Cabinet Regulations No 172 of 28th February 2006 has been replaced/ repealed by Cabinet Regulations No 289
of 23rd March 2010 which now lays down requirements for Observational Studies in Latvia which include the requirement for both Competent Authority and Ethics Committee approval prior to study start.
Prior to commencement of observational studies, a physician or
a representative of the medicinal product manufacturer, who is responsible for
coordination of the observational study, shall submit the below listed
documents to the State Agency of Medicines and the Ethics Committee:
An application containing the following details:
Name of the observed medicinal product, its generalized
name, form and strength;
Description of the observational study project (as
well as criteria for inclusion of patients in the observational study and data
analysis methods to be used);
Physicians participating in the conduct of the
observational study, stating the name, surname and speciality);
Medical institutions participating in the conduct of
the observational study;
The planned number of patients to be involved;
Whether the disease, which is supposed to be treated
using the observed medicinal product, is included into the medicine refund
Whether the observed medicinal product is included
into the list of refunded medicines;
Period of the observational study, stating the days of
commencement and completion;
A specimen of a document whereby a patient shall certify
his/her consent to the treatment data collection and processing;
A specimen of an observational data recoding document
The applicant shall cover all costs related to reviewing of
his/her request for authorization of an observational study in accordance with
the State Agency of Medicines' pricelist for public services.
An observational study may be commenced if the Ethics
Committee has issued a favourable opinion and the State Agency of Medicines has
not informed the applicant of its grounds for non-acceptance within 30 days of
the day the request was filed.
The physician shall report any adverse drug-related
reactions stated during the observational study to the State Agency of Medicines
in compliance with the regulation on adverse reaction surveillance.
Within 90 days of completion of an observational study,
the physician or the person referred to in Paragraph 129 of these Regulations,
shall notify the State Agency of Medicines in writing about the completion of
the observational study and submit a consolidated report on the number of
patients involved and any adverse drug-related reactions stated.
The compliance of observational studies with these
Regulations shall be supervised by the State Agency of Medicines and inspected
by the Health Inspection within the limits of their competency.
Persons involved in observational studies shall not
disclose the personal and clinical data of the patients except in cases the
said data are requested by the institutions, which are entitled to familiarize
themselves with patient's data as provided by the Law on Medical Care.
These regulations came into effect on 1 April 2010.
For further information refer to:Cabinet Regulations No 289
: Procedures for Clinical
Trials and Observational Studies of Administration of Medicinal Products,
Marking of Investigational Medicines and Assessment of Conformity to Good