uzbekistan mandatory serialization medicines group 1

[Blog] Uzbekistan Pharma Serialization – what is coming after the first deadline?

Almost 1 year after Uzbekistan`s Decree 737 for the establishment of obligatory digital labeling, pharma supply chain participants meet the first deadline for mandatory serialization.

 

 

 

 

 

 

On the first day of September, also came the first deadline for the serialization of medicines in Uzbekistan. Earlier in April, Uzbekistan’s Cabinet of Ministers adopted Resolution No. 149, “On the introduction of a system of mandatory digital labeling of medicines and medical devices.”, in which were announced the deadlines for the four groups of medicinal products:

 

  • From September 1, 2022 – 1st group;
  • From November 1, 2022 – 2nd group;
  • From March 1, 2023 – 3rd group;
  • From February 1, 2025 – 4th group.

 

From 1st September, the first group of drugs that include medicinal products with secondary (external) packaging (except orphan drugs) fall under mandatory serialization. The drug import into the territory of the Republic of Uzbekistan of the following medical products could be performed only in course of the requirements.

 

Regarding the labelling requirements, it was announced the possibility of labelling by sticking the serialized labels in addition to the technology of direct application.

 

Moreover, we point out the attention to the established norm according to which the foreign manufacturers have to open an official representative office in Uzbekistan or sign a representative agreement with a local company that will support them and present their interests and obligations in the field of the introduction of digital labelling. The time limit for this is 12 months from the date of the introduction of mandatory digital labelling.

 

The next deadline is coming on 1st November this year affecting the group of medicines with primary (inner) packaging (provided there is no secondary (external) packaging) (except orphan drugs).

 

Uzbekistan Pharma Serialization is a hot topic in the industry because of the market`s robust development. The supply chain participants are focused to be prepared for the new requirements and deadlines on time. We are following the journey of Uzbekistan`s traceability system and supporting the participants during all stages.

 

 

 

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