Import & Export
Your medicines arrive quickly to their destination
The import and export of pharmaceuticals is subject to complex and often very bureaucratic import and export regulations. These regulations are outlined in §§ 72-74 of the German Medicines Act (AMG). Within the economic area of the European Union and the contracting states of the European Economic Area, no trade restrictions apply to medicinal products.
Import of medicinal products
When importing medicinal products, the following special features must be observed: finished medicinal products, i.e., medicinal products intended for distribution to the consumer, may in principle only be imported into Germany if they are also licensed there and only pharmacies, wholesalers, pharmaceutical entrepreneurs, veterinarians and holders of a special permit may import medicinal products.
When importingfrom non-EU countries, an import permit in accordance with § 72 AMG is required. It must meet the same personnel and material requirements as for the manufacture of medicinal products. For the import of medicinal products and certain active ingredientsrequiring a permit, a certificate according to § 72a AMGis also required, as well as an inspection by the district government at the production site for medicinal products or active ingredients located abroad. The costs of such an inspection are to be borne by the applicant (Section 72a (1) sentence 2 AMG Foreign Inspection). Furthermore, an import permit (Section 72 AMG), a certificate according to Section 72a AMG and a certificate for customs clearance (Section 73 (6) AMG) are required.
In addition to finished medicinal products, Active Pharmaceutical Ingredients (API) and excipientsalso require a special permit or authorization for import and export.
Export of medicinal products
Whenexporting or exporting medicinal products, the pharmaceutical company must apply to the competent authority for an export certificate(corresponding to the exporter or the competent authority of the country of destination) inaccordance with the certificate system of the World Health Organization (WHO) under Section 73a (2) AMG.
Whenimporting and exporting pharmaceuticals, complex customs requirements and monitoring must also be observed (e.g., Authorized Economic Operator [AEO] , Customs-Trade Partnership Against Terrorism (C-TPAT)).
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