Healthcare, Medicine & Pharmaceuticals

AEQUITAS is one of a few Kazakhstan’s law firms having an active dedicated practice in the field of healthcare, medicine and pharmaceuticals.

The firm’s clients are more than 20 international, foreign and local manufacturers of medical and pharmaceutical products.

The firm’s lawyers are perfectly knowledgeable about the applicable Kazakhstan’s and the Eurasian Economic Union’s (EAEU) legislation governing medical and pharmaceutical activities and promptly update the clients of all the current and contemplated legislative changes relevant to businesses.

AEQUITAS maintains cooperation with the Association of International Pharmaceutical Manufacturers in the Republic of Kazakhstan, which gives its lawyers an opportunity to participate in the discussion and legal evaluation of draft laws relating to medical and pharmaceutical activities and to take into account the clients’ interests when developing the legislation improvement recommendations.

Services

• Advice on labeling (marking), advertising, registration and certification of medicines, medical products and medical equipment.
• Legal support to the importation of pharmaceutical products and medical equipment into the Kazakhstan territory, advice regarding counterfeit product control and parallel import using customs register mechanism.
• Advice on public procurement of medicines, medical products and medical equipment.
• Drafting and review of contracts related to the supply and distribution of medicines, medical products, medical equipment and dietary supplements, advertising of pharmaceutical products and medical services, including issues of antimonopoly regulation of pharmaceutical companies, pricing of medicines, customer relations, and other aspects of pharmaceutical activities.
• Drafting and review of internal corporate documents (including standard operating procedures) governing the specifics of pharmaceutical activities, including anticorruption and compliance procedures, in order to identify and prevent corruption risks and observe the rules for regulation and prevention of the conflicts of interests when doing business in the territory of Kazakhstan and the EAEU.
• Advice regarding licensing and obtainment of healthcare licenses.
• Advice and legal support in the registration, re-registration and amendment of registration dossiers for medicines, medical products, medical equipment and certain types of human-harmful products and substances.
• Advice and support in the verification of conformity (safety) of healthcare goods, work and services in the context of the national legislation of the Republic of Kazakhstan and supranational legislation of the EAEU.
• Advice and legal support in obtaining permits for advertising in healthcare field.
• Client representation in case of inspections by pharmaceutical control authorities and medical services control authorities.
• Law drafting and representation of pharmaceutical companies manufacturing medical products in the context of law-making initiatives.
• Trainings and seminars dedicated to regulatory, antimonopoly, anticorruption, labor, compliance and other matters conducted as per clients’ individual enquiries.