updated September 2024
Administrative fees (within the meaning of item 152 of the Annex to Act No 145/1995 Coll. on Administrative Fees, as amended) shall be paid by the applicant when submitting the application in accordance with the provisions of Section 142(2) of Act No 362/2011 Coll. No. 362/2011 Coll. on Medicinal Products and Medical Devices, as amended (hereinafter referred to as "Act No. 362/2011 Coll.").
IMPORTANT!!!
When making the payment, please do not forget to indicate the correct Variable symbol (VS). For non-cash payments from abroad, it is necessary to specify the E2E reference code in an identical form (number of characters, slashes) as displayed on your Payment Instruction.
This is important so that your payment can be matched with the Payment Instruction for the fee and afterwards your service request can be processed.
In case of an incorrect VS or payment of an expired Payment Instruction, your payment will be returned to you.
The CESP electronic portal can be submitted via eAF (Electronic Application Forms) and documentation submitted in the form of eCTD. All types of applications can be submitted. These applications are submitted on the day they are delivered to ŠÚKL; on this day, the administrative procedure regarding the application to the SIDC is started. Notification of the acceptance of applications and the allocation of a registration number will be sent to the postal address of the contact person for the Slovak Republic, which is listed in the eAF or whose authorization (original or notarized copy) has been delivered to ŠÚKL.
It is possible to submit an application electronically using a form published on the Central Portal of Public Administration (slovensko.sk). It is possible to submit only types of applications that do not have an application and documentation submitted in eCTD format via the CESP portal (for example, a request for a transfer, a request for the cancellation of a medicine,...). For electronic submission to slovensko.sk, it is necessary to use eID (electronic identity card) and KEP (Qualified Electronic Signature). These applications are submitted on the day they are delivered to ŠÚKL; on this day, the administrative procedure regarding the application to the ŠÚKL is started. The notification of receipt of the application and the allocation of the registration number will be sent to the e-mail address of the person who submitted the application or to the contact person for the Slovak Republic, who is listed in eAF or whose authorization (original, notarized copy or PDF with a valid electronic signature) has been delivered to the SIDC.
More information can be found here or here
In the Client Center, it is possible to submit applications directly, as well as to consult on possible deficiencies in the application. It is possible to submit only types of applications that do not have an application and documentation submitted in eCTD format via the CESP portal (for example, a request for a transfer, a request for the cancellation of a medicine,...). The date of submission of the application to the Client Center is the date of submission of the application by the applicant; t. j. is the date of initiation of administrative proceedings in the matter of the application to ŠÚKL. The notification of receipt of the application and the allocation of the registration number will be sent to the e-mail address of the person who submitted the application or to the contact person for the Slovak Republic, who is listed in eAF or whose authorization (original, notarized copy or PDF with a valid electronic signature) has been delivered to the SIDC.
You can find the client center on the ground floor of ŠÚKL and the office hours are published here
In the case of submitting an application to the SIDC Registry Office, in addition to the application, it is necessary to submit a cover letter with identification data related to the application in question. It is possible to submit only types of applications that do not have an application and documentation submitted in eCTD format via the CESP portal (for example, a request for a transfer, a request for the cancellation of a medicine,...). The date of submission of the application to the registry office is the date of submission of the application by the applicant; t. j. is the date of initiation of administrative proceedings in the matter of the application to ŠÚKL. The notification of receipt of the application and the allocation of the registration number will be sent to the e-mail address of the person who submitted the application or to the contact person for the Slovak Republic, who is listed in eAF or whose authorization (original, notarized copy or PDF with a valid electronic signature) has been delivered to the SIDC.
Submission of applications on an electronic medium (CD/DVD) with an eCTD sequence is only possible for medicines registered by the national procedure with a cover letter and only through the SIDC office. The electronic carrier (CD/DVD) must be labeled with the following information:
Name of the drug, pharmaceutical form (abbreviation), strength, type of application (new registrations, extension, IA/IB change, in the case of MRP/DCP applications also procedural number, sequence number and total number of data carriers (e.g. 1/3, 2 /3....)
You can find the office on the ground floor of ŠÚKL and the office hours are published here
Applications delivered via the Post Office or by courier are submitted on the day they are delivered to SIDC; on this day, the administrative procedure regarding the application to the ŠÚKL is started.
If the applicant for the registration of a human medicinal product does not have a place of residence or registered office and the territory of the Slovak Republic, he is obliged to authorize a natural person with a place of residence or registered office in the Slovak Republic or in another member state for the entire procedure regarding the registration of the given medicine, for all procedural acts in the given procedure as well as for receiving delivered documents.
The power of attorney must be signed by the manager/executives of the company (the person/persons authorized to act according to the entry in the commercial register) and must be submitted to SIDC as an original, notarised copy or PDF with a valid electronic signature in the Slovak language or in the English language.
In the case of a change of authorized person, it is necessary to submit the cancellation of the power of attorney valid until then.
If the applicant for a decision on the registration of a medicinal product submits the application in question for the first time in the Slovak Republic, he shall electronically attach a current extract from the commercial register in the form of a pdf in the eCTD sequence or by email in the form of a scan. If it is not possible to send the extract from the commercial register electronically, it can be submitted in paper form in the form of a photocopy. The extract from the commercial register is sent by the applicant even if an important change has been made to it, such as name, address, etc.
