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velupharm ☆ 2007-03-29 16:34 (6621 d 16:12 ago) Posting: # 602 Views: 3,744 |
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Dear all We have a active substance which is a pharmacological alternative (different salt) of an already approved drug in Europe. But our salt is approved in other countries. In this scenario,if we prove Bioequivalence of ours with reference available in Europe, can we register the dossier in Europe? |
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Ohlbe ★★★ France, 2007-03-29 18:10 (6621 d 14:36 ago) @ velupharm Posting: # 603 Views: 2,806 |
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Dear Velupharm, According to Article 10.2.b of Directive 2001/83/EC, as amended by Directive 2004/27/EC, which gives the definition of generic medicinal products, "The different salts, esters, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts (...) must be supplied by the applicant". You will indeed be requested to perform a bioequivalence trial using a European reference product. You will be expected to discuss any expected differences in safety/efficacy (easier for different salts than different esters or isomers !). The level of proof and amount of information to provide will probably vary from country to country. Regards Ohlbe |
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velupharm ☆ 2007-03-29 19:53 (6621 d 12:53 ago) @ Ohlbe Posting: # 604 Views: 2,852 |
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Dear Ohlbe, thank You so much for the useful information. |
Ing. Helmut Schütz