December 2004

Import Regulations - The Netherlands

Trademarks:
For information on registering a trademark, contact the Benelux Trademarks Office:

Benelux-Merkenbureau (BMB)
Bordewijklaan 15
P.O. Box 90404
2509 LK The Hague
Tel: (00 31) 70 349 1111
Fax: (00 31) 70 347 5708
E-mail: info@bmb-bbm.org
Web site: http://www.bmb-bbm.org

Patents:
The Netherlands is a signatory to the Paris Convention, the World Intellectual Property Organization, the Patent Coordination Treaty and the European Patent Convention. This means that any person applying for a patent in one of the signatory countries enjoys a one-year priority right to register the same patent in the Netherlands. Companies should contact the European Patent Office at the address below for inquires about registering patents.

European Patent Office (EPO)
Patentlaan 2
P.O. Box 5818
2280 HV Rijswijk
Tel: (00 31) 70 340 2040
Fax: (00 31) 70 340 1076
E-mail: epoline@epo.org
Web site: http://www.european-patent-office.org

Labelling:
Dutch packaging regulations are completely in line with EU law. Details can be obtained from the Keuringsdienst van Waren, which is part of the Department of Health in the Netherlands:

Voedsel en Waren Autoriteit
Prinses Beatrixlaan 2
2595 AL The Hague
P.O.Box 19506
2500 CM The Hague
Tel: (00 31) 70 448 48 48
Fax: (00 31) 70 448 47 47
E-mail: info@vwa.nl
Web site: http://www.vwa.nl

Customs:
Import duties on products brought into the Netherlands constitute no serious barrier. Customs duties for products imported from Canada are based on the CIF value (value of goods plus shipping costs). In addition, a 19.5% value added tax (BTW) applies to the duty-paid value of goods and equipment. For more information contact:

Customs Office in Amsterdam
Kingsfordweg 1
1043 GN Amsterdam
Postbus 58944
1040 GN Amsterdam
Fax: +31 (20) 687 77 77
Tel: +31 (20) 687 72 99
Internet: http://www.belastingdienst.nl

Customs Office in Rotterdam
Laan op zuid 45
3072 DB Rotterdam
Postbus 50966
3007 BJ Rotterdam
Tel: (010) 290 44 44
Fax: (010) 290 44 74
General customs information line: +31 45 574 30 31
Web site: http://www.belastingdienst.nl/9229237/v/e-index.htm

Certification:
Certification requirements for use of the CE (Conformité Européenne) mark vary depending on the product. For some, such as those in low-risk Class I, the manufacturer (or importer if the product is made outside the EU) may itself certify compliance with EU requirements and affix the CE mark; for others, certification by a "notified body" (an accredited certification agency such as NEN, TNO or KEMA) is required.

Nederlands Normalisatie-instituut (NEN)
Netherlands Bureau of Standards
Vlinderweg 6
P.O. box 5059
2600 GB Delft
Tel: 015 269 0390
Fax: 015 269 0190
Web site: http://www.nen.nl

TNO Certification
(Productcertificatie en Systeemcertificatie)
Laan van Westenenk 501
P.O. Box 541
7300 AM Apeldoorn
Tel: 055 549 3468
Fax: 055 549 32 88
E-mail: certification@certi.tno.nl
Web site: http://www.tno.nl

KEMA (corporate head office)
Utrechtseweg 310P.O. Box 9035
6800 ET Arnhem
Tel: 026 356 9111
Fax: 026 351 5606
E-mail: information@kema.com
Web site: http://www.kema.nl

Netherlands-Canadian Chamber of Commerce (NCCC): The Netherlands-Canadian Chamber of Commerce is a forum that allows its hundred or so members to meet Dutch and Canadian business leaders with a special interest in the economic and political relations between the two countries.

Netherlands Canadian Chamber of Commerce
Nieuwe Uitleg 26
2514 BR The Hague,
The Netherlands
Internet: http://www.netherlandscanada.nl
Contact: Mr. Willem Dutilh, Chairman

Import Regulations

Medical devices and products:
Dutch regulations covering medical technical equipment follow EU directives, which provide rules for the classification of all health care products by risk category. The manufacturer is obliged by the directives to assign its device to one of the risk classes.

Netherlands medical product laws: (a) Besluit Active Implantaten of 1993 applies to all equipment used in the human body; (b) Besluit Medische hulpmiddelen of 1995 applies to all equipment, instruments and materials used on or in the human body. Both laws implement EU guidelines covering medical devices and require a CE (Conformité Européenne) mark for all medical devices.

For some low-risk Class I products, the manufacturer may itself certify compliance with EU requirements and affix the CE mark; for others, certification by a "notified Dutch body" (an accredited certification agency such as NNI, TNO or KEMA) is required.

Language dispensation:
The CE mark requires that user interface software, user manuals, warning labels and technical manuals should be in the national language, i.e. Dutch. However it is possible to obtain a dispensation. Depending on which and how many persons will handle the equipment, and how much training is given to those persons, English only may be accepted.

Pharmaceuticals: Pharmaceuticals may be imported only by qualified pharmaceutical companies located in the Netherlands or other EU countries.

Canadian manufacturers must have their prescription drugs approved before they can be sold in the Netherlands. This process can be undertaken either in the Netherlands through the Medicines Evaluation Board (MEB) or in any other EU state, since registration in any EU state is recognized by all other EU members, or through the European Agency for the Evaluation of Medical Products (EMEA).

In order to obtain marketing authorization for new products, Canadian prescription drugs must be registered by a Dutch company (either a manufacturer or distributor) officially designated to submit registration applications. This company must submit information related to the quality, safety and efficacy of the product, as well as a proposal for the public product information leaflets. Once the file is reviewed by a panel of experts, the MEB decides whether to grant marketing authorization and, if such authorization is granted, finalizes product information texts. All product labelling must include the marketing authorization number, beginning with "RVG."

All manufacturers and wholesalers of pharmaceuticals must have an action plan for the rapid removal of products that are shown to be harmful or ineffective once on the market. All labelling and leaflet information must be in Dutch and written in language that is easy to understand. Other languages are permitted, provided they give the same information as in Dutch.

Homeopathic medicines:
The MEB has also been tasked with authorizing homeopathic products for safety and quality in order to comply with European regulations. All homeopathic medicines must therefore be registered with the MEB before being approved for sale in the Netherlands. (Separate registers are used for homeopathic products and for prescription drugs.) All remedies must be manufactured according to agreed European methods before they can be registered and distributed within EU countries. Registration can be carried out by an agent on behalf of a Canadian firm if required and may be in Dutch or English.

Strict regulations governing the sale of vitamins and nutritional supplements were relaxed in 1995, and nutritional supplements are now sold without registration, provided that they are not harmful and make no medical claims to cure illnesses.

Medicines Evaluation Board
Ministry of Health, Welfare and Cultural Affairs
P.O. Box 16229
2500BE The Hague, The Netherlands
Tel.: +31-70 356 74 83
Fax: +31-70 356 75 15
Email: info@cbg-meb.nl
Web site: http://www.cbg-meb.nl

European Agency for the Evaluation of Medicinal Products (EMEA)
7 Westferry Circus
Canary Wharf
London, E14 4HB United Kingdom
Tel: +44-207 4188400
Fax: +44-207 4188416
E-mail: mail@emea.eu.int
Web site: http://www.emea.eu.int/

Environmental products and services:
EU harmonization of safety requirements and related standards are being implemented for industrial products through EU directives. All environmental equipment and machinery exported to the Netherlands must comply with safety regulations and technical standards. For example, many products require the CE (Conformité Européenne) mark, which indicates that the products conform to the safety standards of the EU.

Consumer products:
Many consumer products, e.g. all children's toys, require a CE (Conformité Européenne) mark prior to being sold in the Netherlands. Information on EU Directives and advice on obtaining the CE mark is available from a number of sources. The Canadian Standards Association (CSA) offers assistance to manufacturers exporting products to Europe. The CSA Web site includes information about CE Marking services.

Biotechnology: The Netherlands follows EU regulations regarding biotech products.

Wood & Building Products: The Netherlands follows EU regulations. Canadian exporters of softwood lumber and some softwood items as packaging should ensure that any product exported to the Netherlands is accompanied by a certificate of heat treatment (full details are available from the local office of Agriculture Canada).

Agrifood and Seafood:
The Netherlands strictly follows EU regulations on food safety and imports. It strives to maintain its image as a supplier of quality food products. The 175 cases of BSE that were reported in the last decade has not had a crippling effect on the agricultural sector.

Several recent cases have had an impact on Canadian exports including:

- EU regulation 2003/804 on bivalve molluscs had a major impact on live mussel exports. Although problems were resolved between Canada and the EU, it is important that exporters of molluscs carefully check EU import regulations prior to exporting.

- Saskatoon berries, eaten in North America for centuries, were recently banned from the EU market. Regulation EC 258/97 came into force in May 1997 concerning introduction to the market within the community of novel foods and novel food ingredients. One EU member state decided that the legislation applied to these berries and the Canadian federal government had to intervene. It looks like Saskatoon berries have been accepted by Germany (end 2004) and the fact that Germany's acceptance means a automatic acceptance by all other EU member states, the end decision by Brussels is still awaited.

Import regulations for the Netherlands can be found at http://www.vwa.nl (English available).