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Information updated on 18.05.2021.
How to notify the Health Inspectorate of the performance of the duties imposed during the control, how pharmaceutical operators can submit a notification to the Health Inspectorate, how to apply for an authorisation, opinion or assessment of the Health Inspectorate.
Authorities concerned: Health Inspectorate (VI), Enterprise Register (UR)
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Representatives of the health inspection (hereinafter - VI) supervisory facilities (medical treatment, education, beauty and other institutions) have the possibility to inform VI electronically regarding the non-compliance and performance of duties determined during the control, as well as to request an extension of the time period for the performance of duties imposed.
Need for checks
Ensuring that the public is safe to provide quality services for medical treatment, education, beauty, etc. In the institutions of VI supervisors, VI shall carry out occasional planned or unplanned inspections evaluating the provision of services by the institution, assessing the compliance of the institution with the mandatory requirements, as well as verifying compliance with the requirements of other regulatory enactments, which determine the work of the institutions, such as the purchase, storage, accounting and destruction of medicinal products, basic hygiene requirements, compliance with the requirements.
See the procedure for carrying out the VI checks here, and the model for completing the control documentation is here.
Where non-compliance is found
If, as a result of the verification carried out, the VI finds any non-compliance, it shall make recommendations to the authority for the elimination of the non-compliance and shall instruct it to rectify it within the
Response to the correction of shortcomings, extension of deadline
The Authority may inform VI of the non-compliance identified during the control and of the implementation of the measures to be taken, as well as request for an extension of the deadline, by selecting, by electronic means, an e-service Communication on the www.latvija.lv portal on the performance of the duties imposed during the control of the Health Inspectorate, which provides the possibility to connect via the Internet to the non-conformities identified and measures to be taken. For the purposes of preparing the notification, the authority must indicate the data of the controlled facility and the control act, indicate which non-conformities identified are intended to be reported, provide information on the non-conformities eliminated and/or the justification for the extension of the period.
After sending a notification
After sending the notification, in the www.latvija.lv portal, information will be displayed that the VI notification has been received, as well as the document number with which the notification was registered in VI.
The notification VI will be reviewed in accordance with the procedures specified in regulatory enactments, the necessary actions will be taken and a response will be prepared. For additional information and other uncertainties, VI will contact the applicant by email or telephone.
Representatives of pharmaceutical companies have the possibility to submit electronically a notification to the Health Inspectorate (hereinafter - VI) regarding the withdrawal of medicinal products, a promotional seminar for medicinal products, as well as statements on material or other support provided to associations, foundations and medical institutions.
The notification shall be made by the operator as a representative of the legal person, indicating the information of the company represented as well as the contact details to be used for communication with VI on the direction of the notification. When preparing the notification, the information required for the corresponding type of notification must be provided, and the necessary files with the documents must be attached, if any, if required.
After sending the notification, in the www.latvija.lv portal, information will be displayed that the VI notification has been received, as well as the document number with which the notification is registered in VI. The notification VI will be reviewed in accordance with the procedures specified in the regulatory enactments, the appropriate actions will be taken and a response will be prepared if necessary. In the event of additional information and other uncertainties, VI will contact the operator by email or telephone.
Natural and legal persons, including local governments, have the possibility to submit an application electronically for the receipt of a Health Inspectorate permit, opinion or assessment in the fields of monitoring of the Health Inspectorate, for example to apply for a permit for the purchase of medicinal products (medical institutions and social care institutions), as well as public services in the field of assessment of compliance with environmental health and hygiene requirements.
Types of opinions/assessment
By selecting an e-service Application for a Health Inspectorate authorisation, opinion or assessment on the www.latvija.lv portal, the option is to select and apply for:
Add the necessary information
The application shall fill in all the requested information concerning itself and, if necessary, shall be accompanied by attachments. As well as indicate the type of reply - to the address specified, to the e-mail provided, to the Health Inspectorate.
Individual opinions are fees
Individual opinions, evaluations are a fee service. If the service is charged, you will be informed about the number of days after you have received an e-invoice when you complete your application. The Public Service Price List of Health Inspectorate Charges is available for consultation of here in .
When authenticating, I agree and undertake to comply with the rules for the use of the electronic identification solution.
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