EXTRAORDINARY NEWSLETTER Nº 26/2017
Informativos . 31/10/17
It was published on the Official Gazette, Section 1, from 10/19/2017, RDC 183 from 10/17/2017 that disposes about programs of inspection and administrative procedures to Grant Good Manufacturing Practices Certification for establishments that manufacture medical devices located abroad and in Mercosul.
This Resolution establishes that ANVISA will evaluate the compliance of GMP primarily through specific inspection programs, however the respective certification will be granted through the following:
- Documental evaluation of confidential information obtained from other partners regulatory agencies, or;
- Reports of inspection performed by third party audit agencies recognized by ANVISA, by country member of IMDRF, or even through the MDSAP program.
Besides documental analysis, ANVISA may, also, decide to perform an in loco complete or reduced inspection, according to risk assessment.
The resolution explains the procedures and documents to be presented at the request of certification and defines, as well, transience terms.
From the publication date, companies that have GMPc petition which inspection has not be scheduled yet will have a 60 days term to confirm the interest on the certification and present, through an amendment, documents listed on the resolution which have not the yet presented, under penalty of denial of the certification. During this period, scheduled inspection will take place normally and it will not be admitted any request to change dates of inspections.
After the 60 days term, ANVISA will proceed to the analysis of all petitions that were waiting for inspection scheduling, respected chronologic order of entrance.
Regardless of the way the GMPc will be granted, the company is not exempt of receiving in loco inspection of ANVISA anytime, even during the term of validity of GMPc already issued. Penalties for refusal of receiving the inspection are described at the resolution.