Medicinal products and narcotics

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.

What rules must be observed in connection with intra-community movement?

Movement to Germany

Basically, you do not require any medical product legislation permits or certificates for the intra-community movement of medicinal products and active substances.
For finished medical products you must, however, comply with the provisions concerning the prohibition of introduction pursuant to Section 73 (1), AMG.
You require a formal certificate only for the first movement of so-called known tissue preparations from another EU member state to Germany. You must apply to the Paul-Ehrlich-Institut for this certificate.

Movement out of Germany

Basically there is no restriction on the movement of medicinal products and active substances into another EU member state, unless such movement infringes against a prohibition of the marketing of

• unsafe medicinal products (Section 5, AMG),
• medicinal products for doping purposes in sport (Section 6a, AMG),
• medicinal products that are radioactive or that have been treated with ionising radiation (Section 7, AMG),
• poor-quality or counterfeit medicinal products or active substances or medicinal products or active substances with a misleading name, information, or packaging (Section 8 (1), AMG), and
• "outdated" medicinal products (Section 8 (2), AMG)

since marketing within the meaning of Section 4 (17) of the AMG also takes place where medicinal products are held with the intention of sale or other form of distribution, or where they are offered to, or offered for sale or distribution by, others abroad.

The movement of the above-mentioned medicinal products into other EU states for the purpose of placing them on the market is thereby prohibited. Such medicinal products may solely be moved for the purpose of testing and/or (subsequent) destruction in, for example, a foreign-based subsidiary of the company.

Approval by the competent authority in the country of destination

In derogation of the above, pursuant to Section 73a (1) of the AMG,

• unsafe medicinal products (Section 5, AMG),
• poor-quality or counterfeit medicinal products or active substances, or medicinal products or active substances with a misleading name, information, or presentation (Section 8 (1), AMG)

may be moved to another EU member state where such movement has been approved by the competent authority in the country of destination. The respective permit must clearly state that the above-mentioned deficiencies are known.

Narcotics

The same prerequisites and document requirements apply to the movement of narcotics to or from other member states of the European Union as they do to the movement to or from non-EU states.
Notwithstanding this, there is no intra-community customs clearance under narcotics legislation, unless the goods concerned originate outside the community.

Information on the import of Narcotics