31.07.2015
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD) implements decision of the European Commission (EC) no. C(2015) 5100 final, of 16.07.2015 to suspend marketing authorisation (MA) of medicinal products authorised based on bioequivalence studies carried out at the Hyderabad (India) site of the GVK Biosciences Company
In result of the European Commission decision on suspension of marketing authorisations for medicinal products for human use authorised based on bioequivalence studies carried out at the Hyderabad (India) site of the GVK Biosciences Company, the NAMMD hereby advises on the following:
On the occasion of an inspection conducted in 2014 by the French competent authority (Agence Nationale du Medicament et de sécurité des Produits de Santé – ANSM) at the Hyderabad (India) site of the GVK Biosciences company, critical non-compliances were found in conduct of bioequivalence studies carried out from 2008 to 2014. Lack of compliance with Good Clinical Practice Rules raised suspicions about the reliability of data supporting a positive benefit-risk ratio for these medicinal products.
Therefore, a referral procedure was triggered by the European Commission under Article 31 of Directive 2001/83/EC as amended. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has conducted an assessment of the potential impact of these findings on the benefit-risk balance of medicinal products authorised based on clinical studies carried out at the inspected site.
The decision of the European Commission is in line with the CHMP opinion and concerns suspension by Member States of marketing authorisations for medicinal products relying on inaccurate data related to bioequivalence with the EU reference products. For Romania, medicines proposed by the European Commission for MA suspension are provided in the table attached.
Under the European Commission decision, EU national competent authorities may opt for a maximum 24 months delay in implementation since issuance of the decision with regard to medicines considered critically important nationwide, based on assessment of potentially unmet medical needs. In such cases, the Member State shall require MA Holders to submit a bioequivalence study within 12 months since adoption of the European Commission decision.
In this context, the NAMMD has decided to suspend marketing authorisations for medicinal products only for which MA Holders have not yet submitted evidence of bioequivalence with an EU reference product and implicitly of positive benefit-risk ratio. For such medicinal products, therapeutic alternatives are available in Romania.
In line with the decision of the European Commission, the NAMMD revokes the MA suspension on submission by the MA Holder of evidence of bioequivalence with an EU authorised reference medicinal product based on a fresh bioequivalence study.
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