Regularization of controlled medicines

Controlled medicines are substances that have the potential to cause addiction or abuse, and are therefore regulated to protect the health of the population. These include medicines containing psychoactive substances, such as some painkillers, anxiolytics and sedatives. These products can only be specified by qualified professionals and are subject to specific controls in their manufacture, distribution and sale.

The regularization of these medicines involves a series of steps to guarantee their quality, safety and efficacy. Among the main stages are:

Registration with Anvisa: For a controlled drug to be marketed, the manufacturer must register it with Anvisa, presenting clinical data that proves its efficacy and safety.

Production and distribution control: The manufacture and distribution of these drugs must follow strict rules to avoid detour to the illegal market. Pharmaceutical companies must have audited and certified processes.

Prescription and Prescription Control: The prescription of medicines is restricted to doctors and must be made by means of a specific prescription, as required by Anvisa. The prescription has a limited validity and must be registered to prevent counterfeiting.

Inspection: Health surveillance agencies carry out constant inspections to ensure that these medicines are not diverted to the parallel market or misused.

The regularization of controlled medicines is not just a bureaucratic issue; it is crucial to protecting the health of the population. Without effective control, these medicines can be misused, creating risks of addiction, overdose or other damage to health. In addition, strict control prevents the trafficking and detour of medicines to the illegal market, ensuring that they reach the people who really need them.

In addition, the regularization process contributes to public confidence in medicines, as it ensures that the substances available on the market are properly tested and meet quality and safety standards.

The regularization of controlled medicines by Anvisa is a complex process that requires technical knowledge, attention to regulatory standards and specific compliance with deadlines and requirements. In this scenario, Stone Okamont acts as a strategic partner, offering complete and specialized solutions for pharmaceutical companies seeking to regularize their products efficiently and safely.

The regularization of controlled drugs with Anvisa is a complex process that requires technical knowledge, attention to regulatory standards and strict compliance with deadlines and requirements. In this scenario, Stone Okamont acts as a strategic partner, offering complete and specialized solutions for pharmaceutical companies seeking to regulate their products efficiently and safely.

Personalized Regulatory Consulting:

Stone Okamont offers specialized advice on all stages of the process, including: 

• Analysis and adaptation of the technical documentation required by Anvisa.
• Guidance on obtaining Operating Authorizations (AFE) and Special Authorizations (AE).
• Correct classification of the drug according to the lists of controlled substances.

Management of deadlines and regulatory processes:

We manage all stages of the regulatory process to ensure that deadlines are met: 

• Continuous monitoring of the progress of applications to Anvisa.
• Intermediation with health authorities to resolve any pending issues or requirements.

With Stone Okamont's expertise, your company gains a reliable partner to safely navigate the complex process of regularizing controlled drugs. We have the necessary experience to facilitate the entry of your products onto the market, ensuring quality, efficiency and regulatory compliance at every stage.