Mateea has developed significant experience advising some of the world's leading pharmaceutical companies operating in Romania on strategic regulatory matters relating to medicinal products and medical devices, including marketing authorisation and market access, pricing and reimbursement, promotion, as well as interactions with the competent authorities.
Mateea also advises leading international and national manufacturers, distributors and retailers across a broad range of industries on the legal and regulatory framework applicable to cosmetics, food supplements, food products, infant formula, household appliances, detergents, clothing and automotive products. Her practice further covers consumer protection, e-commerce and digital platforms, advertising and commercial practices, as well as product liability.
An association of international medicines manufacturers, on various enactments and initiatives concerning the social health insurance system and the national health programs, the pricing and reimbursement of medicinal products, including dispute resolution legal work related to the constitutionality and the legality of the clawback system implemented in Romania.
A major pharmaceutical company from France, in connection with various matters including market access, health technology assessment, the inclusion of medicines in the reimbursement list, pricing, the trade and distribution of medicinal products, the implementation of educational and promotional programs, the donation of medicines, the drafting and conclusion of logistic services agreements, services and supply agreements, as well as numerous other agreements with healthcare professionals and healthcare organizations, the sponsorship of physicians, medical institutions and scientific events. We have successfully represented the Romanian subsidiary of this company before the courts in numerous litigations having as object the challenging of clawback notifications for various quarters.
A large pharmaceutical company from Switzerland, on numerous regulatory and commercial legal matters, such as the distribution and trade of medicinal products and of medical devices, the clawback tax, the conclusion of cost-volume agreements, protocols and other agreements with the healthcare authorities, public institutions, healthcare professionals and healthcare associations, the supply of medicines under public procurement procedures.
A pharmaceutical company from the United States, on numerous pharmaceutical regulatory matters, including without limitation to the issuance of the marketing authorization for medicinal products, the approval of the medicines’ prices, the inclusion of medicinal products in the national list of reimbursed medicines, the supply of medicines under public procurement proceedings, clinical trials, the conclusion of numerous agreements with healthcare professionals and various services providers and business partners.
A multinational pharmaceutical company from Denmark, on numerous pharma regulatory matters, including the conclusion of wholesale distribution agreements, the donation of medicinal products and medical devices, the implementation of educational programs for physicians and data protection matters; successful representation of the company before the competent courts in the clawback litigations.
A pharmaceutical company from Japan, with respect to the distribution and establishing the price of medicines, the pricing of medicines, the drafting and conclusion of various sponsorship, consulting services, speaker services and advisory board agreements, as well as on relevant data protection matters.
A pharmaceutical company from Germany, in relation to the distribution of its medicinal products in Romania, the payment of the clawback tax and the conclusion of wholesale distribution agreements with Romanian business partners.
One of the largest pharmaceutical groups in Europe in relation to numerous regulatory aspects in the pharmaceutical field, such as the clawback contribution, representation of the client before the competent authorities, sponsorship contracts concluded with healthcare professionals, marketing and distribution of medicines, donation of medicines.
A leading U.S. pharmaceutical company in connection with promotion of medicinal products, clinical trials, implementation of educational programs for healthcare professionals, sponsorship of scientific events, clawback contribution.
One of the largest pharmacy chains in Central Europe in relation to contractual and regulatory matters regarding the successful acquisition of the largest pharmaceutical wholesaler and a chain of 600 pharmacies, including in relation to the reimbursement and distribution of medicines and supply of medical devices, supplements and cosmetics.
A major global pharmaceutical company in connection with the health technology assessment, pricing and reimbursement of medicines, conclusion of protocols and cost-volume/cost-volume-result agreements with health authorities, clawback contribution, etc.
One of the largest FMGC companies in the world regarding the review and approval process of labeling and promotional materials, as well as campaigns for products launched on the Romanian market, including review of TV commercials, online spots, etc.
A giant US provider of subscription video-on-demand streaming services in connection with the launch in Romania of its streaming platform and the evaluation of any regulatory and consumer protection issues that could affect the launch and the services offered to subscribers.
One of the most important manufacturers of electrical household products worldwide in connection with the marketing campaigns for the launch of a range of new products on the Romanian market, the promotion and labeling of electrical household products, including in relation to energy labeling issues.
A leading manufacturer of electrical equipment and machinery in Japan and worldwide, in connection with the advertising and promotion of certain products, including online advertising and promotions, as well as in connection with several corporate and regulatory matters.