Rules for authorizing, selling and funding medicines in Spain

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1. No industrially manufactured medicine can be sold without authorization from the Spanish Agency of Medicines and Medical Devices. To be authorized it must be of quality, safe, effective, properly identified and come with clear patient information.
2. A medicine's authorization lasts five years and can be renewed. It expires if the medicine is not marketed within three years, and it can be suspended or withdrawn if its benefit-risk balance stops being favorable.
3. Generic medicines cannot be marketed until ten years after the original medicine was authorized, or eleven if the original gains a new indication with significant clinical benefit.
4. Selling prescription-only medicines and medical devices by internet, mail or home delivery is banned. Only physicians and dentists may prescribe medicines.
5. Offering gifts, prizes, bonuses or non-permitted discounts to health professionals who prescribe, dispense or administer medicines is banned, to protect their independence from the industry's commercial interests.
6. Clinical trials require prior authorization, a favorable report from an ethics committee and the participant's written consent. The sponsor must publish the results, whether good or bad, and cover harm through insurance.
7. Public funding of medicines is selective: it is decided based on therapeutic value, how serious the illness is and the degree of innovation. The law also regulates the reference price system and what patients pay.
8. Offenses are classified as minor, serious or very serious, with fines of up to €1,000,000. Very serious ones include selling prescription medicines online, counterfeiting medicines or marketing medicines without authorization.

Who it affects

• Patients and the public: Ensures the medicines they buy or are prescribed are authorized, safe and come with clear information, including readable leaflets and braille data.
• Health professionals: They cannot accept gifts from the industry or work as sales representatives for laboratories; only physicians and dentists may prescribe.
• Pharmaceutical laboratories: They must get their products authorized, keep the market supplied, report units sold and make contributions to the National Health System based on sales.
• Pharmacies and wholesale distributors: They must dispense prescription medicines only with a prescription, keep minimum stocks and guarantee medicine traceability.
• Companies running clinical trials: They need authorization, a favorable ethics committee, participant consent, insurance and publication of results.

Words worth knowing

Farmacovigilancia (pharmacovigilance)

Monitoring the risks of a medicine once it is already on sale, especially its side effects.

Medicamento genérico (generic medicine)

A medicine with the same active ingredients and form as the original, proven to work the same, usually cheaper.

Exclusividad de datos (data exclusivity)

A period during which the original medicine's data cannot be used to authorize generics, so the original stays alone in the market.

Precio de referencia (reference price)

The maximum amount the National Health System funds for a group of presentations of the same active ingredient; if the medicine costs more, the patient pays the difference.

Trazabilidad (traceability)

Knowing a medicine's full path at all times, from the laboratory to the patient.

It summarizes the law as published in the BOE. It is written by artificial intelligence and may contain mistakes: the official text is what counts. Read the official text · How we make summaries