Applying for a permit for the importation of medicines
Do you wish to import medicines from non-EU/non-EEA states? Then you require a permit from the competent authorities.
Note: You also require the permit for active ingredients and starting materials which
- originate from humans or animals
- or which are manufactured genetically.
the Tübingen Regional Council, Coordinating Office for the Control of Pharmaceutical Products (Regierungspräsidium Tübingen, Leitstelle Arzneimittelüberwachung)
You can apply for the permit formlessly at the competent body. The application must contain the following details:
- Exact description of the applicant person and details concerning legal form.
- Description of the business premises (name, road, town/city)
- Details concerning external storage
- Details concerning the activities planned with the importation at the business premises
- Name, telephone and fax number
- of a competent person in accordance with § 15 of the German Medicines Act (Arzneimittelgesetz)
- of a production manager
- of a quality control manager, giving details of telephone and fax numbers
- Details in tabular form concerning the medicines which are intended to be imported
- Details of the companies engaged in the inspections
Tip: Contact the competent body before making the application in order to clarify the particulars.
Once you submit the complete documents, the competent body will carry out an acceptance inspection.
Your completed application should be submitted at the latest four weeks prior to starting importation.
- Extract from the commercial register
- Proof of availability of the premises, for example
- copy of lease agreement or
- extract from the land register
- Floor plans of the business premises and the inspection and storage areas
- In case of external storage facilities: floor plans
- Proof of necessary specialist knowledge of the expert person and the managers (original or certified copy)
- Delimitation of responsibility agreements with the manufacturers abroad
- Up-to-date "site master file", description of the facility or quality assurance handbook
Tip: More information concerning the necessary documents can be found in the import permit leaflet on the Internet pages of the medicine monitoring control centre (Leitstelle Arzneimittelüberwachung).
Costs will be incurred in accordance with the State Fees Ordinance
The German original version of this text was drafted in close cooperation with the relevant departments. The Ministerium für Arbeit und Soziales released it on 17.06.2015. Only the German text is legally binding. The Federal State does not assume any liability for the translated texts.
In cases of doubt or if you have any questions or problems, please contact the relevant authorities directly.