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).
Pursuant to Paragraph 109.1 of Regulation 416, prior to initiation of distribution of parallel imported, parallel distributed and unauthorised medicinal products in cases stipulated by Paragraph 4 and 5 of Annex 8 to this regulation, the wholesaler shall submit information regarding medicinal product batches to be distributed and the distributor to the State Agency of Medicines (SAM).
The wholesaler is authorised to distribute medicinal products mentioned in Paragraph 109.1 of this regulation after SAM has informed the wholesaler of the permission to distribute the relevant medicinal products, based on the certificate issued by an Official Control Authority Batch Release (OCABR) or public health interests, because the medicinal product is not available on the market and there is an immediate risk related to the spread of a viral disease or a risk to human health or life.
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.
The European Directorate for the Quality of Medicines & HealthCare OCABR guidelines