Pricing and reimbursement

Preparation of strategies in proceedings on setting or changing maximum prices, reimbursement amounts and conditions, including arranging technical materials for preparing strategies. Preparation of applications on setting or changing maximum prices, reimbursement amounts and conditions; conducting the actual administrative procedures and carrying out regular procedures

Legal services to M.D.

Preparation of agreements between the marketing authorisation holder and health insurance companies

Legal review of legal relationships in administrative proceedings for drug registrations, proceedings on setting, changing or abolishing maximum prices, reimbursement amounts and conditions

LEGAL services related to the registration process and pharmacovigilance

• Legal communications and resolution of any disputes with government authorities in the registration process
• Legal review of legal relationships in the administrative proceedings for drug registrations, proceedings on setting, changing or abolishing maximum prices, reimbursement amounts and conditions
• Preparation and review of contractual relationships on registration transfers
• Legal review of legal relationships in the production of medicinal products
• Legal review of legal relationships in drug research and clinical trials
• Preparation and review of contractual relationships with the investigator and health care facility in a clinical trial
• Legal review of legal relationships in prescribing and dispensing medicinal products
• Legal review of duties to pay drug registration maintenance fees
• Contractual relationships in clinical trials
• Preparation of agreements on securing pharmacovigilance duties
• Review of contractual relationships in the distribution of medicinal products
• Representation in punitive proceedings launched for violating the Drug Act, Act on Prices, Act on Medical Devices and Act on the Regulation of Advertising