Medicine Import Guidelines of Germany for Personal Use

Author: Admin

Category: Medicine Import Guidelines

Published: 23, Dec 2024 Last Updated: 28, Jan 2025

Medicine Import Guidelines of Germany for Personal Use

The German Medicines Act (AMG) regulates the requirements for manufacturing, approving, dispensing, and importing medicines. Under certain circumstances, life-saving medications that are not approved or not available in Germany for personal use can be imported.

Legal Framework

According to Section 73 Paragraph 2 of the AMG, the import of medicines that are not approved in Germany is permitted under certain conditions. This exception allows patients to access necessary medications that are not available domestically.

Rules for Importing Medicines

Medications for Personal Use : The import must be for the personal use of the importer or a specific patient. The medication must not be intended for resale or commercial distribution.
Quantity limitation : The imported quantity must cover the usual personal needs and must not exceed a certain maximum amount. As a rule, an amount of up to three months' worth of therapeutic needs is permissible.
Medical prescription and certificate : There must be a valid medical prescription or a medical certificate confirming that the medication is necessary for the patient's treatment and that no suitable alternative is available in Germany.
Source of Supply : The medication must be obtained from a pharmacy in a member state of the European Union or a contracting state of the Agreement on the European Economic Area. This ensures a certain level of safety regarding the quality of the medication.

Details on Section 73 Paragraph 2 of the AMG.

Section 73 AMG regulates the import of pharmaceuticals from abroad. According to section 73 paragraph 1 AMG, medicinal products may only be imported into Germany if they are approved by the competent authority or if there is a marketing authorization. However, there are exceptions to this principle in Section 73 paragraph 2 AMG.

Specifically, section 73 paragraph 2 number 6 AMG allows private individuals to import medicines without German approval for personal use, provided certain conditions are met.

Medical Certificate and Prescription

The medical certificate should contain detailed information, including:

Name and date of birth of the patient
Diagnosis and medical necessity of the medication
Information about the medication (name, ingredients, and dosage)
Explanation of why no alternative treatment option is available in Germany
It is advisable to present the certificate in German or with a certified translation to avoid misunderstandings with the authorities.

Sources for the medication

The medication should come from trusted sources. Preferred are pharmacies within the EU or the European Economic Area. This ensures that the medication complies with European safety standards.

Customs checks and documentation

When importing, all required documents must be provided, including:

Medical prescription or certificate
Invoice or delivery note from the foreign pharmacy
Proof of the necessity of the medication

Customs authorities may inspect the shipment and request additional information or documents. All documents must be easily accessible to avoid delays.

Restrictions and risks

Certain medications may be subject to restrictions, especially those that fall under the Narcotics Act (BtMG) or contain special active ingredients. The import of such medicines is generally prohibited or only possible under strict conditions.

Liability risks and responsibility

The import is at your own risk. In case of side effects or damages, the manufacturer abroad may not be liable under German law. The patient is responsible for ensuring that all legal regulations are followed.

Recommendations for Patients

Research: Thoroughly inform yourself about the required medication and its availability.
Medical advice: Consult your doctor and have a detailed certificate issued.
Official clarification: Contact the customs authorities or the Federal Institute for Drugs and Medical Devices (BfArM) for further information.
Safe source: Ensure that the medication comes from a reputable pharmacy.
Documentation: Prepare all necessary documents for customs clearance.
Criminal consequences for violations: Violations of the Medicines Act can have serious consequences, including fines or imprisonment. This applies particularly to the importation of prohibited substances or larger quantities that exceed personal use.