EN PL

HMA: CMD(h) Recommendations for Applications submitted according to Article 10 when the strength and/or pharmaceutical form of the reference medicinal product differs between RMS/CMS(s)

04.06.2009
Article 10.1 concerns products where the particular strength or form of the reference medicinal product is authorised in the Member State (MS) to which the application is made (generic). Whereas Article 10.3 concerns products where the particular strength and/or form of the medicinal product is not authorised in the MS to which the application is made (hybrid).