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English to Polish translations [PRO]
Medical - Medical: Pharmaceuticals | | English term or phrase: substitution indication | Pending RDP the generic route of article xx is prohibited and the applicant must not seek to obtain an authorisation by submitting the same generic dossier but under a different legal basis and with a substitution indication, with the purpose of bypassing the re-quirements for an appropriate data package.
However, we would like to bring to your attention some further considerations based on the fact that RRR may have chosen to apply for a substitution indication only.
However, if such a generic copy would be authorised after all with the same limited generic data package merely by changing the legal basis and by choosing a substitution indication, thereby bypassing the data requirements by reducing the data package to a generic package, this would amount to circumven-tion of RDP which is prohibited.
tytul rozdziału: Appropriate data package: RRR and generic copies with substitution indication |
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