Procedure descriptions

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Applying for a permit for the manufacture of medicines

If you wish to manufacture medicines, you require a permit from the central office for medicine monitoring.

Note: The central office is responsible for monitoring the following in the area of medicines both for humans and animals across Germany:

  • the classic pharmaceutical manufacturers
  • manufacturers of blood products
  • exporters
  • importers and
  • external testing laboratories.

Responsible authority

the Tübingen Regional Council, Coordinating Office for the Control of Pharmaceutical Products (Regierungspräsidium Tübingen, Leitstelle Arzneimittelüberwachung)

Prerequisite

The requirements are:

  • Your company has:
    • A competent person with the necessary reliability
    • Suitable rooms and facilities for the intended manufacture, inspection and storage of the medicines
  • You can guarantee that you:
    • Manufacture and inspect medicines in accordance with the state of science and technology
    • Also comply with the regulations of the second paragraph of the Transfusions Act when taking blood and blood parts

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
  • 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 concerning manufacturing activities (products, procedures, quantity per year)
  • Whether you are applying for a permit for human or animal medicines
  • Description of the forms of medicine and administration forms, production quantities and procedures.
  • Details of the companies engaged in the inspections in accordance with the German Medicines Act (Arzneimittelgesetz).

Tip: Contact the competent body before making the application in order to clarify the particulars.

Should the full documents be present, the competent body will visit the premises and approve them.

Required documents

  • Floor plans of the business premises and the manufacturing, inspection and storage areas
  • In case of external storage facilities: floor plans
  • Proof of availability of the premises, for example
    • copy of lease agreement or
    • extract from the land register
  • Proof of necessary specialist knowledge of the expert person and the managers (original or certified copy)
  • Up-to-date "site master file", description of the facility or quality assurance handbook
  • List of manufacturing activities

.

Deadlines/Duration

Your completed application should be submitted at the latest four weeks prior to starting production.

Costs/Benefits

Costs will be incurred in accordance with the State Fees Ordinance.

Release note

The German original version of this text was drafted in close cooperation with the relevant departments. The Sozialministerium released it on 13.01.2017. 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.

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