Sunrise considers its Management System, developed in accordance with the ISO 9001:2015, ISO 14001:2015, and ISO 13485:2016 standards, one of the primary drivers for employee engagement and process improvement. The company bases its operational decisions on the following principles:

• Correctness: Understood as meeting customer expectations and fulfilling commitments.
• Seriousness: Understood as the reliability of the products marketed.
• Compliance: Understood as adherence to contractual and legal requirements.

Sunrise’s primary objective is the commercialization of products that fully meet the needs of its customers. In particular, the company believes it is of fundamental importance to provide clients with reliable, high-quality products that comply with the specified order requirements.

Therefore, Sunrise is committed to:

• Developing a “culture of quality” throughout the company.
• Placing the customer at the center of its strategies and improvement processes.
• Optimizing business processes to achieve and maintain the highest level of effectiveness and efficiency.
• Involving employees in defining improvement objectives and quality system development plans.
• Respecting the performance standards characteristic of the activities performed.
• Complying with current legislation and defined contractual agreements in its operations.
• Meeting all applicable requirements of the ISO 9001:2015, ISO 13485:2016, and ISO 14001:2015 standards.
• Improving operational methods to prevent potential inefficiencies.
• Defining a structured framework of quality and environmental protection objectives, which is periodically reviewed.
• Making its policy available to interested parties and periodically reviewing it to ensure its suitability.
• Evaluating and promoting initiatives to prevent abnormal situations that could compromise operational efficiency, worker safety, or the environment, while preparing necessary actions to mitigate potential impacts or incidents.
• Evaluating and promoting initiatives to improve the environmental impact of activities related to the organization, both under normal conditions and in abnormal or emergency situations.
• Procuring energy-efficient products and services that impact energy performance and investing in research and development to improve service quality and safety, with a focus on reducing environmental impact and enhancing energy efficiency to achieve set objectives.

Sunrise has obtained all the necessary authorizations for the distribution of human-use medicines and narcotic drugs. Authorizations 219 and 309 are significant regulatory references in the pharmaceutical distribution sector.

Authorization 219

This authorization refers to Legislative Decree 219/2006, which implements European Directive 2001/83/EC regarding the Community code relating to medicinal products for human use.

Main Purpose:

• Regulate the authorization for the marketing (MA) of medicines.
• Establish rules for the manufacturing, quality control, distribution, and advertising of medicines.

Authorization 309

This authorization pertains to Presidential Decree 309/1990, known as the Consolidated Law on Narcotic Drugs and Psychotropic Substances.

Scope of Application:

• Governs the production, trade, possession, and use of narcotic or psychotropic substances, including their medical use.
• Applies to medicines containing active ingredients classified as narcotics or psychotropics, such as opioids for pain management.

Specific Requirements:
Strict controls on:

• Quantities purchased and sold.
• Destination of the medicines.
• Data recording and storage (via narcotics register).
• Mandatory periodic reporting to the competent authorities (Local Health Authorities or Ministry of Health).