Applying for a permit for the importation of medicines
You also require the permit for active ingredients and starting materials which
- originate from humans or animals
- or which are manufactured genetically.
Responsible department
the Tübingen Regional Council, Coordinating Office for the Control of Pharmaceutical Products (Regierungspräsidium Tübingen, Leitstelle Arzneimittelüberwachung)
Details
Prerequisite
- An expert person is present.
- Suitable rooms and facilities for the intended manufacture, inspection and storage of the medicines are available.
- It is guaranteed that
- the manufacture or inspection of the medicines takes place in accordance with the state of science and technology and
- the taking of blood and blood constituents also complies with the regulations of the second paragraph of the Transfusions Act (Transfusionsgesetz).
Procedure
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 an expert person in accordance with § 15 of the Medicines Act (Arzneimittelgesetz) or
- of a responsible person in case of the import of medicines of human origin for direct use on persons
- 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.
Deadlines
Your completed application should be submitted at the latest four weeks prior to starting importation.
Required documents
- 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
Depends onthe individual case.
Processing time
Also depends on
- the type of medicine for which the importation permit is being applied for and
- whether an inspection abroad is necessary.
Legal basis
Release note
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 31.01.2019. 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.