Cetirizin "Copyfarm" 10 mg Filmcoated tablet Oral Energivej 15, POB 69 DK-5260 Odense S Denmark Netherlands. Cetirizine dihydrochloride

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1 ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 1

2 CETIRIZINE DIHYDROCHLORIDE COPYFARM 10 mg AND ASSOCIATED NAMES Member State Marketing Authorisation Holder Product Name Strength Pharmaceutical Form Route of administration Copyfarm A/S, Cetirizin "Copyfarm" 10 mg Filmcoated tablet Oral Energivej 15, POB 69 DK-5260 Odense S Netherlands Copyfarm A/S Cetirizine dihydrochloride 10 mg Filmcoated tablet Oral Energivej 15 POB 69 DK-5260 Odense S Copyfarm 10 mg Norway Copyfarm A/S Cetirizin Copyfarm 10 mg filmcoated tablet Oral Energivej 15, POB 69, DK-5260 Odense S Sweden Copyfarm A/S, Energivej 15 POB 69 DK-5260 Odense S Cetirizin Copyfarm 10 mg Filmcoated tablet Oral 2

3 ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA 3

4 SCIENTIFIC CONCLUSIONS OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CETIRIZINE DIHYDROCHLORIDE COPYFARM 10 MG AND ASSOCIATED NAMES 1. Introduction and background Cetirizine is a second generation long-acting antihistaminic agent. It is indicated for the symptomatic treatment of seasonal or perennial allergic rhinitis and of chronic idiopathic urticaria and is marketed in various European Member States as film-coated tablets containing 10 mg cetirizine dihydrochloride. Cetirizine dihydrochloride Copyfarm 10 mg and associated names are generic medicinal products and the Marketing Authorisations (MAs) have been granted in accordance with Article 10 (1) of Directive 2001/83/EC, as amended, through the mutual recognition procedure with the Netherlands acting as Reference Member State (RMS). The Netherlands granted also the national marketing authorisations from 2000 to Such generic applications require that bioequivalence (BE) of the generic medicinal product with the reference medicinal product has been demonstrated by appropriate bioavailability studies. All BE studies are performed by contract research organisations (CROs) although the holders of the marketing authorisation are ultimately responsible for the quality and integrity of the data submitted in support of their application. In the case of Cetirizine dihydrochloride Copyfarm 10 mg and associated names, the marketing authorisations were based on a BE study (03/INNO/99) testing the generic medicinal product versus the reference medicinal product Zyrtec. During a repeat procedure that started in September 2004 for one of the mutually authorised cetirizine dihydrochloride generic medicinal products, the United Kingdom (UK) as concerned member state (CMS) raised serious concerns with respect to the GCP/GLP compliance of this first BE study (03/INNO/99). Hence, the reliability of the results of this BE study conducted by a CRO, were questionable. Because of these concerns the RMS requested the marketing authorisation holders (MAHs) to submit a second BE study to confirm the results of the original study (03/INNO/99). In October 2004 the MAHs submitted a second BE study (CZE/2004/133) which was performed by another CRO. This second BE study (CZE/2004/133) did not raise major concerns regarding the scientific results. However, since the GCP/GLP status of the concerned CRO was unknown it was considered appropriate to initiate a joint GCP/GLP inspection of this second BE study by the French and Dutch Competent Authorities. The final conclusions of this GCP/GLP Inspection for the second BE study, which became available to the Dutch National Competent Authority in March 2006, indicated that the number and importance of the inspection findings highlight the insufficiency of quality control and quality assurance measures at the time the trial was performed, and that these observations appear liable to jeopardise the acceptability of the results of the second BE study (CZE/2004/133). Based on the final conclusions of this inspection, the Dutch National Competent Authority considered that the second BE study (CZE/2004/133) should be rejected because of GCP/GLP non-compliance and was of the opinion that the particulars supporting the application as provided for in the Art 10(1) of Directive 2001/83/EC, as amended, were not reliable and therefore incorrect. Further to the consideration that suspension of the Marketing Authorisations (MAs) granted for Cetirizine dihydrochloride Copyfarm 10 mg and associated names (see Annex I) was necessary for the protection of public health, the Netherlands referred the matter to the EMEA on 26 April 2006 in accordance with Article 36(1) of Directive 2001/83/EC, as amended. 2. Discussion 4

5 Having considered the grounds for the referral triggered by the Netherlands, the CHMP, during its April 2006 plenary meeting, requested the MAHs in view of the outcome of the GCP/GLP inspection for study CZE/2004/133 to address its impact on the quality and reliability of the documentation submitted in support of the MAs granted for Cetirizine dihydrochloride Copyfarm 10 mg and associated names. The MAHs were requested to provide that the legal requirements for the granting of a MA are nevertheless fulfilled and satisfactorily established, in accordance with Art 10 (1) of Directive 2001/83/EC, as amended, and therefore justify the maintenance of the MAs for Cetirizine dihydrochloride Copyfarm 10 mg and associated names. In their responses, the MAHs provided the results of a third BE study (UK/05/015), initiated at the time the preliminary inspection results on the second BE study (CZE/2004/133) became available. In their responses the MAHs are critical on the fact that several months have passed between the availability of the first inspection report of the second BE study and the initiation of the referral under Article 36(1) of Directive 2001/83/EC, as amended, for reasons of protecting public health. Having taken the above into consideration, the CHMP noted that the preliminary inspection results of the second BE study (CZE/2004/133) were available in August 2005 and raised serious doubts regarding the GCP/GLP compliance of the BE study (CZE/2004/133). The Dutch National Competent Authority communicated these concerns to all CMS and the MAHs, indicating that these were only preliminary results and that the inspection report would only be finalised by the inspectors after it had been transmitted to the inspectees (the concerned CRO) and once the inspectees had the possibility to address each of the inspection deficiencies identified. Only then, after finalisation of the inspection report, could the Dutch National Competent Authority reach its conclusions on the second BE study (CZE/2004/133). The final conclusions of this GCP/GLP inspection were made available to the Dutch National Competent Authority in March 2006 and concluded that the number and importance of the inspection findings highlight the insufficiency of quality control and quality assurance measures at the time the clinical trial (CZE/2004/133) was performed by the concerned CRO and that these observations jeopardise the acceptability of the data of this clinical trial. The Dutch National Competent Authority therefore considered there were potential consequences for public health and triggered a referral under Article 36(1) of Directive 2001/83/EC, as amended, to the EMEA on 26 April During its April 2006 plenary meeting, the CHMP adopted a list of Question (EMEA /CHMP/ /2006) to which the company answered by providing a third BE study (UK/05/015). In view of the results for the third BE study (UK/05/015), the CHMP considers that no scientific concerns are raised. However due to the lack of information concerning the GCP/GLP compliance on the study site of the third study and having considered that the third BE study (UK/05/015) has not been subject to a GCP/GLP inspection by any of the EU Member States, the CHMP considered that a GCP/GLP inspection of the CRO is deemed necessary before any conclusions can be made on the bioequivalence results of this third BE study (UK/05/015). In addition, since GCP/GLP concerns were raised on two previous studies submitted by the MAHs in support of the MAs, the CHMP is of opinion that the quality and reliability of the BE studies submitted by the MAHs to support the MAs could not be established and therefore recommends the suspension of the MAs for Cetirizine dihydrochloride Copyfarm 10 mg and associated names (see Annex I). The CHMP considers that certain particulars supporting the application as provided for in Article 10 (1) of Directive 2001/83/EC, as amended, are incorrect. The CHMP agreed that a GCP/GLP inspection of the BE study (UK/05/015) should be a condition of the marketing authorisation i.e. an EU GCP-GLP inspection of the BE study (UK/05/015) shall be performed and concluded within 12 months period at a national level. 3. Conclusions 5

6 The CHMP recommended that the MAs granted for Cetirizine dihydrochloride Copyfarm 10 mg and associated names listed in Annex I should be suspended, subject to the following condition: An EU GCP-GLP inspection of the BE study (UK/05/015) shall be performed and concluded within 12 months period at a national level GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS Whereas, - The Committee considered the referral made under Article 36(1) of Directive 2001/83/EC, as amended for Cetirizine dihydrochloride Copyfarm 10 mg and associated names containing medicinal products detailed in Annex I; - The Committee agreed that since GCP/GLP concerns were raised on two studies submitted by the MAHs in support of the national MAs, the quality and reliability of the documentation to support the MAs could not be established and hence, considered that the legal requirements laid out in accordance with Article 10 (1) are no longer fulfilled; The CHMP recommended that the MAs granted for Cetirizine dihydrochloride Copyfarm 10 mg and associated names listed in Annex I should be suspended, subject to the following condition: - An EU GCP-GLP inspection of the BE study (UK/05/015) shall be performed and concluded within 12 months period at a national level. 6

7 ANNEX III CONDITION OF THE MARKETING AUTHORISATIONS 7

8 CONDITION OF THE MARKETING AUTHORISATIONS An EU GCP-GLP inspection of the BE study (UK/05/015) shall be performed and concluded within 12 months period at a national level. 8

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