Medicine Import Guidelines of Spain for Personal Use

When importing medicines into Spain for personal use, it’s important to follow the rules set by the European Medicines Agency and the Spanish Ministry of Health to ensure safety. 

The EMA ensures that medicines are safe and effective for use in Europe. Meanwhile, the Spanish Ministry of Health regulates the import of drugs to protect public health. 

Requirements for Importing Medicines

• You can usually only bring enough medicine for personal use, often limited to a 3-month supply.
• For prescription medicines, you must have a valid prescription from a licensed doctor. The prescription should explain why you need the medicine.
• Must include the doctor’s contact details and the patient’s medical condition.
• A medical report or supporting documentation explaining why the medicine is needed.
• Confirm that the medicine is approved for use in Spain and does not contain prohibited ingredients.
• Keep the medicine in its original box or container, with labels that show the name of the medicine, its ingredients, and how much to take.

Importing over-the-counter (OTC) medicines

• OTC medicines, which do not require a prescription, can be brought into Spain more easily.
• However, limits may apply to the quantity you can bring, so ensure you carry only a reasonable supply for personal use.

Special access to medicines not approved or unavailable in Spain

If the medicine you need is not yet approved or available in Spain, you can apply for special access through the AEMPS.

Steps for applying for special access

This application can only be made by laboratories, healthcare centers, or autonomous communities authorized by the AEMPS.

To find out which documents are needed, the AEMPS has established a step-by-step procedure for each type of applicant:

• For laboratories, click here.
• For healthcare centers, click here.
• For autonomous communities, click here.

A valid prescription from your treating physician

The prescription must meet the following criteria:-

• Details of the doctor: Including the doctor’s full name, registration number, and official letterhead.
• Patient information: The name and date of birth of the patient.
• Medicine details: The name of the medicine, its dosage, and the quantity prescribed.
• Date: The prescription must indicate the date it was written.
• Signature and stamp: The doctor’s signature and an official stamp must be present.

To avoid misunderstandings, it is recommended that key documents, such as prescriptions and doctors’ letters, be translated into Spanish.