Pharmaceuticals and medicines
Pharmacy Drug Control BJV
The pharmaceuticals department of the Authority for Justice and Consumer Protection (Bereich Pharmaziewesen der Behörde für Justiz und Verbraucherschutz Pharmacy, abbr. BJV) monitors pharmaceutical manufacturing and sales in Germany. They also look after the proper execution of clinical trials for pharmaceuticals, donor protection according to the Transfusion Act, the safe manufacture of tissue preparations, and they advise the institutions subject to their supervision on questions relating to pharmaceutical law.
More information on pharmacies, drug manufacturers and pharmaceutical entrepreneurs, import permits, pharmaceutical wholesale, manufacturing of medicines by doctors/alternative practitioners, clinical trials is available here (German only).
Contact:
Behörde für Justiz und Verbraucherschutz
Amt für Verbraucherschutz
Abteilung Pharmaziewesen und Medizinprodukte
Postfach 30 28 22, 20310 Hamburg
Clinical trials
Clinical trials represent the last step in the development of a new drug. These trials are carried out on humans in order to prove clinical or pharmacological effects of medicinal products or to determine side effects (Section 4 paragraph 23 of the Medicines Act).
But even after a drug has been approved, clinical trials provide important insights into the long-term effects of the treatment. Clinical trials should provide valid data on the effectiveness and safety of drugs. Legal regulations for the clinical testing of medicinal products can be found in paragraphs 40 – 42b of the Medicines Act and in the corresponding GCP regulation.
Since 2004, clinical trials of medicinal products in Germany have to be approved by the competent higher federal authority – Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices) and the Paul-Ehrlich-Institut, as well as ethics committees.
Both the companies and doctors carrying out clinical trials must report to the responsible local authorities.
Further information including a link to the relevant forms and a Q&A (in German) can be downloaded here.
Blood donation and blood product manufacturing
Legally speaking, blood products are medicinal products. This includes the blood obtained and processed by blood donation services and transfusion medicine institutes as well as special products prepared in hospitals, medical practices or other facilities.
The same requirements apply to the production of medicinal products from blood as to the production of any other medicinal products.
The regulatory specificities for companies that deal with the collection and processing of blood result from the special regulations in the Medicines Act (AMG), the Medicines and Active Ingredient Manufacturing Ordinance (AMWHV), the Transfusion Act (TFG) and Germany’s hemotherapy guidelines. In individual cases, other legal norms may also be relevant.
For more information in German, click here.
What are medical devices?
Medical devices are apparatuses, instruments, software or substances, used individually or in combination, which a manufacturer has intended for the diagnosis, therapy, prevention or alleviation of human diseases or disabilities or for the regulation of conception. In contrast to pharmaceuticals, medical devices mainly work physically (e.g. thermally, electrically or mechanically).
Medical devices include:
- medical-technical devices (e.g. ECG recorders, ultrasound diagnostic devices, magnetic resonance tomographs),
- implants (e.g. hip prostheses, pacemakers)
- in-vitro diagnostics (e.g. blood glucose meters)
- medical aids (e.g. bandages, walking aids, glasses)
Medical device accessories are treated as a separate medical device.
Monitoring according to the Medical Devices Act (MPG)
The BJV is the authority responsible for the MPG in Hamburg. It monitors the local companies and facilities in which medical devices are:
- produced
- subjected to a clinical trial or performance evaluation test
- packaged, displayed or placed on the market
- built, operated and applied
- processed
This also applies to sponsors and people who carry out the aforementioned activities on a commercial basis, as well as to people and associations of people who collect medical devices for others.
Before any medical device can be placed on the market in Hamburg, it must be determined that the device meets all legal requirements.
Goal: protection of patients, users and third parties
In order to ensure the protection of consumers (patients, users and third parties) in the area of operating and using medical devices, facilities that operate and use medical devices, such as hospitals and established medical and dental practices, are monitored. Their accordance with any applicable legal regulations – such as the ordinance on the installation, operation and use of medical devices (Medical Device Operator Ordinance - MPBetreibV) and the ordinance on the recording, assessment and prevention of risks in medical devices (Medical Device Safety Plan Ordinance - MPSV) – is monitored.
You can find more information in the brochure available (in German) here:
https://www.hamburg.de/contentblob/125542/251f2e37497cd3f8048809cbdf61eb9b/data/m28.pdf
Special requirements
Anyone who carries out safety checks or metrological checks on medical devices must:
- have up-to-date knowledge in the respective area, as well as the necessary means, rooms, devices and other work equipment,
- not be subject to any instructions regarding the professional assessment,
- carry out the activities properly and comprehensively.
In addition, there is the obligation according to section 14 MPBetreibV for those who intend to carry out metrological controls in the future. They must notify the competent authority of their plans before starting work and, if requested, prove that they meet the above requirements.
The form for notification of the implementation of metrological controls (MTK) is available for download (in German):
Contact
Behörde für Justiz und Verbraucherschutz
Address
Postfach 302822
20310 Hamburg
E-Mail:
medizinprodukte@justiz.hamburg.de