CHAPTER IVTRANSITIONAL AND FINAL PROVISIONS

Article 9Transitional provisions

1

Until 8 December 2013, applicants may choose to submit applications falling under the scope of this Regulation under Regulation (EC) No 641/2004 in the version of that Regulation in force on 8 June 2013.

2

By way of derogation from Article 4(2), in the case of studies launched prior to the date of entry into force of this Regulation and conducted under quality assurance systems other than GLP and ISO, the applicant shall provide:

a

a thorough description of the quality assurance system under which such studies were performed; and

b

comprehensive information on the protocols and the results obtained from the studies including the raw data.