Manufacturers, responsible for designing & manufacturing products have an obligation to ensure that a product is designed and manufactured and its conformity assessed in accordance with the provisions of the directives. The manufacturer may appoint any natural or legal person to act on his behalf as an authorized representative.
The importer is responsible to provide the market surveillance authority with the necessary information about the safety of the product and a copy of the Declaration of Conformity (DoC) if requested.
Conformity Assessment Procedure
Goods subject to the directives on product safety must be tested according to the rules applying for the products. If the testing was successful the manufacturer is allowed to apply the so called 'CE sign' on the product or where this is not applicable (for example, surgical instruments) at the retail package.
The tests can be done by a manufacturer or a notified body assigned by the manufacturer.
Market Surveillance is organized and performed at national level. Customs authorities are usually part of the market surveillance activities. On customs request the "Declaration of Conformity" must be provided by the shipper, the manufacturer or his assigned representative or the importer.
Goods imported as samples for the purpose of testing can be imported by authorized representatives within the customs procedure temporary importation without the CE sign or Declaration of Conformity.
It is not required for all, however shipments can be held by local authority in United Arab Emirates after screening due to lack of MSDS (Material Safety Data Sheet) or NON DG (Dangerous Goods) declaration letter from the shipper resulting to misconnections and impacting end-to-end service.
It would be advisable for all shipments originating, transiting and terminating for UAE to have MSDS or NON DG declaration from shipper enclosed in the shipment and copies to be uploaded in IDIS.
Any shipment, valued over 22 EUR, shall be subjected to customs clearance procedure.
By law, customs procedure must commence within 20 days after the arrival of the shipment. After the expiration of the foreseen 20 days, the shipment can be customs cleared by a mandatory penalty imposed by the customs authority only.
By law, if the customs procedure is not initiated within 20 days, the customs authority shall be entitled to confiscate the shipment for the benefit of the state or to forward the same to destruction, if a procedure for shipment return within the foreseen deadline of 20 days has not been initiated. Mandatory penalty imposed by the customs authority, may apply.
Shipments retained for customs procedure cannot be delivered until the customs duties are paid by the importer or its agent (freight forwarder).
Additional costs for the importation of a shipment might be charged, for brokerage services, storage services, or other services connected with the customs clearance procedure.
There are special stipulations on the following commodities when shipping to Macedonia (FYROM). If you plan to ship one of the commodities listed below, be sure to adhere to the following stipulations in order to avoid delays and holds at customs.
An Import License is required for commercial shipments of medicine. The Prescription has to accompany the package. However, it is not required to be on the outside of the package. It is acceptable to be included inside the package.
For private individuals, an Import Approval is not needed if the quantity of products does not exceed the quantity considered to be for personal use. If the quantity is higher than accepted for importation by private individuals, the goods are handled as commercial imports and require an import approval.
The importation of an accumulator, intended to be used in a bottling machine, requires the following documents and proofs:
When the company is not registered as above, the final receiver or customer (the company or organization which will receive or buy the medicines) should also be registered as above otherwise the import will not be possible. If this requirement is met, the consignee will have to obtain an import permit or license from the Ministry of Health. In accordance with customs law, 20% tax and duties are applied.
An Import Approval for Medicinal Products for Personal Use issued by the Ministry of Health Bureau of Medicines is requested with no exception for shipments of medicines to private individuals. Private individuals can only import medicines which are not registered in Macedonia. It is mandatory for the receiver to have a prescription certified by the Ministry of Health. Quantity must not exceed the quantity of medicines prescribed by a doctor, in order to prove that the medicine is not for trading.
Duties and taxes are applied according to the Customs law. Whoever buys the medicines must obtain this legal registration to import if the consignee or company is not registered. If this legal requirement is met, then the consignee must obtain an import permit or license from the Ministry of Health. Customs law requires 20% tax and duties.
Duty and taxes apply on the software devices only, not on software itself.
However, at the discretion of Customs officials, shipments from individuals to individuals valued less than 4,320.00 MKD may be declared as a gift. Only one shipment is allowed. Technical goods cannot be shipped as gifts.
Shipments of documents do not require an invoice.
The consignee's telephone number, mobile number and email address if available, should appear on the invoice.
The destination country or territory considers the following items as document shipments. If criteria are listed, the shipment must meet the criteria to be considered a document shipment.
Event tickets coming from a printing company and sent to the organizer of the event or ticket sales offices cannot be sent as documents.
In addition to the prohibited commodities listed here, it is prohibited to ship the following commodities to Macedonia (FYROM).
Private persons are not able to apply for such an approval. They are not allowed to import these products.
Food supplements as medicinal products need an Import Approval. For more information please see 'Medicine'.
Private persons are not able to apply for such an approval, therefore, they are not allowed to import these products.
An Import Approval from the Ministry of Health Sanitary Inspection is needed even for samples.
For private individuals an Import Approval is not needed if the quantity of products dosen't exceed the quantity considered to be for personal use. If the quantity is higher than accepted for importation by a private individual, the goods are handled as commercial imports and require an import approval.
Saturday Delivery Available: No
Always check Calculate Time and Cost for details of service availability and guarantee information within a country or territory. All Service Levels may not be available to or from every address within a country or territory.
Goods subject to control by the Food and Veterinary Agency must be accompanied by a Health Certificate in order to enter the procedure for requesting an Import Approval.
The company that imports such commodities must have a warehouse with HTP (document is issued by the Sanitary Inspectorate from the Ministry of Health. It ensures that the company meets the minimum hygienic technical conditions for acommodation of this kind of goods) and an approval from either the sanitary inspection or an approval from the food agency in order to store that kind of goods in the warehouse, depending on the type of goods, whether it is food or sanitary products. These documents are needed for the request of import approval. If the company does not have an HTP, an agreement for using a warehouse owned by another company and HTP for the same needs has to be submitted.
The expenses for issuing the import approval and potential laboratory analyses or super analyzes are charged to the importer.
Batteries and Accumulators
The importer must be registered as importer of batteries at the Ministry for Ecology and Environment responsible for issuing the necessary certificates for importation.
Private individuals are not able to import batteries and accumulators.
Convert metric quantity for weight, length, and area.