The European Falsified Medications Directive came into effect on February 9, 2019. From that time most of the prescription and reimbursable medicines on the market must bear safety features. At each link in the distribution chain, the safety features must be checked so that the authenticity of the medicine upon delivery can be guaranteed.
The Falsified Medications Directive came into effect on February 9, 2019. The FAMHP has bundled a few practical guidelines for handling the problems in the start-up phase in a newsletter and has decided to set a transition period.
LYNPARZA® capsules (50 mg) and LYNPARZA® tablets (100 mg and 150 mg) are not interchangeable on a milligram by milligram basis due to variations in dose/dosage and the biological availability of each formulation.
Within the framework of the Falsified Medicines Directive, FMD) which is effective as of February 9, 2019, all drug packaging falling under this legislation must be equipped with an anti-tampering device (ATD). Packaging of these drugs not subject to this obligation may also have an ATD. The marketing authorization holder must submit a request for this to the FAMHP.
The law on allogenic ATMPs dated 30 October 2018 changes various elements in the law dated 19 December 2008 regarding human tissue products (HTP) with the intention of medical application on humans or for scientific research.
Report to all licensees or potential future licensees for drugs for human use: as of January 1, 2019, every file for acquisition of a license to market a drug for human use must be submitted in eCTD format.
The patient is one of the most important partners for the Federal Agency for Medicines and Health Products (FAMHP). In response to this, two symposia have already been organized regarding working with and for the patient.
As of 1 January 2019, the holders of a marketing authorisation (MA) must use the OTC version of the QRD template for drugs delivered on medical prescription or written request according to article 3 of the regent decree dated 6 February 1946.