Report from the Commission to the European Parliament and the Council on the exercise of the delegation conferred on the Commission pursuant to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use and pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and v

The EU legal framework for medicinal products for human use is intended to ensure a high level of public health protection and to help the internal market function effectively. Moreover, the measures taken should encourage innovation. The framework works on the principle that medicinal products are placed on the market only if granted marketing authorisation by the competent authorities.

The requirements and procedures for authorising the marketing of medicinal products for human use, and the rules on continuous supervision of products after they have been authorised, are laid down principally in Directive 2001/83/EC and Regulation (EC) No 726/2004. These texts also lay down harmonised provisions in related areas such as the manufacture, wholesale distribution and advertising of medicinal products for human use. They cannot properly be understood in isolation from one another but must instead be considered together.

The Directive, as amended by Directive 2010/84/EU and Directive 2011/62/EU, empowers the Commission to adopt delegated acts on post-authorisation efficacy studies, the principles of good manufacturing practice for active substances, criteria to assess the potential falsified character of medicinal products transiting through the EU and safety features for medicinal products.

The Regulation, as amended by Regulation (EU) No 1235/2010, empowers the Commission to adopt delegated acts on post-authorisation efficacy studies.

The present report is a requirement under Article 121a(1) of the Directive and Article 87b(1) of the Regulation. These provisions delegate powers to the Commission for five years from January 2011 and require it to report on its exercise of those powers at the latest six months before the end of this period.

During the period the Commission adopted two delegated acts, one on post-authorisation efficacy studies and the other on the principles of good manufacturing practice for active substances. In both cases, the exercise of the empowerment responds to the need to supplement non-essential elements of a legislative act.

• Primary Source

EUR-Lex: COM(2015)138: Follow the progress of this report through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2015:138:FIN

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