EXTRAORDINARY INFORMATION Nº 08/2019
Informativos . 26/02/19
It was published in the Official Gazette of 26/02/2019 the Collegiate Board Resolution Nº 268, of February 25th 2019 proposing a change in Collegiate Board Resolution – RDC nº 234, of June 21st 2018 that rules the outsourcing of production steps, quality control analysis, transportation and storage of medicines and biologic products, and other measures.
The new rule suspends the art. 30 and art. 31 of RDC nº 234, of June 21st, 2018 and provides other measures until it is regulated the laboratories accreditation and revised the rules Ordinance nº 802, of October 8th 1988, RDC n° 10, of march 21st 2011 and RDC n° 11, of February 16th 2012.
They come into force with a new writing the art. 33 from RDC nº 234/2018; the art. 8º, art.9º and subsection VIII of art. 10 of RDC nº 10/2011. It is revoked the RDC n° 257, of December 18th 2018.
In summary, it is kept the obligation to the importing companies to have its own warehouse and quality control laboratory, including specific space to store reference samples.
It was opened the possibility to outsource total or partially the quality control for the following medicines: dynamized; specifics containing active substance of animal or vegetal origin; herbal drugs.
It will be allowed the outsourcing of quality control for the other medicines, in specific situations, among them we highlighted the following:
– for contracts between medicine manufacturing companies;
– for contracts between importing and manufacturing companies, only when the manufacturing company is the contracted part;
– medicines for rare or neglected diseases;
– assays for impurities quantification, microbiology or determination of microstructure.