Legal Update: UAE Pharmaceutical Products Traceability

In June 2021 the UAE Ministry of Health and Prevention (“MOHAP”) issued a pharmaceutical products traceability decree, which applies to all conventional medicines that are being traded in the United Arab Emirates (“UAE”).

What are the compliance deadlines?

There is a 6-month grace period, after which all pharmaceutical products imported into the UAE must comply with the decree by applying a 2D matrix barcode and human readable format, in accordance with GS1 standards; the deadline is 13 December 2021.

There is an 18-month period for serialization reporting and onboarding onto the Tatmeen platform. The deadline for this is 13 December 2022.

All sites that are licensed to dispense medicines in the UAE will be required to be registered with a GS1 global location number (“GLN”) within 18 months of the decree’s issuance, being 13 December 2022.

Are there exemptions?

Pharmaceutical products already within the UAE prior to 13 December 2021 may continue to be sold without complying with the decree, until such time that the quantities in country runs out at the various trading points.

Products that are exempt from serialization include:

  • Free samples of pharmaceutical products;
  • Pharmaceutical products imported for personal use only;
  • Medical devices and supplies; and
  • GSL products.

We detail the decree’s impact on supply chain stakeholders and the general requirements for product identification in our full article.

Read full article      

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