FEE PAYMENT APPLICATION - User manual...1/2015, regarding the fees for the different services the...

FEE PAYMENT APPLICATION

User manual.

Version 1.0.0

Spanish Agency of Medicines and Health Products

Publication date: 23 November 2017 IT systems division


User manual.


MINISTERIO DE SANIDAD, SERVICIOS SOCIALES E IGUALDAD

Agencia Española de Medi-camentos y Productos Sanitarios, AEMPS

INDEX

1. INTRODUCTION ...................................................................................................................... 1

2. APLICATION ACCESS ............................................................................................................... 1

2.1. Access ........................................................................................................................................... 1

2.2. Payer and taxpayer information .................................................................................................. 2

3. SERVICES PROVIDED BY AEMPS DEPARTMENTS .................................................................... 2

3.1. Departments of Human Use and Veterinary Medicines .............................................................. 3

3.2. Control and Inspection Department .......................................................................................... 19

3.3. Medical Devices, Cosmetics and Personal Care Products Department ..................................... 22

3.4. Notified body ............................................................................................................................. 32

4. FEE SCREEN INFORMATION ................................................................................................. 34

4.1. Information about fees and special considerations for Services provided by the AEMPS. ....... 34

4.2. Additional payments .................................................................................................................. 38

5. SUMMARY AND FEE PAYING METHODS .............................................................................. 41

5.1. FEE PAYING METHODS ............................................................................................................... 41


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Agencia Española de Medicamentos y Productos Sanitarios, AEMPS

1. INTRODUCTION

In its efforts to modernise and improve applications, the AEMPS has launched a new fee paying appli-cation. This online payment application is still a single process, to be completed by following all the steps properly so the operation gives a satisfactory result. This application provides the exact amount to be paid to the Agency for the services requested. Once the proof of payment has been obtained, this amount will be paid to terminate the operation.

The philosophy of the application is based on the adaptation of articles 123 and following of Law 1/2015, regarding the fees for the different services the Agency provides to the public. The user chooses the AEMPS department to pay a fee to, followed by one of the services - or subservices, if nec-essary - that entail the payment of fees. The choice of the services and subservices results in the pay-ment of a fee and receipt of document 317...

2. APLICATION ACCESS

2.1. Access

The application is accessed from the AEMPS electronic office and then from online payment, as well as at the following link: https://tasas.aemps.es the following screen will be displayed:

The main difference with the previous application is that only two options are provided: Fee payment or Fee Consultation. The previous application had 3 options: Online Payment, Download Form 317 or Consult fees.

https://tasas.aemps.es/


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In the new application, the options Online Payment and Download Form 317 are grouped in the op-tion, Fee Payment. The Fee Consultation still has the same functionality as in the previous application; that is, to consult and download receipts for fees paid by card or by debit from a bank account, which are via the online payment platform.

2.2. Payer and taxpayer information

This section is for information about the payer. If the payer is different from the taxpayer (the person obliged to submit the application due to being the name of the recipient of the service provided by the AEMPS), the taxpayer information section on the form will have to be filled in. This option is enabled in the form by checking the option “Same as Payer”, whereupon the following fields are shown.

3. SERVICES PROVIDED BY AEMPS DEPARTMENTS

The following are chosen in this screen:

• The Department, i.e. the AEMPS section requested to provide a service and therefore that which has to be paid a fee.

• The Service Type the citizen wishes to pay a fee for, which is provided by the department chosen in the Department field.

• Medication type, the type of medication selected in each case for which a fee is to be paid.

• The Subservice Type, which is used to better focus the service that the citizen wants to pay for; e.g. for clinical trials, a Subservice would be the type of clinical trial to be paid for.


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3.1. Departments of Human Use and Veterinary Medicines

Once the Department of human use is chosen, the services this department provides which are subject to the payment of fees are chosen. The services that can be paid for online from the aforementioned department are:

• Batch release • Booking vacancy • Certification • Clinical Trial • Innovation • Modification of authorisation • National Annual Fee • New Registry • Others • Ownership Transfer • Parallel import • Renewal • Scientific Advice


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The Veterinary Area is chosen in the same line as the Human Use Department, followed by the services that this department provides which are subject to the payment of fees. The services that can be paid through electronic payment system from the aforementioned department are:

• Batch release • Booking vacancy • Certification • Clinical trial • Modification of Authorisation • National Annual Fee • New Registry • Ownership Transfer • PSUR • Parallel import • Renewal • Scientific Advice

3.1.1. Payment for a new registry (medicine) for Human Use or Veterinary.

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Depart-ment where the fee is to be paid and therefore the request to be submitted is chosen. Then, select New registration in the Service type field followed by the Medication type (COMPLETE, GENERIC, MEDICINAL GAS, ALLERGEN, TRADITIONAL PLANT-BASED MEDICINE (MTP), MEDICINAL PLANTS (WELL-ESTABLISHED USE), HOMEOPATHIC (WITHOUT IT), HOMEOPATHIC (WITH IT); then the Procedure type field is enabled: National, Decentralised and Mutual Recognition. If choosing Decentralised and/or Mu-tual Recognition, it must be specified if Spain is a Reference Member State or a Concerned Member State in the field for this purpose. Selecting the different options corresponds to the payment in the fee sections appearing in article 123 of Law 1/2015, which are:

• Fee for the evaluation, authorisation and entry in the register of a new medicine for human use (authorisation file issued in accordance with article 17, with the exception of the provision in 17.3).


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• 1.2 Fee for the evaluation, authorisation and entry in the register of a new generic medicine for human use (authorisation file issued in accordance with article 17.3).

• 1.3 Fee for the evaluation, authorisation and entry in the register of a new medicinal gas. • 2.1 Fee for the national evaluation procedure, authorisation and entry in the register of a new

allergy medicine for human use for diagnostic use. • 9.1 Fee for applying for market authorisation for a veterinary medicine, except for applications

outlined in article 17.3. • 9.2 Fee for applying for market authorisation for a generic veterinary medicine (file issued in accor-

dance with article 17.3). • 3.1 Evaluation, authorisation and entry in the register of a new traditional plant-based medicine

(MTP). • 3.3 Evaluation, authorisation and entry in the register of a new plant-based medicine for human

use for a well-established use. • 4.1 Evaluation, authorisation and entry in the register of a new homeopathic medicine without

approved therapeutic indications Fee for simplified processing in Spain. A single strain. • 4.2 Evaluation, authorisation and entry in the register of a new homeopathic medicine without

approved therapeutic indications Fee for simplified processing in Spain. BETWEEN TWO AND FIVE STRAINS.

• 4.3 Evaluation, authorisation and entry in the register of a new homeopathic medicine without approved therapeutic indications Fee for simplified processing in Spain. MORE THAN SIX STRAINS.

• 4.5 Evaluation, authorisation and entry in the register of a new Homeopathic Medicine with appro-ved therapeutic indications.


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3.1.2. Payment of a Booking Vacancy for a medicine for Human Use or Veterinary.

A Booking Vacancy is paid only in the Decentralised or Mutual Recognition Procedure when the Appli-cant wants Spain to be the Reference Member State. This fee is also known as a Booking Vacancy. To pay this fee, the information in the payer window is filled in before going to the Service window to fill in the following data:

Under Department, Medicines for Human Use or Veterinary is chosen. In Service Type, Booking Va-cancy is chosen. In Type of medicinal product, the desired medicine is chosen.

Type of procedure is chosen.

Reference Member State is chosen.

Selecting the different options corresponds to the payment in the fee sections appearing in article 123 of Law 1/2015, which are:

• 1.20 Fee for reserving a vacancy to act as the Reference Member State in a decentralised or mu-tual. recognition procedure.

• 9.15 Fee for reserving a vacancy for Spain to act as the Reference Member State in a Decentralised or Mutual Recognition procedure.


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3.1.3. Payment of a Modification of the Authorisation for a plant-based medicine for Human Use or Veterinary

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Department where the fee is to be paid and therefore the request to be submitted are chosen. Then, Authorisation Modification is chosen. The Next button is then pressed, which leads to the variation calculation algo-rithm where the necessary fields are selected to obtain the fee according to the request to be submitted.

The fields that appear in this service are already known, so the only change made is in the application interface, as can be seen in the following image.


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The Single Modification option is used for the payment of applications with a single variation affecting several medicines from the same holder.

The Grouping of Modifications option is used for different medicines and different variations which can be grouped in the same application according to EC Regulation 1234/2008, November 24, 2008. This is also used to pay for Parallel Variations requests, for variations in medicines that affect the same holder, which is submitted in a single format and at the same time within a period not exceeding 24 hours.

While calculating the fees for Modifications of Authorisation in both the single modification and the Grouping of modification options, a series of questions have to be answered according to the type of request to be submitted.

The different questions include the fee exemptions of article 123 of the Royal Legislative Decree 1/2015, and the provisions of article 111.6 of Law 10/2013, regarding Modifications as a result of Euro-pean Commission decisions which do not involve scientific evaluation by the Spanish Agency of Medi-cines and Medical Devices, as well as the provisions in 111.6, sections 3 and 4 and article 111.7 regard-ing RMS or CMS.


• 1.5 Fee for the procedure of modifying the authorisation for medicine for human use, classed as of «major importance» Type II.

• 1.6 Fee for the procedure of modifying the authorisation for medicine for human use, classed as Type IB.

• 1.7 Fee for the procedure of modifying the authorisation for medicine for human use, classed as type IA (including those of type IA with immediate notification).


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• 1.19 VARIATION IN MEDICINES FOR HUMAN AND VETERINARY USE. • 2.3 Fee for the procedure of modifying the authorisation for medicine for diagnostic use classed as

of «major importance» Type II. • 2.4 Fee for the procedure of modifying the authorisation for medicine for diagnostic use classed as

Type IB. • 2.5 Fee for the procedure of modifying the authorisation for medicine for diagnostic use classed as

type IA (including those of type IA with immediate notification). • 3.2 Modification of the authorisation for a traditional plant-based medicine (MTP). • 3.5 Modifying the authorisation for a plant-based medicine for human use classed as of «major

importance» Type II. • 3.6 Modifying the authorisation for a plant-based medicine for human use classed as Type IB. • 3.7 Modifying the authorisation for a plant-based medicine for human use classed as Type IA (in-

cluding those of type IA with immediate notification). • 4.4 Fee for the procedure of modifying the authorisation for a Homeopathic Medicine without ap-

proved therapeutic indications. • 4.4 Fee for the procedure of modifying the authorisation for a Homeopathic Medicine without ap-

proved therapeutic indications. • 4.7 Fee for the procedure of modifying the authorisation for a homeopathic medicine with appro-

ved therapeutic indications classed as of «major importance» Type II. • 4.7 Fee for the procedure of modifying the authorisation for a homeopathic medicine with appro-

ved therapeutic indications classed as of «major importance» Type II. • 4.8 Fee for the procedure of modifying the authorisation for a homeopathic medicine WITH appro-

ved therapeutic indications classed as Type IB. • 4.8 Fee for the procedure of modifying the authorisation for a homeopathic medicine WITH appro-

ved therapeutic indications classed as Type IB. • 4.9 Fee for the procedure of modifying the authorisation for a homeopathic medicine with appro-

ved therapeutic indications classed as Type IA. • 4.9 Fee for the procedure of modifying the authorisation for a homeopathic medicine with appro-

ved therapeutic indications classed as Type IA. • 9.4 Fee for the procedure of modifying the authorisation for veterinary medicine, classed as of

«major importance» Type II. • 9.5 Fee for the procedure of modifying the authorisation for veterinary medicine, classed as Type IB. • 9.6 Fee for the procedure of modifying the authorisation for veterinary medicine, classed as type IA

(including those of type IA with immediate notification).

3.1.4. Payment of 5-year authorisation renewals

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Depart-ment where the fee is to be paid and therefore the request to be submitted is chosen. RENEWAL is chosen. The Medication type is chosen in the Service Type field and Procedure type in the Procedure Type field. Once the procedure type is selected, Decentralised or Mutual Recognition, the option to choose RMS or CMS will be activated.


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• 1.8 Fee for the authorisation renewal procedure for a medicine for human use. • 2.3 Fee for the authorisation renewal procedure for an allergy medicine for diagnostic use. • 3.8 Fee for the authorisation renewal procedure for a traditional plant-based medicine. • 3.9 Fee for the authorisation renewal procedure for a plant-based medicine authorised for a well-

established use. • 4.10 Authorisation renewal procedure for a homeopathic medicine WITHOUT approved therapeu-

tic indications. • 4.11 Authorisation renewal procedure for a homeopathic medicine WITH approved therapeutic

indications. • 9.7 Fee for the authorisation renewal procedure for a veterinary medicine.


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3.1.5. Payment for transferring the ownership of authorisation

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Department where the fee is to be paid and therefore the request to be submitted is chosen. OWNERSHIP TRANSFER is chosen in Type of Service and the type of medicines in the Type of medicinal product field.


• 1.4 Fee for transferring the ownership of authorisation for a medicine for human use, or for chan-ging the owner's representative.

• 2.3 Fee for transferring the ownership of authorisation for an allergy medicine for diagnostic use. • 3.4 Transferring the ownership of authorisation for a traditional plant-based medicine or an aut-

horised plant-based medicine authorised for a well-established use. • 4.6 Transfer of ownership of a homeopathic medicine. • 9.3 Fee for transferring ownership of authorisation of a veterinary medicine, or for changing the

owner's representative.

3.1.6. Payment of National Annual fee for medicines for Human use and Veterinary medicines.

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Depart-ment where the fee is to be paid is chosen. For Medicines for Human or Veterinary Use, the Service Type chosen is Market Maintenance and medication type is also chosen.


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• 1.9 Annual single maintenance fee for an already-authorised medicine for human use. • 2.7 Annual single fee for declaring an intention to market an already authorised veterinary medici-

ne. • 3.10 Annual single maintenance fee for an already-authorised traditional plant-based medicine. • 3.11 Annual single maintenance fee for a traditional plant-based medicine authorised for a well-

established use. • 4.12 Annual single maintenance fee for an already-authorised homeopathic medicine for human

use WITHOUT approved therapeutic indications. • 9.8 Annual single fee for declaring an intention to sell an already-authorised veterinary medicine.

This option is only available from the Medication Marketing Notifications system.

https://sinaem.agemed.es/WebComercializacion/login.aspx?opc=humana

This option is available only from the application of Intention of commercialization of veterinary medicines.

https://sinaem.agemed.es/WebComercializacion/login.aspx?opc=veterinaria

3.1.7. Payment of a Parallel Import

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen. For Medicines for Human Use or Veterinary, the Service Type cho-sen is Parallel Import and type of medicinal product is also chosen. For Parallel Import service, a series of Subservices are also established for the Department of Medicines for Human Use, such as:

• Authorisation. • Modification. • Renewal. • Notification.

For the Department of Veterinary Medicines, there are no subservices established as AEMPS only pro-vides the Parallel Importing Authorisation service.







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• 1.10 Fee for the authorisation procedure for the «parallel importing» of a medicine for human use. • 1.11 Fee for the procedure of modifying the authorisation for the «parallel importing» of a medici-

ne for human use. • 1.12 Fee for the authorisation renewal procedure for the «parallel importing» of a medicine for

human use. • 1.13 Import notification fee. • 9.9 Fee for the authorisation procedure for the «parallel importing» of a veterinary medicine.

3.1.8. Payment for Batch Release

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Depart-ment where the fee is to be paid is chosen. For Medicines for Human Use or Veterinary, the Service Type chosen is Batch Release, while the type of medicinal product, Vaccines-Blood Products, is also chosen. For the Batch Release service, a series of Subservices is also established for the Department of Medicines for Human Use and Veterinary, such as:

• Issue of an European Certificate when batch analysis is required. • Individual application. • Between 6 and 10 applications/year. • Between 11 and 40 applications/year. • Between 41 and 160 applications/year. • More than 160 applications/year. • Issue of an European Certificate when a bulk analysis is required. • Issuing of an European Certificate of immunological medicinal product according to Article 81 of

Directive 2001/82/EC. • Issuing of an European Certificate of immunological medicinal product according to Article 82 of

Directive 2001/82/EC.


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• 1.14 Fee for issuing European certification for the release of batches of vaccines and blood pro-ducts for human use when the batch-analysis of a medicine is required.

• 1.15a Fee for releasing batches of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October.

• 1.15b Fee for releasing batches of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October.

• 1.15c Fee for releasing batches of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October.

• 1.15d Fee for releasing batches of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October.

• 1.15e Fee for releasing batches of blood products and vaccines in accordance with articles 41.4 and 43.3 of Royal Decree 1345/2007, of 11th October.

• 1.16 Fee for issuing European certification for the release of batches of vaccines and blood pro-ducts for human use when a bulk-analysis is required (by bulk quantity).

• 9.13 Fee for issuing European certification for the formal release of a batch of immunological vete-rinary medicines in accordance with article 81 of Directive 2001/82/EC.

• 9.14 Fee for issuing European certification for the formal release of a batch of immunological vete-rinary medicines in accordance with article 82 of Directive 2001/82/EC.

3.1.9. Payment of a clinical trial.

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Depart-ment where the fee is to be paid is chosen. For Medicines for Human Use or Veterinary, the Type of Service chosen is Clinical Trial. For the Clinical Trial service, a series of Subservices is also established for the Medicines for Human Use and Veterinary, such as:

• Evaluation of the first clinical trial with non-authorized medicines in a country belonging to the International Conference Harmonisation (ICH) with active substances that are not authorised in Spain.


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• Authorisation according to paragraphs a), b), c) and d). • With medicines authorised and registered in Spain or with medicines in investigation elaborated by

a Pharmacy Service. • Qualification of a vet medicine not authorised in Spain. • Vet clinical trial.


• 5.1 Fee for the process of evaluating the first clinical trial with medicines that are not authorised in a country that belongs to the International Conference on Harmonisation (ICH) with active princi-ples that are not authorised in Spain.

• 5.2 Fee for procedure (a) (b) (c) and (d) of the law. • 5.3 Fee for procedure (a) and (b) of the law. • 5.4 Procedure for classifying a veterinary medicine that is not authorised in Spain as a product in

the clinical research phase. • 5.5 Fee for the veterinary clinical trials procedure.


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3.1.10. Payment of a Certification

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Depart-ment where the fee is to be paid is chosen. For Medicines for Human Use or Veterinary, the Type of Service chosen is Certification.


• 7.1 Fee for issuing a certificate.

3.1.11. Payment of scientific advice

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Depart-ment where the fee is to be paid is chosen. For Medicines for Human or Veterinary Use, the Service Type chosen is Scientific Advice and medication type is also chosen. For the Scientific Advice service, a series of Subservices is also established depending on the type of Medicine, such as:

For a Complete medicine

• On quality, safety and clinical development, or quality and clinical development or safety and clini-cal development, or pre-submission assessment of an excipient.

• Classifying variations that have not been classified and for the grouping of variations, according to EC Regulation 1234/2008.

• About medicines for paediatric use.


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For a Generic medicine.

• About clinical development, or quality and safety or quality and bioequivalence studies. • About quality or safety or bioequivalence studies. • Monitoring on clinical development, or quality and safety or quality and bioequivalence studies. • Monitoring on quality, or safety, or bioequivalence studies. • Classifying variations that have not been classified and for the grouping of variations, according to

EC Regulation 1234/2008. • About medicines for paediatric use.

Traditional plant-based medicine (MTP), Medicinal plants (well-established use) and Medicinal gas.

• Classifying variations that have not been classified and for the grouping of variations, according to EC Regulation 1234/2008.

• About medicines for paediatric use.


• 7.2 Fee for scientific advice for medicines, including multidisciplinary questions on (a) quality, safe-ty and clinical development, or (b) quality and clinical development or (c) safety and clinical deve-lopment, or (d) advice prior to submitting a file.


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• 7.3 Fee for scientific advice for medicines, including questions about (a) clinical development, or (b) quality and safety or (c) quality and bioequivalence studies in the case of generic medicines.

• 7.4 Fee for scientific advice for medicines, including questions about (a) quality or (b) safety or (c) bioequivalence studies in the case of generic medicines.

• 7.5 Fee for follow-up advice in those cases included in subsection 7.2. • 7.6 Fee for follow-up advice in those cases included in subsection 7.3. • 7.7 Fee for follow-up advice in those cases included in subsection 7.4. • 7.8 Fee for advice on classifying variations that have not been classified, in accordance with article

5, and for the grouping of variations, in accordance with article 7 of European Commission (EC) Re-gulation 1234/2008.

• 7.9 Fee for scientific advice on medicines for paediatric use in any of the cases included in the abo-ve subsections.

3.1.12. Payment for a Periodic Safety Report for a Veterinary medicine.

Once the payer and taxpayer information is completed, the SERVICE tab is chosen. Here, the Depart-ment where the fee is to be paid is chosen. For Veterinary Medicines, the Service Type chosen is Peri-odic Safety Report (IPS) and medication type is also chosen. For the IPS service, a series of Subservices is also established, such as:

• Semi-annual evaluation, whether or not the medication is registered in Spain. • Annual evaluation, whether or not the medication is registered in Spain. • Evaluation every 3 years or more, whether or not the medication is registered in Spain.


• 9.10 Fee for assessing the six-monthly safety report of a veterinary medicine, whether or not the medicine is registered in Spain.


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• 9.11 Fee for assessing the annual safety report of a veterinary medicine, whether or not the medi-cine is registered in Spain.

• 9.12 Fee for assessing the three-yearly or greater safety report of a veterinary medicine, whether or not the medicine is registered in Spain.

3.2. Control and Inspection Department

Once the Control and Inspection Department is chosen, the services this department provides which are subject to the payment of fees is chosen. The services that can be paid for online from the afore-mentioned department are:

• Authorisations. • Modification of the authorisation. • Inspection. • Registration. • Certification. • Scientific Advice.

3.2.1. Payment for an Authorisation from the Inspection and Control Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Inspection and Con-trol. The Service Type chosen is Authorisations. For the Authorisations service, a series of Subservices is also established, such as:

• Opening of a pharmaceutical laboratory. • Procedure for authorising the manufacture of medicines approved in other countries and not regis-

tered in Spain. • Exceptional third party manufacturing of medicines for human and/or veterinary use. • Medicine storage areas under customs control or supervision. • Cultivation of plants that can be used to manufacture medicines, narcotics. • Exporting narcotic and psychotropic medicines to EU countries and third countries.


• 6.1 Authorisation to open a pharmaceutical laboratory. • 6.5 Procedure for authorising the manufacture of medicines approved in other countries and not

registered in Spain.


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• 6.6 Special third party authorisation procedure for medicines for human and/or veterinary use. • 6.7 Procedure for authorisation and/or certification of drug distribution warehouses: customs wa-

rehouses as well as those of free zones or warehouses that store medicines. • 6.8 Procedure for authorising the cultivation of plants that can be used to manufacture medicines,

narcotics and psychotropic substances. • 1.18 Authorisation to export narcotic and psychotropic medicines to EU countries and third coun-

tries.

3.2.2. Payment for an Authorisation Modification from the Inspection and Control Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Inspection and Con-trol. The Service Type chosen is Authorisation Modification. For the Authorisation Modification ser-vice, a series of Subservices is also established, such as:

• A pharmaceutical laboratory with minor changes. • A pharmaceutical laboratory with major changes without an inspection visit. • A pharmaceutical laboratory with major changes with an inspection visit.


• 6.2 Authorisation to make minor changes in a pharmaceutical laboratory. • 6.3 a) Procedure for making major changes to the authorisation for a pharmaceutical laboratory,

when the activities do not include an inspection visit. • 6.3 b) Procedure for making major changes to the authorisation for a pharmaceutical laboratory

when the inspection activities include an inspection visit.

3.2.3. Payment for an Inspection from the Inspection and Control Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Inspection and Con-trol. The Service Type chosen is Inspection. For the Inspection service, a series of Subservices is also established, such as:

• Actions at the national level, except for a complaint or request from association or consumers. • Actions in third countries, except for a complaint or request from association or consumers. • Actions in third countries at the request of the interested party.


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• 6.4a Individual inspection activities, unless a complaint has been made or it is at the request of a representative association of users and consumers, in Spain.

• 6.4b Individual inspection activities, unless a complaint has been made or it is at the request of a representative association of users and consumers, in third countries.

• 6.4c Individual inspection activities, in third countries, non-mandatory, at the request of the inte-rested party.

3.2.4. Payment for Registration from the Inspection and Control Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Inspection and Con-trol. The Service Type chosen is Registration. For the Registration service, a series of Subservices is also established, such as:

• Registration, modification or updating the registration of manufacturing companies that import or distribute active ingredients.

• Registration of intermediation entities for medicines for human use.


• 6.9 Initial registration, notification of mandatory changes or annual updating of the register of companies that manufacture, import or distribute active principles.

• 6.10 Registration in the register of persons who broker the distribution of medicines for human use.


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3.2.5. Payment for Certification from the Inspection and Control Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Inspection and Con-trol. The Service Type chosen is Certification.

Selection of this option corresponds to the payment of the fees section 7.1 Fee for issuing a certificate which appears in article 123 of the Royal Legislative Decree 1/2015.

3.2.6. Payment for Scientific Advice from the Inspection and Control Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Inspection and Con-trol. The Service Type chosen is Scientific Advice.

Selection of this option corresponds to the payment of the fees section 7.10 Scientific or technical advice on the design of manufacturing facilities and processes in accordance with good manufactur-ing guidelines which appears in article 123 of the Royal Legislative Decree 1/2015.

3.3. Medical Devices, Cosmetics and Personal Care Products Department

There are 2 established areas in the Medical Devices, Cosmetics and Personal Care Products Depart-ment:

• Medical devices. • Cosmetics and Personal Care products.


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3.3.1. Medical Devices Department Services

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Service Type chosen is

• Certification. • Medical Device Clinical Investigations. • Initial licence. • Licence modification. • Product modification. • Product registration. • Licence renewal.

3.3.1.1. Payment for Certification from the Medical Devices Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Service Type chosen is Certification, and the subservice type is Certification Issuing procedure.

Selection of this option corresponds to the payment of the fees section 8.5 Certification Issuing proce-dure which appears in article 123 of the Royal Legislative Decree 1/2015

3.3.1.2. Payment for Medical Device Clinical Investigations from the Medical Devices Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Medical devices.


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The Service Type chosen is Medical Device Clinical Investigations.

Selection of this option corresponds to the payment of the fees section 8.9 Medical Device Clinical In-vestigations Authorisation which appears in article 123 of the Royal Legislative Decree 1/2015.

3.3.1.3. Payment for an Initial licence from the Medical Devices Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Service Type chosen is Initial Licence, which has the following subservices established:

• Manufacturing and grouping establishment. • Import establishment.

Selecting the different options corresponds to the payment in the fee sections appearing in article 123 of Royal Legislative Decree 1/2015.

• 8.12 Preliminary operating licence procedure for healthcare products and disinfectants: manufac-turing establishment, association.

• 8.13 Preliminary operating licence procedure for healthcare products and disinfectants: importing establishment.

3.3.1.4. Payment for a licence modification from the Medical Devices Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES.


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The Service Type chosen is Licence Modification, which has the following 3 subservices established:

• Initial licence to establish Manufacturing and grouping. • Initial licence to establish Imports. • Initial licence for operation of establishments.


• 8.14 Preliminary operating licence procedure for the site of healthcare product and disinfectant establishments: manufacturing establishment, association.

• 8.15 Procedure for modifying the Preliminary operating licence procedure for the site of healthcare product and disinfectant establishments: importing establishment.

• 8.16 Procedure for modifying the Preliminary operating licence procedure for healthcare product and disinfectant establishments.

3.3.1.5. Payment for a product modification and revalidation from the Medical Devices Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Medical devices. The Service Type chosen is Product modification and revalidation.

Selection of this option corresponds to the payment of the fees section 8.33 Medical Device modifica-tion procedure which appears in article 123 of the Royal Legislative Decree 1/2015.


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3.3.1.6. Payment for a product Registration from the Medical Devices Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which Medical devices is. The Service Type chosen is Product Registration.

Selection of this option corresponds to the payment of the fees section 8.03 Medical Device Registra-tion procedure which appears in article 123 of the Royal Legislative Decree 1/2015.

3.3.1.7. Payment for a licence renewal from the Medical Devices Department.

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Service Type chosen is Licence Renewal, which has the following subservices established:

• Renewal of Manufacturing establishments. • Renewal of Import establishments.


• 8.17 Procedure for revalidating the licence of healthcare product and disinfectant establishments: manufacturing establishment.

• 8.18 Procedure for revalidating the licence of healthcare product and disinfectant establishments: importing establishment.


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3.3.2. Cosmetics and Personal Care Products Department Services.

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Cosmetics and Per-sonal Care Products. The Service Types chosen are:

• Certification • Declaration from responsible person • Inspection • Initial licence • Licence modification • Product modification • Cosmetic products, biocides and personal hygiene • Licence renewal.

3.3.2.1. Payment for a Cosmetics and Personal Care Products Department Certification.

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Medical devices. The Service Type chosen is Certification. Certificate issuance procedure.

Selection of this option corresponds to the payment of the fees section 8.5 Certification Issuing proce-dure which appears in article 123 of the Royal Legislative Decree 1/2015.


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3.3.2.2. Payment for a Cosmetics and Personal Care Products Department Declaration from Responsible person.

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Ser-vice Type chosen is Declaration from Responsible person, which has the following subservices established:

• Manufacturing Check and control • Import Check and control • Manufacturing modifications Check and control • Import modifications Check and control


• 8.6 Verification and control procedure for the statement of compliance for the manufacture of cosmetics and personal care products.

• 8.7 Verification and control procedure for the statement of compliance for the activity of importing cosmetics and personal care products.

• 8.8 Verification and control procedure for the statement of compliance for changes to the manu-facture of cosmetics and personal care products.

• 8.9 Verification and control procedure for the statement of compliance for changes to the activity of importing cosmetics and personal care products.

3.3.2.3. . Payment for a Cosmetics and Personal Care Products Department Inspection.

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Medical devices. The Service Type chosen is Inspection.


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Selection of this option corresponds to the payment of the fees section 8.10 Individual actions to check the responsible person declaration which appears in article 123 of the Royal Legislative Decree 1/2015

3.3.2.4. Payment for a Cosmetics and Personal Care Products Department Initial Licence.

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Service Type chosen is Initial Licence, which has the following subservices established:

• Manufacturing and grouping establishment. • Import establishment.


• 8.12 Preliminary operating licence procedure for healthcare products and disinfectants: manufac-turing establishment, association.

• 8.13 Preliminary operating licence procedure for healthcare products and disinfectants: importing establishment.

3.3.2.5. Payment for a Cosmetics and Personal Care Products Department Licence modification.

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Service Type chosen is Licence Modification, which has the following 3 subservices established:

• Initial licence to establish Manufacturing and grouping. • Initial licence to establish Imports. • Initial licence for operation of establishments.


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• 8.14 Preliminary operating licence procedure for the site of healthcare product and disinfectant establishments: manufacturing establishment, association.

• 8.15 Procedure for modifying the Preliminary operating licence procedure for the site of healthcare product and disinfectant establishments: importing establishment.

• 8.16 Procedure for modifying the Preliminary operating licence procedure for healthcare product and disinfectant establishments.

3.3.2.6. Payment for a Cosmetics and Personal Care Products Department Product modification and revalidation

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Medical devices. The Service Type chosen is Product modification.

Selection of this option corresponds to the payment of the fees section 8.4 Modification and validation procedure for hygiene products and disinfectants which appears in article 123 of the Royal Legislative Decree 1/2015.


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3.3.2.7. Payment for Cosmetics, biocides and personal hygiene products from the Cosmetics and Personal Care Products Department.

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Service Type chosen is Cosmetics, biocides and personal hygiene products, which has the follow-ing 3 subservices established:

• Special declaration. • Individual registration and authorisation. • Cosmetic ingredients confidentiality.


• 8.2 Procedure of individually registering and authorising personal care products and disinfectants.

3.3.2.8. Payment for a Cosmetics and Personal Care Products Department Licence renewal.

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Service Type chosen is Licence Renewal, which has the following 2 subservices established:

• Renewal of Manufacturing establishments. • Renewal of Import establishments.


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• 8.17 Procedure for revalidating the licence of healthcare product and disinfectant establishments: manufacturing establishment.

• 8.18 Procedure for revalidating the licence of healthcare product and disinfectant establishments: importing establishment.

3.4. Notified body

There are 2 Services types within the Notified Bodies:

• Auditing. • Certification.

3.4.1. Payment for an audit from the Notified body Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is MEDICAL DEVICES. The Service Type chosen is Auditing, which has the following 5 subservices established:

• Complete quality assurance system. • Production quality assurance. • Product quality assurance. • Certification extension and follow-up. • Additional premises and repeat audits.


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• 8.26 Initial audit in accordance with the complete quality assurance system. • 8.27 Initial audit in accordance with production quality assurance. • 8.28 Initial audit in accordance with product quality assurance. • 8.29 Follow-up audits and certification extension audits for the CE mark. • 8.30 Audits on additional premises and repeat audits.

3.4.2. Payment for a Certification from the Notified body Department

Once the payer and taxpayer information is completed as in section 1.2 of this document, the SERVICE tab is chosen. Here, the Department where the fee is to be paid is chosen, which is Notified body. The Service Type chosen is Certification, which has the following 5 subservices established:

• Evaluation of the CE mark for the complete system. • Evaluation of the CE mark for examination of production type and quality or product verification or quality. • Evaluation of the CE mark for compliance with production type and quality or product verification

or quality. • Verification of products and batches of products. • Evaluation of the CE mark for design examination. • Modification of CE mark administrative data. • CE mark extension. • Delivery.


• 8.5 Certificate issuance procedure. • 8.20 Assessment report on active principles contained in healthcare products. • 8.21 Assessment of CE mark certification files for healthcare products from the same family

through the complete quality assurance system. • 8.22 Evaluation of CE mark certification dossiers. • 8.23 Evaluation of CE mark certification dossiers. • 8.24 Verification of products and batches of products.


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• 8.25 Assessment of CE mark certification files for healthcare products through CE design examination. • 8.31 Changing of administrative data on «CE» mark certification. • 8.32 Extensions to CE mark certifications.

4. FEE SCREEN INFORMATION

This screen shows information about the fees for services selected in the previous screen. It also in-cludes specifications and exceptional considerations for each of the fee sections in article 123, para-graphs 2, 6 and 7 of the Royal Legislative Decree 1/2015. As well as possible exemptions from article 121 in each section.

The upper part of the screen establishes the possibility of making Additional Payments.

4.1. Information about fees and special considerations for Services provided by the AEMPS.

4.1.1. Line Extensions and Exemptions for Medicines of Human and Veterinary Use Services.

After filling in this service screen, the FEES screen appears.

The Drug Name and registration number fields are filled in; the rest of fields are filled in automatically from information on the Service screen, e.g. the fee amount and the number of actions.

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Law 1/2015.

After selecting the option “Have you already paid the fee for booking a slot?”, A text box appears to enter the booking number, which is validated when the field is completed. The main fee is discounted by a third if paid beforehand when the slot booking service for a decentralised procedure is requested,


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fee section 1.20. If this is not done beforehand, the fee for the full new registration will be paid.

When selecting the Line Extension option, only 70% of the main fee is paid, as established in article 123, point 2 of the Royal Decree 1/2015 “For the purposes of the previous section, a line extension will be understood to be any second and successive applications for authorisation and registration of other pharmaceutical forms, administration routes and medicine concentrations already authorised and reg-istered. The fee for the line extension will be seventy percent of the first medication authorisation. For veterinary drugs, a line extension will be the extension an authorisation to new target species, provided they are food producing species. A line exten-sion will be a modification that requires a new authorisation request to be submitted, in accordance with the European stan-dard regulating authorisation modifications for medicines granted by the competent authority of a Member State. The afore-mentioned provisions concerning line extensions apply also when the medication is not yet authorised and line extensions of a main application are submitted in parallel”.

After selecting the Exemption option, 95% or 100% of the main fee will be discounted, as established in article 121 of RD 1/2015.

The exemptions of article 121, points 4, 5 and 6 will apply for Authorisation Modifications.

4. The modifications or variations of authorisations granted by the Spanish Agency for Medicines and Medical Devices will be partially exempted from the corresponding fee when they necessarily derive from the approval of a new general regulation. The fee will be reduced by 95% in each case.

5. Marketing authorisation holders of medicines will be partially exempt from payment of the corresponding fee when the Spanish Agency for Medicines and Medical Devices or the European Commission requires their modifica-tion for health interest reasons. The fee will be reduced by 95% in each case.

6. ... ... exemption of 70% of the fees corresponding to marketing authorisations, line extensions to minor species or minor uses of medicines already authorised for larger species, to marketing authorisation modifications, scien-tific advice, products undergoing veterinary clinical research, veterinary clinical trials, authorisation renewals, submission of simple annual declaration of marketing intention and periodic safety reports for veterinary drugs authorised by the national procedure, whether by mutual or decentralised recognition. This will not apply to holder and/or holder representative transfer procedures."

Special considerations for Scientific Advice are included in article 123, point 6, paragraph 6 of the RLD 1/2015: “The rate corresponding to section 7.2, ’Fee for scientific advice for medicines that include multidisciplinary questions on (a) quality, safety and clinical development, (b) quality and clinical de-velopment, (c) safety and clinical development or (d) pre-referral advice of a dossier’ will be reduced by 25% for scientific advice that includes questions on clinical development efficiency only; of preclinical quality and safety; or of quality and bioequivalence”.


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4.1.2. Line Extensions and Exemptions for Veterinary Medicines for minor species.

After filling in this service screen, the FEES screen appears.

The Drug Name and registration number fields are filled in; the rest of fields are filled in automatically from information on the Service screen, e.g. the fee amount and the number of actions.

The Special Considerations section has questions to be answered to apply the fee exemptions found in Law 1/2015. For Veterinary Drugs, when selecting the Exemption option, the provisions of article 121, point 6 will apply” ... exemption of 70% of the fees corresponding to marketing authorisations, line extensions to minor species or minor uses of medicines already authorised for larger species, to mar-keting authorisation modifications, scientific advice, products undergoing veterinary clinical research, veterinary clinical trials, authorisation renewals, submission of simple annual declaration of market-ing intention and periodic safety reports for veterinary drugs authorised by the national procedure, whether by mutual or decentralised recognition. This will not apply to holder and/or holder representative transfer procedures".


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4.2. Additional payments

The additional payment option is used if the first payment made was incorrect.

Additional payments for New Registrations are made, for example, when the first payment was for a generic drug “Fee for the evaluation, authorisation and registration of a new generic drug for human use (authorization dossier submitted according to article 17.3)”, but in reality, the drug had a hybrid legal base.

Once proof of payment for a generic drug is received, another payment with the correct data is made. For example, in the above case:

1. A complete medication and the correct procedure are selected.

2. On the Fee screen, the additional payment box is checked to enable the field to enter the payment

receipt number. The amount already paid will then appear in the Amount to be discounted box.


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3. A fee summary appears in the summary tab and finally the amount to be paid, with the previously

paid amount having been deducted.

For additional payments for authorisation modifications, the following occurs if the user paid for a vet-erinary medicine type IA variation when submitting the application, but it was really a 1B variation. In the first payment, the user paid the 9.6 fee of €731.66 when it should have been €1,236.97.


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The following is done to make an additional payment of €500.30 (the difference between the 9.6 and 9.5 fees):

1. Enter the service screen and select the Authorisation Modification service in the Veterinary Drugs Department, then mark the option Additional Payment on the FEES screen.

2. Enter the fee number paid.

3. The amount to be discounted is then shown.

4. Enter the algorithm and select the variation to be correctly submitted.

5. The Summary screen shows the fee resulting from the operation.

6. The total shows the amount to pay (the fee that should be paid minus the amount already paid from the aforementioned receipt).


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5. SUMMARY AND FEE PAYING METHODS

The SUMMARY screen shows the summary information from the previous screens, such as payer and taxpayer details, information about the service or activity selected in the SERVICE screen, fee section information for the amount to be paid, medication type and special fee considerations previously ap-pearing on the FEES screen. Finally, the Total field shows the amount to be paid.

5.1. FEE PAYING METHODS

5.1.1. Online

The following warning appears when the button is pressed.

The online La Caixa payment screen appears. Data entered in the previous screen will appear in this: Fee receipt number, ID/Tax number (NIF/CIF) and the fee amount.


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On this screen, the user can choose to cancel the payment with the “Cancel” button or continue with the “Continue” button.

The following screen is shown after pressing “Continue”.

This screen gives the options of paying by card and Pay fees through ‘Línea Abierta”. The latter is for users who are La Caixa customers.

When selecting the option “Pay by card”, the following screen appears requesting the card number from which the charge will be made.


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IF the Pay fees through “Línea Abierta” option is selected, the following screen is shown. This screen requests La Caixa user credentials.

The following screen appears after payment is made in the La Caixa payment gateway.

Press the Back button to obtain a copy of the proof of payment, where you will be directed to another screen to download the payment receipt pdf and finish the process by pressing the Back button.


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5.1.2. Downloading form

When the button is pressed, a screen with the available payment methods

will appear.

The transfer will be sent to the CAIXABANK account in the name of the Spanish Agency for Medicines and Medical Devices

IBAN: ES57 2100 8981 6102 0000 5869

SWIFT:CAIXES BBXXX

The transfer originator will be the same as in the proof of payment document as payer. If the Transfer option is chosen, the following notice appears:

Pressing the continue option leads to the payment receipt form download screen. To finish the process, press the Back button.


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Cash and EC Account Debit payment options are available at a La Caixa bank branch.

For the cash payment option, this can be done by card at a La Caixa branch ATM via the barcode reader, document 317...

If this option is chosen, use the Bar Code and follow the ATM instructions. Payment can be made by credit or debit card at an ATM.

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FEE PAYMENT APPLICATION - User manual...1/2015, regarding the fees for the different services the...

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