Serialization of medicines in Russia: Deadline is officially extended!
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4y ago
Just before New Year, the Russian federal law No. 346344-7 amending Government Decree 1556 “On approval of the Regulations on the system of monitoring the movement of medicines for medical use” was officially signed and published. This text brings long awaited clarification on several issues, especially the extension of the serialization deadline for medicinal products in Russia. Serialization deadline for medicines in Russia is finally extended The new text pushes the deadline for drug track &am ..read more
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EU FMD : new FAQ document gives guidance on safety features for medicinal products
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4y ago
The European Commission has recently released Version 16 of their QUESTIONS AND ANSWERS regarding safety features for medicinal products for human use compliant with EU Falsified Medicines Directive (EU FMD) 2011/62/EU. Following the high number of alerts triggered when medicines were scanned prior to dispensation, the new version of the FAQS includes recommendations on the construction of unique product identifiers and barcodes. Coding requirements under EU FMD If more than one barcode is used (i ..read more
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FDA delays Product Identifier verification requirement for saleable returns
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4y ago
FDA has just published a new guidance document to clarify requirements for wholesale distributors in the US who must verify the product identifier upon receipt of a returned product before further distribution as per DSCSA requirements. Taking into account concerns expressed by pharma wholesale distributors and other trading partners and stakeholders, US FDA has published a new guidance document, delaying the enforcement of saleable returns Product Identifier verification. Section 582(c)(4)(D) of the FD&C Act requires wholesale distribu ..read more
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Russia : Authorities confirm reduction of crypto code to 44 characters
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4y ago
Crypto code requirements in Russia have been amended. The Russian Government has finally ratified and published the long-awaited Decree No. 1118, confirming the reduction of the crypto code length to 44 characters. Furthermore, the option of adding batch number and expiry date has been removed. This and the decrease in the length of the crypto code will considerably decrease the density of the data matrix to be put on medicine packaging. Payment terms for crypto codes: What is required? The ter ..read more
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Drug Serialization and Aggregation in Saudi Arabia: Latest Updates
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4y ago
Drug Serialization and Aggregation requirements in Saudi Arabia have been further clarified. Indeed, spring 2019 was a very busy time for the Saudi Food & Drug Authority (SFDA), culminating in the publication of V 6.0 of the Saudi Drug Barcoding Specifications (published in July), and two new guidelines in June. New guidelines on Saudi DTTS e-services Two new guidelines explain how to register with and use the Saudi Drug Track & Trace System’s (or in short DTTS) e-services Stakeholder Man ..read more
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Unique Device Identification – An overview of the UDI System in the EU
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4y ago
The European Medical Devices Regulation or EU MDR, as Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 is called brings many changes. One of them is the introduction of a device traceability system based on Unique Device Identification or in short UDI. The UDI System as per EU MDR The Unique Device Identification or UDI system is detailed in Part C of Annex VI of the EU Medical Devices Regulation (MDR). Unique Device Identification allows for the unambiguous i ..read more
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System Operator confirms no delay in Russia Serialization deadline
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4y ago
Following conference on the subject, the Track & Trace Russia system operator CRPT has released a statement confirming that there is no intention of moving the serialization deadlines in Russia (October 1, 2019 for the 12 high-cost nosologies and January 1, 2020 for the rest of the medicinal products). At the Global Track & Trace Russia conference, which took place in Moscow from June 24-26, Anton Kharitonov, Head of Pharma at CRPT, said in a speech that there ‘will be no delay in labeling medicines’. He urged pharmaceutical compani ..read more
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EU MDR – EUDAMED registration deadline clarified
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4y ago
Regulation EU 2017/745 or the European Medical Devices Regulation (EU MDR) was officially adopted in April 2017. Among requirements set out by the EU MDR are Unique Device Identification (UDI), intensive premarket testing and post market surveillance and increased transparency through the setting up of a European database on medical devices called EUDAMED. The database shall include information on devices, economic operators, clinical research and post-market surveillance. EUDAMED will help regulatory authorities coordinate and exchange inf ..read more
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The Basics of the European Medical Devices Regulation (EU MDR)
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4y ago
Regulations for medical devices like the European Medical Devices Regulation or in short EU MDR exist since the 90ies, for example the Medical Devices Directive (MDD) 93/42/EEC. Technological and regulatory developments required important updates though. The results are Regulation (EU)2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices”, commonly called Medical Devices Regulation (which repeals the MDD among other things) as well as Regulation (EU) 2017/746 on in vitro diagnostic medical devices ..read more
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Serialization Countdown in Russia: 4 months to go
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4y ago
Serialization requirements in Russia are among the most complex in the world. Not only is the timeline very tight – October 1, 2019 for the 12 high-cost nosologies and January 1, 2020 for the rest of the medicinal products, the technical sophistication of the requirements is very ambitious as well.   Consumer protection on a different level Pharma serialization and track & trace systems’ ultimate goal is to protect patients from falsified medicines. Russia goes a lot further and aims to track ..read more
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