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- Point in Time (08/04/2005)
- Original (As adopted by EU)
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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1.In order to harmonise the conduct of inspections by the competent authorities of the different Member States, guidance documents containing the common provisions on the conduct of those inspections shall be published by the Commission after consultation with the Member States.
2.Member States shall ensure that national inspection procedures are in compliance with the guidance documents referred in paragraph 1.
3.The guidance documents referred to in paragraph 1 may be updated regularly according to scientific and technical development.
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