Regulation
Borderline products: medicine, food supplement, cosmetic or medical device?
Many parapharmacy products sit close to a legal boundary. A throat spray, a vitamin D product or a wound gel may be a medicine, a food, a cosmetic, a medical device or a biocide. Each status brings different rules on authorisation, labelling, claims and where the product can be sold.
Why classification matters
The legal category decides almost everything about a product. A medicinal product needs a marketing authorisation and is sold through the channels national law allows for medicines. A food supplement is notified, not authorised, and may be sold in general retail. A cosmetic is placed on the market under the responsibility of a "responsible person" after a safety assessment. A medical device needs CE marking under a conformity-assessment procedure that depends on its risk class. A biocide falls under yet another authorisation regime. Since only medicines are reserved to pharmacies, classification also decides whether a product can be sold in a parapharmacy at all.
The competing definitions
- Medicinal product (Directive 2001/83/EC, Article 1(2)): any substance or combination presented as having properties for treating or preventing disease in human beings ("by presentation"), or which may be used or administered to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis ("by function").
- Food supplement (Directive 2002/46/EC, Article 2): a foodstuff that supplements the normal diet, is a concentrated source of nutrients or other substances with a nutritional or physiological effect, and is marketed in dose form.
- Cosmetic product (Regulation (EC) No 1223/2009, Article 2(1)(a)): a substance or mixture intended to be placed in contact with the external parts of the body or with the teeth and oral mucosa, exclusively or mainly to clean, perfume, change the appearance of, protect or keep them in good condition, or correct body odours. Products intended to be ingested, inhaled, injected or implanted are not cosmetics.
- Medical device (Regulation (EU) 2017/745, Article 2(1)): an article intended for a medical purpose that does not achieve its principal intended action by pharmacological, immunological or metabolic means, although it may be assisted by such means.
- Biocidal product (Regulation (EU) No 528/2012): a product intended to destroy, deter, render harmless or control harmful organisms by means other than mere physical or mechanical action — for example hand disinfectants and insect repellents.
The primacy rule
Where a product could fall within the definition of a medicinal product and within the definition of a product covered by other EU legislation, Article 2(2) of Directive 2001/83/EC provides that the medicines legislation applies. In practice, then, the first question is always whether the product is a medicine by presentation or by function. Only if it is not do the other definitions come into play.
Presentation is judged broadly. Claims to treat or prevent disease on the pack, in advertising or on a website, or a get-up that resembles a medicine, can make a product a medicine by presentation whatever it contains. Function is judged on the product's composition and its demonstrated effects at the recommended dose. In Case C-319/05 Commission v Germany (garlic capsules), the Court of Justice held that a product whose effect on physiological functions is no greater than that of the food it derives from is not a medicinal product by function.
Worked examples
| Product | Usual classification | What decides it |
|---|---|---|
| Paracetamol or ibuprofen sachets | Medicinal product | A pharmacologically active substance with an authorised indication. The sachet format does not make it a supplement. |
| Vitamin D drops or capsules | Food supplement or medicinal product | Dose, presentation and claims. Higher-dose products presented for treating deficiency are commonly authorised as medicines. |
| Oral rehydration salts | Medicinal product, or food for special medical purposes | National practice differs; see oral rehydration solutions. |
| Saline nasal spray | Medical device | Acts by physical means such as rinsing or moistening. |
| Plaster or wound dressing | Medical device | Mechanical protection or absorption. A dressing that incorporates a medicinal substance moves to a higher device class. |
| Antiseptic solution for wounds | Medicinal product | An antimicrobial action on the body for a medical purpose. |
| Hand sanitiser | Biocide, or cosmetic | A disinfecting purpose points to a biocide; a mainly cleansing purpose points to a cosmetic. |
| Insect repellent | Biocide | Deters harmful organisms. |
| Sunscreen | Cosmetic | Protects the skin and keeps it in good condition, with no therapeutic claim. |
| Head-lice lotion | Medical device or medicinal product | Physical action (for example, dimeticone coating the lice) suggests a device; an insecticidal active substance suggests a medicine. |
These are typical outcomes, not rulings. The same product can be classified differently in different Member States, and the classification of any particular product depends on its exact composition, presentation and claims.
Who decides
The manufacturer or responsible person chooses a regulatory route, but the classification is ultimately decided by national competent authorities and, in disputes, by national courts and the Court of Justice. The European Commission publishes guidance to promote consistency. This includes a manual on the scope of the Cosmetics Regulation and the Medical Device Coordination Group's guidance on the borderline between medical devices and medicinal products (MDCG 2022-5). This guidance is not legally binding. See national authorities for the agencies concerned.
Frequently asked questions
Can a product be both a food supplement and a medicine?
No. If a product meets the definition of a medicinal product, the medicines legislation applies (Directive 2001/83/EC, Article 2(2)), even if it could also fit another definition.
Is wound care a medicine or a medical device?
It depends on the product. Plasters, dressings and wound-cleansing products acting by physical means are generally medical devices. Antiseptic products acting pharmacologically are generally medicinal products.
Are paracetamol sachets regulated as food supplements?
No. Paracetamol is a pharmacologically active substance, and products containing it are medicinal products whatever their format.
Who decides whether a product is a medicine or a supplement?
National competent authorities decide case by case, subject to review by the courts. EU guidance documents help, but they are not binding.
References & further reading
- Directive 2001/83/EC on medicinal products for human use (consolidated): eur-lex.europa.eu.
- Court of Justice, Case C-319/05 Commission v Germany: curia.europa.eu.
- Regulation (EU) No 528/2012 concerning biocidal products: eur-lex.europa.eu.
- European Commission, medical devices guidance documents (MDCG): health.ec.europa.eu.
Last reviewed: October 2026.