What is covered by the pharmaceutical legislation or. the Medicines Act (AMG)
The AMG aims, in the interests of the proper supply of medicines
of humans and animals for safety in the transport of drugs,
in particular for the quality, Effectiveness and safety of medicines
to provide in accordance with the following provisions.
It applies to drug. Medicines are substances and preparations
Substances, intended, by application on or in the human or
animal body u.a. Diseases, Suffering, Body damage or pathological
To cure ailments, relieve, to prevent or detect.
The AMG does not apply to medical devices.
In this environment, the AMG contains numerous prohibitions and obligations. Thus, it is
prohibited, To get "serious" drugs on the market (§ 5 AMG).
"Alarming" are drugs, where according to the state of
scientific knowledge is reasonable suspicion, that they at
conditions of use have adverse effects, a according to the
Beyond medical knowledge acceptable level.
Therefore be regulated transport requirements for medicinal products (z.B.
Labeling requirements (§§ 10 ff AMG) of medicinal products,
Package inserts, Require certain technical information.
The preparation of medicaments (from. B. Requirement of
Manufacturing authorization) and of course their admission, but also the delivery of
Drugs (from. B. the keywords RENEWAL, Prohibition of self service,
Mail Order, Prescription, the-counter drugs, etc. are
importance of) is regulated.
What governs the Medical Devices Act (MPG)
The purpose of MPG, to regulate the marketing of medical devices and thus for
security, Suitability and performance of medical devices and health
and the need to protect patients, To provide users and third parties.
Medical products are used all alone or interconnected
Instruments, Equipment, Devices, Substances and preparations made from substances or
other items including the proper functioning of a
Medical device software used, by the manufacturer to be used for
People by means of their functions for the purpose u.a. detection, Prevention,
Monitoring, Treatment or alleviation of diseases (§ 3 MPG)..
The MPG regulates prohibitions for the protection of patients, Users and third parties, the
Marketability of medical devices, Responsibilities and also contains
Punishment- and punitive damages provisions.
What does pharmacy law
Pharmacy law is in transition between European law
und Nationaler Tradition. In particular, the Pharmacy Act, the
Regulate pharmacies operating order and the rules of professional ethics
central aspects of the pharmacy law. There are also numerous regulations, as
for example, the drug price regulation.
That § 1 ApoG the responsibility of the pharmacy, the obligation in the public interest
Ensuring proper supply of medicines for people.
Who wants to operate a pharmacy, requires the permission of the competent authority.
The permit is valid only for the pharmacist, which it is granted, and in the
the license certificate designated rooms.
The resulting individual case problems (Prohibition des Versandhandels, the
Metastatic, Advertising bans, Pricing principles, Alternativprodukte etc)
can not be verpauschalisieren; even insolvency law issues
can occur today.
Why the Medicines Act or the Heilmittelwerbegesetz plays a
In that Communication (Advertising, Packaging, etc.)
be food, particular dietary supplement, often "borderline"
advertised; namely with statements, which would be more attributable to a drug.
The latter, however, would significantly affect the marketability and
may result in the rest of the applicability of drug advertising law.
That § 2 Abs. 3 No.. 1 AMG (Drug Law) in
Conjunction with § 2 LFGB arises objectively first question, whether
Food within the meaning of § 2 LFGB present. Foods are to this
Provision such substances, intended, consumed by people to
will, where again the materials are excluded, the "predominantly" to
to be consumed for purposes other than nutrition or consumption. Outgoing
of the purpose of the materials and turning off the traffic outlook
represents a significant opportunity to use objective criterion represents.
Thus, dietary supplements are foods such as only, when
Consumption is due to nutritional reasons, also bspw. an undersupply
leads to the use of such supplements.
Labeling requirements, and features relating to the specific
Food, For example, as. the DiätVO, Note.
What we need, to your regulatory drug, medicine-related
To edit or pharmacies legal issue
Since the respective problems in different areas of law already for
be taken are as complex, can only vote in a particular case, which
Information and documents to process and we solve your problem