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Worldwide Regulatory Updates

March 10, 2019

TraceLink continuously monitors emerging and evolving track and trace regulations around the world. View updates from the past week, and other recent developments below.

Egypt

  • The Egyptian Ministry of Health (MOH) has issued a request for comments on their current draft regulations, requiring data elements of labels to be encoded in a specific order, which is not aligned to global standards.

European Union

  • SecurMed, which is the UK NMVO, announced changes in wording to 11 alert messages and 1 system message that are produced by the NMVS. The changes, which are effective March 17, were implemented to make the messages easier to understand and do not affect the meaning of the alerts and system message.
  • The Netherlands NMVO advised OnBoarding Partners (OBPs) that the OBPs are receiving alerts due to issues with FMD product data. These issues could be from product data not fully being uploaded, an unknown product code being entered, or a batch not being found in the system. The Netherlands NMVO added that the Marketing Authorization Holders (MAHs) and OBPs are responsible for following up on and addressing these alerts.

Kazakhstan

  • The Kazakhstan Ministry of Health (MOH) continues work on their pilot program for pharmaceutical track and trace regulations. The MOH plans to focus on GS1 standards, but it has yet to be determined if they will align more closely with the European Union/Turkey approach or the Russia approach to GS1 standards.

Saudi Arabia

  • The Saudi Food and Drug Authority (SFDA) urged stakeholders to make their best efforts to be compliant. Regulators acknowledged the challenge of meeting the upcoming aggregation deadlines as guidelines for the technical requirements have yet to be published. Regulators are considering the use of Turkey's Package Transfer System (PTS) as the basis for the SFDA requirements.

Sri Lanka

  • The government is beginning to look into digital track and trace requirements and other global approaches as they create their pharmaceutical regulations.
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