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Slovak Republic
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Announcements of a serious adverse event of a transfusion medicine
The service will allow the holder of the authorization for the preparation of transfusion products to provide the State Institute for Drug Control with data in accordance with § 69, Article 6 b) of Act no. No. 362/2011 Coll. On Medicinal Products and Medical Devices, as amended. The relevant information can be provided via the form available on the ŠKL website in paper form, as well as fully electronically through the form published on the Central portal of the public administration (slovakia.sk). For electronic submission to slovakia.sk, it is necessary to use eID (Electronic Citizenship Card) and KEP (Qualified Electronic Signature).
Announcement of the evaluation of the serious adverse reaction of transfusion products
The service will allow the holder of the authorization for the preparation of transfusion products to provide the State Institute for Drug Control with data in accordance with § 69, Article 6 e) of Act no. No. 362/2011 Coll.
Announcement of serious adverse reaction of transfusion medicines
The service will allow the holder of the authorization for the preparation of transfusion products to provide the State Institute for Drug Control with data in accordance with § 69, Article 6 a) of Act no. No. 362/2011 Coll.
Reporting an upcoming ad about the drug
The Marketing Authorization Holder will report SUKL's prepared promotional materials. The form contains information about: - what advertising material it is, - what the person is intended for (eg lay or professional public, post-menopausal women, parents of preschool children, etc.), - the method of dissemination (eg print advertising, leaflet, etc.), - date (in the form of DD.MM.RRRR) of the beginning of the dissemination (it is always an ad captured on the material substrate), - other activities defined by § 8 par. 2 of the Advertising Act.
Appeals against the decision of the public administration body in the public health sector
This end-of-service service provides a form by which a natural person-entrepreneur or a legal entity can appeal against a decision of the RVZ Bardejov.
Notification to the State Institute for Drug Control of the results of the assessment of the serious adverse reaction of transfusion products
The service will allow the holder of the authorization for the preparation of transfusion products to provide the State Institute for Drug Control with data in accordance with § 69, Article 6 e) of Act no. No. 362/2011 Coll. On Medicinal Products and Medical Devices, as amended. The relevant data can be provided via the form available on the ŠKL website in paper form as well as electronically in full through the form published on the Central Public Administration Portal (slovakia.sk). For electronic submission to slovakia.sk, it is necessary to use eID (Electronic Citizenship Card) and KEP (Qualified Electronic Signature).
Submission of intention to manufacture, import or distribute the active substance used as feedstock in the manufacture of the medicinal product
The service will allow a natural person or a legal entity to report on the treatment of active substances within the scope of production, distribution, import in accordance with Section 12a of Act no. No. 362/2011 Coll. On Medicinal Products and Medical Devices, as amended. The relevant information can be provided via the form available on the ŠKL website in paper form, as well as fully electronically through the form published on the Central portal of the public administration (slovakia.sk). For electronic submission to slovakia.sk, it is necessary to use eID (Electronic Citizenship Card) and KEP (Qualified Electronic Signature).
Announcements of a serious adverse event of a transfusion medicine
The service will allow the holder of the authorization for the preparation of transfusion products to provide the State Institute for Drug Control with data in accordance with § 69, Article 6 b) of Act no. No. 362/2011 Coll. On Medicinal Products and Medical Devices, as amended. The relevant information can be provided via the form available on the ŠKL website in paper form, as well as fully electronically through the form published on the Central portal of the public administration (slovakia.sk). For electronic submission to slovakia.sk, it is necessary to use eID (Electronic Citizenship Card) and KEP (Qualified Electronic Signature).
Announcement of the evaluation of the serious adverse reaction of transfusion products
The service will allow the holder of the authorization for the preparation of transfusion products to provide the State Institute for Drug Control with data in accordance with § 69, Article 6 e) of Act no. No. 362/2011 Coll.
Announcement of serious adverse reaction of transfusion medicines
The service will allow the holder of the authorization for the preparation of transfusion products to provide the State Institute for Drug Control with data in accordance with § 69, Article 6 a) of Act no. No. 362/2011 Coll.
Reporting an upcoming ad about the drug
The Marketing Authorization Holder will report SUKL's prepared promotional materials. The form contains information about: - what advertising material it is, - what the person is intended for (eg lay or professional public, post-menopausal women, parents of preschool children, etc.), - the method of dissemination (eg print advertising, leaflet, etc.), - date (in the form of DD.MM.RRRR) of the beginning of the dissemination (it is always an ad captured on the material substrate), - other activities defined by § 8 par. 2 of the Advertising Act.
Appeals against the decision of the public administration body in the public health sector
This end-of-service service provides a form by which a natural person-entrepreneur or a legal entity can appeal against a decision of the RVZ Bardejov.
Notification to the State Institute for Drug Control of the results of the assessment of the serious adverse reaction of transfusion products
The service will allow the holder of the authorization for the preparation of transfusion products to provide the State Institute for Drug Control with data in accordance with § 69, Article 6 e) of Act no. No. 362/2011 Coll. On Medicinal Products and Medical Devices, as amended. The relevant data can be provided via the form available on the ŠKL website in paper form as well as electronically in full through the form published on the Central Public Administration Portal (slovakia.sk). For electronic submission to slovakia.sk, it is necessary to use eID (Electronic Citizenship Card) and KEP (Qualified Electronic Signature).
Submission of intention to manufacture, import or distribute the active substance used as feedstock in the manufacture of the medicinal product
The service will allow a natural person or a legal entity to report on the treatment of active substances within the scope of production, distribution, import in accordance with Section 12a of Act no. No. 362/2011 Coll. On Medicinal Products and Medical Devices, as amended. The relevant information can be provided via the form available on the ŠKL website in paper form, as well as fully electronically through the form published on the Central portal of the public administration (slovakia.sk). For electronic submission to slovakia.sk, it is necessary to use eID (Electronic Citizenship Card) and KEP (Qualified Electronic Signature).
Publication of information by the Public Health Authority of the Slovak Republic and Regional Public Health Offices in the Slovak Republic
/resource_feedback/43860
Notification of work category 2 to the competent public health authority on 31 December of the previous calendar year
Through the form, the end-service provides the submission of data electronically to the competent public health authority concerning employees performing work in the second category as at 31 December of the previous calendar year.
Informing pharmacies and dispensaries of medical devices by requesting information
The service allows you to request published information in the form of electronic submission, which will be sent electronically to your e-mail box.
First Aid Medical Service - Sending Information
The service allows you to request the published information in the form of an electronic submission, which will be sent electronically to your e-mail box.
Informing about emergency services in pharmacies - sending information
The service allows you to request published information in the form of electronic submission, which will be sent electronically to your e-mail box.
Informing about healthcare facilities (hospitals and clinics) - sending information
The service allows you to request published information in the form of electronic submission, which will be sent electronically to your e-mail box.
Informing citizens about their membership of the health district - sending information
The service allows you to request published information in the form of electronic submission, which will be sent electronically to your e-mail box.
Publication of information by the Public Health Authority of the Slovak Republic and Regional Public Health Offices in the Slovak Republic
/resource_feedback/44415
Informing pharmacies and dispensaries of medical devices by requesting information
The service allows you to request published information in the form of electronic submission, which will be sent electronically to your e-mail box.
First Aid Medical Service - Sending Information
The service allows you to request the published information in the form of an electronic submission, which will be sent electronically to your e-mail box.
Informing about emergency services in pharmacies - sending information
The service allows you to request published information in the form of electronic submission, which will be sent electronically to your e-mail box.
Informing about healthcare facilities (hospitals and clinics) - sending information
The service allows you to request published information in the form of electronic submission, which will be sent electronically to your e-mail box.
Informing citizens about their membership of the health district - sending information
The service allows you to request published information in the form of electronic submission, which will be sent electronically to your e-mail box.
Publication of information by the Public Health Authority of the Slovak Republic and Regional Public Health Offices in the Slovak Republic
/resource_feedback/44645
Informing citizens about their belonging to the health district
The service will enable the State Institute for Drug Control to submit additional documentation for registration procedures - comments. The information can be provided through a form available on the ŠÚKL web site in paper form, as well as fully electronically via a form published on the Central Public Administration Portal (slovensko.sk). For electronic submission to slovak.sk it is necessary to use eID (electronic ID) and KEP (Qualified Electronic Signature).
Determining the health care provider to the citizen
The Marketing Authorization Holder will report the SIDC's promotional materials. The form contains information on: - what advertising material is involved, - what persons it is intended for (eg lay or professional public, post-menopausal women, parents of pre-school children, etc.), - way of dissemination (eg advertising in the press, leaflet, etc.), - date (in the form of DD.MM.YYYY) of the start of distribution (this is always an advertisement captured on a tangible substrate), - other activities defined in § 8 para. 2 of the Advertising Act.
Submission of additional responses to registration procedures
The service will enable the State Institute for Drug Control to submit additional documentation for registration procedures - comments. The information can be provided through a form available on the ŠÚKL web site in paper form, as well as fully electronically via a form published on the Central Public Administration Portal (slovensko.sk). For electronic submission to slovak.sk it is necessary to use eID (electronic ID) and KEP (Qualified Electronic Signature).
Reporting the upcoming ad ad
The Marketing Authorization Holder will report the SIDC's promotional materials. The form contains information on: - what advertising material is involved, - what persons it is intended for (eg lay or professional public, post-menopausal women, parents of pre-school children, etc.), - way of dissemination (eg advertising in the press, leaflet, etc.), - date (in the form of DD.MM.YYYY) of the start of distribution (this is always an advertisement captured on a tangible substrate), - other activities defined in § 8 para. 2 of the Advertising Act.
Submission of a quarterly notification to the holder of a medicinal product authorization
The service will enable the drug manufacturer to announce the number and size of packaging and the type of medicines delivered to the domestic and foreign markets. sk). For electronic submission to slovak.sk it is necessary to use eID (electronic ID) and KEP (Qualified Electronic Signature).
Application for registration / notification of the manufacturer of medical devices in accordance with the Act on Medicines and Medical Devices
The service will enable a natural person or legal entity to apply for a marketing authorization for the treatment of designated substances of category 2 and 3, their repair, designation of validity, change or cancellation pursuant to Act No. 362/2011 on medicines and medical devices and on amendments and supplements to certain acts. Applications can be submitted through a form available on the ŠÚKL web site in paper form, as well as fully electronically via a form published on the Central Public Administration Portal (slovensko.sk). For electronic submission to slovensko.sk it is necessary to use eID (electronic identity card) and KEP (Qualified Electronic Signature).
Marketing Authorization Application for Treatment of Designated Substances of Category 2 and 3 under the Medicines and Medical Devices Act
The service will make it possible to apply for a register of the laboratory, which is planning to carry out the assessment of purified water as an auxiliary substance for pharmacies pursuant to Section 28 of Act no. On Medicinal Products and Medical Devices as amended. Applications can be submitted through a form available on the ŠÚKL web site in paper form, as well as fully electronically via a form published on the Central Public Administration Portal (slovensko.sk). For electronic submission to slovak.sk it is necessary to use eID (electronic ID) and KEP (Qualified Electronic Signature).
Submission of a laboratory registration application for the control of purified water as an aid to pharmacies
The service will make it possible to apply for a register of the laboratory, which is planning to carry out the assessment of purified water as an auxiliary substance for pharmacies pursuant to Section 28 of Act no. On Medicinal Products and Medical Devices as amended.
Submission of an application for an extension of the registration of a medicinal product for human use under the Medicines and Medical Devices Act
The service will make it possible for the State Institute for Drug Control to submit an application to extend the registration of a medicinal product for human use in accordance with § 53 par. 8 of Act no. On Medicines and Medical Devices and on Amendments and Supplements to Certain Acts.
Submission of a marketing authorization for a medicinal product for human use
The service will allow the State Institute for Drug Control to submit an application for the registration of a human medicinal product in accordance with Section 47 et seq. of Act no. On Medicines and Medical Devices and on Amendments and Supplements to Certain Acts.
Applying for scientific advice on the development and registration of medicinal products for human use
The State Institute for Drug Control (SIDC) offers companies the opportunity to receive scientific advice on the development and registration of medicinal products for human use. The recommendation focuses primarily on the drug development strategy rather than on the preliminary assessment of the dossier accompanying the future marketing authorization application. It is limited to scientific issues and not to drug registration aspects.
Applying for a medicament certificate under the World Health Organization scheme
The service will enable the State Institute for Drug Control to apply for a medicinal product certificate under the World Health Organization scheme. The certificate is issued in parallel in Slovak and English.
Submission of an application for a special permit for the treatment of specified substances of category 1 pursuant to the Act on Pharmaceuticals and Medical Devices
The Service will allow a natural person or legal entity to request the issuance of a special permit for the treatment of designated substances of Category 1 in a public / hospital pharmacy, their repair, designation of legality, change or revocation pursuant to Act No. 362/2011 on Medicinal Products and Medical Devices and on the amendment of some laws.
Submission of an application for issuance of an authorization for handling specified substances of category 1 pursuant to the Act on Medicines and Medical Devices
The Service will enable a natural person or legal entity to apply for a license to treat specified substances of category 1, their repair, designation, change or cancellation under Act 362/2011 on medicines and medical devices and on amendments and supplements to certain acts.
Submission of a request for a declaration of legality and waiver of decisions in the treatment of drug precursors
The service will allow a natural person or a legal entity to request the designation of the lawfulness in decisions on the handling of drug precursors. Applications can be submitted through a form available on the ŠÚKL web site in paper form, as well as fully electronically via a form published on the Central Public Administration Portal (slovensko.sk).
Applying for a change / change in the registration of a human drug / drug
The service will allow the State Institute for Drug Control to submit a request for a change / change in the registration of a medicinal product for human use in accordance with § 55 par. 1, second sentence of Act no. On Medicines and Medical Devices and on Amendments and Supplements to Certain Provisions
Applying for revocation of a medicinal product for human use
The service will allow the State Institute for Drug Control to submit a request to cancel the registration of a medicinal product for human use in accordance with § 56 par. 4 (a) k) of Act no. On Medicines and Medical Devices and on Amendments and Supplements to Certain Acts.
Rental of medical devices
/resource_feedback/44920
Submitting an application to indicate the validity and enforceability of a decision of a state administration body in the public health sector
/resource_feedback/44921
Submission of an application for a revision examination to verify professional competence in the public health sector
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Submission of an application for verification of professional competence and issuance of a certificate of professional competence for epidemiologically relevant activities
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Submission of a request for issuing a decision of a state administration body in the public health sector
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Submission of a request for issuing a decision of a state administration body in the field of public health in the field of radiation protection
/resource_feedback/44929
Submission of an application for a binding opinion of the state administration body in the public health sector
/resource_feedback/44930
Informing about results of laboratory examinations
The service will enable the citizen to obtain information (notification) that the laboratory examination has been carried out. Notification can be read in the message box and in case of notification notification via SMS or mail. - obtain information on the results of laboratory examinations if the attending physician who requested the examination decided to make them available. It allows the healthcare provider to locate and retrieve patient laboratory requests as well as laboratory results. The results have the approach of the requesting physician for laboratory examination and other medical personnel in accordance with the patient's consent.
Informing yourself about vaccinations completed
Informing yourself of the vaccinations received will allow you to obtain an overview of the vaccinations completed in electronic form, such as the Electronic Vaccination Card, which will include the history of the vaccinations received and the schedule of future vaccinations. A citizen can access this card through HPH.
Informing the patient's medication history
For the citizen, the service provides information from an electronic health book on medication history. The data are also provided to other applicants in accordance with the approved consent of the recipient of the IB / legal representative through the HPH. At the same time, the service ensures the monitoring of other people's access to medication records by recording audit records in an electronic book
Informing yourself about the order in the waiting list
Informing about the order in the waiting list will allow the citizen and physician to obtain information about the status of the electronic ticket in the waiting list. The information obtained includes the scheduled performance date, the type of performance and the health care provider's identification. The IB provider for whom the waiting list is maintained and the general practitioner of the person has the opportunity to search for the patient's inclusion in the waiting lists based on the entry criteria.
Applying for an order from a primary care physician
Submitting an order for a primary ZS physician allows a citizen to order electronically from a first contact physician in an HPH eHealth environment. By entering the service Submission of an order for a primary ZS doctor, a suitable HCC (ie primary ZS physician) and a selected calendar for the desired type of examination is selected. Then a calendar of free dates for examination will be offered.
Submitting a request for appointment with a specialist / special examination
Submission of an order for a specialist / special examination will be possible in an electronic way: - to order a citizen (with his / her active participation) to a specialist, - to order a citizen directly on the basis of the generated electronic request from the previous IB provider via HPH. After selecting the appropriate PZS (ie specialist) and determining the type of examination (entrance examination, subjective complaints, etc.), they will be offered a calendar of free dates for examination
Provision of personal data of the insured person in electronic form
The service enables users through HPH to obtain the output of the policyholder's personal account collection and processing processes from health insurance companies. When providing the insured person's personal account, it is necessary to make a selection of the required data - the aim is to select criteria that define the content of the electronic data output from the insured's personal account (eg overview of provided care and prescriptions, overview of performance and costs, time validity).
Providing patient access health records
The service allows the citizen to monitor access to personal and health information. The service displays records of access to patient's medical information based on the specified criteria. The list also contains authorized accesses and a list of unauthorized access attempts.
Providing access records to a particular patient's electronic health record
The service will return the citizen, upon request, an output with a list of access to individual electronic health records. Patient Access Records are accessible directly from the EZKO web application A list of accesses, which includes who, in what role, by which service and at what time to access the record, is registered and accessible for each entry in the system. The service allows filtering of outputs. The patient may seek access for the date period, search for all access by a particular health care professional for the selected period, search for access for a particular record for the selected period.
Issue a warning to citizens in case of epidemics or other facts and threats
Issuing Citizens' Warnings for Epidemics or Other Facts and Threats will allow citizens to be alerted electronically in the event of epidemics or other relevant health issues by monitoring and publishing public health emergencies and threats.
Entering preventive inspection plan
The service allows the citizen to create - schedule a preventive check-up. Subsequently, the impending deadline is notified. In this planning, the user defines the type of examination by selecting from a predefined list and a term. The service is accessible through the visual interface of the health portal.
Writing data to an electronic health book
The service allows the citizen to enter additional data in an electronic health book. The citizen has the opportunity through the service: - to register contact and ICE persons - to record the use of over-the-counter drugs and free-selling nutritional supplements - to register a note on the provided IB For the providers of health care, it is possible to enroll individual parts of the patient summary, ie to record personal, administrative, summary clinical data .
Change Ordering (Move / Cancel)
Changing the order (transfer / cancellation) will allow the citizen through HPH, subject to certain conditions, to change the reserved or confirmed deadline for the SSC. The service can also be used by the doctor when moving and canceling orders in relation to the citizen (Write a reservation, confirm reservation).
Submitting an inquiry into the healthcare provider's procedure
The service allows the applicant to apply for an inquiry into the healthcare provider's procedure. If a citizen believes that he or she has not been properly treated by the healthcare provider or believes that the other healthcare professional's decision to provide healthcare or healthcare-related services is incorrect, he / she has the right to seek redress from the healthcare provider.
Submission of an application to investigate the procedure of a health insurance company
The service allows the applicant to apply for an investigation into the procedure of the health insurance company. The Office handles complaints related to public health insurance, which relate, for example, to the activities of a health insurance company, the legality of a health insurance company in the process of reinsurance, resolves disputes arising from the annual settlement of premiums for public health insurance, the selection of a health insurance company, reimbursement of health care to and from conditions laid down by law. The service also makes it possible to initiate an emergency medical care if the relevant health insurance company does not have a health care contract with the provider or if the citizen has not been allowed to participate in the health care provided.