Medicines are excluded from the EU passport rule

Medicines and veterinary medicines do not need a European Union (EU) digital product passport. The EU regulation that creates the passport excludes both.

A product that the EU regulates as a medicine is outside the rule. A pet worming tablet that the EU regulates as a veterinary medicine is outside it too.

The exclusion covers a medicine, and not your full range

Two mistakes cost money here.

The first mistake is to build a passport for a product that no rule reaches. The second mistake is to assume that the medicine exclusion covers your full range. A supplement, a skincare product and a medicine can leave one New Zealand factory. EU law then treats each one differently.

The exclusion sits in ESPR Article 1(2)

The Ecodesign for Sustainable Products Regulation (ESPR) creates the digital product passport. It is Regulation (EU) 2024/1781. It is in force from 18 July 2024.

Article 1(2) lists the products that the regulation does not cover:

• food
• feed
• medicinal products
• veterinary medicinal products
• living plants, animals and micro-organisms
• products of human origin
• products of plants and animals that relate directly to their future reproduction

Vehicles are a separate case. ESPR excludes a vehicle only for the product aspects that other EU acts already regulate.

The regulation uses the term medicinal product. This page uses the word medicine for the same thing.

ESPR does not reach a medicine at all, now or after a delegated act. ESPR exclusions covers the article. Food and feed are excluded covers the first two lines, and wine, beer and spirits covers drink.

Cosmetics, medical devices and tobacco stay inside the regulation

Three groups that people expect on the exclusion list are not on it. Cosmetics stay inside ESPR scope. So do medical devices and tobacco products.

A medical device is not a medicinal product. So the exclusion covers your medicine, and it leaves your medical device inside ESPR.

Batteries are not on the exclusion list either. A separate EU law gives three battery categories a passport duty. That duty starts on 18 February 2027. The law names each light means of transport battery, each electric vehicle battery, and each industrial battery above 2 kilowatt hours. See batteries.

The exclusion follows the official classification

The exclusion attaches to what a regulator classifies the product as. It does not attach to the aisle in the shop, to the shape of the bottle, or to the words on your website.

One New Zealand plant extract can reach a European buyer in four forms. The table gives the position of each form.

Three of those forms are outside ESPR, and the fourth is inside it. The capsule can look the same in each form. The classification decides the answer.

This site cannot tell you if the EU classifies a supplement as a food. Get that classification from your EU importer, and get it in writing.

The destination market sets the classification, not New Zealand

Your New Zealand classification does not decide the EU position. Each market applies its own test.

One example from a third market shows the size of the gap. A sunscreen sold in the United States is an over-the-counter drug, not a cosmetic, and it must carry a Drug Facts panel. That United States rule does not decide how the EU classifies the same bottle.

So if you sell a natural health product, you must find out how each market classifies it. Do this for every market that you sell into, and get the answer in writing.

This page cannot classify your product

The sources behind this site do not resolve the classification of any particular product. No page here can tell you if the EU treats your capsule as a food, as a cosmetic or as a medicine.

Two parties can tell you. Your EU importer is usually the operator that places the product on the EU market. A regulatory adviser in that market can confirm the classification. Record what they tell you, and see agreeing data duties with your EU importer.

No New Zealand source answers it either

This site searched for New Zealand material on 16 August 2026, in fifteen separate searches, and read 104 separate pages. The Ministry of Foreign Affairs and Trade wrote the substantial government account, in a market report of October 2025. See what New Zealand agencies have said.

No page in that search names medicinal products.

No New Zealand sector body publishes guidance on digital product passports. A search in August 2026 covered Natural Health Products NZ, the Meat Industry Association, DairyNZ, New Zealand Winegrowers and the Apparel and Textile Federation. See what New Zealand agencies have said.

Inside ESPR scope still means no duty today

A cosmetic sits inside ESPR scope. That position gives it no passport duty today.

ESPR gives a duty to a product group only through a delegated act. As at 14 August 2026 the European Commission has adopted no such act, for any product group. So no ESPR passport is mandatory for any product today. See what is a delegated act and how to read the timeline.

One passport duty in EU law does carry a firm date. It comes from the battery regulation, Regulation (EU) 2023/1542. That duty starts on 18 February 2027. See which products need a passport, and when.

Confirm each classification, and check your packaging in every case

1. Find out how the EU classifies each product line that you sell.
2. If the answer is a medicine, stop here. ESPR cannot reach that product.
3. If the answer is a veterinary medicine, stop here as well.
4. If the answer is a food, the food exclusion applies. See New Zealand food exporters.
5. If the answer is a cosmetic, monitor for a delegated act in that group. Do not buy a passport system this year. See cosmetics and natural health products.
6. Check your packaging duties in every case. Packaging is a separate product in EU law, and no exclusion above covers it. See packaging.

Write down the classification, the market, and the date you confirmed it. Check it again before you change a label claim or enter a new market.