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Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human - GUIDANCE DOCUMENT Final, January 2003 Rev.3, September 2006 Assessment Report Mutual Recognition Procedure OVERVIEW AB/H/ nnnn/ Applicant: Date: Assessment Report Mutual Recognition Procedure Page 1 of 7 TABLE OF CONTENTS I. RECOMMENDATION II. EXECUTIVE SUMMARY II.1 Problem statement II.2 About the product II.3 General comments on the submitted dossier II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles III. SCIENTIFIC OVERVIEW III.1 Quality aspects III.2 Non clinical aspects III.3 Clinical aspects III.4 Risk Management Plan IV BENEFIT RISK ASSESSMENT V RECOMMENDED CONDITIONS FOR MARKETING AUTHORISATION AND PRODUCT INFORMATION V.1 Conditions for the marketing authorisation V.2 Summary of Product Characteristics V.3 Package Leaflet and User Testing V.4 Labelling Assessment Report Mutual Recognition Procedure Page 2 of 7 I. RECOMMENDATION Based on the review of the data on quality, safety and efficacy, the RMS considered that the application for , in the treatment of , could be approved. The national marketing authorisation was granted on . II. II.1 EXECUTIVE SUMMARY Problem statement Rationale for the product: epidemiology, main features of the disease and current therapy. For generic applications this section is not applicable II.2 About the product Mode of action. Pharmacological classification. Claimed indication and recommendation for use and posology. Special pharmaceutical aspects, if any, e.g. novel delivery system II.3 General comments on the submitted dossier State the type of marketing authorisation application incl. reference to the legal basis of the application. If appropriate, elaborate here on the key aspects of the dossier in relation with the legal basis. For applications based on Art 10a (bibliographical applications): The document in Module 1.5.1 summarizing the grounds and evidence used for demonstrating that the constituents of the medicinal products have a well-established use with an acceptable level of safety and efficacy should be discussed here. It should be made clear as to why it is scientifically acceptable to waive certain studies that would normally be performed in-house. For applications based on Art 10 (generics): The document in Module 1.5.2 summarizing the grounds and evidence used in demonstrating that the medicinal product is essentially similar to an authorised medicinal product should be discussed here. For applications based on Art 10 (3) the differences between the medicinal product applied for and the reference product should be discussed. Introduce and comments on the use of an European Reference Product, if applicable. Introduce and comment the clinical development programme in view of the proposed indications and posologies (if applicable). Indicate if, and when Scientific Advice was given and if this was followed by the applicant. Indicate if CPMP guidance documents were followed. Assessment Report Mutual Recognition Procedure Page 3 of 7 Indicate availability and/or need for paediatric development and development in other special populations, such as elderly, male/female and ethnic subpopulations. II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles The RMS has been assured that acceptable standards of GMP are in place for these product types at all sites responsible for the manufacture and assembly of this product prior to granting its National authorisation. < For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites.> < For manufacturing sites outside the Community, the RMS has accepted copies of current GMP Certificates or satisfactory inspection summary reports, 'close-out letters'or 'exchange of information' issued by the inspection services of the competent authorities (or those countries with which the EEA has a Mutual Recognition Agreement for their own territories) as certification that acceptable standards of GMP are in place at those non-Community sites.> Elaborate as appropriate in concordance with points made in the critical assessment modules. A specific comment should be made as to whether any inspections are needed and if so whether it is GMP, GLP and/or GCP. In the MRFG meeting 15 December 2003 the Group adopted the above mentioned wording on GMP. III. SCIENTIFIC OVERVIEW AND DISCUSSION This section might be compiled from the paragraphs “assessor’s overall conclusions on….” in the critical reviews. The respective paragraphs appear at the end of the relevant parts of the detailed assessment reports. These paragraphs could be effectively copied and pasted to the corresponding headings below or written directly below at the discretion of the assessor. However, attempts should be made to have a similar structure for the different part of the assessment. A general conclusion explaining why a marketing authorisation and each of the proposed indications have been approved or rejected and detailing the risk-benefit considerations for the product. The structure is in accordance with the Public Assessment Report structure and thus can be updated at the different stages of the Mutual Recognition Procedure. The text in this chapter should be sufficiently detailed to be used for drafting the Public Assessment Report. Furthermore, when applicable, a list of outstanding commitments after the granting of the national marketing authorisation should be given in this Section. Requested Post-marketing studies should be discussed here. Assessment Report Mutual Recognition Procedure Page 4 of 7 For generic applications: In case an European Reference Product is used, the RMS should make clear whether the justification to use this product is based on their own files or based on the files submitted upon request by another Member State. If the SPC is different from that of the reference product, the assessment report should outline the data supporting the modifications. In particular, if the RMS granted more indications for the reference product than the CMS, information on the underlying documentation for this additional indication should be given Where the SPC of the bandleader has been approved by a Commission Decision after a Referral based on Art 30 of Dir 2001/83 this SPC should be used for products with the same active substance and pharmaceutical form, unless specified. III.1 Quality aspects (see Guidance document on Module 3) Drug substance < Stability studies have been performed with the drug substance. The proposed retest period of is justified.> Drug Product Elaborate as appropriate in concordance with points made in the critical assessment module. The following information might be added: - General information on results of dissolution tests - A statement whether the drug substance and excipients used are well known and of pharmacopoeial quality. - If applicable, a statement on EDQM certificate of suitability is given for the drug substance. III.2 Non clinical aspects (see Guidance document on module 4) Assessment Report Mutual Recognition Procedure Page 5 of 7 Generic applications in general deal with existing substances. A non-clinical assessment should be performed focused on the new information. A non-clinical assessment can only be waived in those cases where the product can be regarded as well known in both RMS and CMS and where no new preclinical data are available. However, as soon as new non-clinical data become available, e.g. regarding pregnancy and lactation, QT, etc, which may impact the SPC, a new non-clinical assessment has to be performed. Bibliographic applications are ‘full dossier’ applications. Non-clinical data should be discussed here. In the AR it should be indicated whether the studies/literature submitted are relevant for the medicinal product. When certain studies are not performed it should be made clear why this is scientifically justified, based upon the criteria of ‘well established medicinal use’ as outlined in Annex 1 to Directive 2001/83/EC as amended. If applicable, a waiver for an environmental risk assessment should be discussed here. Pharmacology Pharmacokinetics Toxicology III.3 Clinical aspects (see guidance documents on Module 5) Generic applications: For medicinal products with a systemic effect, the need of appropriate bioequivalence studies should be addressed here, or it should be justified when these studies were not considered relevant or necessary. The conclusions of the assessment of these studies should be summarized here. A confidential attachment (not to be disclosed to the applicant) should state the full composition of and specification for the reference product used in the bioequivalence studies to enable the concerned Member States to compare it with that of the approved products marketed in their own countries. The justification for using an European Reference Product should be described here. If the SPC is different from that of the original product referred to, the AR should outline the data supporting the modifications. Information on the underlying documentation for granting an additional indication should be given, if the RMS granted more indications for the reference product than the CMS. Bibliographic applications are ‘full dossier’ applications. Clinical data should be discussed here. Pharmacokinetics Pharmacodynamics Clinical efficacy Clinical safety Assessment Report Mutual Recognition Procedure Page 6 of 7 III.4 Risk Management Plan If applicable, the waiver for submission of a risk management plan should be discussed here Non-clinical and clinical safety specifications Pharmacovigilance Plan Risk Minimisation Plan IV. BENEFIT RISK ASSESSMENT V RECOMMENDED CONDITIONS FOR MARKETING AUTHORISATION AND PRODUCT INFORMATION V.1 Conditions for the marketing authorisation Legal Status Follow-up measures Specific obligations V.2 Summary of Product Characteristics (SPC) The English version of SPC approved by the RMS should be included here. V.3 Package Leaflet (PL) and User Testing V.3.1 Package Leaflet The English version of the PL approved by the RMS should be included here. V.3.2 Assessment of User Testing The RMS should include a brief assessment of user testing, if available. Otherwise, a comment on whether user testing is foreseen, or whether the justification for its absence is acceptable V.4 Labelling The English version of the Labelling (line listing) approved by the RMS should be included here. Assessment Report Mutual Recognition Procedure Page 7 of 7