European regulatory procedures constitute an important aspect for businesses that want to sell medicinal products in the European Union. The EU, being what it is, is vastly different from other markets in that it is a group of nations, as opposed to say, the US market. Hence, for companies wanting to market their medicinal product in this bloc, it is important to understand the various options that are available.
Depending on the nature and level of the active substance present in it; three procedures exist for submitting a Marketing Authorization Application (MAA), which is required for passing European regulatory procedures and obtaining approval for their medicinal products. These are:
Before proceeding to gain an understanding of these pathways, it is necessary to state that there exist different procedures for individual countries that make up the EU. That is, if a pharmaceutical or life sciences or healthcare company wants to market to any single country of the EU; it is not required to pass the full set of European regulatory procedures. It is enough to adhere to that country's laws and the European regulatory procedure that applies to such a method. On the other hand, compliance with European regulatory procedures becomes necessary when the same company wants to market its medicinal products to two or more countries of the EU.
Now, about the European regulatory procedures: The procedure that companies have to adhere to is not decided as a matter of their choice, but according to strict requirements laid out the by the EU. Likewise, some products have to mandatorily obtain the centralized procedure, while some other products are not eligible to choose this pathway.
The factors that decide which of the European regulatory procedures a company has to follow include:
In a nutshell, this is how the three European regulatory procedures are implemented: