Field of Healthcare (Heilmittelwerbegesetz – HWG), last amended on 20 System and their Employees were published in December reading of the proposal in November In the second part of .. Germany, the Remedies Advertising Act (Heilmittelwerbegesetz – HWG) were in line with the. Health on the Net Foundation. (accessed 9 June ). I S. ) vom 26 April Heilmittelwerbegesetz.  ICMJE.
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Distribution and marketing of drugs in Germany: Distribution Pre-conditions for distribution. What are the legal pre-conditions for a drug to be distributed within the jurisdiction? Authorisation Under section 21 1 of the Medical Products Act Arzneimittelgesetz AMGa finished medicinal product can only be placed on the market after a heilmittelwerbegssetz authorisation has been issued by the competent German higher federal authority or the European Commission.
Finished medicinal products as defined in section 4 1 of the AMG are medicinal products that are manufactured in advance and placed on the market in packaging intended for distribution to the consumer. Finished medicinal products are not intermediate products intended for further processing by a manufacturer. Section 4 17 of the AMG defines placing on the market as keeping the product in stock for sale or for other forms of supply, the exhibition and offering for sale and the distribution to others.
Exceptions Two types of medicinal products described in section 21 2 of the AMG can be placed on the market without a marketing authorisation:. Medicinal products for which the essential manufacturing stages are carried out in a pharmacy and no more than packages in one day are produced, and are permitted by the pharmacy operating licence. Medicinal products that are intended for use in clinical trials on human beings.
Section 21 2 No. If so, what are the requirements for pre-launch access? There are provisions under German law for both named patient supplies and compassionate use programmes. This legal provision stipulates the following requirements for distributing medicinal products under the conditions of 0210 patient supply: The medicinal product hsilmittelwerbegesetz question is a finished medicinal product. The medicinal product can be legally placed on the market in the country of origin.
The ordering and acquisition of the medicinal product is carried out by heilmittslwerbegesetz pharmacy. The medicinal product is imported only in small quantities.
The medicinal product is imported solely on the basis of a physician’s prescription. A supply deficit exists, that is, no identical medicinal products with respect to active substances, and no comparable medicinal products with respect to strength, are available.
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Separately, compassionate use programmes are in place for patients suffering a life-threatening disease or a disease leading to severe disability, such as some types of cancer, pulmonary infections and life-threatening types of influenza. Otherwise, the requirements for compassionate use programmes are, among others, as follows:. The patients suffer from a life-threatening disease or a disease leading to severe disability.
There is no other satisfying yeilmittelwerbegesetz option with medicinal products approved in the EU.
An authorisation application for the medicinal product is pending or clinical trials Phase III for this medicinal product are still ongoing. What is the procedural structure regarding licensing a drug for distribution? Under section 77 2 of the Medical Products Act Arzneimittelgesetz AMGthe PEI is competent for the licensing of sera, vaccines, blood preparations, bone marrow preparations, tissue preparations, allergens, gene transfer medicinal products, somatic cell therapy products, xenogenic cell therapy products and blood components manufactured using genetic engineering.
Any product placed on the market in Germany and that is the subject of a marketing authorisation, whether from the German authorities or the European Medicines Agency EMAmust have reports on all the results of confirmatory clinical trials substantiating the efficacy and safety of the medicinal product at the disposal of the competent higher federal authority.
This obligation applies regardless of whether any of the trial sites used were located in Germany. Is there a simplified licence proceeding, or relaxed licensing conditions, for drugs which have already been licensed for distribution in another jurisdiction? As Germany is part of the EU, three different marketing authorisation procedures apply:. Any of these can be used, as well as a standalone national authorised procedure. If the medicinal product has already been approved in another member state of the EU when the application is submitted to the competent higher federal authority, this marketing authorisation is recognised under the mutual recognition procedure by German authorities on the basis of the assessment report sent by the other member state section 25b 2Medical Products Act Arzneimittelgesetz AMG.
There is a simplified licence procedure for parallel imported drugs that have already been licensed for national distribution in another EU country. Under section 13 of the AMG, the parallel importer needs a manufacturing authorisation for repacking, labelling and adding the package leaflet to the medicinal product. For generics, a simplified licence procedure is described in section 24b 1 of the AMG.
When applying for a marketing authorisation of the generic product, reference can be made to the documents, including the expert report, for the previous applicant’s medicinal product reference medicinal product.
The previous applicant’s agreement with the use of the reference documents is not necessary. The reference medicinal product must have already been authorised for at least eight years before such an application will be considered. Is virtual drug distribution possible from your jurisdiction? A marketing authorisation obtained in Germany gives the market authorisation holder the right to sell the authorised medicinal product in Germany.
The question of whether the medicinal product may be distributed in another country based on the German authorisation must be answered based on the law of that country. What is the procedure to appeal legal remedy a licensing decision? It is possible to appeal Widerspruch against the federal drug administration’s decision not to grant a licence.
The competent authority will give judgment itself on the appeal by either rejecting it or declaring it to be founded. Additionally, an action can be brought before the local administrative courts Verwaltungsgericht.
What are the costs of obtaining licensing?
heilmittelwrrbegesetz A basic fee of EUR, per application based on a completed dossier. A reduced fee of EUR97, for an application regarding a generic pharmaceutical product. A special reduced fee of EUR, for biological medicinal products.
The costs for obtaining a national marketing authorisation vary depending on the nature of the product. The maximum fee is EUR57, What are the different categories of drugs for distribution? In Germany, there are four different categories of drugs for distribution:. Medicines that can be sold by pharmacists only heilmittelderbegesetz.
Heilmittelwerbegesetz by Germany and Ulf Doepner (, Book) | eBay
Prescription drugs verschreibungspflichtigwhich are available under a doctor’s prescription only. Who is heilmittelwerbegewetz to distribute prescription drugs and over-the-counter drugs to consumers? Prescription drugs Under section 43 3 of the Medical Products Act Arzneimittelgesetz AMGmedicinal products can only be dispensed by pharmacies on prescription. The authorisation is granted by the competent higher federal authority of the state where the pharmacy is established.
The applicant must fulfil certain criteria, such as being licensed to practise pharmacy and being sufficiently reliable to operate a pharmacy. The authorisation to distribute prescription drugs in pharmacies can be granted as well if the applying pharmacist states that he or she operates a pharmacy in another member state of the EU.
To heilmittelwrbegesetz considered as possessing the necessary expert knowledge, the person in question must provide proof of experience and skill in respect of the heilmittelwsrbegesetz filing, packaging, labelling, storing and marketing of medicinal products that are released for trade outside pharmacies.
Additionally, knowledge of the existing regulations applicable to these medicinal products is required. Only pharmacies are entitled to distribute apothekenpflichtige drugs to consumers. What drugs heilmittflwerbegesetz an attending physician distribute and under what circumstances? Physicians are not allowed to distribute drugs. Heilmittrlwerbegesetz is only an exception for free samples that are handed to patients when heilmittlewerbegesetz a physician.
Who is authorised to prescribe prescription drugs to consumers? Under section 1 of the Ordinance regarding the prescription of medicinal products Arzneimittelverschreibungsverordnungdrugs can only be prescribed by physicians or dentists within their professional field. Unlike in other countries, in Germany nurses are not allowed to write prescriptions.
Physicians working in hospitals are only allowed to make prescriptions for the duration of the patient’s stay in hospital. The German legislator introduced an exception to this rule in to close the gap between in-patient and out-patient care, which applies under certain conditions Hospital Discharge Management Entlassmanagement.
A quality assurance system is established to ensure that:. Medicinal products are mailed out to the patient within two days after receipt of the customer order. A system is established to inform heilmittelwerbegesezt about risks of medicinal products. Cross-border sales Medicinal products only available on prescription can only be mailed to other member states of the EU. Over-the-counter drugs can be mailed to patients worldwide, but the import regulations of the receiving country should heolmittelwerbegesetz verified in advance.
What regulatory authority is responsible for supervising distribution activities?
Heilmittelwerbegesetz by Germany and Ulf Doepner (2000, Book)
Federal higher state authorities are responsible for the supervision of distribution of drugs to consumers. What is the procedure to appeal legal remedy a distribution decision?
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. 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 heilmitte,werbegesetz or she geilmittelwerbegesetz 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 heilmittelwerbegeseetz 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 aboveRegulatory authority. In addition, an action can be brought before the local administrative courts. What are the legal consequences of non-compliance with wholesale distribution laws?