Valsts valodas centra izstrādātie ķīmijas un ķīmiskās tehnoloģijas termini

Konteksts: [..] An adverse reaction, the nature, severity or outcome of which is not consistent with the Summary of Product Characteristics (SPC) (Article 1(13) of Directive 2001/83/EC)62. This includes class-related reactions which are mentioned in the SPC but which are not specifically described as occurring with this product. For products authorised nationally, the relevant SPC is that approved by the Competent Authority in the Member State to whom the reaction is being reported. For centrally authorised products, the relevant SPC is the SPC authorised by the European Commission. During the time period between a CHMP Opinion in favour of granting a marketing authorisation and the Commission Decision granting the marketing authorisation, the relevant SPC is the SPC annexed to the CHMP Opinion. [..]
Avots: Cabinet Regulation No 919 Adopted 6 December 2005. Regulations Regarding the Monitoring of Side Effects Caused by the Use of Medicinal Products.