Laws and regulations

• The Falsified Medicines Directive is Directive 2011/62/EU passed by the European Parliament and the Council on 8 June 2011 that amends Directive 2001/83/EC on the Community code relating to medicinal products for human use and prevention of falsified medicines from getting into a legal chain of supply
• The Delegated Regulation is delegated regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use
• Amendments to the Delegated Regulation – Commission Delegated Regulation of 13.1.2021, amending Delegated Regulation (EU) 2016/161 as regards a derogation from the obligation of wholesalers to decommission the unique identifier of products exported to the United Kingdom
• The European Commission questions and answers document (in English) about the implementation of safety features for medicinal products for human use
• Assessment of the impact
• The Pharmaceutical Law regulates the activity of physical and legal entities in the field of pharmacy, as well as ensures manufacturing and distribution of high-quality and medically suitable medicines of a proper preventive, therapeutical and diagnostic level
• Cabinet Regulation No. 220 "Procedures for the Acquisition, Storage, Use, Registration and Disposal of Medicinal Products in Medical Treatment Institutions and Social Care Institutions" 
• Cabinet Regulation No. 304 "Regulations Regarding the Procedures for the Manufacture and Control of Medicinal Products, the Requirements for the Qualification and Professional Experience of a Qualified Person and the Procedures for the Issuance of the Certificate of Good Manufacturing Practice to a Medicinal Products Manufacturing Undertaking"
• Cabinet Regulation No. 57 "Regulations Regarding Procedures for the Labelling of Medicinal Products and the Requirements to Be Set for the Package Leaflet of Medicinal Products" 
• Cabinet Regulation No. 416 "Procedures Regarding the Distribution and Quality Control of Medicinal Products"
• Cabinet Regulation No. 436 "Procedures for the Importation and Exportation of Medicinal Products"