4FDA. Code of Federal Regulations Title 21,314.81 [EB/OL]. [2013-04-01]. http://www.accessdata.fda.gov/scripts/cdrh/ c fdocs/c fcfr/CFRSearch.cfm.
5FDA. FDA Adverse Event Reporting System [EB/OL]. [2012-10-09]. http://www, fda.gov/Drugs/GuidanceComplia nceRegulatoryInformation/Surveillance/AdverseDrugEffects/ default.htm.
6FDA. Guidance for Industry Postmarketing Studies and Clinical Trial [EB/OL]. [2011-04-11]. http://www.fda.gov/ Drugs/GuidanceComplianceRegulatorylnformation/Post- marketingPhaselVCommitments/default.htm.
8EMA. Guideline on the processing of renewals in the centralised Procedure [EB/OL]. [2012-06-22]. http://www. ema.europa.eu/doc s/en_GB/document_library/Regulatory_ and orocedural_guideline/2012/03/WC500124501.