Decree No. 40787 / S – published February 19th – modifies the sanitary requirements for the registration of medicines intended for human use, forcing all laboratories to present a Certificate of Good Manufacturing Practices. In turn, the decree establishes that contracts related to outsourcing and the international status of the drug (resulting from the list of national authorities that inspected the medicine and accepted its distribution) should be disclosed. The dispositions of the decree will become effective as of August, when the six-month period foreseen for its entry into force is fulfilled.
According to the decree, the developer company must also provide information on the quality of the active ingredient and the final format of the asset. Given the importance of the safety and efficacy of the prescription, having this series of data allows a comparison of the innovative biological with its biosimilar version -using vaccines to this same type of analysis.
A procedure is also established before changes to the registration of the drug and the consequent step by step foreseen for the time of renewing the approved registration. Each medication must comply with the detailed requirements and classification, in addition to overcoming the release process for its commercialization and use by the Ministry of Health.
Finally, the Human Consumption Products Office of the Ministry of Health will be responsible for completing the corresponding checks -with taking samples in the market, the pharmaceutical laboratory or the customs. The first batch will be compulsorily subject to control, without successive revisions being underestimated, and the owner or legal representative of the drug will be duly notified beforehand – with the possibility open for the State to outsource the performance of these analyzes.