This the second of a 3-part update on serialisation legislation developments since my last update in mid-2016. To see Part 1, please click here.
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- Export Legislation
- The implementation of the DAVA portal for reporting all export product from India continues to be troubled, as constraints manifest themselves because of the way the system has been configured. The situation does not appear to be being helped by the fact that the DAVA system seems to be being configured for both the export and the separate, yet to be finalised, domestic market requirements.
- The approach to marking product destined for markets that have serialisation requirements, e.g. the USA, has been causing a lot of confusion, as reporting is still required to the DAVA system, but in Indian law serialisation of product packaging is exempt, as the product will be marked with the destination country serialisation. A process for agreeing these exceptions with the government is being managed by Pharmaexcil, the India Pharmaceutical Export Promotion Council.
- The quality of serialised pack marking of US product coming out of India is reported by the wholesalers as having many issues with both what is being printed and the quality of the printing.
- Domestic Legislation
- There has still not been any publishing of a final domestic legislation.
- New pack marking recommendations were published in August 2016 for the batch variable marking of prescription drugs with GS1 Databar or Code 128 barcodes by April 2021.
- Discussions are underway to try to move from the Databar to GS1 Data Matrix. This is a batch variable requirement only, with no serialisation.
- Requirements were published in early 2016 for a phased implementation of a serialisation model.
- 1st July 2018 batch variable coding.
- 1st July 2020 the addition of serialisation.
- International standards are acceptable.
- Further information is expected from the Jordanian FDA on the scope and reporting requirements. The current concern is that the JFDA seems to be wanting to specify a very broad scope of application, including the likes of named patient supply, samples, tenders.
- It has been confirmed that GTINs issued in any country will be acceptable.
- Only GS1 Data Matrix will be allowed on packs after the end of the transition period on 1st July 2018.
- A Kazakhstan Ministry of Health sponsored drug traceability pilot is reported to be ongoing in the country.
- National drug traceability law is being drafted, with a phased implementation of batch-variable coding, then the addition of serialisation.
- The national system could be ready as soon as March 2017.
- The rumoured timelines were very short.
- Final requirements that are overdue have yet to be released. Elections locally appear to be one reason for the delay.
- The current requirement to apply serialised holograms to Malaysian marketed product still stands. However, as there is only one local supplier of the holograms, this causes manufacturers some significant issues.
- The Malaysian Ministry of Health are working with local industry groups on the potential for the introduction of a track and trace system, the adoption of global standards and the phasing out of the hologram.
- No further update since my last summary in mid-2016.
- Oman Ministry of Health published requirements for a barcoding system in October 2016.
- The scope of the legislation is tender pharmaceutical products.
- Phased implementation, although the exact interpretation of the meaning of the implementation date is unclear.
- End 2017: Batch variable marking.
- End 2018: Addition of serialisation.
- No reporting requirements are stated currently.
- The state of Punjab have just issued serialisation requirements with an implementation date of mid-2017. Clearly this is causing concern and clarifications are being sought.
- It is understood that, whilst not stated explicitly in the requirements, the GS1 Data Matrix is intended to be used.
- An unknown Article Identified (27) is also stated as a requirement, which clearly needs some clarification.
- The requirement, or not, for associated human readable text is also subject to clarification.
- Country-wide legislation is also expected.
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