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Health Ministries in Eurasia Focus on Serialization

Drug serialization around the globe

Serialization of Pharmaceuticals Worldwide
05.07.2022
Healthcare & Pharma
Counterfeit Protection

It is not only in Europe that the issue of ‘drug serialization’ is high on the agenda of health ministries. Bahrain, Uzbekistan, Kazakhstan, and the United Arab Emirates are also fighting against the trade in counterfeit medicines.


Serialization of medicines has long been established in EU countries. Anyone who goes to the pharmacy in Germany, Austria, or another member state to buy a prescription drug can rely on the ‘authenticity check’ on site. With the help of various solutions, it is possible to check whether the drug is original or plagiarism. You can find out more about this in our blog post ‘What is Serialization in the Pharmaceutical Sector?

Bahrain, Uzbekistan & Co. Rely on Serialization of Medicines

Drug serialization is also becoming increasingly important outside Europe. Thanks to our innovative serialization solution, we can adapt individually to the countries and rules that apply there. With Arvato CSDB, there is not only the option of serving verification systems here in Germany or throughout Europe. Possible scenarios can include import processes as well as local production. Our solution is flexible enough to be used worldwide for the relevant business processes and the associated serialization. This topic is currently hot in Bahrain, the United Arab Emirates, Uzbekistan, and Kazakhstan.

Bahrain

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In Bahrain, the law on the verification of pharmaceuticals came into force in November 2017. Successive implementation began in April of the following year with the reporting of product master data to the GS1 UAE BrandSync portal. Serialization and barcoding followed, as well as the registration of marketing authorization holders with Bahrain's MVC Traceability Hub. The target date was October 01, 2021 - since then, certified MAHs have been reporting shipping information to the traceability hub. Until May 2022, aggregation was optional, now it is mandatory. The reporting obligation in Bahrain only includes packaging events - unpacking or interim operational events in the warehouse are excluded.

Uzbekistan

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In Uzbekistan, the Cabinet of Ministers formed the starting shot in May 2021. It was decided that mandatory serialization and tracking of medicines will come into force on February 01, 2022. The national verification system is administered by the Center for Research in Perspective Technologies - CRPT Turon for short - which also carried out the six-month pilot phase. All MAHs were able to register successfully during this period, so that since February of this year, only drugs with the appropriate labeling may be imported and produced. Reporting thus begins from the time of ‘entry to market’. The digital labeling required for this consists of a data matrix code, the GTIN, the date of manufacture and expiration, and the serial and batch numbers.

Kazakhstan

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The situation is a little different in neighboring Kazakhstan. There, serialization and tracking of pharmaceuticals are being introduced in stages. Kazakhstan's Ministry of Health, together with the operator of the national verification system CRCE, initially monitored and supervised the test phase, which stretched over 2018 and 2019. Subsequently, serialization and traceability of medicines were voluntary - but since last Friday, July 01, 2022, mandatory for 93 medicines. Step by step, the scope of medicines subject to serialization will be expanded. The next milestone is October 1, 2022, when at least 20% of medicines must be serialized. Finally, on January 1, 2023, tracking of about 60% of medicines will begin until full implementation is completed in July next year. Reporting starts analogously to Uzbekistan and starts at the ‘entry to market’.

United Arab Emirates

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The Emirates on the Persian Gulf rely on the Track & Trace solution ‘Tatmeen’ to ensure the traceability of pharmaceuticals from Abu Dhabi to Dubai. The Ministry of Health and Prevention, like all EU countries, wants to ensure the health and safety of the population and is checking the registration of pharmaceutical companies as well as products. Currently, the implementation of the barcodes is still ongoing until December 13, 2022, when further processes, such as aggregation and more extensive import processes, will become mandatory and the reporting obligation, including integration into Tatmeen, will become unavoidable. To be eligible to register one's products, the appropriate licenses must be available (Shipping Import Permit). The registration of the products must be done at the MOHAP Drug Department in order to receive the certificates. Imported pharmaceutical goods manufactured there must be marked with a data matrix code and a GLN (Global Location Number), regardless of whether the product is registered or not.

Arvato Systems as a Reliable Partner When It Comes to Drug Serialization

For all manufacturers of pharmaceuticals, meeting the various regulations is a major challenge. With Arvato Systems as a reliable partner when it comes to drug serialization, we can deploy the solution for any pharmaceutical company and any country, so that nothing stands in the way of secure distribution and export. Find out more details about our Arvato CSDB solution here.

Arvato CSDB

Arvato CSDB - Serialization in drug production

White Paper - Serialization in Drug Production

Download the White Paper and learn more about international deadlines, statistics & dangers as well as the successful implementation.

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Written by

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Pauline Poppensieker
Expertin für Fälschungssicherheit