Directive 2001/83/EC of the European Parliament and of the… Article 22

Article 22

In exceptional circumstances, and following consultation with the applicant, an authorization may be granted subject to certain specific obligations, including: - the carrying out of further studies following the granting of authorization, - the notification of adverse reactions to the medicinal product. These exceptional decisions may be adopted only for objective and verifiable reasons and shall be based on one of the causes referred to in Part 4 (G) of Annex I.