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Imports of medicinal products

Legal basis

The legal basis for medicinal product legislation in Germany is the Medicinal Products Act (Arzneimittelgesetz - AMG).

What are medicinal products?

Medicinal products are substances or preparations of substances which

  • are intended for use in or on the human or animal body, and which are intended to be agents with properties that heal, palliate, or prevent human or animal diseases or pathological complaints (known as medicinal products by presentation, because they are seen as such by the consumer solely by reason of their presentation, for example their packaging or packaging leaflet), or
  • can be used in or on the human or animal body, or can be administered to humans or animals, in order to either
     

    1. restore, correct, or influence physiological functions through a pharmacological, an immunological, or a metabolic effect, or
    2. to make a medical diagnosis

    (known as medicinal products by function which are medicines solely on the basis of their objective characteristic, independently of their presentation).

Cooperation by the customs authorities

The customs offices cooperate in monitoring the movement and introduction of medicinal products and active substances within the scope of the Medicinal Products Act, and in the export of such products and substances.

In the course of this monitoring they examine in particular whether

  • the required import permits, certificates and certifications have been obtained,
  • the medicinal products have been approved, registered or licensed,
  • the labelling requirements have been complied with, and
  • finished medicinal products from the pharmaceutical industry include a package leaflet in German.

The competent authority for monitoring medicinal products will be informed of any suspicion of an infringement. Where necessary the presentation of the consignment to that authority will be ordered, at the expense and risk of the party at whose disposal the goods are.

The relevant decisions concerning medicinal product legislation are made not by customs offices, but solely by the regional authorities competent for the movement of medicinal products.

The term "import" within the meaning of the Medicinal Products Act

"Import" within the meaning of the Medicinal Products Act is the release for free circulation of goods falling within the scope of the Medicinal Products Act, coming from all non-EU states, with the exception of those from Iceland, Liechtenstein, and Norway.

What documents are required for imports to Germany?

For medicinal products and certain active substances

When importing medicinal products or certain active substances, you always require an import permit pursuant to Section 72, AMG, and a certificate from the country of origin pursuant to Section 72a, AMG, that confirms compliance with the quality standards, and/or an appropriate certification from the medicinal products authority competent for commercial imports in the municipality where your business is established.

Imports of medicinal products or active substances from Iceland, Liechtenstein, and Norway (EEA member states) can be released for free circulation in Germany without the presentation of medicinal product legislation documents (not seen as import within the meaning of the Medicinal Products Act (AMG)).

For tissue and certain tissue preparations

For the import of tissues and/or certain tissue preparations you require an import permit pursuant to Section 72b (1), AMG, from the competent regional authority, and a certificate from the state of origin pursuant to Section 72b (2), AMG, that confirms that the standards observed during the extraction and processing of the tissue/tissue preparations are at least equivalent to the standards of good practice laid down by the European Union (Good Manufacturing Practice - GMP).

Pursuant to Section 21a (9) of the AMG, a certificate from the Paul-Ehrlich-Institut is required for first introduction of tissue preparations from Iceland, Liechtenstein or Norway, to Germany.

Certificate for customs clearance pursuant to Section 73 (6) of the AMG

For the import of finished medicinal products a certificate from the medicinal products authority competent for the consignee is required for customs clearance; the certificate must state the type and quantity of the medicinal products and confirm that the prerequisites for marketability within the scope of the Medicinal Products Act have been met, and that the importer has obtained the required import permit.

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