3. Legal bodies responsible for regulatory procedures


1. Legal bodies responsible for regulatory procedures

1.1. National competent authorities (NCAs)

The competent authorities of the Member States (MS) are responsible for the regulation of medicines which are placed on their markets via non-centralised procedures (national decentralised or mutual recognition)  and that do not pass through the centralised procedure (see below).They also supply European experts who serve as members of the EMA's scientific committees, working parties or in assessment teams supporting their members. The national competent authorities, coordinate their work in a forum called Heads of Medicines Agencies (HMA).

  • When the MA is issued, the MA holder has to be informed by the NCAs about the approval of the summary of product characteristics (SmPC) having been agreed before  between applicant and NCA(s) .
  • The NCAs should make publicly available without delay the MA together with the SmPC (unless prohibited by national law)
  • The NCAs have to provide an assessment report, and update it whenever new information of importance for the evaluation of the quality, safety or efficacy of the medicine becomes available
  • A Public Assessment Report (PAR) in a version without commercially confidential information has to be publicly accessible together with the reasons for their opinion. It shall include a summary written in a manner that is understandable to the public. The summary shall contain, in particular, a section relating to the conditions of use of the medicine.

Legal Basis: Article 21, Directive 2001/83