GUIDE FOR THE NEW ELECTRONIC PAYMENT SYSTEM. Version 1.0 Spanish Agency of Medicines and Medical Devices

Transcription

1 GUIDE FOR THE NEW ELECTRONIC PAYMENT SYSTEM Version 1.0 Spanish Agency of Medicines and Medical Devices

2 NEW ELECTRONIC PAYMENT SYSTEM INTRODUCTION AND ENTRY TO THE SYSTEM DEPARTMENT OF MEDICINES FOR HUMAN USE DEPARTMENT OF INSPECTION AND CONTROL DEPARTMENT OF VETERINARY MEDICINES DEPARTMENT OF COSMETICS AND MEDICAL DEVICES NOTIFIED BODY FEES AND SUMMARY WAYS OF PAYMENT

3 INTRODUCTION This change in the fee payment system arises from the need to facilitate the payment of fees to all pharmaceutical laboratories, companies and citizens. The philosophy of this new system is based on the adaptation of the Law 1/2015 in the article 123 and following, with regard to the fees of the different services provided by the Agency to the citizens. So that now, the user will choose the department of the AEMPS to which he wants to pay a fee, and then will choose one of the services and subservice that entails the payment of fees. The choice of services and subservices will result in the payment of a fee and obtaining document The system interface has been changed. The. system has only one entry and it has different exits, it means, it has different ways of payment.

4 ENTRY TO THE SYSTEM The entry to the system has not changed. The access is through the Electronic Headquarters. Click here, and you will acess the new application The Fee Payment button will redirect you to fees form. The Fee Consultation button will redirect you to payment consultation. This service is only available in the case of credit card payment and Open Line La Caixa for Caixa customers.

5 ENTRY TO THE SYSTEM When you press the button Payment of fees it appears a screen with different tabs at the top The first screen refers to the Identifying data of the taxable person and the Payer. In each of these Screens you can advance and go back to the previous screen at any time

6 NEW ELECTRONIC PAYMENT SYSTEM DEPARTMENT OF MEDICINES FOR HUMAN USE

7 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE On the Service tab you will choose: The Scope, which will match with each of the Departments of the AEMPS that provide services with payment of fees. The Type of Service The type of Subservice where appropriate Type of medicines in your case

8 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE For the Department of Medicines for Human Use, services that are subject to the payment of fees have been defined. The services that can be paid through the electronic payment system for the aforementioned department are: New register Booking vacancy Modification of authorization Renewal of authorization Ownership transfer National Annual Fee Parallel import Clinical trial Batch Release Certification Scientific Advice Others

9 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE Booking Vacancy.It is only paid in case of decentralized procedures where Spain acts as an EMR. In this screen you will choose the type of medicines for which you want to make the booking vacancy. The fee paid for this service is the "1.20 Fee for booking a vacancy to act as a Member State of Reference in a Decentralized or Mutual Recognition procedure." New register. We have thus defined the requests for authorization of new medicines, in the case of Human Use; Full application, Generics, Gases, Homeopathic with IT without IT, Plants MPT and Use well established and Allergens The fees paid for this services are : 1.1 Fee for the evaluation, authorization and registration of a new medicinal product for human use (authorization file submitted under Article 17, except for that referred to in 17.3) 1.2 Fee for the evaluation, authorization and registration of a new generic medicinal product for human use (authorization file submitted under Article Fee for the evaluation, authorization and registration of a new medicinal gas 2.1 Fee for the national procedure for the evaluation, authorization and registration of a new allergen medicinal product for human use for diagnostic use.

10 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE 3.1 Evaluation, authorization and registration of a new traditional herbal medicinal product (MTP) 3.3 Evaluation, authorization and registration in the register of a new herbal medicinal product for well-established use 4.1 Assessment, authorization and registration of a new homeopathic medicinal product without approved therapeutic indication Fee for a national simplified procedure. A single strain 4.2 Assessment, authorization and registration of a new homeopathic medicinal product without approved therapeutic indication Fee for a national simplified procedure. BETWEEN TWO AND FIVE BAYS 4.3 Assessment, authorization and registration of a new homeopathic medicinal product without approved therapeutic indication Fee for a national simplified procedure. MORE THAN SIX BODIES 4.5 Evaluation, authorization and registration of a new Homeopathic Medication with approved therapeutic indication

11 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE Modification of Authorization. We have defined this service for payments of variations, groupings, work-sharing, super groups and parallel presentations. When we choose this service, we will pay the following fee headings with their exceptions, and specific considerations included in the law VARIACION MEDICAMENTO HUMAN AND VETERINARY USE. 1.5 Fee by the procedure of modification of the authorization of a medicine of human use, classified as of "major importance" Type II 1.6 Fee for the procedure to modify the authorization of a medicinal product for human use, classified as Type IB 1.7Fee for the procedure for modifying the authorization of a medicinal product for human use, classified as type IA (including immediate notification types IA) 2.3 Fee for the procedure of modification of the authorization of an allergen medicine for diagnostic use, classified as "major importance" Type II. 2.4 Fee by the procedure of modification of the authorization of an allergen medicine for diagnostic use, defined as Type IB. 2.5 Fee by the procedure of modification of the authorization an allergen medicine for diagnostic use, qualified type IA (including types IA of immediate notification). 3.2 Modification of authorization of a traditional herbal medicinal product (MTP) 3.5 Modification of the authorization of a herbal medicinal product for human use classified as "of major importance Type II. 3.6 Modification of the authorization of a herbal medicinal product for human use classified as Type IB 3.7 Modification of the authorization of a herbal medicinal product for human use classified as Type IA (including immediate notification type IA) 4.4 Fee by the procedure of modification of the authorization of a Homeopathic Medicine without approved therapeutic indication 4.7Fee for the procedure of modification of the authorization of a Homeopathic Medicine with approved therapeutic indication, classified as of "major importance" Type II 4.8 Fee for the procedure of modification of the authorization of a Homeopathic Medication with approved therapeutic indication, classified as Type IB 4.9 Fee for the procedure of modification of authorization of a Homeopathic Drug with approved therapeutic indication, classified as Type IA

12 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE

13 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE Certification. This service has been defined for the payment of export certificates fee of Medicines for Human Use and all certifications that are paid with 7.1 Fee for issuing a certificate.

14 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE Scientific Advice. Services regarding scientific advice provided by the AEMPS to the laboratories have been defined. These services are in line with the fee headings 7.2,7,3,7,4,7,5,7,6,7,7. Depending on the type of medicines, a number of Sub-services have been defined. Full application On quality, safety and clinical development, or quality and clinical development, or safety and clinical development, or pre-referral advice of a file. Classification of unclassified variations and grouping of variations, according to Regulation (EC) 1234/2008 of the European Commission. About medicines for pediatric use Generic Medication, Medicinal Gas, MPT Plants and Well-established Use On clinical development, or quality and safety, or quality and bioequivalence studies. On quality, or safety, or bioequivalence studies Follow-up on clinical development, or quality and safety, or quality and bioequivalence studies. Follow-up on quality, or safety, or bioequivalence studies Classification of unclassified variations and for grouping variations, according to Regulation (EC) 1234/2008 of the European Commission About medicines for pediatric use

15 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE

16 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE Clinical trial. This service has been defined for the payment of fees for clinical trials. Fee Schedule and 5.3. Two Sub-services have also been defined. Evaluation of the first clinical trial with unauthorized drugs in a country belonging to the International Conference on Harmonization (ICH) with active ingredients that are not part of authorized medicinal products in Spain. Authorization under subparagraphs (a), (b), (c) and (d) With medicines authorized and registered in Spain or with medicines in research elaborated by a Service of Pharmacy

17 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE Ownership Transfer This service has been defined for the payment of ownership transfer of the medicines authorized by the AEMPS. The fees that are paid when selecting this service are: 4.6 Ownership transfer Homeopathic Medication 1.4 Fee for the ownership transfer of the authorization of a medicinal product for human use, or by modification of the holder's representative. 2.3 Fee for the procedure of ownership transfer of the authorization of an allergen medicine for diagnostic use. 3.4Transfer of authorization for a traditional herbal medicinal product (MTP) or a herbal medicinal product authorized by established use

18 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE Renewal of Authorization. This service has been defined for the payment of Five Year Renewals of the medicines authorized by the AEMPS. The fees that are paid when selecting this service are: 4.10 Procedure for renewal of the authorization of a homeopathic medicinal product WITHOUT an approved therapeutic indication 4.11 Procedure for renewal of authorization of a homeopathic medicinal product WITH approved therapeutic indication 1.8 Fee for the renewal of authorization procedure for a medicinal product for human use 2.3 Fee for the procedure for renewal of authorization of an allergen medicine for diagnostic use 3.8 Fee for the renewal of authorization procedure for a traditional herbal medicinal product (MTP) 3.9 Fee for the renewal of the authorization procedure for a herbal medicinal product authorized by well-established use

19 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE National Annual Fee This service has been defined for the payment of the Annual Medication Marketing Authorization. The fees that will be paid in this service are: 4.12 Simple annual fee for a homeopathic medicinal product for human use WITHOUT an approved therapeutic indication already authorized. 1.9 Simple annual maintenance fee for a medicinal product for human use already authorized 2.7 Type for simple annual declaration of intention to market an allergen medicine for diagnostic use 3.10 Simple annual fee for a traditional herbal medicinal product (MTP) already authorized 3.11 Simple annual fee for a traditional herbal medicinal product authorized by wellestablished use This option is only available from the Medication Marketing Notifications system. gin.aspx?opc=humana

20 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE Parallel Import. This service has been defined for the Parallel Import of medicines. In the case of the Parallel Import service, a series of Sub-services have been defined for the scope of medicinal products for human use, such as: Authorization Renewal Modification Notification The fees headings that are paid on this service and Subservices are 1.10 Fee for the authorization procedure for the 'parallel import' of a medicinal product for human use 1.11 Fee for the procedure for amending the authorization for the 'parallel importation' of a medicinal product for human use 1.12 Fee for the renewal of the authorization for the 'parallel importation' of a medicinal product for human use 1.13 Fee for import notification.

21 SERVICES OF DEPARTMENT OF MEDICINES FOR HUMAN USE Batch Release: certificates issued by the AEMPS for immunological medicines have been defined. For this service two Sub-services have been defined: Issuance of a European Certificate when batch analysis is required. Individual Application Between 6 and 10 year applications Between 11 and 40 applications year Between 41 and 160 applications year More than 160 applications year. European certificate issuance when bulk analysis is required The fees headings that are paid on this service and Subservices are: 1.14 Charge for the issuance of a European batch release certificate for vaccines and blood products for human use where the analysis of a medicinal product by lot is required 1.15a Rate for the release of batches of blood products and vaccines in accordance with Articles 41.4 and 43.3 of Royal Decree 1345/2007, of October b Rate for the release of batches of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of October c Rate for the release of batches of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of October d Rate for the release of batches of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of October e Rate for the release of batches of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of October Charge for the European certificate of batch release for vaccines and blood products for human use when the analysis of a bulk (bulk)

22 NEW ELECTRONIC PAYMENT SYSTEM DEPARTMENT OF INSPECTION AND CONTROL

23 SERVICES OF DEPARTMENT OF INSPECTION AND CONTROL On the Service tab you will choose: The Scope, which will match with each of the Departments of the AEMPS that provide services with payment of fees. The Type of Service The Type of Subservice where appropriate Type of medicines in your case

24 SERVICES OF DEPARTMENT OF INSPECTION AND CONTROL For the Department of Inspection and Control, services that are subject of payment have been defined. The services that can be paid through the electronic payment system for the aforementioned department are: Scientific advice Authorizations Certification Inspection Modification of authorization Registry

25 SERVICES OF DEPARTMENT OF INSPECTION AND CONTROL Scientific Advice. This service has been defined for the payment of fees under 7.10 scientific / technical on system design and manufacturing processes in accordance with good manufacturing rules. Certification. This service has been defined for the payment of the fees heading 7.1 Fee for issuing a certification. The types of certificates issued by the Department being obliged to pay the fee 7.1 are, among others: Certificate of free sale, sanitary certificate. Certificate of recognition of the Technical Director. Certifying Alcohol Tax. GMP certificate.

26 SERVICES OF DEPARTMENT OF INSPECTION AND CONTROL Authorizations. This service has been defined for the payment of fees related to all types of authorizations granted by the Department. SubServices have been defined for this service: Opening of a pharmaceutical laboratory. Procedure for authorizing the manufacture of drugs approved in other countries and not registered in Spain. Exceptional manufacture by third parties of medicinal products for human and / or veterinary use Drug stores under customs control or surveillance Of crops of plants that can be used for the manufacture of medicines, narcotics Export to intra-community countries and third countries of narcotic drugs and psychotropic and psychotropic drugs. The fee headings that are paid on this service are: 6.1Authorization opening pharmaceutical laboratory 6.5Procedure to authorize the manufacture of medicines approved in other countries and not registered in Spain 6.6Procedure of special authorization by third parties of medicinal products for human and veterinary use 6.7Procedure of authorization and / or certification of drug distribution warehouses: customs warehouses as well as free zones or free warehouses that store medicines 6.8Procedure of authorization of crops of plants that can be used for the manufacture of drugs, narcotic drugs and psychotropic substances Export authorizations for narcotic and psychotropic drugs to intra-community and third countries.

27 SERVICES OF DEPARTMENT OF INSPECTION AND CONTROL Modifications of Authorization. This service has been defined for the payment of fees related to the Modification of Authorization of Pharmaceutical Laboratories granted by the Department. SubServices have been defined for this service: Of a pharmaceutical laboratory for minor changes Of a pharmaceutical laboratory for major changes without an inspection visit Of a pharmaceutical laboratory for major changes with inspection visit The fees headings that are paid on this service are: 6.2 Pharmaceutical laboratory authorization modification for minor changes in the same 6.3 a) Procedure to modify the authorization of a pharmaceutical laboratory for major changes in the same, when the actions do not include an inspection visit. 6.3 b) Procedure to modify the authorization of a pharmaceutical laboratory for major changes in the same when the inspection actions include inspection visit

28 SERVICES OF DEPARTMENT OF INSPECTION AND CONTROL Inspection. This service has been defined for the payment of fees related to inspections of pharmaceutical laboratories carried out by the Department. SubServices have been defined for this service: Actions at the national level, unless denounced or requested by association / consumers Actions in third countries unless denounced or petitioned by association / consumers. Actions in third countries at the request of the interested party. The fees headings that are paid on this service are: 6.4A Individual inspections, except in cases of denunciation or at the request of a representative association of users or consumers, at the national level 6.4b Individual inspections, except in cases of denunciation or at the request of a representative association of users or consumers, in third countries 6.4c Individual inspections in non-compulsory third countries, at the request of the interested party

29 SERVICES OF DEPARTMENT OF INSPECTION AND CONTROL Registry. This service has been defined for the payment of fees related to the records kept by the Department. SubServices have been defined for this service: Registration, modification or updating of the registry of importing companies or distributors of active ingredients. Registration of entities for the intermediation of medicinal products for human use. The fee headings that are paid on this service are: 6.9 Initial registration, notification of mandatory changes or annual update of the registration of manufacturers, importers or distributors of active substances 6.10 Registration in the register of persons engaged in intermediation in the distribution of medicinal products for human use

30 NEW ELECTRONIC PAYMENT SYSTEM DEPARTMENT OF VETERINARY MEDICINES

31 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES On the Service tab you will choose: The Scope, which will match with each of the Departments of the AEMPS that provide services with payment of fees. The Type of Service The Type of Subservice where appropriate Type of medicines in your case

32 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES For the Department of Veterinary Medicines, there have been defined services that are subject of payment. The services that can be paid through the electronic payment system for the aforementioned department are: Batch Release Booking vacancy Certification Clinical trial Modification of authorization New register Ownership transfer Parallel import Renewal of authorization Maintenance in the market Scientific Advice Periodic safety reports.

33 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Batch Release: The certificates issued by the AEMS for immunological medicines have been defined as such. For this service, two Subservices have been defined, which match with the fees 9.13 and Issue of an European certificate of immunological medicinal product according to Article 81 of Directive 2001/82 / EC Issue of an European certificate of immunological veterinary medicinal products according to Article 82 of Directive 2001/82 / EC

34 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Booking Vacancy.It is only paid in case of decentralized procedures where Spain acts as an EMR. In this screen the type of medicines for which you want to make the booking vacancy will be chosen. The fee paid for this service is the 9.15 Fee for booking a vacancy to act as a Member State of Reference in a Decentralized or Mutual Recognition procedure." New register. We have thus defined the requests for authorization of new medicines, in the case of Human Use; Full application, Generics, Homeopathic with IT without IT. The fees paid for this services are : 9.1Fee for application for a marketing authorization for a veterinary medicinal product, except for the applications referred to in Article Fee for application for a marketing authorization for a generic veterinary medicinal product (dossier submitted under Article 17.3). 4.1 Assessment, authorization and registration of a new homeopathic medicinal product without approved therapeutic indication Fee for a national simplified procedure. A single strain 4.2 Assessment, authorization and registration of a new homeopathic medicinal product without approved therapeutic indication Fee for a national simplified procedure. BETWEEN TWO AND FIVE BAYS 4.3 Assessment, authorization and registration of a new homeopathic medicinal product without approved therapeutic indication Fee for a national simplified procedure. MORE THAN SIX BODIES 4.5 Evaluation, authorization and registration of a new Homeopathic Medication with approved therapeutic indication

35 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES

36 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Certification. We have defined this service for paying fees export certificates medicines Veterinarians, and all certifications that are paid with 7.1 Fee for issuing a certificate. Scientific Advice. We have thus defined the services provided by the AEMPS of scientific advice to the laboratories. These services are in line with the rate headings 7.2,7,3,7,4,7,5,7,6,7,7 Depending on the type of medicines, a number of Sub-services have been defined; Full application; On quality, safety and clinical development, or quality and clinical development, or safety and clinical development, or pre-referral advice of a file. Classification of unclassified variations and grouping of variations, according to Regulation (EC) 1234/2008 of the European Commission.

37 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Generic Medication, On clinical development, or quality and safety, or quality and bioequivalence studies. On quality, or safety, or bioequivalence studies Follow-up on clinical development, or quality and safety, or quality and bioequivalence studies. Follow-up on quality, or safety, or bioequivalence studies Classification of unclassified variations and for grouping variations, according to Regulation (EC) 1234/2008 of the European Commission

38 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Clinical trial. We have defined this service for the payment of fees for clinical trials y epigraphs rate. 5.4 Procedure for qualification as a product in the clinical research phase of an unauthorized veterinary medicinal product in Spain 5.5 Rate by procedure veterinary clinical trial. Two Sub-services have also been defined. Qualification of an unauthorized veterinary medicinal product in Spain. Veterinary clinical trial.

39 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Modification of Authorization. We have defined this service for payments of variations, groupings, work-sharing, super groups and parallel presentations. When we choose this service, we will pay the following fee headings with their exceptions, and specific considerations included in the law VARIACION MEDICAMENTO HUMAN AND VETERINARY USE. 4.4 Fee by the procedure of modification of the authorization of a Homeopathic Medicine without approved therapeutic indication 4.7Fee for the procedure of modification of the authorization of a Homeopathic Medicine with approved therapeutic indication, classified as of "major importance" Type II 4.8 Fee for the procedure of modification of the authorization of a Homeopathic Medication with approved therapeutic indication, classified as Type IB 4.9 Fee for the procedure of modification of authorization of a Homeopathic Drug with approved therapeutic indication, classified as Type IA 9.4 Fee for the procedure of modification of the authorization of a veterinary medicine, classified as "major importance" Type II 9.5 Fee for the procedure for modifying the authorization of a veterinary medicinal product, defined as Type IB 9.6 Fee for the procedure for modifying the authorization of a veterinary medicinal product, type IA (including IA types of immediate notification).

40 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES

41 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Ownership Transfer. This service has been defined for the payment of ownership transfer of the medicines authorized by the AEMPS. The fees that are paid when selecting this service are: 4.6Transmission of Ownership Homeopathic Medication 9.3 Fee for the transfer of ownership of the authorization of a veterinary medicinal product, or for modification of the owner's representative

42 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Parallel Import. This service has been defined for the Parallel Import Authorization. The fee to be paid if we choose this service is 9.9 Fee for the authorization procedure for the 'parallel import' of a veterinary medicinal product

43 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Renewal of Authorization. This service has been defined for the payment of Five Year Renewals of the medicines authorized by the AEMPS. The fees that are paid when selecting this service are: 4.10Procedure for renewal of the authorization of a homeopathic medicinal product WITHOUT an approved therapeutic indication 4.11 Procedure for renewal of authorization of a homeopathic medicinal product WITH approved therapeutic indication 9.7 Fee for the renewal of authorization procedure for a veterinary medicinal product

44 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES National Annual Fee. We have defined This service for the payment of the Annual Fee of Marketing Authorization. The headings of fees to be paid for this service are: 4.12 Simple annual fee for a homeopathic medicinal product for human use WITHOUT an approved therapeutic indication already authorized. 9.8 Fee for simple annual declaration of intention to market an already authorized veterinary medicinal product This option is available only from the application of Intention of commercialization of veterinary medicines. c=veterinaria

45 SERVICES OF DEPARTMENT OF VETERINARY MEDICINES Periodic safety reports. This service has been defined for the payment of Periodic Safety Reports. The headings of fees paid for this service are 9.10 Fee for evaluation of a bi-annual periodic safety report of a veterinary drug, whether or not the drug is registered in Spain Fee for evaluation of annual safety report of a veterinary drug, whether or not the drug is registered in Spain Fee for evaluation triennial or superior to three years whether or not the drug is registered in Spain. For this service a series of Sub-services have been defined: Biannual evaluation whether or not the medicine is registered in Spain Annual evaluation Whether or not the medicine is registered in Spain Triannual evaluation or mores than three years whether or not the medicine is registered in Spain

46 NEW TELEMATIC PAYMENT DEPARTMENT OF COSMETICS AND MEDICAL DEVICES

47 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES On the Service tab you will choose: The Scope, which will match with each of the Departments of the AEMPS that provide services with payment of fees. The Type of Service The Type of Subservice where appropriate Type of medicines in your case

48 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES For the Department of Medical Devices and Cosmetics, there have been defined some services that are subject of payment. The services that can be paid through the electronic payment system for the aforementioned department are: Certification Clinical trials of medical devices Inspection Modification and revalidation of products Modification of license Previous License Products Registry Registration and individual authorization of personal care products, disinfectants and repellents Renewal of license Responsible declaration of activities These services have been organized in two distinct areas: Medical devices Cosmetics and Personal Care Products.

49 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Medical Devices services: Certification Clinical trial of medical devices Modification and revalidation of products Modification of license Previous license Products Registry Renewal of license

50 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Certification. This service has been defined for the fees section payment 8.5 Procedure for certification issuing. Clinical trial of medical devices. This service has been defined for the fees section payment 8.9 Authorization for clinical research of medical devices.

51 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Previous license. This service has been defined for the payment of services granted by the department relating to operating license. For this type of service has been defined two Sub-services: Manufacturing and assembly and/or sterilization establishment Import establishment The fee headings that are paid on this service are: 8.12Procedure for pre-licensing of medical devices and disinfectants: manufacturing establishment, grouping 8.13Procedure of prior license for the operation of medical devices and disinfectants: import establishment

52 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Modification of license. This service has been defined for the payment of services granted by the department relating to operating license modification. For this type of service has been defined three Sub-services: License prior to the operation of manufacturing and grouping establishment and/or sterilization License prior to the operation of import establishments License prior to the operation of establishments that do not affect the site The fee headings that are paid on this service are: 8.14 Procedure for modification of the previous license to operate medical devices and disinfectant establishments in relation to their location: manufacturing establishment, grouping 8.15 Procedure for modification of the previous license of operation of medical devices and disinfectant establishments in relation to their location: import establishment 8.16 Procedure for modification of the previous license of operation of medical devices and disinfectant establishments

53 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Modification and revalidation of products. This service has been defined for the payment of services granted by the department relating to modification and revalidation of products. The fee headings that are paid on this service are 8.33 Procedure for the modification of medical devices Product Registry. This service has been defined for the payment of services granted by the department relating to Medical Device. The fee headings that are paid on this service are 8.3 Procedure for registration and registration of Medical Devices.

54 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Licence Renewal. This service has been defined for the payment of services granted by the department relating to Licence Renewal. For this type of service has been defined two Sub-services Renewal of manufacturing establishments, grouping and sterilization. Renewal of import establishments. The fee headings that are paid on this service are: 8.17 Procedure for the revalidation of the license of establishments of medical devices and disinfectants: manufacturing establishment 8.18 Procedure for the revalidation of the license of establishments for medical devices and disinfectants: import establishment

55 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES The services defined for Cosmetics and Personal Care Products, Repellents and Disinfectants are: Certification Inspection Modification and revalidation of products Modification of license Previous License Registration and individual authorization of personal care products, disinfectants and repelents Renewal of license Responsible declaration of activities

56 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Certification. This service has been defined for the fees section payment 8.5 Procedure for certification issuing Inspection. This service has been defined for the fees section payment Individual inspections for the verification of the responsible declaration

57 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Responsable declaration of activities, this service has been defined for the payment of the services granted by the departments relating to the presentation of the responsible declaration of activities. For this type of service has been defined Subservicios: Checking and control manufacturing Checking and control import Checking and control manufacturing modification Checking and control import modification. The fee headings that are paid on this service are: 8.6 Procedure for verification and control of the declaration responsible for the manufacturing activity of cosmetics and personal care products 8.7 Procedure for verification and control of the declaration responsible for the import of cosmetic products and personal care 8.8 Procedure for verification and control of the declaration responsible for changes in the manufacturing activity of cosmetics and personal care products 8.9 Procedure for verification and control of the declaration responsible for changes in the import activity of cosmetics and personal care products

58 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Previous license. This service has been defined for the payment of services granted by the department relating to operating license. For this type of service has been defined two Sub-services: Import establishment Manufacturing establishment The fee headings that are paid on this service are: 8.12Procedure for pre-licensing of medical devices and disinfectants: manufacturing establishment, grouping 8.13Procedure of prior license for the operation of medical devices and disinfectants: import establishment

59 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Lincese Modification. This service has been defined for the payment of services granted by the department relating to operating license modification. For this type of service has been defined three Sub-services: License prior to the operation of manufacturing establishment License prior to the operation of import establishment License prior to the operation of establishment(minor modification). The fee headings that are paid on this service are: 8.14 Procedure for modification of the previous license to operate medical devices and disinfectant establishments in relation to their location: manufacturing establishment, grouping 8.15 Procedure for modification of the previous license of operation of medical devices and disinfectant establishments in relation to their location: import establishment 8.16 Procedure for modification of the previous license of operation of medical devices and disinfectant establishments

60 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Modification and revalidation of products. This service has been defined for the payment of services granted by the department relating to personal care products and disinfectants. The fee headings that are paid on this service are 8.4 Procedure for modification and validation of hygiene products and disinfectants

61 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Individual registration and authorization of products for personal care and disinfectants. This service has been defined for payment of services provided by the Department for Registration and authorization individualized personal care products and disinfectants. The fee heading paid for this service 8.2 Procedure for registration and individual authorization of personal care products and disinfectants

62 SERVICES OF DEPARTMENT OF COSMETICS AND MEDICAL DEVICES Licences Renewal: This service has been defined for the payment of services granted by the department relating to Licence Renewal. For this type of service has been defined two Sub-services Manufacturing plant Renewal. Import plants Renewal. The fee headings that are paid on this service are: 8.17 Procedure for the revalidation of the license of establishments of sanitary products and disinfectants: manufacturing establishment 8.18 Procedure for the revalidation of the license of establishments for sanitary products and disinfectants: import establishment

63 NEW ELECTRONIC PAYMENT SYSTEM NOTIFIED BODY

64 SERVICES OF NOTIFIED BODY On the Service tab you will choose: The Scope, which will match with each of the Departments of the AEMPS that provide services with payment of fees. The Type of Service The Type of Subservice where appropriate Type of medicines in your case For Notified Body, there have been defined services that are subject of payment. The services that can be paid through the electronic payment system are: Audit Certification

65 SERVICES OF NOTIFIED BODY Audit. This service has been defined for the payment of fees related to all types of Audits performed by Notified Body. SubServices have been defined for this service: According to the complete Quality Assurance System According to quality assurance of production According to product quality assurance Monitoring and extension of certification Supplementary and repetition site The rate headings that are paid on this service are: 8.26 Initial audit under a complete quality assurance system 8.27 Initial audit in accordance with production quality assurance 8.28 Initial audit under product quality assurance 8.29 Follow-up and extension of CE marking certification 8.30 Supplementary and repeat room audits

66 Certification. This service has been defined for the payment of fees related to all types of Certifications granted by Notified Body. SubServices have been defined for this service: Evaluation of active substance Evaluation of CE marking by complete system Evaluation of the CE marking by examination of type and quality of production or by verification or quality of the product Evaluation of CE marking by conformity of type and quality of production or by verification or quality of the product Verification of products and batches Evaluation of CE marking by design examin Modification of administrative data of the CE marking Extension of the CE marking Certification The rate headings that are paid on this service are: 8.20 Evaluation report of the active substance incorporated into a medical device SERVICES OF NOTIFIED BODY 8.5Procedure for issuing a certification 8.21Evaluation of certification files for CE marking of health products belonging to the same family by complete quality assurance system 8.22Evaluation of CE marking certification dossiers 8.23Evaluation of CE marking certification dossiers 8.24Verification of products and batches of products 8.25Evaluation of certification dossiers for CE marking of medical devices by CE design examination 8.31Modification of administrative data in the certification of CE marking 8.32Procurement of CE marking certifications

67 FEES AND SUMMARY Pressing Next button, we will go to the Fee screen. In this screen we will find the display with all the services selected in the previous screen, specifications and considerations exceptional circumstances of each services defined for the article 123 of the law. Pressing Next button, we will go to Summary screen, where we will find the information about fees, payer and selected services. We can find at the end of the screen, information about the diferents ways of payment.

68 WAYS OF PAYMENT Electronic Payment: Pressing the button will appear the following warning You will access the Caixa's electronic payment screen. The data that have been entered in the previous screen will appear in this one: Number of the proof of payment, VAT number o registration company number and amount to pay. You can pay with credit card or with open line la Caixa. Once payment is completed, the user must press return button to obtain the proof of payment.

69 WAYS OF PAYMENT Download Model When the button is pressed, a screen will appear with the available payment methods We will choose one of them. Pressing the Continue button will take us to the last screen where we can obtain the proof of payment.