Display of activities with medicinal products
Medicinal products are, in particular, substances or preparations consisting of substances, - intended for use in or on the human or animal body and intended as a means of curing or alleviating 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 an animal in order to: - to restore, correct or influence physiological functions by means of a pharmacological, immunological or metabolic effect, or - to make a medical diagnosis. There is an obligation to notify establishments and establishments which develop, manufacture, clinically test or undergo a residue test, test, store, package, import, market or otherwise trade with establishments and establishments and keep the records related to those activities. You must indicate this before starting activities at the LAVG (in a clinical trial in humans also in the BfArM). You are also required to report: - as a device which obtains tissues which carry out the laboratory examination required for extraction, processes or processes tissues, preserves, tests, stores, introduces or puts them on the market - if you carry out these activities independently and professionally and collect the medicines for others (e.g. also in an association of persons) - as a plant or facility producing, testing, storing, packaging, importing, placing or otherwise trading active substances or other substances intended for the manufacture of medicinal products - as an operation and facility that sets up or manages a data store belonging to the data storage and retrieval system in accordance with Article 31 of the Delegated Regulation (EU 2016/161) - as a doctor or a naturopath or a naturopath if you intend to produce medicines without authorisation. In the advertisement, you specify the type of activity and your establishment. If medicinal products are collected, provide details of the type of collection and storage. When displaying a clinical trial in people, you also indicate their sponsorship, if available, their representation. To this end, you shall also mention by name the person inspecting the case, including the deputy; where necessary, including the position of the clinical trial. You also tell the BfArM about the history, the termination and the results. You must also view subsequent changes. The obligation to notify applies in particular to establishments and establishments that are subject to a permit reservation under the Medicines Act or the Pharmacy Act.
The required documents can be found in the relevant information sheets on the WEBSITE of the LAVG.
Online procedure possible: no Written form required: yes Personal appearance necessary: no
Before you pursue activities with medicines, indicate them in writing: Please read the information sheets for the advertisement in accordance with Section 67 AMG how the display should be made. An informal display is always sufficient. If a form is available, download it online and print it out. If necessary, fill in the form. Add the necessary evidence. Submit the notification and the required application documents to the LAVG. The LAVG confirms the notification in case of an exclusive notification obligation.