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Commission Directive 2005/28/ECShow full title
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance)
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Article 9
1.Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall be required for both total and partial manufacture of investigational medicinal products, and for the various processes of dividing up, packaging or presentation. Such authorisation shall be required even if the products manufactured are intended for export.
Authorisation shall also be required for imports from third countries into a Member State.
2.Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall not be required for reconstitution prior to use or packaging, where those processes are carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member States to carry out such processes and if the investigational medicinal products are intended to be used exclusively in those institutions.
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