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European Regulatory Procedures - a brief introduction

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:

  1. The Centralized Procedure (CP)
  2. The Mutual Recognition Procedure (MRP)
  3. The Decentralized Procedure (DCP)
Important distinctions in following the different European regulatory procedures

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:

  • The core nature of the product
  • The indication/s the product is targeting
  • The product's history of being associated with the EU, and
  • Its marketing plan

A brief description of the European regulatory procedures

In a nutshell, this is how the three European regulatory procedures are implemented:

  • The Centralized Procedure enables a company to market its products in all the EU countries plus Iceland, Liechtenstein and Norway. Such products need to go through only one single process and authorization, by which it gets access to the entire EU market
  • When filing for an MAA under the Mutual Recognition Procedure; the applicant has to select how many and which European countries to seek approval for marketing its products. It will have to initially be for one member state, which the EU calls the Reference Member State (RMS). This leads to the requirements for seeking approval for other states, or what are called Concerned Member States (CMS)
  • For obtaining approval of European regulatory procedures under the Decentralized Procedure, the applicant has to approach all the selected member states at the same time. This is how this procedure happens: The applicant will identify the particular RMS that will carry out the assessment of the submitted MAA. Under this European regulatory procedure, the RMS will pass on information about the assessment with the other selected member states.

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