QA (Quality Assurance): Must ensure all manufacturing, importing, and distribution processes comply with the directive's requirements.
Regulatory Affairs: Must stay updated on amendments and implement necessary changes to maintain compliance.
Manufacturing: Must adhere to the principles of good manufacturing practice (GMP) for active substances and excipients.
Distribution: Must verify the authenticity of medicinal products and comply with safety feature requirements.
Work Suggestions:
QA: Conduct regular audits to ensure compliance with GMP and good distribution practices.
Regulatory Affairs: Monitor updates from the European Parliament and Council for any amendments to the directive.
Manufacturing: Implement strict controls and inspections to ensure active substances meet GMP standards.
Distribution: Develop systems for tracking and verifying the authenticity of medicinal products.
Scope of the Directive: This directive applies to medicinal products for human use within the European Union, focusing on preventing falsified medicinal products from entering the legal supply chain. It covers various aspects including manufacturing, importation, distribution, and safety features for medicinal products.
Key Points Summary:
Definition of Falsified Medicinal Products: Introduces a definition to distinguish falsified products from other illegal or substandard products.
Safety Features: Requires the introduction of safety features for medicinal products to verify authenticity and identify individual packs, providing evidence of tampering.
Good Manufacturing Practice (GMP): Strengthens verification requirements for manufacturers to ensure compliance with GMP for active substances.
Supply Chain Reliability: Legislates that all actors in the supply chain, including brokers, must meet specific requirements to ensure reliability.
International Coordination: Calls for enhanced international cooperation to combat the global issue of falsified medicinal products, particularly in online sales.
Conclusion: The Directive 2011/62/EU is a critical piece of legislation aimed at safeguarding public health by preventing falsified medicinal products from entering the legal supply chain within the EU. It places a strong emphasis on GMP, safety features, and supply chain integrity. The directive also encourages international collaboration to address the global nature of the falsified medicines threat. Above points are only a summary; for comprehensive understanding, the original directive should be consulted.
