Pharma Law

How we can help you:

• Analyse the position of pharmaceutical on the market and analyse potential competitors before the launch to market and business strategy.
• Analyse groups of pharmaceuticals in terms of payments from public health insurance, monitor in-depth and shortened reviews, analyse the prescription and conditions of payments, monitor the development in management and assessment for the process strategy of the participant in the proceedings, or post-review business strategy.
• Provide consultations in the area of prices and payments for pharmaceuticals and medical devices, namely consultations prior to filing the application for the determination or change in the maximum price or payment from the public health insurance, including the pharmaco-economics, and completion of the application; representation in administrative proceedings, including an appellate body/court.
• Provide comprehensive advisory in marketing and advertising (including the assessment of compliance with legal regulations or codes of ethics), relation between a producer and health insurers, professional associations, physicians, patients, business partners, etc.
• Represent your company in administrative proceedings initiated according to the Act on Advertising Regulation and the Act on Pharmaceuticals (eg, administrative torts, proceedings on the application for an extraordinary remedy, specific treatment programme, proceedings on determining the nature of products in case of doubt), including the appellate body/court.
• Provide regulatory compliance advisory, including assistance in internal and external audit reviews in the area of adherence to (legal, internal or ethical) rules, regulating the pharma industry.
• Correctly classify the product in legally regulated categories of medicinal products, medical devices, cosmetics, food supplements, etc. and advisory in follow-up activities, for example the method of the launch to market, registration/notification, advertising strategy, umbrella branding, etc.
• Provide advisory services in the area of good clinical, manufacturing, distribution or pharmaceutical practice (GCP, GMP, GDP, GPP), including a review or cooperation on the preparation of necessary documentation.
• Provide comprehensive services for pharmacies and distributors ranging from the registration to post-registration representation in relation to supervisory activities of administrative bodies (administrative torts, reporting obligations, etc.).