Medical License - EU

One of the common activities in the countries of the European Union (hereinafter referred to as the EU) is the distribution of medicines. This type of activity implies three main types of activity, namely: wholesale trade (export-import), retail trade (sale of goods in pharmacies) and the provision of various services for the storage of medicines. Regardless of the methods of implementation, this type of activity is subject to licensing.

In the system of state authorities of the EU member states, there are special bodies (part of the Ministry of Health) that implement state policy in the field of issuing licenses for the circulation of medicines.

The normative legal act, the main provisions of which have been implemented in the internal legislation of the EU member states, is the EU Council Regulation (EEC) No. establishment of the European Agency for the Evaluation of Medicinal Products. There are also a number of Directives that oblige each EU member state to achieve the goals set in this document, but leave the government of such countries the full right to choose the form and means to achieve them. Directives are the main mechanism for creating a single market, and European legislation governing the circulation of medicines is created mainly through EU Council Directives (for example, EU Council Directive No. , No. 92/25/EEC “On the rules for the wholesale sale of medicinal products for humans”, No. 92/26/EEC “On the definition of categories of medicinal products for humans” and others).

It should also be noted that in most cases, companies wishing to obtain a license for the circulation of medicines in different countries are subject to similar requirements, including documents. However, one should not forget about the existing differences in the procedure for issuing such licenses in different jurisdictions.

The specialists of Finance Business Service are always ready to provide you with competent advice in the field of obtaining a license for the circulation of medicines in the EU member states, select jurisdiction and provide a number of optimal solutions for the implementation of the tasks set.

Clients ask Finance Business Service questions about obtaining a license for security activities. These matters are solved by the specialists of the company in the shortest possible time. Despite the fact that the procedure for obtaining a license has been changed to become simpler, the license applicants have certain questions and there are some nuances that we would like to pay special attention to. We should note at once that, on obtaining a license, the enterprise may not have security...

Obtaining permission to conduct Forex activity on the territory of EU Member States is governed by Directive 2014/65 / EC, which is also called MiFID2, since it is the new version of the Directive "On the Financial Instruments Market" 2004/39 / EC (MiFID), and is a legal basis of a single regulated market of financial instruments in the EU. This means that the rules laid down in this Directive are mandatory for the twenty-eight member countries of the EU and the three countries of the European...

Resolution of the Board of the National Bank of Ukraine №386 from 14.09.2016 year (here and after - the National Bank Ordinance) was suspended issuance of individual foreign exchange licenses to individuals. This measure was introduced in order to significantly reduce the capital outflow from Ukraine. National Bank of Ukraine said that overseas investment is unproductive and negative impact on the economy as a whole. Thus, in accordance with paragraph 7 of the Resolution of the NBU,...

European company (in a translation from Latin «Societas Europaea» - European societies) is a new legal form of business, which is designed to be a tool for deepening the integration processes of the European Community. The company formed (or transformed) in a form that can act throughout the European Union without a separate pass procedures of national treatment in each of them. The first draft of a European company (hereinafter - SE) was proposed in 1970. The idea was to create a concept...