On October 6, 2020, an excerpt of Exempt Resolution No. 3853/2020 of the Institute of Public Health (ISP) was published in the Official Gazette, establishing requirements for the notification and execution of market withdrawal activities for the holders of health registrations and participants in the distribution chain of pharmaceutical products, whether they are voluntary withdrawals or withdrawals instructed by the ISP.
For these purposes, withdrawal activities are classified as Class 1, Class 2 and Class 3, according to the potential health risk that the product involved may represent.
Bearing in mind the above, pharmaceutical product recall activities shall be governed by the following rules:
A. The beginning of the withdrawal shall be notified by electronic means, in the following opportunities:
Once the suspicion or verification of failure or deviation of quality is known, or since the cancellation of the sanitary records, within a maximum period of 24 hours.
Within a period not exceeding 48 hours, accompanying the written records of the notification to each one of the establishments of the distribution chain.
B. In the case of Class 1 withdrawals, the owner of the records shall have the obligation to send a warning message to consumers informing them of the dangers or harmfulness of the lots of the product subject to withdrawal.
C. Obligations are determined for the establishment that has received one or more lots subject to withdrawal shall, establishing standards according to whether it has made previous distribution or not.
D. The holder of the sanitary registration shall submit to the PSI the follow-up reports of the withdrawal from the market and, once the withdrawal is finished, shall submit a conclusive report.
E. The destruction of the medicines shall be the responsibility of the holder of the health registration, according to the regulations in force.