Requirements for quality control of medicines, including special requirements for quality control of immunological preparations (vaccines and medicines derived from human blood and plasma), are stipulated by Section X “Quality Control of Medicinal Products” of the Cabinet of Ministers Regulation No. 416 of 26 June 2007 “Procedures Regarding Distribution and Quality Control of Medicinal Products” (hereinafter – Regulation No. 416).
Paragraph 108 of Regulation No. 416 stipulates that the State Agency of Medicines (SAM) is entitled to recognise the test results of an official medicinal product control laboratory of another European Economic Area state or, if the medicinal products have been manufactured in Latvia, shall declare it to be in conformity with the approved specifications on the basis of the batch manufacturing protocol and the test results. The examination shall be carried out in accordance with the procedures laid down in the Administrative Procedure Law, but not later than within 60 days after receipt of the samples and documentation.
Pursuant to Paragraph 109.1 of Regulation 416, medicinal product marketing authorisation holder shall submit a copy of the certificate issued by an Official Control Authority Batch Release (OCABR) of a European Economic Area state together with information regarding distribution of medicinal products to the State Agency of Medicines. If a justified request to submit samples for testing has not been received from SAM within seven working days, distribution of the medicinal products may be commenced.
According to the guidelines provided by the European Directorate for the Quality of Medicines (EDQM), information must be submitted to SAM at least 7 working days prior to initiation of medicinal product distribution in Latvia or SAM must be informed separately regarding the necessity for authorisation to initiate distribution of specific batches immediately. If no objections have been received from SAM, batch distribution may be initiated within 7 working days or, in case of emergency necessity – upon receipt of SAM approval.
Additional information
The European Directorate for the Quality of Medicines & HealthCare OCABR guidelines
