cos 申请表Application.doc

Certification Unit ECEP 05b 01 2005p 1 of 16 Application Form REQUEST FOR REVISION OR RENEWAL OF CERTIFICATE OF SUITABILITY to be filled in for each request for revision of a Certificate of Suitability to the monographs of the European Pharmacopoeia in accordance with Resolution AP CSP 99 4 Date of submission 1 General Information Dossier number CEP 1 1 Type of application Please tick against the appropriate option NotificationMinor changeMajor changeQuinquennial renewal Multiple minor revisions max 3 Multiple revisions 1 major max 3 in total Consolidated revision more than 3 changes SCOPE Please specify the scope of the change s in a concise way For Notifications and Minor changes Table of Section 3 should also be filled in 1 2Name of the substance using the Recommended International Nonproprietary Name rINN specify any subtitle requested such as sterile micronized 1 3Monograph s you are referring to Name Number Month Year of publication Certification Unit ECEP 05b 01 2005p 2 of 16 ECEP 05b 01 2005p 3 of 16 2 Names and addresses 2 1 Intended certificate holder N B for exceptional cases where the holder will not be the manufacturer please refer to 4 4 Name Street name Building number Locality district Postcode City PO Box State county province area Country Tel Fax E mail Fields marked are required 2 2 Contact name or person company authorised for communication on behalf of the intended holder if different from manufacturer please provide an authorisation letter see Annex 1 Title and surname First name Job title Department Name of the company Street Address Building number Locality district Postcode City PO Box State county province area Country Tel Fax E mail Fields marked are required Tick this box if you do not wish to receive any communication from EDQM by e mail concerning this application ECEP 05b 01 2005p 4 of 16 2 3 Manufacturer if different from the holder please refer to 4 4 Name Street name Building number Locality district Postcode City PO Box State county province area Country Tel Fax E mail 2 4 Manufacturing site s Name Street name Building number Locality district Postcode City State county province area Country Tel Fax Name Street name Building number Locality district Postcode City State county province area Country Tel Fax ECEP 05b 01 2005p 5 of 16 3 SPECIFIC INFORMATION 3 1Notification and minor changes Tick the appropriate change required Change Cod e Not Min N1Change in the name and or address of the certificate holder or the manufacturer of the final substance N2Change in the name and or address of the manufacturing site N3Deletion of any manufacturing site N4Deletion of a manufacturer of any intermediate starting material N5Change in batch size of final substance or intermediate up to 10 fold compared to the original batch size approved at the grant of the certificate of suitability N6Change in batch size of final substance or intermediate downscaling N7Minor changes to an approved test procedure for the final substance or a starting material intermediate reagent used in the manufacturing process of the final substance N8Tightening of the specification limits for the final substance a starting material intermediate or reagent used in the manufacturing process of the final substance N9Change in the code product reference number and or in the brand name of the final substance or any material used in the synthesis of the substance N10Amendment to stability data further to a commitment at the time of granting of the certificate of suitability N11Removal of the retest period from the certificate of suitability N12For a certificate for TSE risk deletion of a source country or change in source of a material used in the preparation of the final substance from a TSE risk material to a vegetable or synthetic origin R1Minor change in the manufacturing process of the substance R2Change in batch size of the substance or an intermediate more than 10 fold compared to the original batch size R3Specification of the final substance intermediate reagent used in the synthesis of the final substance addition of a new test parameter or changes to or replacement of a test procedure R4Change in the manufacturer or addition of a new manufacturer of a starting material or intermediate used in the manufacturing process of the final substance R5For a double certificate of suitability for chemical quality and microbiological purity and for TSE risk change in source of a material used in the preparation of the final substance from a TSE risk material to a vegetable or synthetic material R6Change in the manufacturing site or addition of a new manufacturing site for the final substance R7Change in the retest period of the final substance and or the storage conditions for the final substance when a retest period is already mentioned on the certificate of suitability or request to include a retest period on the certificate of suitability T1Change in the manufacturing site for a certificate of suitability for the TSE risk T2Minor change in the manufacturing process including process parameters or in the specifications of the final substance for a certificate for the TSE risk T3For a TSE risk certificate change in the quality assurance system applied in the manufacturing site updated declarations according to the relevant annexes are to be submitted details should be given in section 3 2 below ECEP 05b 01 2005p 6 of 16 3 2 If you apply for R7 Inclusion of a re test period or change of the re test period and or the storage conditions please fill in this section Proposed retest period Commercial packaging Recommended storage conditions To RH others 4 Declarations Updated declarations should be submitted when relevant 4 1 Signed declaration of manufacture for each manufacturing production site if relevant in accordance with the dossier and according to GMP rules or a suitable quality assurance system if applying for a certificate with regards to TSE risk assessment specifying which rules guidelines standards are followed Please attach a declaration letter as described in Annex 3 4 2 Signed declaration of willingness to be inspected for each manufacturing production site if relevant This also applies for holders when different from manufacturers Please attach a declaration letter as described in Annex 4 4 3 Use or non use of materials of human or animal origin including TSE risk materials to be completed only in case of an application for a Chemical certificate and for Herbal drug preparations Please attach a signed declaration letter as described in Annex 5 4 4 Holder different from manufacturer In exceptional cases where the holder of the certificate will not be the manufacturer please provide the following information An engagement from the manufacturer to commit to inform the holder of any change made so that the dossier submitted to the EDQM can be updated without any delay by the holder see Annex 2 Declarations of willingness to be inspected from both the holder and the manufacturer see 4 2 above ECEP 05b 01 2005p 7 of 16 5 History of the substance list of marketed medicinal products and EDMF This section is to be filled in only for quinquennial renewal 5 1List of marketed medicinal products Please provide a list of marketed medicinal products containing the substance manufactured by your company according to the synthetic route presented in the dossier please use additional sheets Brand name of medicinal products and company name CountryRegistration number and date Commercialisation date 5 2List of submitted EDMF ASMF Please provide a list of countries where your company has submitted an EDMF for the substance with the same synthetic route as presented in the dossier CountryRegistration NumberDate of submissionDate of the last update when relevant ECEP 05b 01 2005p 8 of 16 6 Samples Samples should be provided only for quinquennial renewal The samples should be sent separately clearly referring to the CEP reference number and in accordance with the leaflets attached at the end of this document In particular the material whether in vials bulk drug in glass or plastic tamper proof containers shall be packed safely and if possible in a second inner container or box WARNING For controlled substances psychotropics narcotics precursors please proceed according to the leaflets at the end of this document Batch number amount date of shipment Safety data sheets and batch analysis to be appended 7 The dossier should be sent to the address below EDQM European Pharmacopoeia Certification Unit Council of Europe B P 907 F 67029 Strasbourg Cedex France ECEP 05b 01 2005p 9 of 16 8 Invoicing Following receipt of the application EDQM will send you an invoice CEP number Name of the substance ReferenceItemPriceTick as appropriate CEP04Quinquennial renewal 1 500 CEP05Multiple minor revisions or notifications max 3 in total 1 500 CEP06Simple major revision1 500 CEP07Multiple major revision max 1 and other revisions max 2 1 500 CEP08Consolidated revisions more than 3 2 500 CEP09Multiple notifications max 3 1 000 CEP10Simple minor revision1 000 CEP12Simple Notification500 INVOICING ADDRESS Client Code INTENDED CERTIFICATE HOLDER if different from invoicing address Company Company Address Address City City Postcode Postcode Country Country Contact Name Contact Name VAT No Service ServiceTel Tel Fax Fax E mail E mail Fields marked are required Fields marked with are required for EU only If payment will come from several sources please identify the names of those companies that will pay below For EDQM use only Date of receipt of the application PAYMENT Following receipt of your application we will send you an invoice Please note that we must receive payment within 30 days and that no certificate will be issued without receipt of payment Details of payment methods will be outlined on the invoice However you will be able to settle your invoice by 1 PERSONAL OR COMPANY CHEQUE made payable to Council of Europe or EDQM 2 BANK TRANSFER 3 CREDIT CARD ECEP 05b 01 2005p 10 of 16 Annex 1 Template letter of Authorisation address of the manufacturer date and place LETTER OF AUTHORISATION We name of the manufacturer hereby authorise name of the authorised representative to act as official representative for our Certificate of Suitability for name of the substance Signature ECEP 05b 01 2005p 11 of 16 Annex 2 Template declaration in cases where the manufacturer is not the intended holder of a Certificate of Suitability name and address of the manufacturer date and place LETTER OF AGREEMENT We name of the manufacturer commit ourselves to inform name of the intended holder intended holder of any necessary information and also of any change in the content of the dossier for the Certificate of Suitability name of the substance so that they may be notified to the European Directorate for the Quality of Medicines by the holder during the assessment of the dossier and or after the certificate has been granted Signature Company Representative of Manufacturer of the concerned substance ECEP 05b 01 2005p 12 of 16 Annex 3 Template letter of declaration that the manufacture production of the substance is according to the presented dossier and to GMP rules quality assurance system name and address of the manufacturer date and place LETTER OF DECLARATION OF MANUFACTURE ACCORDING TO THE PRESENTED DOSSIER AND TO GMP RULES AND OR A QUALITY ASSURANCE SYSTEM We name of the manufacturer hereby declare that we manufacture produce name of the substance according to the presented dossier and to the following GMP rules and or quality assurance system Please specify the rules applied give full text reference and date of implementation Signature Company Representative of Manufacturer of the concerned substance ECEP 05b 01 2005p 13 of 16 Annex 4 Template letter of declaration of willingness to be inspected name and address of the manufacturer holder date and place LETTER OF DECLARATION OF WILLINGNESS TO BE INSPECTED ACCORDING TO THE PRESENTED DOSSIER AND TO THE SPECIFIED GMP RULES We name of the manufacturer holder hereby declare that we are willing to be inspected concerning the manufacture production of name of the substance if requested by a relevant authority Signature Company Representative of Manufacturer of the concerned substance ECEP 05b 01 2005p 14 of 16 Annex 5 Template name and address of the manufacturer date and place LETTER OF DECLARATION OF MANUFACTURE REGARDING THE USE OF MATERIAL OF HUMAN OR ANIMAL ORIGIN INCLUDING SUBSTANCES AT RISK OF TRANSMITTING AGENTS OF ANIMAL SPONGIFORM ENCEPHALOPATHIES We name of COMPANY hereby confirm that materials used in the manufacturing process of name of SUBSTANCE are are not of human or animal origin If relevant complete the following The following materials used in the manufacturing process are of human or animal origin Function1 Name SMR Animal origin susceptible to TSE2 Other animal origin Human origin 1SM Starting Material R Reagent 2As defined in the section 2 scope of Ph Eur chapter 5 2 8 Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products and the related general monograph no 1483 If a Ph Eur Certificate of Suitability for TSE is available according to Resolution AP CSP 99 4 of the Council of Europe attach it Signature Company Representative of Manufacturer of the final substance Date and Place to be deleted as appropriate COUNCIL OF EUROPE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES ECEP 05b 01 2005p 15 of 16 CONDITION FOR DELIVERY OF SAMPLES EU Countries All products delivered to the Council of Europe European Directorate for the Quality of Medicines European Pharmacopoeia shall fulfil the following conditions 1 It shall be indicated that the material is for laboratory experimental analytical use only and will not be used on humans or animals 2 The material whether in vials bulk drug in glass or plastic tamper proof containers shall be packed safely and if possible in a second inner container or box 3 The inner containers or boxes shall then be packed where necessary in ice or dry ice An appropriate device indicating temperature variation during transportation should then be included 4 Any information and documentation which is of importance for customs approval shall be attached to the outside of the final container NB if the substance is a controlled drug narcotics psychotropic precursors contact us by e mail at smu pheur org BEFORE shipment for special instruction 5 Delivery address of goods shall strictly be as follows COUNCIL OF EUROPE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES EUROPEAN PHARMACOPOEIA 226 AVENUE DE COLMAR entr e par la rue SCHERTZ 67100 STRASBOURG FRANCE Indicate the person at the EDQM for whom the goods are being delivered Vincent EGLOFF in charge of sample procurement 6 The material is to be shipped rapidly under any specific required conditions to the Council of Europe EDQM offices in Strasbourg and not just as far as the airport door to door shipment 7 If you send by post or express delivery as soon as possible please fax the date of departure and the company used 33 3 88 41 27 71 or send the information by e mail smu pheur org Following these conditions will expedite the transportation of the goods Please follow them carefully Thank you COUNCIL OF EUROPE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES ECEP 05b 01 2005p 16 of 16 CONDITION FOR DELIVERY OF SAMPLES Outside EU Countries All products delivered to the Council of Europe European Directorate for the Quality of Medicines European Pharmacopoeia shall fulfil the following conditions 1 It shall be indicated that the material is for laboratory experimental analytical use only and will not be used on humans or animals 2 The material whether in vials bulk drug in glass or plastic tamper proof containers shall be packed safely and if possible in a second inner container or box 3 The inner containers or boxes shall then be packed where necessary in ice or dry ice An appropriate device indicating temperature variation during transportatio