Conclusions on the granting of the conditional marketing authorisation and > presented by the european medicines agency




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ANNEX IV

CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION AND < THE REQUEST FOR ONE-YEAR > PRESENTED BY THE EUROPEAN MEDICINES AGENCY

Conclusions presented by the European Medicines Agency on:

[For the conditional marketing authorisation status and, in case of similarity and an accepted derogation, please select the statement(s) as provided below.]

The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.



is similar to authorised orphan medicinal products within the meaning of Article 3 of Commission Regulation (EC) No. 847/2000 as further explained in the European Public Assessment Report. >



[only for the superiority derogation] the following derogation laid down in Article 8.3 of the same Regulation apply(ies) as further explained in European Public Assessment Report :

is unable to supply sufficient quantities of the medicinal product>

, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication>

has given his consent to the applicant.>

  • >

[where one-year marketing protection/data exclusivity is accepted, otherwise provide scientific conclusions and grounds]

[For Art 14(11)]

[Art 10(5)] carried out in relation to the new indication were significant as further explained in the European Public Assessment Report. >



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