On this page we would like to tell you about what trade compliance obligations you should be taking into account being a producer in the healthcare industry.
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 digitally 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.
For healthcare products, it is generally necessary to arrange a license/registration in the country of destination.
From an environmental perspective, you should consider:
- Packaging tax. Think of blisters, medicine boxes, but also plasters.
Every country has its own packaging directive and thresholds. In some countries, you must specify all the components of your packaging separately. For example, a syringe: the cap, plastic packaging, the box in which the syringe is in and the syringe itself, all need to be declared.
In order to make your packaging declaration 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.
For many healthcare products the import duty rates are low or zero, limiting the financial risks. Meanwhile, the quality and speed of your import process is very important 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?
To provide you with insight and give you an answer to the above questions, Pincvision developed its solution "Global Broker Window". A dashboard that provides direct insight into:
- Lead times
- Import duties
- Broker performance
- And much more…
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. You can also work with suppliers that work with tax-exempt organizations. Exemptions and deductibility (e.g. pro rata) can be applicable, please note that in that case other declaration requirements may arise.
When you use the 0% VAT rate, please make sure that your "Proof of Origin (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.
We will gladly assist you!
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