Eu distributor

The law recognises the role you play between manufacturers and customers in enabling communication about chemical safety in the supply chain. Your active involvement is required to protect people and the environment from chemical risks.

You are a distributor under REACH and CLP if you source a chemical substance or a mixture within the EEA, store it and then place it on the market for someone else also under your own brand without changing its chemical composition in any way.

You must communicate safety information on the hazards and risks of the chemicals you distribute:. The main instrument for this communication is the safety data sheet, which may be extended to include exposure scenarios for each identified use. This means complying with the requirements of CLP. Important changes were introduced as of 1 Juneincluding new pictograms and hazard statements.

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Be aware that the labelling and packaging of biocidal products and articles treated with them have to comply both with CLP and other specific requirements. These are substances identified under REACH which have serious and often irreversible effects on human health and the environment. You have a duty to provide customers with sufficient information to allow the safe use of the article, including as a minimum, the name of the dangerous substance.

In this way, you can help manufacturers and importers to understand how their substances are used and to register some or all of the uses you have made known to them. When a product a chemical substance or mixtureis identified as hazardous, it has to be labelled and packaged according to the requirements of the CLP Regulation.

This is the responsibility of manufacturers, formulators and importers and distributors. If you re-label or re-package such products to include your own brand, you also take the same responsibility. As a supplier of hazardous products, you have to ensure that they are labelled and packaged correctly. The label should contain:. Until 1 Juneyou are allowed to sell mixtures labelled in the old way if you can provide evidence that they have been in the supply chain since before the legal deadline for the changeover on 1 June Be aware that that there are additional labelling and packaging requirements for treated articles defined in the Biocidal Products Regulation.

Consumers have the right under REACH and the Biocidal Products Regulation to ask if the articles you sell to them contain substances of very high concern above a certain concentration. This also applies to those which have been treated with biocides.

You must answer their request free of charge within 45 days. You are required to provide sufficient information and advice on how to use the article safely or information on the biocidal treatment of the treated article.

Contact your supplier for any additional information you may need. Typical examples of products to which the consumer "right to ask" applies are clothing, furniture, household utensils, sports equipment or other items for daily use.

Before you place on the market a substance, mixture or article, you first have to make sure that it is legally on the EEA market. You act as a bridge between suppliers and their customers and are essential for passing information throughout the supply chain. You have information about the hazards of substances in your portfolio, which you can turn into a business advantage by selecting safer products and raising your brand reputation.

Consumers have the right to ask about dangerous substances in articles.It is a minimum directive, which sets the lower limits for protecting commercial agents in the EU.

The member states are obligated to enforce the directive and the Court of Justice can be consulted by the member states on matters of interpretation of the directive.

The objective of the directive is to create uniform trade conditions within the internal market, promote trade and ensure commercial agents a minimum level of protection. According to art. It was therefore decided to give the member states the choice between the system of compensation and the system of damages. Within the system of compensation, the agent, once the contractual relationship is terminated, has the right to compensation, if and when he has brought the principal new customers or has significantly increased the volume of business with existing customers and the principal continues to derive substantial benefits from the business with such customers after the termination of the contractual relationship.

As a final point an upper limit of the amount of the compensation is specified in the directive, equivalent to an annual compensation, calculated on the basis of the average annual remuneration of the commercial agent during the last five years; and if the contract is concluded less than five years prior the compensation is calculated on the basis of the average remuneration during the contractual relationship.

The compensation embodies the advantages which the principal still has following the efforts of the commercial agent.

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This explains why compensation for goodwill is commercially justified. Compensation shall only be paid if the commercial agent has brought the principal new customers or has increased the volume of business with existing customers. If goodwill is not created or if the principal has not benefited from the existing customers compensation is not to be paid. The principal shall therefore not be forced to pay an unreasonable compensation.

The system of compensation was drafted on the basis of art. This case law and practice should be a valuable help to the courts in the rest of the member states when interpreting art. Finally, the number is adjusted if the amount exceeds the limit in art 17 2 b of the directive. The provision addresses situations where the commercial agent, according to domestic law, is entitled to claim damages for breach of contract or non-compliance of the notice specified in the directive.

According to article 17 3 in the directive the commercial agent is entitled to damages for the loss sustained due to the termination of the relationship with the principal. The system of damages was based on French law from with the purpose of compensating the commercial agent for his loss due to the termination of the agency contract.

As is the case with the German system of compensation, an extensive amount of case-law has been generated regarding the right to and the level of damages. In several rulings the French courts have justified the award of damages on the grounds that it illustrates the costs entailed in the purchase of the agency to the successor of the commercial agent, or that it compensates the time necessary for the commercial agent to recover the customers, of which he was robbed.

In case-law the level of compensation is established as the total amount of commission of the past two years or the total amount of the commission of two years calculated as an average of the last three years of the agency contract, which is in accordance with the practice in the profession.Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 and earlier versions. Please upgrade your Internet Explorer to a newer version. Close Do not show this message again.

Close Find out more on how we use cookies. Real-life cases Supply chain workshops Networks Funding and technical support Data to prevent regrettable substitution Find substitution partners News and activities Why substitute? Distributors You are a distributor if: you source a chemical substance or a mixture within the EEA, store it and then place it on the market for someone else also under your own brand without changing its chemical composition in any way.

You are not a distributor if: you buy chemicals from outside the EEA and place them straight on the market in the EEA — then you are an importer; you buy chemicals within the EEA and mix them with other chemicals, dilute them or re fill containers, before supplying them to others — then you are a downstream user. Safety data sheets.

Extended safety data sheets Interactive guide on safety data sheets and exposure scenarios. Tagged as: Communication in the supply chain click the tag to search for relevant content.

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eu distributor

Compressor Systems. Parts and Accessories. Power Tools. Find a Distributor Select a business below to search for a distributor. Find a Distributor.Infrapatellar strap reduces pain Phone : 61 0 2 Toll free: Sales: sales gatewayrehab. Phone : 43 0 Toll free: 43 0 Sales: kundenservice ofaaustria. Phone : 7 Fax: 7 Sales: sales nikamed. Phone : 32 0 52 25 94 10 Fax: 32 0 52 25 94 19 Sales: info vitamed. Phone : 0 2 Fax: 0 2 Sales: orthoteh abv. Phone : 1 0 Toll free: 1 Sales: info canortho.

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Sole Distributors in the EU

Phone : 31 0 88 0 Sales: info lomed. Phone : 64 0 9 Toll free: 64 0 Fax: 64 0 9 Sales: info attherapy. Phone : 46 0 8 20 Fax: 46 0 8 25 33 Sales: info jhinova.

Address: ul. Phone : 48 0 71 80 84 Fax: 48 0 71 53 05 Sales: biuro e-med-orth. Company : Ideal Medical Solutions w. Address: Twin Palm Tower, 46th. Box City: Doha Country: Qatar. Phone : 4 Fax: 4 Sales: office euromedicagrup. Company : Integratif Medical Pte Ltd. Phone : 65 0 62 24 84 68 Fax: 65 0 62 27 67 62 Sales: enquiry integratif.In the Medical Device Regulation, not only are the various economic operators defined Art.

Nevertheless, there is still a need for clarification in this respect. Distributors now have to verify that the medical devices they sell meet the defined requirements as outlined in Art.

Among other things, distributors must check whether the medical devices are CE-marked and have a valid declaration of conformity. Also they must ensure that the instructions for use and labels of the products are available in the official language of the countries in which the product is sold. In the case of imported medical devices, it must also be checked whether the importer fulfills his requirements as defined in Art. This means that the distributor assumes part of the responsibility for the conformity of the products he sells.

In case a distributor has reason to believe that a device is not in conformity with the requirements of the new regulation, he is not allowed to put the devices on the market.

Under the MDR and IVDR, distributors are obliged to inform the authorities if they suspect that the product is falsified or poses a serious risk. So it is not enough not to sell the product, a notification to the authorities is inevitable. In addition, the distributor should keep a register of complaints, of non-conforming devices and of recalls and withdrawals. In order to meet the requirements of the new regulations, it is recommended that distributors implement a Quality Management System QMS.

In the medical device industry, ISO is used in particular, but certification according to ISO could also be an option for a distributor. A certified QMS is not an obligation for distributors as formulated in the Medical Device Regulation, but it could be a competitive advantage, since customers especially hospitals evaluate their suppliers and an existing QMS certificate could strengthen trust.

According to Art. Nevertheless, it is my recommendation to implement a QMS which is ideally based on this standard. The situation is different if the distributor makes country-specific adjustments to a medical device already on the market, in particular the translation of the instructions for use and other documents, as well as changes to the packaging.

The distributor assumes responsibility for these changes and must have his QMS certified by a Notified Body. He also has to notify the national competent authority of the respective country and the original manufacturer in advance of the adapted products. The cooperation between manufacturer and distributor will certainly be intensified, as the distributor has to verify certain documents and is jointly responsible that the documentation e.

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It is advisable for distributors to define these points contractually with the individual manufacturers so that, for example, it is regulated who bears the translation costs in the case of missing translations of the instructions for use or also how quickly these are made available.

This is particularly evident in the fact that distributors are increasingly receiving enquiries regarding the availability of products. This is a positive development, as the MDR divides the responsibility among the different market players and the obligation to actively inform themselves about the legal requirements applies to everyone.

The Medical Device Regulation will also lead to more work in this area and it makes sense to prepare for more intensive cooperation and communication with all parties involved. This means that distributors of medical devices will have to comply with the new obligations from 26 May If distributors only sell in vitro diagnostic medical devices, the deadline will be 26 May With the date of application of the new regulations, distributors will have to carry out a number of concrete tasks and obligations, and it will become apparent which implementation problems in this area will need further clarification.

Certificates issued by Notified Bodies in accordance with the Directives generally remain valid until the date indicated in the certificate or until 27 May at the latest, whichever is earlier. It is, therefore, possible that after 26 May a manufacturer will still have a valid certificate according to the Directives and he may continue to place his products on the market. At the latest when the certificate expires, the manufacturer should have an MDR certificate.

In the worst case, there is an interruption between the expiry of the existing certificate under the Directive and the receipt of the new certificate under the MDR, during which time the manufacturer may not place any products on the market. Again, distributors and manufacturers need to communicate with each other as early and openly as possible in order to ensure supplies to customers.

This provision is intended to limit the period during which products that comply with the Directives and have already been placed on the market may be made available. All products that are still in the supply chain and have not reached their end users e. This means that as of 27 Maydistributors will no longer be allowed to sell medical devices certified under the MDD. It is, therefore, advisable to plan this period exactly and to prepare this step with the manufacturers and to specify the responsibilities in the contract.

The same deadline applies to distributors of in vitro diagnostics. The product has a shelf life of 10 years expiry date If this product is still in stock at the distributor on 27 Mayit may no longer be distributed. Although the product still has a valid shelf life, it may no longer be sold as it does not meet the requirements of the MDR.The sole-distributor agreement, in contrast to the commercial agent agreement, is not directly regulated by EU-law, and with the exception of Belgium, the EU member-states have not passed laws that refer directly to sole-distributors.

Sole-distributor agreements that are in existence within the EU are merely subject to the limitations of the laws of contractual freedom in the country regulating the agreement. EU-competition law regulates, to a certain extent, sole-distributor agreements if the agreement has Community dimension.

According to art. As an outset, sole distributor agreements are in breach of TFEU art. The producer can, as an outset, not appoint other distributors, and the exclusive distributor will typically not engage in distributing competing products.

eu distributor

If the sole-distributor agreement meets the requirements in the regulation the agreement is automatically exempted from the prohibition. If this is not the case the exclusive distributor or the producer can apply for individual exemption. The Block Exemption Regulation sets forth a set of requirements that have to be met in order for a specific sole-distributor agreement to be exempt from the prohibition in TFEU art The first requirement is that the agreement cannot contain any of the severe limitations, set forth in the Block Exemption Regulation.

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The first severe limitation concerns resale price maintenance: the suppliers are not allowed to fix the minimum price, to which the exclusive distributor may resell his products. The second severe limitation concerns limitations concerning the area or the costumers, to whom the exclusive distributor is allowed to sell. This severe limitation concerns market allocation according to territory or customer groups. Exclusive distributers shall freely decide where and to whom, they wish to sell.

The Block Exemption Regulation has an exception to this rule, which allows corporations to operate with an exclusive or a selective distribution system. The third and the fourth severe limitation concerns selective distribution. Firstly, exclusive distributors, who are prohibited to sell to unauthorised distributors, cannot be restricted in their choice of end-users.

Regarding the supplier, the market considered is the market share on the relevant supply market, i. Regarding the exclusive distributor, the market considered is the market share on the relevant procurement market, i. The Block Exemption Regulation applies on all vertical limitations with the exception of aforementioned severe limitations. Furthermore it contains specific requirements regarding three vertical limitations:.

When the requirements are not met these vertical limitations fall outside the scope of the exemption according to the Block Exemption Regulation. The Block Exemption Regulation will however still apply on the rest of the sole-distributor agreement, if it can be assessed separately from the vertical limitations that are not covered by the exemption.

Sole-distributor agreements can also be covered by the prohibition of abuse of a dominating position in TFEU art. Legal Basis The sole-distributor agreement, in contrast to the commercial agent agreement, is not directly regulated by EU-law, and with the exception of Belgium, the EU member-states have not passed laws that refer directly to sole-distributors.

EU-competition Law EU-competition law regulates, to a certain extent, sole-distributor agreements if the agreement has Community dimension.

Furthermore it contains specific requirements regarding three vertical limitations: non-competition clauses during the term of the contract non-competition clauses after the termination of the contract exclusion of specific brands in a selective distribution system When the requirements are not met these vertical limitations fall outside the scope of the exemption according to the Block Exemption Regulation.


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