pack through data exchange.