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Market Control Division: Overview
The Market Control Division plays a vital role in the regulatory oversight of medical products within the marketplace, ensuring compliance with safety, quality, and efficacy standards. This division is tasked with overseeing the importation, distribution, and marketing of medical products to protect public health by preventing the introduction and circulation of substandard or falsified products. Through rigorous regulatory measures, comprehensive surveillance, and collaboration with relevant stakeholders, the division ensures that only safe and effective medical products are available in the market.
Scope of the Market Control Division
The Market Control Division's scope encompasses a wide range of responsibilities critical to regulating medical products throughout their lifecycle, from import to distribution. Key areas of focus include:
1. Regulation of Import Activities: Overseeing the importation of medical products to ensure that they meet national safety, quality, and regulatory standards. This process is essential to prevent non-compliant products from entering the market.
2. Prevention and Detection of Substandard and Falsified Medical Products: Actively working to detect and prevent the introduction of substandard and falsified medical products. This initiative aims to safeguard public health and ensure that only legitimate, effective products are available for consumers.
3. Collection of Import and Manufacturing Data: Collecting and analyzing consignment-specific data on imported and manufactured medical products. This data provides critical insights for assessing product quality and regulatory compliance.
4. Market Surveillance Programme: Implementing a market surveillance program that monitors the quality of medical products throughout the supply chain. The program is designed to identify and mitigate risks to product safety and quality, ensuring continuous compliance with established standards.
5. Control of Promotional, Marketing, and Advertising Activities: Regulating the promotional, marketing, and advertising activities related to medical products through an established Advertisement Committee. This ensures that promotional practices are aligned with ethical standards and regulatory requirements.
6. Oversight of Product Recalls: Managing and overseeing the recall of medical products from both the private market and public sector. This oversight ensures that unsafe, defective, or non-compliant products are efficiently removed to minimize potential risks to public health.
7. Post-Market Sampling and Quality Assurance: Jointly responsible with the National Medicines Quality Assurance Laboratory (NMQAL) for post-market sampling planning and execution. This includes sampling from both private and public sectors to ensure ongoing product quality after market entry.
8. Inspection of Good Distribution Practices (GDP): Initiating inspections to ensure that distribution practices comply with Good Distribution Practices (GDP) standards.
These inspections ensure that medical products are handled, stored, and transported in ways that maintain product integrity and safety.
9. Information Sharing and Public Engagement: Ensuring the effective dissemination of regulatory information to patients, the public, and retail outlets. This promotes transparency and provides stakeholders with critical information regarding medical product safety, regulatory actions, and recall notices.
The Market Control Division is committed to upholding the highest standards of public health protection through comprehensive regulatory activities, vigilant monitoring, and continuous collaboration with stakeholders in the healthcare sector.
Guidelines
1. Guideline for safe disposal of expired and unusable pharmaceuticals 2. Guideline on import control activities
3. Guideline on post marketing surveillance
4. Good distribution practice
Application forms
Submission of Import data / Manufacturing data of Pharmaceuticals
https://cdn.prod.website
files.com/666d0695ca3ba7fa496a5068/677509c6d16c34a8681137e4_Import%20details%20
( 1).docx
Destruction of local waste
Destruction of shipboard and air cargo waste
National Medicines Regulatory Authority,
State Engineering Corporation Building (2nd Floor),
No. 130,
W.A.D Ramanayaka Mawatha,
Colombo 02,
Sri Lanka