Pharmaceutical products

Chemical substances or products may in some cases be eligible for duty relief, if they have been listed as pharmaceutical substances by the World Health Organization.

In some cases, you may enjoy duty relief for chemical substances and products listed as pharmaceutical substances by the World Health Organization. The intended purpose of the substances and products is not relevant; the substance or product itself is relieved of customs duty.

What substances or products may be duty-free?

Substances and products to which duty relief may apply are listed in four annexes to the Combined Nomenclature (CN):

• Annex 3 – International non-proprietor names (INN) provided for pharmaceutical substances.
• Annex 4 – List of prefixes and suffixes which, in combination with the inns of Annex 3, describe the salts, esters or hydrates of inns; these salts, esters and hydrates are free of duty, on condition that they are classifiable in the same 6-digit HS subheading as the corresponding INN
• Annex 5 – Salts, esters and hydrates of INNs, which are not classified in the same HS heading as the corresponding INNs and which are free of customs duty
• Annex 6 – List of pharmaceutical intermediates, i.e. compounds of a kind used for the manufacture of finished pharmaceutical products, which are free of customs duty.
  

The following applies to each respective substance and product in the annexes:

Annex 3

Substances with INN enumerated in the list are described by their KN number and CAS number INN is sufficient for duty relief, if no CAS number is indicated in the annex (0-00-0). If you have a CAS number, you can determine the KN number in the ECICS database. The KN number is not sufficient for duty relief.

Search the ECICS database.

Normally, only pure substances qualify for duty-free treatment. When a substance is mixed with water, it does not affect the classification of the substance; however, it changes the conditions for duty relief. This mixture is likely to have a different CAS number than the pure substance, which means that it no longer qualifies for duty-free treatment. In most cases, if the substance is mixed with any other substance than water, the KN number also changes. Duty-free treatment is only granted in such cases if the KN number is listed together with the new CAS number.

It is not necessary to use the substance or product to obtain pharmaceutical products, or that it be imported by a pharmaceutical company. Duty relief is granted based solely on the substance or product.

Annex 4

INN substances in Annex 3 may be combined with specific prefixes or suffixes to form salts, esters or hydrates. These qualify for duty-free treatment if you are classified under the same HS subheading as the corresponding INN. In the case of such salts, esters or hydrates, the CAS number does not need to match. Compound substances have different CAS numbers than the principal substance, and the number of variants is so vast that it is impossible to include all in a list.

Annex 5

Sometimes, the combination of an INN, in accordance with Annex 3, and a prefix or suffix, in accordance with Annex, leads to a new classification of the substance. This annex contains a small number of substances that qualify for duty-free treatment nonetheless. Duty-free treatment is only given if both the KN number and the CAS number match the Annex.

Annex 6

For intermediates enumerated in the list, the KN number and CAS number must correspond with the information in the Annex to qualify for duty-free treatment. If there is no CAS number in Annex 6, the listed chemical name will suffice. The conditions for Annex 3 apply.

Enter supplementary code 2500 when applying for duty relief in the import declaration.