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Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
According to Government Decision 734/2010 regulating the organisation and functioning of the National Agency for Medicines and Medical Devices, the agency is the main body responsible for supervising and controlling the medicine and medical devices market.
It supervises and controls the manufacture, import and distribution of human-use medicines by way of issuing authorisations, performing periodic inspections and planned or unannounced control activities. At the same time, it examines all complaints regarding the effect or quality of medicines and performs inspections on behalf of the Ministry of Health, at the latter’s request.
The agency is also responsible for authorising and verifying the performance of clinical studies, as well as the organisation, guidance and control of pharmacovigilance activities.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
Certain provisions regarding the combat of bribery, fraud, collusion, counterfeiting and dishonest practices can be found in different normative acts regulating the pharmaceutical sector, although these are mostly regulated by way of generally applicable laws, such as those dealing with anti-corruption or intellectual property. The mechanisms set in place in this regard consist of authorisation and control procedures.
Ministry of Health Order 194/2015 regulating the advertising of medicinal products contains implicit provisions against bribery in the chapter regulating permitted forms of advertising materials intended for healthcare professionals. According to this, the offer, supply or promise of gifts, financial advantages or other benefits to a healthcare professional in order for him or her to prescribe, purchase, provide, sell or administer a medicine is prohibited unless these are worth less than €35 and are for advertising material relevant to the practice of medicine or pharmacies.
At a general level bribery is regulated by the Criminal Code (286/2009) and the Prevention of Corruption Law (78/2000).
Mechanisms for combating fraud can be found in the Criminal Code, the Prevention of Corruption Law and the Punishment for Corruption Law (161/2003), which set out punishments, ways for the public to notify competent authorities and the powers of these competent authorities. In addition, the Tax Code (277/2015) sets out registration and reporting mechanisms.
Collusion is generally regulated by the Competition Law (21/1996), which punishes certain types of agreement (ie, price fixing, market sharing and the limitation of production, technical developments and investments) as anti-competitive practices. The law also establishes the Competition Council as the main regulatory and control authority in the field.
The Healthcare Reform Law (95/2006) obliges the National Agency for Medicines and Medical Devices and other competent authorities to take measures against the introduction of suspected counterfeit medicines, even when they are not intended for marketing in Romania.
The agency has set up a website (www.crimemedicine.ro) whereby the public can notify it of potential counterfeits.
The law’s provisions on packaging and labelling provide an obligation for marketing authorisation holders to use anti-counterfeiting measures in the packaging of medicines in order to allow authorised distributers to verify the authenticity of medicines.
In addition, the Trademarks Law (84/1998) and the IP Customs Regime Law (344/2005) set out remedies for the placement on the market of counterfeit goods.
Other dishonest practices
Provisions dealing with other dishonest practices are set out in the Competition Law and the Law on Misleading and Comparative Advertising (158/2008), which set out dishonest practices notification procedures and control and penalty mechanisms to be carried out by the Competition Council, the Ministry of Finance and the National Audiovisual Council.
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