Authority for Justice and Consumer Protection

Notification of activities involving medicinal products

Prerequisites

If you, as a company or institution, develop, manufacture, clinically test or subject drugs to a residue test, check, store, package, import, place on the market or otherwise trade with them, you are subject to the obligation to report.

If you, as a company or institution, keep records related to the above-mentioned activities, you are also subject to the obligation to report.

There is also an obligation to report if:

• Facilities that carry out the laboratory tests required for tissue collection, process or process tissue, preserve, test, store, import or place on the market.
• You carry out these activities independently and professionally and collect the medicines for others (for example in an association of people)
• You as a company and facility that manufacture, test, store, package, import, place on the market or otherwise trade in active ingredients or other substances intended for the production of pharmaceuticals
• You, as an organization and institution, set up or manage a data storage facility that is part of the data storage and retrieval system in accordance with Article 31 of the Delegated Regulation (EU 2016/161).
• You, as a doctor or alternative practitioner, intend to manufacture medicines without a license.

Documents required

In the advertisement you indicate the type of activity and your place of business.

If you collect medicines, provide details about the type of collection and storage location.

If you display clinical trials in humans, you should also state their sponsorship and, if available, their representation. To do this, please also name the person carrying out the examination and their representative; if necessary, also stating the position as manager of the clinical trial. You will also inform the BfArM about the course, completion and results.

Please note

Medicines are in particular substances or preparations made from substances that

• are intended for use in or on the human or animal body and are intended as agents with properties for healing or alleviating or preventing human or animal diseases or pathological complaints
• can be used in or on the human or animal body or administered to a human or animal in order to
  • to restore, correct or influence physiological functions through a pharmacological, immunological or metabolic action
  • to make a medical diagnosis

Deadlines

View the activities related to medicines before starting the activities.

Procedure

• Read the information sheets at hamburg.de/pharmaziewesen
• Create an informal ad.
• Add the necessary evidence.
• Submit the notification and the required evidence to the responsible authority.
• The responsible authority will examine your complaint and, if necessary, request further documents or information from you.
• The responsible authority records your report.
• The responsible authority will confirm the notification to you in the event of an exclusive reporting obligation.

Processing time

If all the necessary documents and information are available, processing your ad will take between 1 and 3 months.

Fees

In the event of a reservation of permission, the fees are based on the Hamburg fee schedule for public consumer protection in the currently valid version. The amount of the fees depends on the time required for processing the application and the on-site inspection.

Legal remedies

No legal remedy provided.

Legal basis

• § 67 Medicines Act (AMG)