Pharmaceutical law, food supplements, and cosmetics
In the field of Pharmaceutical Law, we advise on:
- advertising of medicinal products, representing Clients in proceedings before the Chief Pharmaceutical Inspector, preparing agreements with advertising agencies, developing internal policy, conducting internal training for sales representatives;
- wholesale and retail trade in medicinal products, including in particular the preparation and evaluation of distribution agreements, the preparation of changes to the distribution system in order to apply the direct distribution model, the preparation of applications for wholesale authorisation or the operation of a pharmacy open to the public;
- activities which do not constitute advertising of medicinal products, including in particular educational campaigns and radio and television sponsorship;
- clinical trials, including, inter alia, the preparation of model contracts for the conduct of the clinical trial (tripartite: sponsor – researcher – centre and bilateral: sponsor – researcher, sponsor – centre), providing opinions on contracts, negotiating contracts with researchers and centres, preparing documentation related to the protection of personal data in clinical trials, supporting sponsors or CROs in discussions with the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and bioethical committees;
- parallel import, including, among others, assessment of compliance of conducted activities with the Pharmaceutical Law and the ECJ case law;
- manufacture of medicinal products, including, inter alia, the granting or modification of a manufacturing authorisation;
- wholesaler's DPD activities, legal support in case of inspections carried out by the Pharmaceutical Inspection;
- activity of pharmacies in the context of their advertising, representing the above entities before the Pharmaceutical Inspection;
- registration of medicinal products, including the legal aspects of the registration, the shortening or renewal of the marketing authorisation of a medicinal product, and data exclusivity issues.
In the field of dietary supplements, we provide assistance in the following areas:
- classification of products in the group of food supplements or other foodstuffs;
- providing opinion on the composition of the products, including any acceptable limits for vitamins, minerals and other substances with a nutritional or physiological effect;
- marketing of dietary supplements on the territory of the Republic of Poland, including the preparation and submission of notifications to the Chief Sanitary Inspector;
- labelling of foodstuffs with respect to the mandatory indications and health claims;
- investigation of product qualifications conducted by the Chief Sanitary Inspector, including preparation of applications for opinions to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products together with justification of product qualifications (we represent our Clients at their request);
- official food controls, including representation of Clients before competent authorities of the State Sanitary Inspection;
- advertising of foodstuffs with particular emphasis on nutrition and health claims, the opinion of leaflets and advertising campaigns.
We advise on:
- classification of products as medical devices and the assignment of the relevant class;
- labels for medical devices;
- placing medical devices on the market in the territory of the Republic of Poland for the first time, including in particular customer support in the scope of applications and notifications submitted to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;
- advertising of medical devices, including opinions on advertising leaflets;
- trade in medical devices and distribution diagrams;
- contracts for the manufacture and distribution of medical devices.
We advise on:
- classification of products in the group of cosmetics;
- notification obligations, including the preparation of applications for CPNP;
- labelling and advertising of cosmetics.