generic medicinal product means a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, 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, esters or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.
generic medicinal product means a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. …
generic medicinal product means a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, 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; the various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form,
More Definitions of generic medicinal product
generic medicinal product means a generic medicinal product as defined in point
generic medicinal product means a medicinal product which has the same qualitative and quanti- tative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appro- priate bioavailability studies. The different salts, esters, ethers, 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, esters or derivatives of
generic medicinal product means a medicinal product which has
generic medicinal product means a medicinal product that has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product;
generic medicinal product means a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference
generic medicinal product means a medicinal product which has the same qualitative and quantitative composition in active principles and the same pharmaceutical form, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability tests. The various immediate-release oral pharmaceutical forms are deemed to be one and the same pharmaceutical form. Bioavailability studies may not be required of the applicant if he/she can demonstrate that the product meets the criteria of Annex I.
generic medicinal product means a product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the comparator product, and whose bioequivalence with the comparator product has been demonstrated by appropriate bioavailability studies;