As a producer in the Healthcare industry you should be informed correctly about which trade compliance obligations you need to take into account. On this page you can find a description of these compliance obligations with respect to Export documents, Customs, Environmental, VAT & Intrastat declarations.
For many healthcare products the import duty rates are low or zero, limiting the financial risks. Correct HS classification is crucial and the quality & speed of your import process is very important as well for this product category. The value of the goods may be high, or you are dealing with expiry dates of your products. What is important for you:
- Insight in your logistics process. What are the lead times for each part of your supply chain, where you run risks and where are the opportunities for process optimization.
- Broker performance. Do you check the quality of your broker(s), do they follow your broker instruction? Are you sure that they can provide the right documentation for "Proof of Delivery" for using the 0% VAT rate?
Pincvision can help you to secure/improve the quality of your broker(s). For instance, through our Pincvision "Global Broker Window" (GBW) solution. Additionally, Pincvision can also help by the classification of HS codes for your goods.
The packaging directive applies to primary, secondary and tertiary packaging. As an example of a product in the Healthcare industry, you can find below a description of the packaging that you should take in to account when you are an exporter of toothpaste.
- Primary packaging: The first product packaging containing the sold item. Thus, in this case the tube that contains the toothpaste and the cap.
- Secondary packaging: You often see that toothpaste tubes are packaged in a 3-pack or a 5-pack. The packaging that holds the tubes together is categorized as secondary packaging.
- Tertiary packaging: Transport packaging that is used to transport the toothpaste. Think of the cardboard box containing the tubes and the pallets on which they are transported.
Each country has its own guideline and threshold values for the declaration of packaging tax. For instance, in some countries you must indicate separately all parts of your packaging. For example, with a syringe: the cap, the plastic packaging, the box containing the syringe, and the syringe itself.
The battery directive applies to built-in batteries and to subsequently delivered batteries. If you exceed the applicable threshold in a country, you are required to periodically submit battery declarations. Think for example of a scale.
In order to make your environmental compliance process quickly and faultless, it is very important that your source data is in order. This data is used to extract the required information for the declaration in the country of destination. Our team of Compliance Analysts can assist you to enhance and enrich your data and then submit your periodic declarations with the authorities. This optimizes the speed and quality of your processes.
From the flow of goods, agreements on transportation, and import & export duties may arise VAT obligations in other countries. This usually leads to:
- VAT registration(s)
- Invoice requirements
- Declaration obligation (with or without a payment obligation)
- Other local declaration requirements (e.g. SII reporting, SAF-T, VAT Book)
For healthcare products, you need to look carefully at the applicable VAT rate, you might use a reduced or low tariff in the country of destination. This differs per country. In addition, as a supplier you can also deal with customers who are exempt from the levy of sales tax. Exemptions and deductions (e.g. pro rata) can therefore be a subject. In that case other declaration requirements may arise.
When you use the 0% VAT rate, please make sure that your proof of delivery (POD) is in order. Fiscal authorities may ask for this during an audit. With the POD solution of Pincvision, you are assured of a guaranteed process.
Should you deliver goods within the European Union (EU) you will often also face Intrastat obligations. With the advent of free trade within the EU, Intrastat is being introduced. A statistical requirement by which organization's declare to the local statistical bureaus how much they are 'exporting & importing' within the EU. Every country knows its own thresholds and deadlines.
Please ensure your Intrastat declarations are well managed as errors in this process may cause authorities to perform an audit. Not just covering Intrastat but often combined with your VAT processes.
Depending on the country of destination it may be required to prove the origin of your goods in the form of a:
- Certificate of Origin (CO), possibly complemented by a legalized invoice. Both documents need to be digitaly attested by the Chamber of Commerce. An additional requirement may be that the documents need legalization by an Embassy and Ministry of Foreign Affairs.
- EUR.1 certificate/EURMED or an invoice declaration may be possible where the country of destination has a free trade agreement with the European Union. You will pay less or no import duties.
- Certificate of Conformity (CoC). When exporting to countries in the Middle-East and/or Africa please keep in mind the applicable conformity programs, such as PSI and PCA. For this you will need a CoC which is used to prove that your products are pre-registered and tested to (for example) country specific technical specifications and consumer safety standards.
In the Healthcare industry it is often important to indicate how many products of a certain composition will enter the market. This applies in particular to i.a. baby food and medicines. Our export documents specialists know all about this and are happy to help making your export documents process a controlled, worry-free and global proess within your supply chain.
Our team of specialists will assist you in meeting your obligations and ensure that the laws and rules are no barrier to your global trade. Compliance in Control.
- Healthcare References