Over-the-counter medicines and pharmacy products

• Directive 2001/83/EC — medicinal products for human use
• Regulation (EC) No 726/2004 — centralised authorisation
• Directive 2011/62/EU — falsified medicines
• Regulation (EU) 2016/161 — safety features

Who has to appoint one

Anyone placing medicinal products on the EU market. The marketing authorisation holder must be established in the Union, and there is no representative arrangement that substitutes for it. A product is medicinal either by presentation, because of the claims made, or by function, because of its pharmacological action.

Thresholds and exemptions

None. Even traditional herbal medicinal products follow a registration route, and homeopathic products a simplified one, but all require authorisation of some kind.

What must appear on the label

The name, strength and pharmaceutical form, the active substances, the marketing authorisation number, the batch number, the expiry date, the authorisation holder's name and address, storage conditions, and the safety features consisting of a unique identifier and an anti-tampering device for prescription products.

Marketplace fields

Distance selling of medicines to consumers is permitted only by pharmacies registered under the national scheme and displaying the EU common logo, and marketplaces generally prohibit the category entirely.

Documentation you must hold

The marketing authorisation dossier, good manufacturing practice certification for every manufacturing site, batch release by a qualified person established in the Union, pharmacovigilance system master file, and the qualified person responsible for pharmacovigilance resident in the Union.

Standards and testing

Full pharmaceutical quality testing, stability studies, bioequivalence for generics, and clinical data as required by the authorisation route.

Language requirements

Labelling and package leaflet in the official language of each member state where the product is marketed, in the format approved with the authorisation.

When it applies

Authorisation before placing on the market. Any variation to the product requires approval before implementation.

How long records are kept

Batch records and pharmacovigilance data for the periods set by pharmaceutical law, which extend well beyond ten years for some documents.

What happens if you do not comply

Withdrawal, licence suspension and criminal proceedings. Placing an unauthorised medicinal product on the market is a criminal offence throughout the Union, and border seizures are routine.

Who enforces it

National medicines agencies and the European Medicines Agency, national medicines inspectorates and customs.

Where the boundary lies

This is the hardest boundary in the whole catalogue: a supplement making a therapeutic claim becomes a medicinal product by presentation, and a product with pharmacological action becomes one by function regardless of its claims. Both routes lead to a requirement no representative can satisfy.

Questions we are asked

Can a representative act for us instead of a marketing authorisation holder?

No. The holder must be established in the Union and carries the full pharmaceutical obligations, including batch release by a qualified person.

When does a supplement become a medicine?

When it claims to treat, prevent or cure disease, or when its pharmacological action is such that it restores or modifies physiological functions.