19 April 2011, 14:05
Under the bill (Reg. No.7412), if the medical drug containing a new active ingredient is registered in Ukraine as original (innovative) on the grounds of the documents testifying its quality, safety and effectiveness (entire registration dossier), the registration information shall not be used within three years since the registration date (irrespective of validity term of any license concerning the medical drug) to fill in the application form for the state registration of another medical drug containing the same active ingredient, except when the applicant was granted the right to refer to or use such information, or submitted personal registration data in the scope sufficient to confirm quality, safety and effectiveness of the medical drug.