Notification of activities with medicinal products
Medicinal products are in particular substances or preparations of substances, - intended for use in or on the human or animal body and intended as a means enserating or preventing human or animal diseases or morbid ailments, or - which may 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 by means of a pharmacological, immunological or metabolic action, or - to make a medical diagnosis. Companies and institutions that develop, manufacture, clinically test or subject to residue testing, testing, storage, packaging, import, placing on the market or otherwise trade in medicinal products as well as establishments and establishments and establishments that keep records related to the aforementioned activities are obliged to notify. You must report this to the LAVG (in the case of a clinical trial in humans also to the BfArM) before commencing the activities. You are also obliged to notify: - as a body which obtains tissue, which carries out the laboratory examination necessary for the production, which processes or processes, preserves, tests, stores, imports or places on the market tissues - if you carry out these activities independently and professionally and collect the medicines for others (for example, also in an association of persons) - as an establishment and body which manufactures, tests, stores, packages, imports, places on the market or other substances intended for the manufacture of medicinal products - as an establishment and entity setting up or managing a repository that is part of the data storage and retrieval system referred to in Article 31 of delegated regulation (EU 2016/161) - as a doctor or as a non-medical practitioner, if you intend to manufacture medicines without a permit. In the advertisement, you specify the type of your activity and your permanent establishment. If medicinal products are collected, provide details of the type of collection and storage site. When reporting a clinical trial in humans, you also indicate their sponsorship, if available, its representation. To this end, you shall also name the examining person together with the deputy; if necessary, also with an indication of the position as head of the clinical trial. You also inform the BfArM of the course, the termination and the results. You must also display subsequent changes. The obligation to notify is waived in particular for companies and institutions that are subject to a reservation of permission under the Medicines Act or the Pharmacy Act.
The required documents can be found in the corresponding information sheets on the obligation to notify on the LAVG website.
Online procedure possible: no Written form required: yes Personal appearance required: no
Before you carry out activities with medicinal products, indicate them in writing: Read in the information sheets for the advertisement according to § 67 AMG how the advertisement should be made. An informal display is generally sufficient. If a form is available, download it online and print it out. If necessary, complete the form. Add the necessary evidence. Submit the notification and the required application documents to the LAVG. The LAVG confirms the notification to you in the event of an exclusive notification obligation.
Responsible for the content
Ministry of Social Affairs, Health, Integration and Consumer Protection of the State of Brandenburg
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