Online pharmacies and medicine distance selling

• Directive 2001/83/EC Article 85c on distance selling
• Directive 2011/62/EU — falsified medicines
• Regulation (EU) 2016/161 — safety features
• Regulation (EU) 2016/679 — GDPR

Who has to appoint one

Anyone selling medicines at a distance to consumers in the EU. Only persons authorised to supply medicines under the law of the member state where they are established may sell at a distance, and only into member states that permit it. Prescription medicines may not be sold at a distance in most member states.

Thresholds and exemptions

None. The permission depends on national law, and several member states prohibit distance selling of prescription medicines entirely.

What must appear on the label

The website must display the EU common logo linking to the national register, the contact details of the competent authority, and the pharmacy's registration details. Products carry the safety features required by the falsified medicines rules.

Marketplace fields

Marketplaces generally prohibit medicine sales, and search engines restrict advertising to verified pharmacies. Websites without the common logo are treated as illegal by default.

Documentation you must hold

National authorisation or registration as a supplier of medicines, notification to the competent authority of the intention to sell at a distance, verification connection to the European Medicines Verification System, and GDPR documentation for the health data processed.

Standards and testing

Not applicable, though the verification system checks each pack's unique identifier at dispensing.

Language requirements

The website and product information in the language of the member state served.

When it applies

Registration and notification before the first distance sale into a member state.

How long records are kept

Dispensing records per national pharmacy law, and health data minimised within that.

What happens if you do not comply

Website blocking, criminal prosecution for supplying medicines without authorisation, and coordinated international enforcement operations against illegal pharmacy sites.

Who enforces it

National medicines agencies and pharmacy regulators, and the European Medicines Verification Organisation for the safety features.

Where the boundary lies

Health data processed by an online pharmacy is special-category data at scale, and several authorities have fined pharmacies for using it in marketing or for inadequate access controls. Cross-border sales require compliance with both the origin and the destination member state.

Questions we are asked

Can we sell prescription medicines online across the EU?

Most member states prohibit distance selling of prescription medicines, and where permitted it requires registration in that state. There is no EU-wide permission.

What is the common logo?

A mandatory logo displayed on legally operating distance-selling websites, linking to the national register that lists authorised retailers.