What if your medicine is not sold in Spain?

Terms used

• AEMPS — AEMPS is Spain's medicines agency, which authorises medicines and decides on imports of foreign ones.
• CIMA — CIMA is the AEMPS online database where you look up any medicine's authorisation, marketing status and supply problems.
• Comercializado — Comercializado means a medicine is currently on sale in Spain, not just authorised.
• Medicamento extranjero — A medicamento extranjero is a medicine authorised abroad but not in Spain, imported for a named patient.

Key rules

• Check first: A medicine can be authorised in Spain yet not on sale, so check its marketing status before looking for alternatives.
• Substitutes: Changing to a different ingredient needs a new prescription from your Spanish doctor.
• Imports: You cannot ask AEMPS to import a medicine yourself; your prescriber or a hospital must file the request.
• Personal supply: You can carry three months of treatment in original packaging, with a prescription or doctor's letter.

Check first whether it is really unavailable

A medicine can be authorised in Spain and still not be on sale. Search for it by name or active ingredient in CIMA, the AEMPS medicines database. Open the record and look for "comercializado". Then look at the supply-problems list, which gives start and expected end dates and often suggests alternatives.

Your pharmacy can also check stock and order the medicine for you. Supply changes often, so the pharmacist's answer is the one that counts for your town.

Option 1: a substitute

Your Spanish doctor can prescribe another presentation of the same ingredient. They can also prescribe a different ingredient of the same therapeutic class. This is a clinical decision, so the doctor decides.

• If the ingredient changes, you need a new prescription. The doctor will check dose equivalence, side effects and any monitoring.
• A pharmacist alone can only swap within the legal limits, for the same ingredient, and when a supply problem is documented.
• During shortages, AEMPS may allow specific alternatives.

Option 2: an over-the-counter version

Some products are sold without a prescription, but often only in certain doses or pack sizes. Low-dose paracetamol and small packs of ibuprofen 400 mg are examples. Higher strengths need a prescription. Antibiotics, insulin, antidepressants, hormonal contraceptives and asthma inhalers always need one. Ask the pharmacist whether a version exists in your dose and pack size.

Option 3: import through AEMPS

If there is no authorised alternative, AEMPS can authorise a "medicamento extranjero", a medicine authorised abroad but not in Spain. You cannot apply yourself. Your prescriber or a hospital pharmacy service files the request for you, with clinical reasons and your consent, through the AEMPS online application for special-situation medicines. AEMPS decides case by case. These medicines usually reach you through the hospital pharmacy or an authorised distributor, so do not buy them privately abroad.

Ask your doctor early. Approval takes time, and requirements can change.

Bringing your own supply

You may carry a personal supply for treatment, in original packaging, with a prescription or doctor's letter. The limit is set out on the page about travelling with medicines: three months of treatment.

Controlled drugs, such as narcotics and psychotropic substances, need extra paperwork. Confirm the quantity and documents with AEMPS or customs before you travel. Anabolic steroids and medicines bought illegally online are restricted. Commercial quantities need a licensed importer.

Use the decision, documents list and checklist below to choose your route.

Choosing between options

Your medicine is not available in Spain. What do you do?

• Another presentation of the same ingredient: Fits when the same ingredient exists in another form or strength; your prescriber can prescribe it.

• A different ingredient of the same therapeutic class: Fits when no form of your ingredient is available; you need a new prescription and your doctor checks dose, side effects and monitoring.

• Over-the-counter product: Fits for minor needs such as low-dose pain relief or antacids, which you can buy without a prescription; ask the pharmacist.

• Foreign medicine import through AEMPS: Fits when there is no authorised alternative; your doctor or hospital pharmacy service requests it for you by name.

Check first whether the medicine is marketed in Spain. If it is not, try a substitute with your prescriber, and ask for the import route only when no authorised alternative works.

Documents you need

• A prescription or a doctor's letter for the medicine you carry as a personal supply for treatment.

• A Schengen certificate, or an equivalent from the issuing authority, if your medicine is a controlled substance such as a narcotic or psychotropic.

• A new prescription from your Spanish doctor if the substitute has a different ingredient.

Checklist

• Open the record and check whether it is authorised and shows as currently marketed ("comercializado").

• Check with AEMPS or customs before travel if your medicine is a controlled drug or you plan to bring a supply.

Frequently asked questions

Can I ask AEMPS to import my medicine myself?

No, you cannot apply to AEMPS yourself; a doctor or a hospital pharmacy service must request the import for you. The request names you as the patient, gives the clinical reason and includes your consent. AEMPS decides case by case, usually when no authorised alternative exists.

Can my pharmacist swap my medicine for a different one?

A pharmacist can only swap within legal limits, and only for the same ingredient during a documented supply problem. A different ingredient needs a new prescription, because the doctor must check the dose, side effects and monitoring.

Can I buy my medicine abroad and bring it to Spain?

Foreign medicines not authorised in Spain are generally supplied through a hospital pharmacy or authorised distributors, not bought privately abroad. Medicines bought online illegally are restricted, so ask your prescriber about the import route instead.

Does a medicine that is authorised in Spain always have stock in pharmacies?

No, a medicine can be authorised in Spain but not currently marketed or in short supply. Your local pharmacy can check stock through the supply system and order it for you.