Submission and examination of complaints concerning the activities of the Agency

Handling of complaints in the State Medicines Control Agency (hereinafter - the Agency) is regulated by:

• Law on Public Administration of the Republic of Lithuania;
• Resolution / decision of the Government of Lithuania No. 875 of August 22, 2007 “On the Approval of the Rules for the Examination of Requests and Complaints and the Servicing of Persons in Public Administration Entities”;
• Order of the Head of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania No 1A-12 of January 3, 2012 “On Approval of the Job Regulations of the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania”.
• Requirements of the standard LST EN ISO 9001: 2015 “Quality Management Systems. Requirements”

Complaint - a written personal appeal to the Agency stating that there is a violation of his/her or another person's rights or legitimate interests and asking to defend them.

Complaint – expression of dissatisfaction made to an organization, related to its product or service, or the complaints-handling process itself, where a response or resolution of explicitly or implicitly is expected.

A written complaint has to:

• be written in the state language or have a translation into the state language, the authenticity of which would be certified in accordance with the procedure established by the Law on Notaries of the Republic of Lithuania;
• be written legibly;
• be signed;
• state the name and surname of the person providing the complaint and name of a company, if complained on behalf of the legal person, the address or other contact details by which the person wishes to receive a reply;
• if the person's representative applies to the institution on behalf of the represented person, in addition to his name, address or other contact details, he/she has indicate in the application the name of the represented person (if applied on behalf of individual) and provide a document certifying representation or a copy thereof.

A complaint can be provided to the Agency in a one of the following ways:

-       by post to State Medicines Control Agency, 139A Žirmūnų str., Vilnius;

-       by fax: +370 5 263 9265;

-       by email: [email protected] (scanned copy);

-       deliver to the Agency, cabinet no. 35.

For your convenience, there is prepared a complaint form, which you can download, complete and submit to the Agency in the ways provided above.

Reasons of complaint may be (the list is not completed):

• nonconformity with the established and announced customer service time;
• delays in providing the service (non-compliance with deadlines);
• not provided service;
• decisions, conclusions made or results provided that did  not satisfy a customer;
• delays in responding to inquiries;
• inadequate, misleading information or avoiding or refusal to provide it;
• rude, unethical behavior of the employee;
• corruption (abuse of authority, discrimination against customers, improper use of available official information, etc.);
• dissemination or loss of confidential information related to the customer or employee;
• delays in dealing with received complaint.

Complaints are accepted and registered at Administration and Resources Management Unit in accordance with the established general procedure for registration of documents received by the Agency.  An impartial person or a commission has to be appointed to examine the complaint.

A document confirming the fact of acceptance of the complaint is sent to the complainant not later than within 3 working days from the day of receipt of the complaint at the Agency.

Complaints regarding actions, omissions or administrative decisions taken by the Agency are examined in accordance with the Third Section of the Law on Public Administration of the Republic of Lithuania “Administrative Procedure”.

When examining a complaint, the Agency has the right to request the complainant to submit documents and information that are not in state registers or other state information systems.

The complaint must be examined and an administrative decision taken within 20 working days of receipt of the complaint by the Agency.

The answer to the complainant is provided in the official language and in the manner in which the complaint was received or in the manner specified in the complaint.

At objective reasons, the time limit for examining the complaint may be extended. The complainant shall be informed about such extension in writing no later than 2 working days after the decision is made.

Please note that in accordance with Item 3 of Article 23 of the Law on Public Administration of the Republic of Lithuania, complaint that does not indicate complainants’ name, address or is unsigned by a person, may not be examined by the decision of the Head of the Agency or his authorized person.

Complaint form (download)