This Resolution aims to establish administrative procedures for granting Certifications of Good Manufacturing Practices for Medicines, Health Products, Cosmetics, Perfumes, Personal Hygiene Products, Sanitizing Products and Pharmaceutical Inputs and Certifications of Good Distribution Practices and/or Storage of Medicines, Health Products and Pharmaceutical Inputs.
This Resolution applies to companies that manufacture Medicines, Health Products, Cosmetics, Perfumes, Personal Hygiene Products, Sanitizing Products and Pharmaceutical Supplies located in the national territory, in Mercosur or in other countries and to companies that store, distribute and import Medicines, Products for Health and Pharmaceutical Supplies located in the national territory.
The granting of the Certification dealt with in this Resolution will depend on the verification of the effective fulfillment of the requirements established by the current rules of Good Manufacturing Practices and Good Practices of Distribution and/or Storage with the observance of the established in this Resolution.
The validity of the Certification of Good Manufacturing Practices and the Certification of Good Distribution and/or Storage Practices will be two years, counting from the date of its publication in the Federal Official Gazette.
The Certificate of Good Practices will be issued in a single copy in the name of the establishment where the activity object of the Certification is carried out. Additional copies may be requested by the company requesting the original Certification.
When the establishment object of the Certification is not responsible for all production stages of a certain pharmaceutical form or biological active pharmaceutical ingredient, the certificate will describe the respective intermediates or production stages for which the establishment is responsible.
The cases of new establishments or new production lines will depend on a new application for Certification. Evidence of carrying out self-inspection must be available during the health inspection. Anvisa may, at any time, carry out a routine health inspection or investigation of a complaint or possible irregularity on any product dealt with in this regulation, regardless of the Certification process.