The attitudes of the Romanian population towards falsified medicinal products
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List of medicinal products with marketing authorisations which should bear safety features
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About serialisation and the Romanian Organisation for Serialisation of Medicinal Products (OSMR)
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For the purpose of protecting patients, all interested parties, especially end users (UF) registered in the OSMR, must be aware of the obligations under the delegated regulation (EU) 2016/161 of the Commission to supplement Directive 2001/83/EC of the European Parliament and of the Council by establishing detailed rules for the safety elements on the packaging of medicinal products for human use.
Failure to comply with the legal obligations mentioned in the Directive related to falsified medicinal products and in the Delegated Regulation of the Commission are a violation of the EU legislation. In fulfilling their duties, NAMMDR inspectors shall verify, during the inspections carried out, compliance with the obligations provided in the Commission Delegated Regulation (EU) 2016/161 and in Order of the Minister of Health no. 1473/2018.
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To the attention of interested persons: ‘Patient safety due to medicinal product safety’ – OSMR & NAMMDR
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