According to the document, inspections will not be conducted uniformly for all businesses, but will take into account the level of risk identified for each type of activity. This approach, according to the authors, will make oversight more targeted, reduce the administrative burden on compliant operators, and strengthen supervision in high-risk areas.
The new methodology will apply to several areas under the agency’s jurisdiction, including:
– the manufacture and wholesale distribution of human medicines;
– clinical trials;
– pharmacovigilance;
– pharmacy operations;
– medical devices;
– the distribution of narcotic and psychotropic substances and precursors;
– consumer protection in the field of pharmaceutical and parapharmaceutical products.
Special attention is given to the control of the circulation of narcotic and psychotropic substances and precursors. The need to apply specific risk criteria stems from the special legal regime governing these substances and the need to prevent them from entering illicit circulation. Controls in this area will be coordinated by the Standing Committee on Drug Control.
General risk assessment criteria will include the date of the last inspection, the history of compliance with legislation and the Agency’s regulations, as well as the type of economic activity conducted by the enterprise. Special criteria will take into account the specific characteristics of each sector. These include the complexity of production processes, the type and significance of the products manufactured or distributed, the size of the enterprise, the number of employees, the type of clinical trials, the length of the company’s operations, the number of registered drugs, the operational risk profile, and potential violations in commercial practices.
In addition, the methodology provides for an analysis of complaints from citizens and companies.
The document is to be adopted by the government.
