This only applies to medications prescribed by your physician, by the way. You have to pay the full amount yourself for other drugs. If you require immediate attention during the night or on weekends, you can go to the emergency room of the next hospital. If you cannot reach a hospital on your own, you simply dial on a telephone to call an ambulance. You can reach this service by dialling Drugs you may get over-the-counter in other countries could still require a prescription here.
Depending on the state where the drugs are distributed, it may possible to appeal against the competent federal higher state authority's decision. Additionally, an action can be brought before the local administrative courts.
What are the legal consequences of non-compliance with consumer distribution laws? In the case of non-compliance, the penalties can include imprisonment or a fine. In particularly serious instances, the penalty can be imprisonment from one to ten years.
In addition, administrative fines of up to EUR25, may be imposed. Wholesale distribution. What is the legal regime regarding wholesale distribution of drugs? The wholesale of drugs is defined in section 4 22 of the AMG as any professional or commercial activity for the purpose of doing business that consists of the procuring, storing, dispensing or exporting of medicinal products, with the exception of the dispensing of medicinal products to consumers other than physicians, dentists, veterinarians or hospitals.
Name the specific sites for which the authorisation is to be issued. Submit evidence that he or she is in possession of suitable and adequate premises, installations and facilities to ensure the proper storage and distribution and, where envisaged, proper decanting, packaging and labelling of medicinal products.
Appoint a responsible person who possesses the required expert knowledge to perform the activity. Enclose a statement in which he or she commits himself in writing to observe the regulations governing the proper operation of a wholesale enterprise. The decision on granting the authorisation is taken by the competent federal higher state authority of the state in which the wholesaler is established. The authorisation can be refused if facts justify the assumption that the applicant or the person responsible for the wholesale does not possess the necessary reliability to perform the activity.
What regulatory authority is responsible for supervising wholesale distribution activities? Regulatory authority The federal higher state authorities of the state in which the wholesale is established supervise the distribution activities. Supervision See above , Regulatory authority. Rights of appeal Depending on the state where the drugs are wholesaled, it may be possible to appeal against the competent federal higher state authority's decision.
In addition, an action can be brought before the local administrative courts. What are the legal consequences of non-compliance with wholesale distribution laws? In the case of non-compliance, penalties can be imprisonment for a term not exceeding three years or a fine.
In addition, administrative fines of up to EUR25, can be imposed. Marketing Promotion. What is the general legal regime for the marketing of drugs? Legal regime The Advertisement of Healthcare Products Act Heilmittelwerbegesetz HWG contains the legal requirements for marketing activities of pharmaceutical companies addressed to health care professionals or consumers. In general, a marketing activity only falls within the scope of the HWG if the marketing activity is product-related and intended to increase sales of a respective product.
Finally, the Medicinal Products Act Arzneimittelgesetz AMG also imposes legal requirements for interactions with health care professionals and patient organisations. Are there other codes of conduct for the marketing of drugs for example, by professional or industrial organisations? There are several industry guidelines applicable to product or company-related marketing activities of pharmaceutical companies. Those industry guidelines are either addressed to health care professionals or the general public.
The following are particularly relevant:. In case of non-compliance, fines of up to EUR, can be imposed by one of the arbitration boards. In particularly serious cases, the arbitration board can publicly rebuke the pharmaceutical company. Industry codes are not compulsory but serve as a means of interpretation for the courts when assessing whether a marketing activity infringes the applicable legal provisions. For this reason, judges have found them useful and refer to them in judgments on breaches of the law.
However, decisions have objected to the general application of such industry guidelines for non-members of the VfA. It is possible that judges will continue to use such conclusive guidelines to assess if specific practices in the field of the pharmaceutical industry infringe the general legal provisions which apply also to other industry sectors.
Marketing to consumers. What is the legal regime for marketing to consumers? Legal regime The Advertisement of Healthcare Products Act Heilmittelwerbegesetz HWG describes in detail which advertising activities are permitted with regard to consumers. Products Under section 10 1 of the HWG, prescription drugs can only be advertised to health care professionals. In addition, treatments against insomnia and sleep disorders cannot be advertised to consumers.
Under section 3 a of the HWG, marketing activities for unlicensed medicines are prohibited, as well as marketing activities regarding off-label use of licensed medicines. What kinds of marketing activities are permitted in relation to consumers and the products which may be advertised to them? The following marketing activities in relation to consumers are prohibited, among others section 11 1 , Advertisement of Healthcare Products Act Heilmittelwerbegesetz HWG :.
Marketing activities referring to scientific studies and professional publications. Marketing activities referring to an individual's medical history. Marketing activities that can give rise to uncertainty and anxiety. Promotional contests, drawings, and raffles.
Under section 4 3 of the HWG, all marketing activities to consumers must include the following notice: "For information on risks and side effects please read the pack insert and ask your doctor or pharmacist". Is it permitted to provide consumers with free samples? Are there particular restrictions on special offers for example, "buy-one-get-one-free"?
It is not permitted to provide consumers with free samples of drugs section 11 1 No. Under Article 7 1 of the HWG, special offers such as "buy-one-get-one-free" are prohibited.
The Federal Supreme Court Bundesgerichtshof ruled that discounts and bonuses are only permissible regarding insignificant gratuities, such as consumer magazines or small advertising gifts whose value is below EUR1. Only section 1 6 of the Advertisement of Healthcare Products Act Heilmittelwerbegesetz HWG states that the HWG does not apply to order forms of online pharmacies regarding the information necessary for ordering of drugs online.
What regulatory authority is responsible for supervising marketing activities to consumers? Regulatory authority The competent authorities for supervising marketing activities are the higher regional authorities in the federal states in which the pharmaceutical company is established. Infringements of rules for the protection of fair competition by pharmaceutical manufacturers can be pursued by the competent national authorities.
Under section 64 3 of the Medicinal Products Act Arzneimittelgesetz AMG , the competent authority must ensure that the provisions relating to advertisements of medicines are observed. In practice, the higher regional authorities rarely pursue pharmaceutical manufacturers for infringements of unfair competition law. Apotheken are easily identified by a large, red A on the outside of their locations. There are thousands of Apotheken in Germany and German law requires that an Apotheke be owned and operated by a pharmacist.
An individual pharmacist is only allowed to own up to three locations. Consequently, there are not any large drugstore chains that are found throughout countries like the USA. All medications, including non-prescription drugs, are kept on shelves behind the counter or in large drawers behind the counter or in a back room. There is normally a selection of different types of non-medicinal health related products in the pharmacy.
One important project is to introduce a comprehensive medication management which would allow community pharmacies to monitor prescriptions and self-medication of their patients. Pharmacies in Germany Consumer Protection. Update your browser for more security, speed and convenience on this page.
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