Regulatory Affairs Professionals Society 63 International Counterfeit Regulation Updated by Viky Gilles Daniel Verna, MS, BME, MSPharm, RAC (Global) Chapter 7 OBJECTIVES ‰ ‰ Review the problem of falsified and counterfeit medical products ‰ ‰ Define substandard and falsified (SF) medical products ‰ ‰ Explain the aims and scope of the Falsified Medicines Directive (FMD) 2011/62/EU, the Drug Supply Chain Security Act (DSCSA) and other international regulations ‰ ‰ Explain the aims and scope of the Unique Device Identifier (UDI) frameworks in the US, EU and other regions ‰ ‰ Identify requirements for different stakeholders in the medical product supply chain arising from the FMD, DSCSA and UDI requirements ‰ ‰ Discuss challenges in implementing FMD, DSCSA and UDI requirements ‰ ‰ Provide a list of third countries covered by the FMD ‰ ‰ Outline an explanation of international regulations and expected timelines for implementation DIRECTIVES, REGULATIONS AND GUIDELINES COVERED IN THIS CHAPTER ‰ ‰ Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products ‰ ‰ Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity ‰ ‰ Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use ‰ ‰ Commission Delegated Regulation (EU) 2016/161 of 2 October 2015—supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
Previous Page Next Page