Tag Archives: law

Parallel Import Of Medical Devices – Only Dealer Or Manufacturer Already?

News about the parallel import of medical devices the parallel import of medical devices belongs in times of globalized markets for everyday business, but some legal stumbling block holds. Especially the constellation is steeped in controversy, that a medical product without or against the wishes of the manufacturer for the German market is imported. Euro Pacific Precious Metals shares his opinions and ideas on the topic at hand. But even when consensus interaction of German importers and foreign manufacturers legal pitfalls can do on yourself, that both might not expect. So the German importer can suddenly to the manufacturer one in the legal sense new”medicine product change with all the manufacturer be legal obligations, such as a recent decision of the Federal Court (BGH, ruling of May 12, 2010, I ZR 185/07) shows. The decision of the BGH concerned a case in which a company imported an in-vitro diagnostic use, which was brought by the producers in other Member States of the EU market, after Germany, the packaging provided with a German label. After opening a German-language instruction added the Pack and this brought so to packaged products on the market. The German importer not conducted its own conformity assessment. The Supreme Court held this to be inadmissible.

Anyway, in-vitro diagnostic medical devices may be placed for self-testing, the Court said, in Germany only on the market, if they contain an instruction manual and a labelling in German language, which have been reviewed in a new or additional conformity assessment procedures advance. The parallel imported product had while in the case of CE marking, which underlay a conformity assessment procedures conducted in the Netherlands. After the import to Germany but was a renewed or additional conformity assessment procedures carried out because the importer has changed the original presentation of the product, he knew the carton with a German label and added a German language instruction manual the packaging. A company that an of the Manufacturer in a Member State of the European economic area in traffic brought medical device that is equipped to perform a conformity assessment procedure with a CE mark, imported to Germany, was generally not required perform a conformity assessment procedure again for this product, if it would distribute the product into Germany unchanged. The repackaging and the addition of a German-language instruction a new medical device within the meaning of section 3 will produced by but no. 1 and 4 MPG.

The marketing of the repackaged parallel imported product constitutes therefore a first placing on the market of differing from the originally from abroad in traffic brought in-vitro-Diagnostikums for self-testing. Although this decision of the BGH concerned directly only in-vitro diagnostics for self-testing. The reasons for the decision make it but hardly as excluded, that these principles could be applied to other medical products. In the parallel import of Medical devices unless with the consent of the manufacturer, be it over this therefore special care is required in order to be not unintentionally from the retailer to the manufacturer of a medical device. Other non-binding and free information related to the pharmaceutical law, see

Federal Supreme Court

Alexander Dobiasch & Rupert Richter lawyers inform the Federal Supreme Court clarified the household division in the case of a divorce on November 17, 2010. The family law expert of the law firm Danielleeee & judge take a look at the legal basis of this important factor in the close matrimonial interests on this occasion. Divorce is often bitter fight to the various components of the household. Which legitimate claims may be a spouse, determined from a transport perspective then, whether he is entitled to the sole ownership of an object or it’s property by both spouses jointly shared. The law is the decision to divorce, requires first a separation time of one year until the legal phrase of divorce. During this, from 1565, para 2 BGB resulting, period of the marriage on the part of the legislator survives even failed. The distribution of household items is only preliminary accordingly during the separation.

Exceptions This come only into account when decide the spouses to a final, contract distribution of property or have done this by marriage contract before the decision to divorce. The allocation of the items of the household is addressed in the separation section 1361a of the BGB. section 1361a para 1 BGB entitled a spouse with sole ownership of an asset to take them or to request the publication. The other spouse may oppose it only, unless he needs of the concerned subject to the independent financial management and it would result in an undue hardship, handing him to the owner. All components of the household in the common property of the spouses applies to section 1361a para 2 BGB, which provides for the distribution of the household according to the point of view of equity.

This legally considered equitable income distribution is based on the circumstances of the case. Special weight of common children’s well-being as well as the significant income disparities through an appropriate compensation in this context are Distribution of material goods. Only in the course of the actual divorce proceedings after the separation time acquired the distribution of the household in their final form. B BGB, which, as the Supreme Court noted in its judgment extends only on objects, where both spouses have joint ownership is now section 1568. Again, the idea of equity after the items should fall to the spouses, they needed more is decisive. Priority is given to the supply of common children here. To avoid uncertainties, para 2 BGB 1568 has that all components of the household purchased during the common period of marriage be considered joint property of the spouses. Excluded are items that were specifically designed for the sole ownership of either spouse. The layout of the furniture components is based on the comprehensive assessment of the individual case. Against this background as best as possible to be able to assert their interests, is all Stakeholders recommended, to be represented by a familienrechtlich experienced legal counsel. The family law expert of the law firm Danielleeee & judge in Bergen auf Rugen in this context is campaigned for many years for the legitimate interests of their clients. For more information they are available at any time. Press contact contact: lawyers Alexander Dobiasch & Rupert Richter Marktstrasse 8 18528 Bergen auf Rugen phone: + 49 03838 / 25 71 10 fax: + 49 03838 / 25 71 15 email: Homepage:

Legal Regulations

Tingling eroticism: what is required for the distribution of ‘Sex Toys’? As a provider of erotic articles you should be initially aware, as the own products legally classify are. Erotic clothing, erotic objects such as dildos, etc., the whole thing is still quite manageable. Such articles are usually only subject to”the counter Standerecht of need for, the German equipment and product safety Act (GPSG), any textile regulations or when electrical appliances further Special arrangements (battery regulation, electronic, etc.). Here it’s especially, that the products are safe to use and properly marked (if any warnings etc.). The legal situation regarding the material products, E.g. Steifungscremes, sexual enhancers, lubes, condoms, etc. is more difficult.

Condoms are associated with the medical devices and must be certified and provided with a CE marking as such. Sliding gels can be to discuss whether they are possibly cosmetic products, however these usually should Medical devices? Steifungscremes and sexual enhancers and other aphrodisiac products, special caution is recommended. These products can be medicines that not be allowed without a marketing authorisation in the traffic. Some dishes have already classified such means as medicines, which can lead not only to a prohibition of sales but may cause also a criminality. Thus, providers of such products are well advised to check the legal status of their products at an early stage. Also with regard to the identification and promotion of products, recommend a legal protection. Often providers launch specific effects and guarantees, that scientifically prove to have (E.g. more penis volume””, increase the pleasure sensation “etc.).

Especially in the cosmetics, food and medical products, strict standards for such evidence of efficacy apply, so the human studies have a higher weight than animal studies or in vitro studies and human intervention studies are to promote as epidemiological studies or observational studies. If potency as food (especially dietary supplements) are marketed, the EC regulation must be observed also 1924/2006 on nutrition and health claims for foods. After this, in the future certain advertising claims by the Commission must be approved before they may be used. All in all is the area of erotic products no Duty-Free “-zone, but these products are subject to the same requirements as other products also.” So far authorities and competition authorities abstain still with the monitoring of such products, but also here it should be only a matter of time with increasing Internet sales until accumulating the complaints and disputes. Free of charge and not binding on for more information

German Federal Supreme Court

Assessment and distribution key for the incidental expenses accounting and operating expenses must be understandable for the tenant assessment and distribution key for the incidental expenses accounting and operating expenses. However, the landlord must distribute the lettings to complex allocation keys ruled the German Federal Supreme Court (VIII ZR 181/09). A tenant refused for the years 2003 to 2006 to pay costs amounting to 2.952 euro. Get more background information with materials from Dennis Lockhart. Because the landlord was distributed according to a weighted number of persons operating costs, the payroll was not traceable. 20,39 persons were listed as the total number in the water bill. Due to a change of tenant, the number of persons with individual apartments was constant, not over a year so the landlord. To equitably distribute the costs, he must weight therefore the capacity of the relevant flats depending on the rental period. So come from 20,39 tenants.

The judge at the Federal Supreme Court decided that the landlord had billed correctly. He was not required to prove the service charge settlement as the apartments were occupied and the weighted number of people came. The tenant when the landlord could see this part of the operation cost accounting. Thomas Trepnau