The REACH Trustee Service has developed a new web-based system to efficiently track substances through complex supply chains and provide quantity import data to Only Representatives for registration purposes. The system allows non-EU manufacturers to enter their products, then invite downstream customers to also enter export sales to the EU without disclosing confidential information. This overcomes prior difficulties of gathering such data while complying with competition laws. The system is advantageous as it demonstrates commitment to customers, eases their REACH burden, and ensures low-cost compliance.
Statistics Sweden replaces traditional collection of price data with scanner data for samples of outlets and products in some parts of the consumer price index. A fixed basket approach is used, where the computing of indices is equivalent to the computing methods applied within the previous production system of the national CPI.
The use of scanner data has lowered the collection costs with annuals savings of approximately 80 000 EUR per year. In addition, the sample sizes could be increased and the standard errors of index could thereby be decreased at a low cost. About 2 000 unique products are included in 90 product groups each year, and some 100 000 price observations from scanner data are used in the Swedish CPI each month
http://www.istat.it/en/archive/168897
http://www.istat.it/it/archivio/168890
One of the results of the recently approved EU Falsified Medicines Directive imposes the application of a Unique Product Identifier and a Tamper Evidence Feature. This is only the top of the iceberg. It is not just printing a code and adding a label on a box, it means Authentication Data Flow, design the proper IT architecture, learn a new way of handling the products with a precise deadline: February 2019.
From this date all prescription products (with some exceptions)
must be serialized and data must be loaded into the EU hub.
Sharp can support you, thanks to 8 years of experience, 2 billions of sales units serialized to date, 4 plants already serializing for USA (US Drug Quality Security Act enforced from 27th November 2017), China, Brazil, South Corea.
Seminar of Sustainable Agribusiness Forum (SAF Ukraine) for business leaders in the agricultural sector.
April 26, 2018
Details: https://saf.org.ua/en/
BRAND OWNERS BEWARE: THE NEW EU TRADEMARK REFORM IS HERE!Thomas O. Dubuisson
Trademarks are often among the most important and valuable assets of a business. A distinctive trademark allows a business to create goodwill, acquire a reputation, and to guarantee that the goods or services bearing the same trademark have the same quality. A Community trademark (CTM) protects your exclusive rights in all the 28 Member States of the EU and has the benefit for its proprietor to obtain a Europe-wide injunction to prevent further or threatened infringement.
Statistics Sweden replaces traditional collection of price data with scanner data for samples of outlets and products in some parts of the consumer price index. A fixed basket approach is used, where the computing of indices is equivalent to the computing methods applied within the previous production system of the national CPI.
The use of scanner data has lowered the collection costs with annuals savings of approximately 80 000 EUR per year. In addition, the sample sizes could be increased and the standard errors of index could thereby be decreased at a low cost. About 2 000 unique products are included in 90 product groups each year, and some 100 000 price observations from scanner data are used in the Swedish CPI each month
http://www.istat.it/en/archive/168897
http://www.istat.it/it/archivio/168890
One of the results of the recently approved EU Falsified Medicines Directive imposes the application of a Unique Product Identifier and a Tamper Evidence Feature. This is only the top of the iceberg. It is not just printing a code and adding a label on a box, it means Authentication Data Flow, design the proper IT architecture, learn a new way of handling the products with a precise deadline: February 2019.
From this date all prescription products (with some exceptions)
must be serialized and data must be loaded into the EU hub.
Sharp can support you, thanks to 8 years of experience, 2 billions of sales units serialized to date, 4 plants already serializing for USA (US Drug Quality Security Act enforced from 27th November 2017), China, Brazil, South Corea.
Seminar of Sustainable Agribusiness Forum (SAF Ukraine) for business leaders in the agricultural sector.
April 26, 2018
Details: https://saf.org.ua/en/
BRAND OWNERS BEWARE: THE NEW EU TRADEMARK REFORM IS HERE!Thomas O. Dubuisson
Trademarks are often among the most important and valuable assets of a business. A distinctive trademark allows a business to create goodwill, acquire a reputation, and to guarantee that the goods or services bearing the same trademark have the same quality. A Community trademark (CTM) protects your exclusive rights in all the 28 Member States of the EU and has the benefit for its proprietor to obtain a Europe-wide injunction to prevent further or threatened infringement.
The European Medicines Agency has announced on 6th July that the Agency will continue its operations as usual, in accordance with the timelines set by its rules and regulations.
RIPE Atlas is the biggest internet measurement network composed of more than 8000 probes distributed worldwide.
The new RIPE Atlas streaming service allows you to tap into the real-time data flow of all the collected public results. Every time our system receives a data point or a probe connectivity event occurs, it's also delivered to the clients that are "tuned in" to that result stream. This feature is implemented using web sockets.
La Policía Nacional del Perú (PNP) trabajando por nuestro bienestar. Proyecto “Huaraz te quiero sin ruido”, por una ciudad LIBRE DE CONTAMINACIÓN ACÚSTICA.
Passionate business professional with over 19 years of experience in performing relevant business tasks including experience in performance management, project management, remediation, staff training/development and pipeline management.
The European Medicines Agency has announced on 6th July that the Agency will continue its operations as usual, in accordance with the timelines set by its rules and regulations.
RIPE Atlas is the biggest internet measurement network composed of more than 8000 probes distributed worldwide.
The new RIPE Atlas streaming service allows you to tap into the real-time data flow of all the collected public results. Every time our system receives a data point or a probe connectivity event occurs, it's also delivered to the clients that are "tuned in" to that result stream. This feature is implemented using web sockets.
La Policía Nacional del Perú (PNP) trabajando por nuestro bienestar. Proyecto “Huaraz te quiero sin ruido”, por una ciudad LIBRE DE CONTAMINACIÓN ACÚSTICA.
Passionate business professional with over 19 years of experience in performing relevant business tasks including experience in performance management, project management, remediation, staff training/development and pipeline management.
Safeguarding Chemical Regulations Compliance throughout the Supply ChainBaytouch Solutions
The future regulation of chemical supply chain handling and source material tracking is certain. As consumers increasingly seek assurance that products are safe and of identifiable origin, the need for robust supply chain management and tracking is something that the chemistry using sector cannot escape – regardless of cost.
Baytouch Ltd - creator of ReachSuite - has developed an innovative new web-based solution to the supply-chain tracking headache - ‘ProductTraq’.
This presentation discusses the factors that are driving regulation across the chamicals-handling industry and the opportunities that exist for businesses to take positive action to improve systems and processes.
Traceability is absolutely vital for a meat packer to comply with a multitude of policies and regulations. When it comes to the complexity of a meat packer’s supply chain, traceability challenges exist within essentially every process - both forward and backward across the supply chain. There are more steps to bringing a meat product to consumers than most other food products, and with more steps come more events that need to be tracked and traced. The breadth and scope of the traceability challenges facing today’s meat packer, including maintaining compliance with the regulations and policies, are becoming nearly impossible to manage without the help of technology.
Robocom Systems International has focused for nearly 30 years on developing and implementing Supply Chain Execution software solutions. Robocom’s solutions include Warehouse Management, Transportation Management, Voice Technology, Order Management and Labor Management. Our investment in research and development is keenly focused on the needs of the business leaders responsible for the day-to-day results in warehousing, distribution center and trucking operations.
WIth the go-live date of MiFID II just around the corner, I take the liberty to offer you an overview of regulations coming in the next period and which should have your focus.
Also, I take the opportunity to wish you all a Happy, Successful and Healthy 2018!
The enclosed presentation covers a number of the most important regulatory topics to hit the financial markets as of 2018.
This slide deck gives background to, and an update on, the Falsified Medicines Directive and Delegated Regulation. More more information about the FMD, please visit: http://www.abpi.org.uk/our-work/falsified-medicines-directive/Pages/default.aspx
Part two of the compliance webinar series will be about customizing your solution to meet your specific needs in compliance. This will include the use of process extension and data import tools that assist with bringing all your compliance information into the Agile system.
Presentation at the MedTech Summit 2018 in Brussels concerning the new EU regulatory regime for economic operators in the supply chain of medical devices and IVDs
Similar to RTS content for introduction brochure (20)
1. Non- EU
Manufacturer
Non-EU
Customer
EU-ImporterSubstance
Formulation
with the
substance
EU
Outside EU
OR
Introduction
An Only Representative (OR) for a non-EU manufacturer can relieve EU importers from their
registration obligations under REACH, provided the OR maintains a record of the quantities being
supplied to the EU importer. This process is often referred to a “registering within the supply chain”.
For substances that are supplied directly to the EU this is a straight forward process as the non-EU
manufacturer has this information readily available. However, if the supply chain outside the EU is
more complex (e.g. the non-EU manufacturer sells his substances to a non-EU entity such as a
formulator, trader or a polymer manufacturer) and these non-EU actors sell to the EU, there would
be an issue in how the non-EU substance
manufacturer would legally be able to
obtain the volume and import destination
details for his OR. Gathering information
(product composition, customer details etc.)
through the supply chain would jeopardise
CBI (Confidential Business Information) and
likely breach competition / antitrust laws, so
generally this is advised against.
This problem can be overcome by
downstream actors reporting their export
data to a third party or Trustee (such as a
Law Firm). This is typically a manual process which is very time consuming, complicated and can be
expensive.
The REACH Trustee Service’s new web-based system has been developed to provide an elegantly
and efficiently solution to this problem, enabling the non-EU manufacturers’ sponsored substances
to be tracked effortlessly through the complex supply chain and data on quantities being importer
into the EU to be provided to the OR, while protecting CBI. The REACH Trustee Service allows the EU
importer to take full advantage of registration in the supply chain enabling compliance with REACH
and competition / antitrust laws.
How the system works
1. The non-EU manufacturer (which we term the Sponsor) opens an account on the REACH
Trustee services system and then they enter their products on to the data base.
2. The non-EU manufacture invites his non-EU customer to join the system who then sets up
their products on the system.
3. The non-EU customer enters on the system all sales of products into the EU.
4. Steps 2 and 3 are repeated for successive levels in the supply chain.
5. The Sponsor or their OR can interrogate the system at any time and obtain reports on the
volumes of their substances that are exported to the EU through the complex supply chain
2. (they will not get customer details but that information would be made available to any
competent authority if required).
The advantage for the Non-EU Manufacturer
• Demonstrates to all customers that you are a committed supplier of the chemicals
• Is an elegant and efficient solution that conveys a level of professionalism commensurate
with your image as a market leading company committed to excellence in business
processes
• Reduces the REACH compliance burden on your customers which can be seen as a form of
Enhanced Product Stewardship that will add value to your product offering distinguishing
your products in the marketplace and ensuring enhanced customer loyalty
• Meets all REACH Compliance as well as Competition /Antitrust law requirements
• Low costs compared to all other systems
• Easy to set up, with actors down the supply chain in-putting their data so work burden is
shared.
Fee Structure
• The Sponsor will be responsible for the fee through the complex supply chain. The Sponsor
will also control the level of sponsorship supported within the supply chain.
Why we do not invoice all the customers in the supply chain?
• The supply chain believes this approach is consistent with suppliers supporting their
products and customers (product stewardship ethos).
• The low level of administration burden from the invoicing process means that we the total
cost is kept to a very low level, making the System economical to use for everyone, ensuring
a high up-take of the system.
• The customers dependent on registration within the supply chain will show greater loyalty
to their preferred suppliers enabling price adjustment that would easily outweigh the cost of
maintaining the system.