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.