THE WRIT OF MANDAMUS FOR THE CONCLUSION OF THE PROCESS OF CERTIFICATION FOR GOOD MANUFACTURING PROCEDURES REQUIRED FOR THE REGULARIZATION OF HEALTH PRODUCTS OF CLASS RISK II AND IV CONFRONTED WITH THE ANVISA RESOLUTION N. 15/2014

On March 31st 2014 the ANVISA Resolution n. 15/2014 has entered into force, which has regulated the possibility of requesting the registration or alteration of registration/inclusion of manufacturer of healthcare products classified as risk classes III and IV with only the protocol of the request for the International Good Manufacturing Procedures.

However, the conclusion of the requests for the registration or alteration of registration/inclusion of manufacturer will be conditioned to the publication of the International Certification of Good Manufacturing Procedures, according to the Sole Paragraph of Article 2 of this Resolution.

According to the information provided at the ANVISA website, the average time waited for the sanitary inspection to be performed by ANVISA for the Certification of Good Manufacturing Procedures is of 1080 (one thousand and eighty) days, keeping in mind that, as explained by ANVISA itself, such deadline regards only the suggestion of dates for the performance of the inspection.[1] [7]

Thus, besides such deadline, there is yet another one, not informed by ANVISA, for the other stages which are necessary for the process of CERTIFICATION OF GOOD MANUFACTURING PROCEDURES: emission of the report, elaboration of the opinion for approval, denial or demand, and, lastly, the publication of the decision of approval or denial of the GMP on the Official Gazette.

Therefore, the whole process for the certification of GMP should be considered to take more than 3 (three) years, and so, the writ of mandamus remains as the appropriate legal remedy for the conclusion of such process by ANVISA.

Nowadays, and based on the latest decisions pronounced by the Federal Court, the judges have granted injunctions for ANVISA to conclude the whole GMP Certification process, in an average of 60 to 90 days, for processes which have been waiting for progress for over 6 months.

Although there are judges who follow the strict terms of the law, granting injunctions for processes which have been waiting for a reply from ANVISA for over 30 or 90 days, in accordance to the legal deadlines established on Laws 9.784/99 and 6.360/76, most judges only grant injunctions when the processes have been pending at ANVISA for, at least, six months.

So, in order for the process of regularization of health products of risk classes III and IV not to be pending as well, awaiting only the conclusion of the request for the GMP certification, according to the new ANVISA Resolution n. 15/2014, the writ of mandamus remains as the most common legal alternative among companies that wish to reduce such deadline at ANVISA.

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