The ANSM reminds all players in the pharmaceutical circuit of their obligations in terms of traceability, in particular for drugs withdrawn from the market.
Some operators and distributors of the unscrupulous pharmaceutical circuit are in the crosshairs of the ANSM. In his last press release, the National Medicines Safety Agency has seen fit to remind these players in the pharmaceutical world of the importance of the proper execution of recall decisions for batches of withdrawn medicines. The ANSM was indeed led to “observe dysfunctions in the pharmaceutical circuit which led to the distribution to pharmacies of batches of drugs withdrawn from the market. The Agency observed the distribution of drugs which have been withdrawn, either in application of the provisions of the public health code, or as a precautionary measure and therefore potentially dangerous for the health of patients.
“Consequently, the ANSM draws attention to the full and entire responsibility of operators in terms of placing medicinal products on the market and that of each actor in the distribution chain for their contribution during a recall procedure. “In fact, in order to avoid the distribution of batches that have been the subject of a recall, the ANSM reminds that it is up to the operators of specialties to take all the necessary measures, particularly in terms of communication and to ensure good dissemination of information.
Traceability obligations
The ANSM also explains that “it is also necessary to take into account, during this batch recall procedure, all of the drugs that have been the subject of this recall whether they are stored in an establishment pharmaceutical, pharmacy dispensary, pharmacy for indoor use or those being delivered. “
The obligations in terms of traceability are also highlighted. When a batch of drugs that has been the subject of a recall is being delivered, it is up to the issuer to take the necessary measures to proceed with the withdrawal of the latter.
In 2013, drugs based on tetrazepam, such as Myolastan and its generics, were withdrawn from the market, due to their active substance which can “lead to risks of rare but very serious and sometimes fatal skin reactions compared to other benzodiazepines. “. To consult the list of all the batches and drugs withdrawn from the market in 2013 (and even since January 1, 1999), please refer to the dedicated page on the ANSM website.
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