Committee approves extended validity for drug certifications

09/12/2008 05h00

The agreements closed in Mercosul about that matter have already established a two-year deadline for their renewal

On Wednesday (12/3), the Committee on Social Security and Family approved the extension of the term for the renewal of the Certification for Production Good Practices for the pharmacy industry from one to two years.
The agreements closed in Mercosul on the matter have already been establishing a two-year term for that renewal.

The certification, granted by the National Agency for Sanitation Inspection (Anvisa), attests the required standards by the sanitation legislation for a production line for medicines. The bill (Bill 5800/05) was proposed by the Deputy Manoel Salviano (PSDB-CE).

He argues that, due to the reduced number of inspectors, those inspections are superficial. According to him, the duplication of the certificate’s expiration time will allow Anvisa to enhance inspection work, without negatively affecting the products in the market.

The deputy reminds that pharmaceutical industries can be inspected and punished anytime, if any infraction to sanitation laws is found.

The Committee agreed with the opinion of the rapporteur on the matter, Deputy Darcísio Perondi (PMDB-RS). For him, that extension will not affect the quality of the products. “Current rules already require a set of technical procedures that oblige producers to maintain a specific routine, which is hardly changed along the year”.

Procedure
The Project will he reviewed by the Committee on the Constitution, Justice and Citizenship, and later by the House Floor.

From the newsroom/PR
With information from the Committee on Social Security and Family
Translation - Positive